domingo, 2 de octubre de 2011

Prime Minister Recognises Cancer As A National Health Priority: Cancerbackup Welcomes Cuts On Waiting Times, UK

In response to Prime Minister Gordon Brown's speech, Cancerbackup issues the following statement:


"The Prime Minister has shown today that cancer is one of his absolute priorities," says Joanne Rule Cancerbackup Chief Executive. "It is vital that treatment for cancer is started as soon as possible to ensure the best chance of survival, which is why we welcome today's announcements to reduce cancer waiting times and particularly treat all breast cancer cases as urgent.


"We know from a MORI poll carried out for Cancerbackup last year, that 76 per cent of the public believe that cancer is a national health priority, placing it way ahead of other illnesses. What we need now is for the Cancer Reform Strategy to be published soon and for it to include real targets."


Results of Cancerbackup's Ipsos MORI poll on cancer priorities


1. Cancerbackup is the only national charity that specialises in providing information on all types of cancer.


2. All Cancerbackup services are free to cancer patients, their relatives and friends.


3. Cancerbackup Freephone Information Service: 0808 800 1234 (Mon-Fri, 9am-8pm). Cancerbackup Centres can be found in St Bartholomew's Hospital, Charing Cross Hospital, the London Clinic, The Christie Hospital, Ipswich Hospital, Nottingham City Hospital, Coventry's University Hospital and Jersey. The charity's website can be found at cancerbackup


4. Cancerbackup, as a charity, receives 54% of its funding from individuals, 11% from charitable trusts, 5% from grants, 14% from companies, 2% from investments and 14% from its trading company. Pharmaceutical companies contributed 9% of the total 2005/06 income.


5. In April 2006 Cancerbackup changed its name from CancerBACUP, so that the charity's name better represents the service the charity provides: information, understanding and support to anyone affected by cancer.


cancerbackup

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Peptimmune Completes Phase I Study With A Novel Peptide Copolymer For The Treatment Of Multiple Sclerosis

Peptimmune, Inc. a privately
held biotechnology company, announced that it has completed its first
clinical trial to evaluate the safety, tolerability, pharmacokinetics and
pharmacodynamics of PI-2301, a novel peptide copolymer for the treatment of
multiple sclerosis and other autoimmune diseases.


The Phase I single ascending dose, double blind placebo controlled
randomized study involved 56 healthy volunteers who received the drug in
eight escalating dose cohorts. All doses were safe and well tolerated, and
there were no serious adverse events. Pharmacodynamic assays demonstrated
evidence of immune exposure consistent with the pharmacologic mechanism of
action for PI-2301, and dose related pharmacokinetics were observed. The
Company plans to initiate its first repeat dose study in multiple sclerosis
patients in Q2/2008.



"We are pleased to see that PI-2301 was well tolerated and that this
trial has provided evidence of single dose priming of healthy subjects.
This effect is important as repeated doses in multiple sclerosis patients
should lead to therapeutic immune modulation," stated Thomas P. Mathers,
President and CEO of Peptimmune. "We have designed PI-2301 to maximize the
therapeutic benefit of a proven, safe compound class in multiple sclerosis
as well as increasing patients' convenience."



PI-2301 is a second generation peptide copolymer from a similar
compound class as Copaxone(R) (Teva Pharmaceuticals). PI-2301 works through
immune modulation by enhancing the regulatory response of the immune system
to control the pathogenic autoimmune response in certain diseases. PI-2301
has been optimized using Peptimmune's novel platform peptide chemistry and
in pre- clinical studies, has shown to be more potent and effective than
Copaxone in treating disease models for multiple sclerosis. PI-2301 has
also shown efficacy in pre-clinical models of autoimmune diseases where
immune modulation may be effective, such as Crohn's disease, rheumatoid
arthritis and autoimmune uveitis. Peptimmune has also introduced highly
reproducible manufacturing methods that allow very strict control and
characterization of PI-2301 and should provide a superior level of batch to
batch consistency.



Over 400,000 Americans have multiple sclerosis (MS), and worldwide MS
may affect over 2.5 million individuals. MS is an autoimmune disease in
which the individuals' immune system responds against multiple components
of nerve- insulating myelin. The effects of these immune-mediated attacks
can range from relatively benign to somewhat disabling to devastating, as
communication between the brain and other parts of the body is disrupted.



About Peptimmune



Peptimmune, Inc. is a privately held clinical stage biotechnology
company focused on the development of peptide therapies to improve the
management of chronic autoimmune and inflammatory disorders. The Company is
in clinical development with second-generation therapeutics that are
expected to result in safer and more effective products for multiple
sclerosis and pemphigus vulgaris. Current investors include New Enterprise
Associates, MPM Capital, Hunt Ventures, Boston Medical Investors, Silicon
Valley Bank Capital, and Genzyme Corporation. For additional information,
access our website at peptimmune.


Peptimmune, Inc.

peptimmune



View drug information on Copaxone.

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Structure Of DNA Repair Complex Reveals Workings Of Powerful Cell Motor

Over the last years, two teams of researchers at The Scripps Research Institute have steadily built a model of how a powerful DNA repair complex works. Now, their latest discovery provides revolutionary insights into the way the molecular motor inside the complex functions - findings they say may have implications for treatment of disorders ranging from cancer to cystic fibrosis.



In a paper published in an Advance Online Edition of Nature Structural and Molecular Biology March 27, 2011, the scientists say that the complex's motor molecule, known as Rad50, is a surprisingly flexible protein that can change shape and even rotate depending on the task at hand.



The finding solves the long-standing mystery of how a single protein complex known as MRN (Mre11-Rad50-Nbs1) can repair DNA in a number of different, and tricky, ways that seem impossible for "standard issue" proteins to do, say team leaders Scripps Research Professor John Tainer, Ph.D., and Scripps Research Professor Paul Russell, Ph.D., who also collaborated with members of the Lawrence Berkeley National Laboratory on the study.



They say the finding also provides a critical insight into the ABC-ATPase superfamily of molecular motors, of which Rad50 is a member.



"Rad50 and its brethren proteins in this superfamily are biology's general motors," said Tainer, "and if we know how they work, we might be able to control biological outcomes when we need to."



For example, knowing that Rad50 changes its contour to perform a function suggests it might be possible to therapeutically target unique elements in that specific conformation. "There could be a new generation of drugs that are designed not against an active site, like most drugs now (an approach that can cause side effects, but against the shape the protein needs to be in to work," Tainer said.



Russell added, "Proteins are often viewed as static, but we are showing the moving parts in this complex. They are dynamic. They move about and change shape when engaging with other molecules."



First Responder



The MRN complex is known as a first-responder molecule that rushes in to repair serious double-strand breaks in the DNA helix - an event that normally occurs about 10 times a day per cell due to ultraviolet light and radiation damage, etc. If these breaks are not fixed, dangerous chromosomal rearrangements can occur that lead to cancer. Paradoxically, the complex also mends DNA breaks promoted by chemotherapy, protecting cells against cancer treatment.



When MRN senses a break, it activates an alarm telling the cell to shut down division until repairs are made. Then, it binds to ATP (an energy source) and repairs DNA in three different ways, depending on whether two ends of strands need to be joined together or if DNA sequences need to be replicated. "The same complex has to decide the extent of damage and be able to do multiple things," Tainer said. "The mystery was how it can do it all."
















To find out, Tainer, head of a structural biology group, and Russell, who leads a yeast genetics laboratory, began collaborating five years ago. With the additional help of team members at Lawrence Berkeley National Laboratory and its Advanced Light Source beamline, called SIBYLS, the collaboration has produced a series of high-resolution images of the crystal structure of parts of all three proteins (rad50, Mre11, and Nbs1), taken from fission yeast and archaea. The scientists also used the lab's X-ray scattering tool to determine the proteins' overall architecture in solution, which approximates how a protein appears in a natural state.



The scientists say that the parts of the complex, when imagined together as a whole unit, resemble an octopus: the head consists of the repair machinery (the Rad50 motor and the Mre11 protein, which is an enzyme that can break bonds between nucleic acids) and the octopus arms are made up of Nbs1 which can grab the molecules needed to help the machinery mend the strands.



In this study, Tainer and Russell were able to produce crystal and X-ray scattering images of parts of where Rad50 and Mre11 touched each other, and what happened when ATP bound to this complex and what it looked like when it didn't.



In these four new structures, they showed that ATP binding allows Rad50 to drastically change its shape. When not bound to ATP, Rad50 is flexible and floppy, but bound to ATP, Rad50 snaps into a ring that presumably closes around DNA in order to repair it.



"We saw a lot of big movement on a molecular scale," said Tainer. "Rad50 is like a rope that can pull. It appears to be a dynamic system of communicating with other molecules, and so we can now see how flexibly linked proteins can alter their physical states to control outcomes in biology."



"We thought ATP allowed Rad50 to change shape, but now we have proof of it and how it works," Russell said. "This is a key part of the MRN puzzle."



An Engine for Many Vehicles



Rad50 and ATP provide the motor and gas for a number of biological machines that operate across species. These machines are linked to a number of disorders, such as cystic fibrosis, which is caused by a defect in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which is a member of the ABC ATPase superfamily.



"Our study suggests that ABC ATPase proteins are used so often in biology because they can flexibly hook up to so many different things and produce a specific biological outcome," Tainer said.



Given this new prototypic understanding of these motors, Tainer and Russell envision a future in which therapies might be designed that target Rad50 when it changes into a shape that promotes a disease. For example, chemotherapy could be coupled with an agent that prevents the MRN complex from repairing DNA damage, promoting death of cancer cells.



"There are some potentially very cool applications to these findings that we are only beginning to think about," Russell said.


Notes:


Co-authors of the paper, "ABC ATPase signature helices in Rad50 link nucleotide state to Mre11 interface for DNA repair," include Gareth J. Williams, Soumita SilDas, and Michal Hammel of the Lawrence Berkeley National Laboratory; and R. Scott Williams, Jessica S. Williams, Gabriel Moncalian, Andy Arval, Oliver Limbo, and Grant Guenther of The Scripps Research Institute.



The study was funded by the National Cancer Institute, the National Institutes of Health, and the Department of Energy.



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Researchers At HIV/AIDS Vaccine Conference Discuss New Methods, Ongoing Trials

Researchers at the AIDS Vaccine 2008 conference in Cape Town, South Africa, last week examined how setbacks in developing a vaccine have "forced them to look for entirely new ways of creating a defense against the disease," AFP/Google reports. "We are in the middle of quite a profound shift of mindset in the research community," Alan Bernstein, director of the Global HIV Vaccine Enterprise, said at the conference, which ended on Friday. He added that setbacks have made researchers examine new research methods in the effort to develop an HIV/AIDS vaccine (Blandy, AFP/Google, 10/18).

Merck in September 2007 announced it had halted a large-scale clinical trial of its experimental HIV vaccine after the drug failed to prevent HIV infection in participants or prove effective in delaying the virus' progression to AIDS. The vaccine candidate also might have put some trial participants at an increased risk of HIV. Following news of the Merck vaccine, trials of NIH's Vaccine Research Center's HIV vaccine candidate were scaled back (Kaiser Daily HIV/AIDS Report, 10/16).

"The Merck result was such a surprise, and everyone was kind of shocked off their horses," Mitchell Warren of the AIDS Vaccine Advocacy Coalition said, adding, "What happened, no one could have predicted. They still don't understand exactly what happened. That finding forces people to realign and look at new ways and new approaches to how we are going to find an AIDS vaccine because it was so surprising." According to Warren, the results of the Merck trial have made researchers rethink assumptions about how vaccines work. "People are really grappling with new ways of doing things," he said.

About 30 clinical trials for vaccine candidates are under way worldwide, and the "most watched" is a study in Thailand that began in 2003, according to AFP/Google. Results from the trial are expected next year, and about 16,000 people are participating. According to some researchers, the trial will provide important information about HIV/AIDS whatever its outcome.

According to Bernstein, the most interesting new research into HIV/AIDS vaccines involves defenses in the body called the innate immune system. The innate immune system serves as an "early warning system for invading diseases," AFP/Google reports, and Bernstein said that the system could stop HIV if researchers determine a method of triggering it early. "We now know we may have only hours, at most days, before we have a window of opportunity to stop HIV," he said, adding, "So that's reason to think this early warning system might be critical to activate if we are going to design a vaccine" (AFP/Google, 10/18).


Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation.?  All rights reserved.


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EntreMed Commences Phase 2 Study With MKC-1 In Pancreatic Cancer

EntreMed, Inc.
(Nasdaq: ENMD), a clinical-stage pharmaceutical company developing
therapeutics for the treatment of cancer and inflammatory diseases,
announced that it has commenced a multi-center Phase 2 clinical trial with
MKC-1 in patients with advanced pancreatic cancer. The primary objectives
of this study will be to determine the antitumor activity of
orally-administered MKC-1 in unresectable or metastatic pancreatic cancer
patients who have failed at least one prior chemotherapy regimen. The study
will also assess the safety, tolerability and overall median survival time
of pancreatic cancer patients treated with MKC-1. Massachusetts General
Hospital Cancer Center is the lead institution for the study and Eunice
Kwak, M.D., Ph.D., Assistant in Medicine, Tucker Gosnell Center for
Gastrointestinal Cancers, will serve as the principal investigator.


MKC-1 is a novel, orally-active cell cycle inhibitor with in vitro and
in vivo efficacy against a broad range of human solid tumor cell lines,
including multi-drug resistant cell lines. Prior preclinical studies have
demonstrated that MKC-1 has significant antitumor activity as both a single
agent and in combination with an approved epidermal growth factor/epidermal
growth factor receptor (EGF/EGFR) inhibitor in pancreatic cancer models.
MKC-1 has also demonstrated broad-acting antitumor effects, including tumor
growth inhibition or regression, in multiple preclinical models. MKC-1 has
been shown to inhibit mitotic spindle formation, prevent chromosome
segregation in the M-phase (mitosis) of the cell cycle, and induce
apoptosis.



Carolyn F. Sidor, M.D., M.B.A., EntreMed Vice President and Chief
Medical Officer, commented on the study, "Pancreatic cancer patients
continue to need more effective and better tolerated treatment options.
MKC-1 has shown good activity in preclinical testing against pancreatic
tumors, supporting its use in this patient population. Positive results
from this clinical trial will provide the basis for designing future
randomized Phase 2 studies. With this clinical trial initiation, we are now
evaluating MKC-1 as a single agent or in combination in patients with
pancreatic cancer, metastatic breast cancer, non- small cell lung cancer
(NSCLC), and leukemia."



About Pancreatic Cancer



Pancreatic cancer is the abnormal cell growth in the tissue of the
pancreas. The pancreas is an organ about six inches in length which is
located behind the stomach, next to the small intestine. The pancreas
produces enzymes that aide in the digestion and absorption of food. Unless
pancreatic cancer is detected early, it is difficult to control. At the
present time, there is no effective screening for pancreatic cancer and,
because the pancreas is hidden by other organs, it is difficult to
diagnosis. Pancreatic cancer is the fourth leading cause of cancer death in
the United States. The American Cancer Society estimates that approximately
37,000 Americans will be diagnosed with cancer of the pancreas in 2007,
resulting in approximately 33,000 deaths.
















About EntreMed



EntreMed, Inc. is a clinical-stage pharmaceutical company developing
therapeutic candidates primarily for the treatment of cancer and
inflammation. Panzem(R) NCD (2-methoxyestradiol or 2ME2) is currently in
multiple Phase 2 clinical trials for cancer. MKC-1, an oral cell-cycle
regulator, is in multiple Phase 1 and 2 studies for cancer. ENMD-1198, a
novel tubulin-binding agent, is in Phase 1 studies in advanced cancers.
Panzem(R) is also in preclinical development for rheumatoid arthritis, and
ENMD-2076, a dual-acting Aurora-angiogenesis inhibitor, is in preclinical
development for cancer. EntreMed's goal is to develop and commercialize new
compounds based on the Company's expertise in angiogenesis, cell-cycle
regulation and inflammation -- processes vital to the treatment of cancer
and other diseases, such as rheumatoid arthritis. Additional information
about EntreMed is available on the Company's web site at entremed
and in various filings with the Securities and Exchange Commission.



Forward Looking Statements



This release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act with respect to the outlook
for expectations for future financial or business performance (including
the timing of royalty revenues and future R&D expenditures), strategies,
expectations and goals. Forward-looking statements are subject to numerous
assumptions, risks and uncertainties, which change over time.
Forward-looking statements speak only as of the date they are made, and no
duty to update forward-looking statements is assumed. Actual results could
differ materially from those currently anticipated due to a number of
factors, including those set forth in Securities and Exchange Commission
filings under "Risk Factors," including risks relating to the need for
additional capital and the uncertainty of additional funding; variations in
actual sales of Thalomid(R), risks associated with the Company's product
candidates; the early-stage products under development; results in
preclinical models are not necessarily indicative of clinical results,
uncertainties relating to preclinical and clinical trials; success in the
clinical development of any products; dependence on third parties; future
capital needs; and risks relating to the commercialization, if any, of the
Company's proposed products (such as marketing, safety, regulatory, patent,
product liability, supply, competition and other risks).


EntreMed, Inc.

entremed

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The 45th Annual Meeting Of The American Society Of Clinical Oncology

The following are based on abstracts or posters to be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida, May 29 - June 2, 2008.



Abstract # 9075, 8 a.m. to noon on Monday, June 1, 2009

Antiparasitic drug is promising in animal studies of metastatic melanoma



Seth J. Orlow, M.D., Ph.D., the Samuel Weinberg Professor of Pediatric Dermatology and chairman of the Ronald O. Perelman Department of Dermatology and professor of cell biology and pediatrics.



A drug used to treat parasitic infections shows early promise in animal studies as a potential treatment for metastatic melanoma. Researchers from NYU Langone Medical Center report that the orally administered drug, mebendazole, inhibited the growth and progression of human melanoma tumors grafted in mice. The researchers observed in the animals a 72 percent reduction in tumor volume, the inactivation of a key protein that normally promotes melanoma survival and a concomitant 81 percent increase in cancer cells that were programmed to die. The researchers are now planning a clinical trial to investigate the appropriate dosing of the drug, a first step toward assessing the drug's effectiveness in patients with metastatic melanoma.



Abstract # 9006, 1:30 p.m. on Saturday, May 30, 2009

MicroRNAs may aid in prognosis of metastatic melanoma



Eva Hernando-Monge, Ph.D., assistant professor of pathology

Iman Osman, M.D., associate professor of dermatology and urology and director of the Interdisciplinary Melanoma Cooperative Group

Miguel F. Segura, Ph.D., postdoctoral fellow



Ongoing research at the NYU Cancer Institute suggests that micoRNA - a genetic element that controls protein-coding genes - may be useful as a biomarker for melanoma. In the latest study, levels of a specific group of microRNAs were associated with longer survival among patients with metastatic melanoma and among those whose cancer has recurred after treatment. Researchers analyzed single-stranded RNA molecules in cancer tissue samples at various sites in the body, including the brain and lymph nodes, from 59 metastatic melanoma patients. Higher levels of 18 specific miRNAs were associated with surviving more than 18 months. The researchers are evaluating whether 10 of these co-called "protective" miRNAs identified in the study can help predict the likelihood of surviving 18 months after cancer recurrence and whether these miRNAS may help predict the aggressiveness of the disease in earlier stages of melanoma.



Abstract # 9044, 8 a.m. to noon on Monday, June 1, 2009

Blood-based marker may be tied to poor melanoma prognosis



Iman Osman, M.D., associate professor of dermatology and urology and director of the Interdisciplinary Melanoma Cooperative Group
















Higher levels of a protein found in the blood may be associated with a poor prognosis in melanoma patients. Researchers at the NYU Cancer Institute found that HU177, a connective tissue protein, was associated with a subset of melanoma patients with a poor prognosis. The study involved 209 patients whose serum levels of the protein were measured at the time of diagnosis. Thirty-eight of the 209 (18%) patients developed recurrences, and 34 of these patients subsequently died during the+ follow-up period of the study. Median follow-up time for survivors was 54.9 months, ranging from two to 81 months. The chances of staying free of cancer after a particular treatment, as well as the likelihood of survival over a certain period of time, were associated with higher serum levels of the protein. The correlation occurred even when other prognostic factors, such as tumor thickness and histology, were taken into account.



Abstract # 11034, Sunday, May 31, 2009, 2 p.m. to 6 p.m.

Overexpression of an oncogene linked to worse melanoma prognosis



Iman Osman, M.D., associate professor of dermatology and urology and director of the Interdisciplinary Melanoma Cooperative Group



Researchers at the NYU Cancer Institute present preliminary evidence that overabundant expression of an oncogene called Skp2 was associated with a worse melanoma prognosis. The activity of this gene was also linked to organs in the body where melanoma had spread. The study measured Skp2 protein levels in 122 metastatic melanoma specimens taken from patients' tissues. It found that increased Skp2 was associated with lower survival during a three-year period after recurrence.



Abstract # 11019, Sunday, May 31, 2009, 2 p.m. to 6 p.m.

Potential biomarker for early stage lung cancer



Jessica Donnington, M.D., assistant professor of cardiothoracic surgery



NYU Langone Medical Center researchers report that a protein in the blood appears to be a promising tool for monitoring early stage lung cancer. In a small study, they found higher levels of an extracellular structural protein called osteopontin (OPN) in patients with early stage non-small cell lung cancer compared to current or former smokers, and they also found that the levels decreased among patients who had undergone lung cancer surgery. The study involved 60 patients with early stage lung cancer, 56 current or former smokers, 78 patients with lung cancer advanced enough to be considered pre-operative and another matched group who had already undergone surgery. The researchers say the findings warrant further investigations of this biomarker in the early stages of this form of lung cancer.



Abstract #2017, Saturday, May 30, 2009. 8 a.m. to 1 p.m.

Drug may increase survival in brain cancer patients



Michael Gruber, M.D., clinical professor of neurology and neurosurgery

Shahzad Raza, M.D., clinical research associate in the department of radiation oncology

Ashwatha Narayana, M.D., associate professor of radiation oncology



Bevacizumab is a cancer treatment approved by the FDA to treat advanced or metastatic colorectal, lung, and breast cancers, and relapsed malignant glioblastoma, a form of brain cancer. A small study by researchers at NYU Cancer Institute suggests the drug may have a role in treating patients with newly diagnosed glioblastoma. The treatment, which inhibits tumor growth by blocking the formation of new blood vessels, was given to 24 glioblastoma patients who also received radiation and concomitant chemotherapy; another 31 patients received similar treatments but without bevacizumab. The group receiving bevacizumab lived longer during and after treatment without their disease worsening - half of the patients lived without their disease worsening a median of 12 months, compared to seven months in the non-bevacizumab group. One- and two-year overall survival rates were 85 percent and 50 percent, respectively, in the bevacizumab group compared to 74 percent and 22 percent in the other group. The researchers say that the results are encouraging and the drug merits testing in a phase III study.



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Allsup Outlines Five Critical Issues For Caregivers Preparing To Take On Financial And Healthcare Responsibilities, USA

Each year millions of individuals suffer a sudden or progressive impairment that makes it difficult or impossible for them to make sound financial and healthcare decisions on their own, according to Allsup, which offers services that support the financial well-being and health of individuals with disabilities. Stepping in for these individuals are caregivers, generally family or friends who don't have professional financial consulting experience. In addition, these caregivers now are in the very serious role of making critical decisions for the individual they've agreed to care for.



"The most important thing caregivers can do is to educate themselves on their responsibilities once they've taken on this role," said Paul Gada, an attorney and personal financial planning director of the Allsup Disability Life Planning Center . "It's not easy and can be further complicated by the emotional involvement the caregiver often has with the person they're caring for, be it a spouse, parent, other close relative or friend.



"It's also important, however, that caregivers recognize they are not alone and that they seek help when they need it," Gada added.



Having committed to be a caregiver, there is a lot of work that will need to be done. Following, Allsup outlines five crucial first steps.



Secure power of attorney



A power of attorney for property provides a caregiver the legal authority to make decisions about and exercise control of various assets and transactions. A healthcare power of attorney, directive or proxy allows an individual to designate someone to make decisions about their healthcare, including carrying out an individual's wishes about whether or not to use artificial life support (sometimes provided for separately in a living will document).



Most state governments and state bar associations offer a statutory template of these forms that can be pulled from their Web sites. Many hospitals and healthcare organizations also can provide individuals with the health-related forms.



While someone can designate the power of attorney for financial matters to one person and healthcare power of attorney to another, it's often simpler and avoids conflicts to have one person take on both roles.



"Inevitably, when you begin talking about someone's healthcare, financial matters come into play. So you want to designate someone you can trust who will be able to look at the whole picture," said Gada.



Healthcare power of attorney forms generally follow a similar format. However, a power of attorney for property and finances can be set up in various ways. These include:



- A durable power of attorney. This is effective immediately and remains in effect should the grantor (the person that is granting power of attorney) become disabled. It allows the agent (the individual the grantor has designated to act on his or her behalf) to make decisions about property and finances as outlined in the power of attorney document without the grantor's advanced approval.
















- A springing power of attorney. This only becomes effective if and when a person becomes disabled. Only then can the agent begin making decisions about the grantor's property and finances.



- A nondurable power of attorney. This limits the agent's authority to a specific situation or type of legal action for a limited time period, and it ceases to be effective should the grantor become disabled. It is commonly used for buying or selling real estate or allowing an agent to deposit or withdraw funds from the grantor's bank account.



Some individuals may fear they are giving up control by granting an agent durable power of attorney as the agent can immediately take control and begin making decisions. However, a springing power of attorney can present a problem if there is a disagreement between healthcare providers and family members regarding when the individual granting power of attorney became disabled or incompetent.



"As a caregiver with power of attorney, you are acting on another person's behalf," said Gada. "You want to make sure that you have a very clear understanding of what the individual you are caring for wants and that you truly are committed to acting in their best interest."



Gather and organize records



Caregivers should make certain that they have a copy of any power of attorney and living will, plus have secured access to other important legal and medical documents, including the individual's will or trust documents.



Other important financial information to gather includes:



??? Bills, including utilities, household maintenance payments, medical fees, etc.

??? Deeds, mortgage papers and ownership statements

??? Loan agreements

??? Medical records

??? Stock and bond certificates and statements

??? Pension, 401(k) and other retirement benefit statements

??? Bank and brokerage account information

??? Insurance policies, including long-term disability, healthcare, home, auto, etc.

??? Social Security payment information if Social Security or Social Security disability already has been secured

??? Pay stubs if the individual was working prior to the impairment

??? State and federal income tax returns



"Just as you do with your own financial records, as a caregiver you want to set up a system so that you can keep track of all the important documents of the individual for whom you are caring. Remember, you really are stepping into their shoes. You are responsible for making sure you know where things are and what needs to be done when," said Gada.



Create a financial profile and budget



The caregiver needs to understand the individual's financial circumstances. This means getting a handle on the resources available, or assets (e.g., home, investments, life insurance contracts, etc.) and liabilities (e.g., loans, mortgage, credit card debt, etc.).



Also, the caregiver likely will need to establish a monthly budget. This requires understanding income (e.g., from a long-term disability insurance policy, Social Security, investments or other resources) and expenses. As with any budget, this will need to be adjusted as circumstances change, but it's an important roadmap for ensuring that assets are available to support the individual, or recognizing where there are shortfalls so additional resources can be sought if possible.



"Many working adults don't set up monthly budgets. So long as the money coming in is far more than the money going out or needed for savings, this lack of planning can work," Gada said. "But when you're dealing with an individual that has a disability that is likely increasing their healthcare costs and keeping them from ever returning to full-time work, good planning is essential."



Depending on the individual's resources, the caregiver may want to consult with a professional financial advisor. Various financial software and online tools also can help caregivers determine a budget and monitor income and expenses, including free resources offered as part of Allsup's Financial Matters site.



Identify income resources



An individual with a severe disability generally will be relying on insurance payments for all or part of their future income. Approximately three in 10 workers is covered by a private long-term disability policy.



A caregiver should determine if the individual they are caring for has a long-term disability policy and, if so, what the qualifications and restrictions are for collecting on the policy. Examples include how soon the policy begins offering income, offsets to that income and when the policy expires (in some cases at age 65). Also, some policies include a Social Security rider, which requires that the individual apply for Social Security Disability Insurance (SSDI) in order to comply with the long-term disability insurer's requirements.



Most individuals who have worked are eligible for SSDI. To qualify, a person must have worked and paid into the program for five of the last 10 years; been disabled before reaching full-retirement age (65-67) and meet Social Security's definition of disability. The Social Security Administration (SSA) uses a process called sequential evaluation to determine who receives benefits.



Any caregiver responsible for securing SSDI benefits should understand that it's a complex and time-consuming process and can take several years to complete. Organizations like Allsup, however, can facilitate the SSDI application process and ensure the individual begins receiving SSDI benefits as quickly as possible.



"Two-thirds of SSDI applications are rejected and the average time it now takes, from initial application through appeals, to get an award is two to four years. Given all the responsibilities a caregiver has, getting help from a representative reduces the burden substantially," said Gada.



Determine health insurance coverage



If the individual was employed immediately before becoming disabled, the caregiver may look into helping him or her secure COBRA coverage. COBRA coverage can continue for up to 18 months after employment ends. This may be extended by an additional 11 months if an individual is awarded SSDI benefits.



"While these plans can be costly, they can be an essential financial planning component for individuals unable to get any other insurance and facing mounting healthcare costs while awaiting Medicare eligibility," said Gada.



Caregivers also need to be aware that after receiving SSDI benefits for 24 months, an individual - regardless of their age - is eligible for Medicare, including hospital, medical benefits and prescription drug plans. Just as important is understanding the different options available and which plans are best based on the individual's particular circumstances.



"Not all Medicare plans are created equal and people often opt for the traditional plan thinking it's the 'safe' choice. But for people with disabilities, Medicare Advantage plans often are the optimal choice: you can't be turned away for coverage due to a pre-existing condition, they usually cost less than a traditional Medicare and supplemental plan combined, and most Medicare Advantage plans include prescription drug coverage," explained Gada.



About Allsup


Allsup, Belleville, Ill., is a leading nationwide provider of financial and healthcare related services to people with disabilities. Founded in 1984, Allsup has helped more than 100,000 people receive their entitled Social Security Disability Insurance and Medicare benefits. Allsup employs more than 500 professionals who deliver services directly to consumers and their families, or through their employers and long-term disability insurancecarriers.


Allsup

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Do Women With Silicone Breast Implants Need Follow-Up MRI Scans?

The U.S. Food and Drug Administration currently recommends regular follow-up magnetic resonance imaging (MRI) scans for women with silicone breast implants. But a new review shows significant flaws in the evidence supporting this recommendation, reports the March issue of Plastic and Reconstructive Surgery®, the official medical journal of the American Society of Plastic Surgeons (ASPS).


Because of these scientific limitations, the available data may overestimate the ability of MRI to detect ruptured breast implants-particularly when scans are performed for screening purposes in symptom-free women. The study was led by Dr. Jae W. Song of University of Michigan, Ann Arbor.


Review Questions Diagnostic Value of Screening MRI Scans


The researchers reviewed 21 studies evaluating MRI and/or ultrasound to detect rupture of silicone breast implants. Although the FDA recommends MRI, some physicians prefer ultrasound for screening purposes.


The combined data suggested that MRI was fairly accurate in detecting implant-related problems. However, it was much more likely to detect problems in women with implant-related symptoms: 14 times more likely than in women without symptoms. Even in a mixed "screening sample"-consisting of some women with and some without symptoms-the detection rate was twice as high as in asymptomatic women.


Because most of the women in the studies had symptoms, the true accuracy of MRI for detecting implant-related problems in asymptomatic women was likely much lower. For ultrasound, reported accuracy rates varied widely.


Silicone breasts implants have been extensively studied due to concerns about possible adverse health effects. Based on reports linking ruptured implants to autoimmune diseases, the FDA banned silicone implants in 1992. The ban was lifted in 2006, when repeated studies failed to confirm the association with autoimmune diseases.


However, the FDA recommended that women undergo regular MRI scans in the years after surgery to screen for implant rupture. Given that more than 1.25 million American women have received silicone implants, it's important to evaluate the evidence that MRI is an effective screening test.


The study raises important questions about the accuracy of MRI scanning, especially in women without symptoms. Beyond the issue of accuracy, the authors note that screening tests are generally performed to detect diseases with serious consequences-whereas the health risks associated with ruptured silicone implants, if any, are still unknown.


The researchers also note that in reported cases of implant rupture, the average age of the implants is over 10 years. Dr. Song and coauthors write, "[T]he benefits of screening within the first 10 years are unclear, and the effectiveness of such a screening program warrants further investigation." Further studies are also needed to evaluate the long-term health effects of ruptured silicone breast implants, the effectiveness of MRI or other screening tests, and the costs of and patient preferences for screening.


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Understanding The Migration Of Cancer Cells

Lamellipodia are veil-shaped protrusions of the plasma membrane, that can turn into upward-curled ruffles if they fail to adhere to the substrate. A dendritic meshwork of short and highly branched actin filaments might constitute their main structural component. The other type of protrusion, the filopodia, are finger-like and consist of parallel, long and unbranched actin filaments. Interestingly, fast-crawling cells mainly form lamellipodia/ruffles while poorly migrating or non-motile cells often show the coexistence of both lamellipodial and filopodial protrusions. These observations suggest that the lamellipodia-to-filopodia selection might regulate cell migration. Moreover, the pivotal contribution of lamellipodial and filopodial protrusions to important developmental and homeostatic processes certainly requires tight regulatory mechanisms.



Unfortunately, while the microscopic morphology, dynamic development and protein signature of both lamellipodia/ruffles and filopodia have been investigated, little is known about the mechanisms whereby cells co-ordinate these actin-based extensions. Therefore, we urgently need to better understand this basic process to ultimately increase our therapeutic intervention arsenal against the metastatic progression of cancers.



It is known that the activity of regulatory proteins for the growth of the actin cytoskeleton Arp2/3 complex along with WAVE and mDia2 produce a burst of actin polymerization required for the formation of lamellipodia/ruffles and filopodia, respectively. In the forthcoming issue of Nature Cell Biology Metello Innocenti and coworkers report that, starting from the unexpected observation that mDia2, WAVE and Arp2/3 form a complex, they discovered how filopodia extensions are generated and integrated with lamellipodia/ruffles in human cancer cells. At the molecular level, WAVE and Arp2/3 jointly promote lamellipodia/ruffles outgrowth and cell migration and at the same time inhibit mDia2-dependent filopodia formation. Moreover, emission of filopodia occurs only after the disassembly of the mDia2-WAVE-Arp2/3 complex. Thus, it is likely that suppression of filopodia by the ruffling-making machinery is needed for cancer cells to move efficiently.



Their results pave the way to a cogent molecular analysis of the interplay between lamellipodia/ruffles and filopodia in regulating both the migratory and invasive abilities of cancer cells. The researchers anticipate that new and more specific therapies to counteract cancer will be developed exploiting these exciting findings.







Contact: Metello Innocenti


Goethe University Frankfurt


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Paclitaxel Poliglumex (OPAXIO(TM)) Added To Cisplatin And Radiation Produces 45% Pathologic Complete Remissions In Patients With Esophageal Cancer

Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced that, in a study released from Brown University at the 2009 American Society for Clinical Oncology (ASCO) Annual Meeting, patients with cancer of the lower esophagus had evidence of a high pathological complete response ("CR") rate when given OPAXIO, a biologically enhanced paclitaxel, in addition to cisplatin and full-course radiotherapy.


Concurrent chemotherapy with 50.5 Gy of radiation is the standard pre-surgical therapy for patients with potentially resectable, locally-advanced esophageal cancer. Although the addition of chemotherapy to radiation is beneficial, the cure rate for esophageal cancer is low. Standard neoadjuvant treatment for esophageal cancer uses a regimen of cisplatin, and fluorouracil (5-FU) chemotherapy with concurrent radiation, a regimen associated with a 15% to 17% pathologic CR rate (complete elimination of the cancer in the surgical specimen) and a high incidence of Grade 3-4 toxicity to the upper gastrointestinal track necessitating prophylactic insertion of feeding tubes. Published preclinical studies have demonstrated that, unlike standard paclitaxel and other chemotherapeutic agents that enhance radiation killing by a factor of 1.5 to 2.0, OPAXIO increases tumor specific radiation cell kill by a factor of 7.2 to 8.4 -fold (Milas Luka et al, Poly(L-glutamic acid)-paclitaxel conjugate is a potent enhancer of tumor radiocurability, Int'l J. Radiat. Oncol. Biol. Phys. 55(3), 707-12 (2003)).


The Brown University Oncology Group lead by Dr. Howard Safran published preliminary data on their phase II trial in the ASCO proceedings. In this study, which follows their earlier report of a phase IB trial (Dipetrillo,Thomas et al, Am. J. Clin. Oncol. 4:376-9 (2006)), patients with pathologically confirmed, locally advanced adenocarcinoma or squamous cell carcinoma of the esophagus or gastro-esophageal junction with no evidence of distant metastasis received weekly paclitaxel poliglumex (50mg/m2) and cisplatin 25mg/m2 for six weeks with concurrent 50.5Gy of radiation. Twenty-three eligible patients were enrolled at the time of abstract submission. Five of the first 11 patients (45%) who underwent resection had a pathologic complete response. A prophylactic feeding tube was not routinely used. Grade 3-4 toxicity in the first 15 patients included dehydration (n=5), loss of appetite (n=5), esophagitis/dysphagia (n=4), nausea (n=2) and weight loss (n=1). The authors concluded that these preliminary data suggest paclitaxel poliglumex may provide enhanced radiation sensitization as compared to standard therapy. Accrual is continuing on this study.


"We are very encouraged by these preliminary phase II results. Patients who have a pathologic CR in most historical studies have had a major survival advantage over those patients with lesser responses. These interesting preliminary findings in an ongoing study indicate that paclitaxel poliglumex may be a uniquely active and selective radiosensitizing therapeutic. Most importantly, patient tolerability appears improved over standard therapy with 5-FU and cisplatin due to the lower incidence of severe gastrointestinal toxicity. It is likely that this is due to the selective accumulation of paclitaxel poliglumex in tumor tissue with continual slow release of the active agent, paclitaxel," noted Jack Singer, M.D., Chief Medical Officer at CTI.















CTI plans to explore with the U.S. Food and Drug Administration (the "FDA") a potential U.S. phase III registration strategy for paclitaxel poliglumex in this indication given the high pathologic CR rates being reported in this study combined with the lower than expected gastrointestinal and other severe toxicities.


About OPAXIO(TM)


OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which was formerly known as XYOTAX(TM), is an investigational, biologically enhanced, chemotherapeutic that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue's exposure to high levels of unbound, active chemotherapy and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that OPAXIO is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing the paclitaxel chemotherapy. Preclinical and clinical studies support that OPAXIO metabolism by lung cancer cells may be influenced by estrogen, which could lead to enhanced release of paclitaxel and efficacy in women with lung cancer compared to standard therapies.


About Cell Therapeutics, Inc.


Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.


This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of OPAXIO include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with OPAXIO in particular, including, without limitation, the potential for OPAXIO to be proved safe and effective (or to achieve response rates) for the treatment of the indications noted in this press release or any other indication, determinations by regulatory, patent and administrative governmental authorities, the possibility that the FDA will not approve a phase III registration strategy for paclitaxel poliglumex if proposed by CTI, CTI's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, and costs of developing, producing and selling OPAXIO. You should also review the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.


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New Review Suggests Caution On Drugs To Raise "Good" Cholesterol

With 40 percent of all heart attacks and related cardiovascular problems occurring in people who have low levels of so-called "good" cholesterol, researchers have long sought medications to increase the amount of this type of cholesterol in the body's circulation.


But a new review of 31 randomized controlled trials published in the Journal of the American Medical Association suggests that so far, only modest evidence supports the use of most medications to raise levels of high-density lipoprotein (HDL) good cholesterol. Some are even harmful.


The authors concluded that while efforts to lower low-density lipoprotein (LDL or "bad cholesterol") "have consistently reduced cardiovascular disease risk, HDL-based approaches are much more complex and sometimes disappointing." As a result, "the primary focus should be on LDL," said review co-author Mehdi Shishehbor, D.O., of the Cleveland Clinic.


"The news is that not everything that raises HDL will be beneficial," said Ronald Krauss, M.D., spokesman for the American Heart Association and director of atherosclerosis research at Children's Hospital Oakland Research Institute in California.


"HDL is a much more complicated issue than LDL," said Prediman Shah, M.D., director of the Atherosclerosis Research Center at Cedars-Sinai Medical Center in Los Angeles. "It's not only important how much HDL there is, but what kind it is. Quality is as important as quantity. Is the function good or is it [a form of HDL] that doesn't do the job properly?"


There are many types of HDL, not all of which nurture the heart and blood vessels. The good kinds seem to carry fat out of arteries to the liver and perform functions in cell membranes and elsewhere. However, HDLs vary considerably in size, density and other chemical properties that change their ability to sustain health.


Certain kinds of HDL could even increase inflammation, clogging arteries rather than clearing them, and doctors currently do not have a simple way to tell this "bad" type of "good" cholesterol from the genuinely beneficial kind in their patients. Right now, only expensive tests used in research settings can sort this out.


Fortunately, lifestyle changes can help without negative side effects, according to the review. "The safest way to raise HDL is by weight loss, exercise and smoking cessation," Shishehbor said.


The review also found support for moderate alcohol use one or two drinks a day for men, one for women although physicians do not recommend that nondrinkers take up drinking to protect their hearts. Raising HDL by eating fish or taking fish oil to increase intake of omega-3 fatty acids is another effective strategy, the review suggested.


As for pharmacological approaches, the review found that the most effective currently available drug to raise HDL is the vitamin niacin, taken in high doses. "Statins, niacin and fibrates are available pharmacologic agents that increase HDL; however, they may be associated with adverse side effects," said Shishehbor, who recommended close medical supervision.















At least one-third of patients cannot tolerate high-dose niacin, according to Shah. "The most common side effect is flushing and itching that drives some people nuts." He said methods exist to minimize the problem, but they do not work for everyone.


Meanwhile, new medications have proved disappointing. Trials of one drug, torcetrapib, ended abruptly because the drug increased mortality risk and raised blood pressure. The class of diabetes drugs called thiazolidinediones (which include Avandia and Actos) increase HDL, but also seem to raise the risk of cardiovascular problems.


The once highly touted weight-loss drug rimonabant, which blocks the brain receptors activated by marijuana, does raise HDL; however, the U.S. Food and Drug Administration recently refused to approve it because it also seems to elevate risk for psychiatric problems like depression.


"I'm much more excited about the prospect of what's coming in this area in the next three to five years," said Shah, who is studying approaches to boosting HDL that use different mechanisms from those that have been associated with problems. Clinical trials of a gene therapy based on his research are currently under way.


"Despite the recent negative HDL trials, this field is extremely exciting and the pace of discovery is unbelievably fast," Shishehbor said. At least one other drug with a novel mechanism of action is also in trials and at least three other approaches have led to new drugs in the pipeline.


People with blood levels of HDL lower than 35 mg/dL have eight times the risk of heart disease compared to those with 65mg/dL or more. Some 16 percent to 18 percent of men have low levels, compared with 3 percent to 6 percent of women.


Singh IM, Shishehbor ME, Ansell BJ. High-density lipoprotein as a therapeutic target. JAMA 298(7), 2007.


Health Behavior News Service

Center for the Advancement of Health 2000 Florida Ave. NW, Ste 210

Washington, DC 20009

United States

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'Is Dark Chocolate Good For You?'

Volunteers are to have chocolate delivered to their homes and be encouraged to eat 50g of it every day for eight weeks as part of a new research study.



Researchers at Queen's University Belfast, funded by Northern Ireland Chest, Heart & Stroke and the NI Research and Development Office, are to study 110 people with high blood pressure for the opening stage of a three-year project starting in August.



The aim is to discover if a high fruit and vegetable diet incorporating dark chocolate and berries - which are all rich in important compounds called polyphenols - is better for the cardiovascular system than a diet low in fruit and vegetables.



Dr Pascal McKeown from Queen's School of Medicine, Dentistry and Biomedical Sciences who is leading the study, said: "The important thing to stress is that the chocolate we will be using will be very high in cocoa - at least 70 per cent. Standard milk chocolate has nothing like the polyphenol content of dark chocolate.



"One group of patients will be put on a low polyphenol diet - probably the average UK diet, since most people tend to eat only two portions of fruit and vegetables per day. Another group will be encouraged to eat six portions of fruit and vegetables, including one portion of berries, each day, together with the 50g of dark chocolate. We will examine people's blood vessel health and the stickiness of their blood at the start and end of the study to discover whether a diet rich in polyphenols can reduce the risk of developing heart disease."



Andrew Dougal, Chief Executive of NI Chest, Heart & Stroke (NICHS), said: "This is a great example of high quality research which has the potential to benefit first and foremost the people of Northern Ireland, but also has applications further afield. We hope it will provide a solid evidence base for fine-tuning the government's advice on healthy eating."



NICHS has provided funding of ??32,000 for the project. One of the researchers, Dr Rebecca Noad, has also secured a Fellowship award from the Department of Health's Research and Development Office.



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First Patient Treated In BioInvent's Phase I Study Of The Drug Candidate BI-505 To Treat Multiple Myeloma

BioInvent International AB (STO:BINV) announced that the first patient has been treated in an open, dose-escalation phase I study of the company's antibody BI-505 for patients with advanced multiple myeloma.


"We are delighted that the clinical studies of BI-505 have started. We believe that BI-505 can address a major unmet medical need and be an important treatment alternative for multiple myeloma."


The phase I study will investigate safety, pharmacokinetics and pharmacodynamics and will aim to define the optimal dose of the antibody for upcoming clinical phase II development. The study will involve 30 - 40 patients. The patients will be treated with intravenous doses of BI-505 every other week for a 28-day period with the possibility of extending the treatment until the condition deteriorates again. The study will be conducted at clinics in the US and will be overseen by renowned multiple myeloma experts.


Last year the US Food & Drug Administration (FDA) approved BioInvent's application to conduct a clinical trial with BI-505 in the US. BI-505 has also been granted orphan drug designation in the US and Europe for multiple myeloma.


BI-505 is a human antibody derived from BioInvent's proprietary n-CoDeR® library based on its ability to bind to a tumour-associated receptor (the adhesion molecule ICAM-1) and induce programmed cell death (apoptosis) in tumour cells. Preclinical studies have shown that the substance also activates the body's own (Fc:Fc gamma receptor dependent) anti-tumour mechanisms and fights cancer more effectively than existing drugs.


Svein Mathisen, CEO of BioInvent, commented: "We are delighted that the clinical studies of BI-505 have started. We believe that BI-505 can address a major unmet medical need and be an important treatment alternative for multiple myeloma."


Source

BioInvent International AB

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ONGLYZA™ (saxagliptin) Launched In The UK For The Treatment Of Type 2 Diabetes

Bristol-Myers Squibb Company and AstraZeneca announced the launch of ONGLYZA™ (saxagliptin) in the UK for the treatment of Type 2 diabetes in adults, as add-on therapy with metformin, a thiazolidinedione or a sulphonylurea.


In an extensive clinical trial programme saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor (more commonly known as a gliptin), was shown to improve glycaemic control, with no increased risk of side-effects such as weight gain and hypoglycaemia (hypos), associated with other commonly-used oral diabetes treatments such as sulphonylureas. This was assessed by reductions against all key measures of glucose control; HbA1c, post prandial glucose (PPG) and fasting plasma glucose (FPG).


Anthony Barnett, Professor of Medicine, Consultant Physician and Clinical Director of Diabetes and Endocrinology at Heart of England NHS Foundation Trust, UK commented, "The launch of saxagliptin as a new treatment option for Type 2 diabetes in the UK is good news for both patients and clinicians. It comes at a time of change for Type 2 diabetes management in the UK with HbA1c and QOF targets having recently been reduced from ?‰¤7.5% to ?‰¤7.0% for the majority of patients and also the recent recommendations from NICE for a target HbA1c of 6.5% for the first two treatment steps. Treatments such as saxagliptin, which provide additional glycaemic control with no increased risk of hypoglycaemia, have the potential to make a real difference in helping patients reach recommended glycaemic targets."



There are currently at least 2 million people living with Type 2 diabetes in the UK. Many of these currently experience poor glycaemic control and as such are failing to reach target HbA1c levels, whilst at the same time experiencing side-effects such as hypoglycaemia and weight gain as a result of their treatment. A recent study has shown that 39% of patients taking sulphonylureas have experienced mild hypoglycaemia. Hypoglycaemia is associated with a reduced quality of life, reduced treatment satisfaction and reduced treatment adherence.



Gwen Hall, Diabetes Nurse Specialist and Clinical Educator, Surrey PCT commented, "It is clear that hypoglycaemia, a side effect associated with some of the therapies used to treat Type 2 diabetes, is relatively common and can affect an individual's quality of life. People hate having hypos and risk poor control of their diabetes to prevent them. We now have a range of therapies available to treat Type 2 diabetes and need to help people make informed choices about their medication, including those which have no increased risk of hypoglycaemia while maintaining effective control of their blood glucose levels."



The launch of saxagliptin follows marketing authorisation on 5 October 2009 by the European Medicines Agency (EMEA). The decision was reached after the Committee for Medicinal Products for Human Use (CHMP) reviewed data from a comprehensive clinical development programme that included six core Phase III trials which assessed the safety and efficacy of saxagliptin as a once-daily therapy. These involved 4,148 patients with Type 2 diabetes, including 3,021 patients treated with saxagliptin.-
















In a joint statement, Frederic Duchesne, General Manager, Bristol-Myers Squibb UK and Dr Guy Yeoman, Medical Director, AstraZeneca UK commented, "The launch of saxagliptin in the UK, the first market to launch in Europe, represents a significant step forward for the Bristol-Myers Squibb and AstraZeneca diabetes collaboration as we work towards becoming a key partner in the diabetes community. Saxagliptin will provide another option for the many people with Type 2 diabetes who are not achieving optimal disease control with the current treatments available."


About Gliptins


Gliptins are a class of compounds that work by preventing the breakdown of natural hormones, incretins, which are released by the gut after food. Incretins decrease elevated blood glucose by increasing insulin production in the pancreas and decreasing glucagon secretion.



About Saxagliptin


Saxagliptin is indicated as a once-daily 5mg dose in adult patients with Type 2 diabetes to improve glycaemic control:


- in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;


- in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate; or


- in combination with a thiazolidinedione, when the thiazolidinedione alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate.-



About Type 2 Diabetes


Type 2 diabetes is a chronic disease in which the body does not produce or properly use insulin. Type 2 diabetes is associated with long-term complications that affect almost every part of the body. The disease may lead to blindness, heart and blood vessel disease, stroke, kidney failure, amputations and nerve damage.



HbA1c is a measurement of a person's average blood glucose level over a two-to-three month period and is considered an important marker of long-term glucose control. Other important markers for Type 2 diabetes include fasting plasma glucose (FPG), a measure of a person's blood glucose after at least eight hours of fasting, and postprandial glucose (PPG), a measure of a person's blood glucose after a meal.



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Bristol-Myers Squibb and AstraZeneca


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GTx Presents Bone Turnover Marker Data And Additional PSA Progression Safety Analysis For Toremifene 80 Mg Phase III ADT Clinical Trial

GTx, Inc. (Nasdaq: GTXI) presented a safety analysis demonstrating that fewer men treated with toremifene 80 mg had PSA progression over time compared to placebo in the Phase III clinical trial evaluating toremifene 80 mg for the treatment of multiple serious side effects of androgen deprivation therapy (ADT) for advanced prostate cancer. These data, as well as an additional analysis of bone turnover markers and fracture risk, were presented at the 2008 Annual Meeting of the American Society for Bone and Mineral Research in Montreal, Canada.


Among men in the intent-to-treat population with a detectable PSA (PSA ?‰? 1 ng/ml) at baseline (n=419), significantly fewer men treated with toremifene 80 mg had PSA progression over time compared to men taking placebo (27% versus 37%, respectively; p < 0.05). This subgroup analysis is consistent with the recommendations of the Prostate Cancer Clinical Trials Working Group to measure prostate cancer progression in clinical studies. In another analysis among men with an undetectable PSA (PSA < 1 ng/ml) at baseline (n= 698), there was no difference in PSA progression in men treated with toremifene 80 mg compared to men taking placebo.


"These new safety data are consistent with the mechanism of action observed in other studies evaluating toremifene, which have demonstrated inhibition of prostate growth in animal models, as well as in our Phase IIb clinical trial evaluating toremifene for the prevention of prostate cancer," said Mitchell S. Steiner, MD, Chief Executive Officer of GTx.


"In men with advanced prostate cancer, PSA is a sensitive marker of progression and is followed closely by physicians and patients to monitor the underlying cancer," Dr. Steiner continued. "It is encouraging to find that in our Phase III clinical trial in men with advanced prostate cancer on ADT, who have castrate levels of testosterone and estrogen, toremifene 80 mg treatment resulted in fewer men with detectable PSA at baseline demonstrating PSA progression over time when compared to placebo."


Additional data from the study were also highlighted during the presentation. An efficacy analysis studied changes in three serum markers of bone turnover: C-telopeptides, bone specific alkaline phosphatase (bALP), and osteocalcin. Changes in the three markers were further evaluated among men in the trial who experienced a new morphometric vertebral fracture. The analysis of these data show:


- Increases in C-telopeptides serum levels were associated with a significantly greater risk for the development of a new morphometric vertebral fracture (p < 0.01).


- Increases in bALP serum levels were associated with risk for new morphometric vertebral fracture (p < 0.01).















- Changes in osteocalcin serum levels were similar to those observed for other serum markers, but did not reach statistical significance.


About the toremifene 80 mg Phase III ADT clinical trial


The two year double-blind, placebo-controlled, randomized study of 1,389 ADT patients, was conducted at approximately 150 clinical sites in the United States and Mexico. The primary endpoint was new morphometric vertebral fractures. Other key secondary endpoints included bone mineral density, lipid changes, hot flashes, and gynecomastia.


Safety


Toremifene 80 mg was well tolerated. Among the most common adverse events that occurred in over 2% of study subjects were joint pain (treated 7.3%, placebo 11.8%), dizziness (treated 6.3%, placebo 5.0%), back pain (treated 5.9%, placebo 5.2%), and extremity pain (treated 5.0%, placebo 4.4%). Venous thromboembolic events (VTE), which included both deep venous thrombosis and pulmonary embolism, were 2.4% in the toremifene 80 mg treated group and 1.02% in the placebo group. The majority of VTEs occurred in men at high risk for a VTE including: age greater than 80 years, history of VTE, recent surgical procedure and immobilization. Excluding high risk patients over the age of 80 years and with a history of VTEs, the VTEs were 1.3% in the toremifene 80 mg treated group and 1.0% in the placebo group (p=0.38). There was no difference in strokes, myocardial infarctions, or deaths between the two groups.


About GTx


GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules that selectively target hormone pathways to treat cancer, osteoporosis and bone loss, muscle wasting and other serious medical conditions. GTx is developing toremifene citrate, a selective estrogen receptor modulator, or SERM, in two separate clinical programs in men: first, a completed pivotal Phase III clinical trial evaluating toremifene 80 mg for the treatment of serious side effects of androgen deprivation therapy for advanced prostate cancer, and second, an ongoing pivotal Phase III clinical trial evaluating toremifene 20 mg for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia, or PIN. In 2006, GTx and Ipsen Group entered into a development and collaboration agreement for toremifene in all indications except breast cancer for Europe and the Commonwealth of Independent States (CIS). GTx will file for marketing approval and, if approved, plans to commercialize toremifene 80 mg in the United States. In December 2007, GTx and Merck & Co., Inc. formed a collaboration to discover and develop selective androgen receptor modulators (SARMs), a new class of drugs with the potential to treat sarcopenia, which is the loss of skeletal muscle mass resulting in reduced physical strength and ability to perform activities of daily living, cancer cachexia (muscle wasting), as well as other musculoskeletal conditions. Merck and GTx are conducting several Phase I and Phase II clinical trials evaluating multiple SARM product candidates including Ostarine(TM) (also designated as MK-2866) for sarcopenia. Ostarine is also in a Phase II clinical trial for cancer cachexia which will be completed in 2008. Merck and GTx are evaluating additional muscle loss indications for potential SARM clinical development. GTx also is developing its preclinical compounds, GTx-758, an oral LH inhibitor for advanced prostate cancer, and GTx-878, an estrogen receptor beta agonist for the treatment of benign prostatic hyperplasia and chronic prostatitis. gtxinc


Forward-Looking Information is Subject to Risk and Uncertainty


This press release contains forward-looking statements based upon GTx's current expectations. Forward-looking statements involve risks and uncertainties. GTx's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risks that (i) GTx and its collaboration partners will not be able to commercialize their product candidates if clinical trials do not demonstrate safety and efficacy in humans; (ii) GTx may not able to obtain required regulatory approvals to commercialize product candidates; (iii) clinical trials being conducted by GTx and its collaboration partners may not be completed on schedule, or at all, or may otherwise be suspended or terminated; and (iv) GTx could utilize its available cash resources sooner than it currently expects and may be unable to raise capital when needed, which would force GTx to delay, reduce or eliminate its product development programs or commercialization efforts. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release. GTx's quarterly report on Form 10-Q filed August 5, 2008 contain under the heading, "Risk Factors," a more comprehensive description of these and other risks to which GTx is subject. GTx expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

GTx, Inc.

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Church Street Associated Dental Centers Reached More Than 16,000 Children During National Children's Dental Health Month

Church Street Health Management (CSHM) announced that more than 16,000 children nationwide received free dental screenings or oral health education during National Children's Dental Health Month in February.


Free screenings and community events were held throughout the month by caregivers from CSHM's associated network of more than 70 dental clinics in 22 states across the country as part of the company's Healthy Child, Happy Smile Day.


"Every day we see the impact that dental disease has on children and families," said Michael G. Lindley, Chairman and CEO of CSHM. "Unfortunately, tooth decay adversely affects children and families from low-income populations for a variety of reasons - the most dramatic being a lack of access to care. At CSHM associated centers, we strive to provide children and families with a lifelong dental home where they can get everything from preventative education to restorative treatment and advanced care such as orthodontics."


Now in its third year, Healthy Child, Happy Smile Day and supporting community outreach initiatives focus on providing free dental screenings as well educating children and parents about brushing and flossing, good nutrition habits and the importance of regular dental visits.


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Keeping It Cool Across The Globe

Losing hair during chemotherapy is a devastating effect of cancer treatment and serves as a constant reminder to the life threatening disease, but Paxman Ltd's cooling systems reduce the risk of hair loss; improving patient's self confidence and enabling them to retain their dignity.



Paxman Ltd's next generation hair loss prevention systems - Orbis I & II - aim to minimise patient distress with figures showing that on average 70-90% of patients who use the system do not require a wig.



The company will be at MEDICA this month - the largest healthcare trade show in the world - offering their self esteem raising solutions to a worldwide audience.


Cooling the scalp during chemotherapy means that less of the chemotherapy drug reaches the hair follicles so the hair is less likely to fall out; reducing distress for the patient at an already traumatic time and enabling them to have the confidence to live an unrestricted life.


Former patient, Debbie Wolfe, said: "My illness would have been 100% more difficult for me if I had not used the system. I wouldn't have felt confident enough to go out as much and my life would have taken longer to get back to normal."


Made from lightweight, silicone tubing, the scalp cooling cap itself is soft and flexible - providing a snug yet comfortable cap during treatment.



Moulding to all head shapes and sizes, liquid coolant passes through the cap extracting heat from the patient's scalp, ensuring the scalp remains at an even, constant temperature; minimising hair loss.



The caps are worn 30 minutes before the start of chemotherapy, during the treatment itself and for a period of time after infusion of the chemotherapy depending on the toxicity of the drugs.



With straightforward programming and controls, including recommended cooling time guides, the new compact system is uncomplicated and easy to understand for both medical staff and patients.



The Paxman system is available in two models. Orbis I provides cooling for a single patient and is suitable for a small chemotherapy suite or private bed, whilst the Orbis II provides cooling for one or two patients simultaneously with each cap working independently.



The systems are used all over the world and Paxman are travelling to Medica this month to speak to current and potential distributors across the globe.



Richard Paxman, Operations Director, said: "Preserving self esteem during chemotherapy leads to a more positive attitude to treatment and gives patients a rare light in a dark time of their lives. We're passionate about providing help to patients around the world and hope Medica will allow us to offer the solution to thousands more patient's worldwide."




To meet with Paxman Coolers at MEDICA or for further information on their products, please visit their website paxman-coolers.



MEDICA is the largest medical technologies fair in the world and will be taking place between 17-20th November at the Messe D??sseldorf. Throughout the show Paxman will be located on the UK Pavilion, hall 16 stand G10.



Notes


More information about Paxman Coolers


Cancer chemotherapy affects rapidly dividing cells and at any given time, 90% of human hair follicles are in the actively dividing phase. Hair loss frequently occurs due to partial or total atrophy of the hair root bulb, causing constriction of the hair shaft, which then breaks off easily.


Cooling the scalp during selected chemotherapy regimes has been shown to reduce or prevent otherwise inevitable total hair loss.


Other systems based on this principle utilise packs of crushed ice and frozen gel caps. These have the disadvantage of being uncomfortable, heavy to wear and are applied to the scalp at an unbearable temperature of -25°C which heats rapidly when in contact with the scalp, and perhaps more important however is the application and monitoring aspect, which is very time consuming for nursing staff.


Thermocircular systems utilised a cold cap of circulating glycol in the past as long ago as 1982. Paxman Coolers have applied the same principles using modern technology to produce the Paxman Scalp Cooler. A system that works, is user friendly, is a cost effective way to reduce the need to supply wigs, and has been accepted by doctors, nursing staff and patients alike. Previous problems associated with cold therapy treatments have been eliminated.


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Santarus Initiates Phase I Clinical Study With SAN-300

Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, announced that it has initiated a Phase I clinical study with SAN-300, its anti-VLA-1 antibody. The randomized, placebo-controlled, blinded, single-center, single-dose, dose-escalation study is being conducted in Australia in a total of approximately 60 subjects, including healthy volunteers and two cohorts of patients with rheumatoid arthritis. The objectives of the study are to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of SAN-300. The company expects to complete this Phase I clinical study with SAN-300 in the first half of 2012.


"We believe SAN-300 represents a novel approach to autoimmune and inflammatory disease therapy with potential applicability in multiple diseases, including rheumatoid arthritis, inflammatory bowel disease, psoriasis and organ transplantation," said Santarus president and chief executive officer Gerald T. Proehl.


Santarus senior vice president of clinical research Mark C. Totoritis, M.D., said, "SAN-300 targets a major collagen receptor, VLA-1 (?±1??1 integrin), and has shown activity in multiple preclinical models of inflammation. This integrin, a cell adhesion molecule, plays a key role in the migration, retention and proliferation of activated T cells and monocytes at sites of chronic inflammation."


Santarus acquired the exclusive worldwide rights to SAN-300 in September 2010, through the acquisition of closely held Covella Pharmaceuticals, Inc., and a related amended license agreement with Biogen Idec. The anti-VLA-1 antibody was initially developed by Biogen Idec and licensed to Covella in January 2009.


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HIV/AIDS Treatment Specific To Each Patient Moves Closer To Reality

An innovative treatment for HIV patients developed by McGill University Health Centre researchers has passed its first clinical trial with flying colours. The new approach is an immunotherapy customized for each individual patient, and was developed by Dr. J-P. Routy from the Research Institute of the MUHC in collaboration with Dr. R. S?©kaly from the Universit?© de Montr?©al. "This is a vaccine made for the individual patient - an "haute couture" therapy, instead of an off-the-rack treatment" said Dr Routy.



By "priming" the immune system, as with a vaccine, to fight the specific strain of HIV/AIDS infecting a given patient, the scientists believe they have developed a therapy that shows immense promise and could be an even more effective weapon against the virus than the anti-retroviral cocktails currently in use. The results of the first-stage clinical trials, which tested the therapy in conjunction with anti-retroviral drugs, were published recently in Clinical Immunology. Phase 2 of the clinical trial, which is nearly complete, is testing the therapy's efficacy on its own at 8 different sites in Canada.



The new therapy uses dendritic cells which are removed from each HIV-infected patient and subsequently multiplied in-vitro. Dendritic cells present material from invading viruses on their surface, allowing the rest of the immune system to identify and attack the invaders. "They are the "grand conductors" of the immune response," explains Dr Routy. "With them, you push the immune system, in all its functions, at the same time." In the current trial, dendritic cells were exposed to a sample of HIV RNA (ribonucleic acid) specific to the patient involved. This exposure encouraged the cells to develop defences specific to that viral strain. The modified cells - called AGS-004 - were then injected back into the patients.



Not only were there few reported side-effects from the AGS-004, but the researchers also measured increased levels of CD8-lymphocytes in the patients - the "attack" cells of the human immune system that the treatment is intended to mobilize, thus confirming that the intervention was targeted and controlled.



By boosting the immune system in this way, Routy hopes to develop an HIV/AIDS treatment that will require fewer injections and less long-term toxicity for patients than antriretrovirals.



Dr. Jean-Pierre Routy is a practitioner in the Division of Hematology at the MUHC as well as a researcher in the Infection and Immunity Axis at the Research Institute of the MUHC. He is also an Associate Professor of Hematology at McGill University in addition to a senior clinical researcher with the Fonds de la Recherche en Sant?© du Qu?©bec (FRSQ).



Funding: This study was funded by a grant from the Canadian Network for Vaccines and Immunotherapeutics (CANVAC), the Canadian HIV Trials Network (CTN), the National Institutes of Health (NIH) and Argos Therapeutics.



Partners: This article was co-authored by Rafick-Pierre S?©kaly, Universit?© de Montr?©al, Mohamed-Rachid Boulassel of the McGill University Health Centre (MUHC), Bader Yassine-Diab and Oleg Yegorov of the Universit?© de Montr?©al and Centre Hospitalier de l'Universit?© de Montr?©al (CHUM), Lothar Finke, Don Healey, Renu Jain, Tamara Monesmith ,Charles Nicolette and Irina Tcherepanova of Argos Therapeutics, In, Durham, USA.



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Researchers Find How A Common Genetic Mutation Makes Cancer Radiation Resistant

Many cancerous tumors possess a genetic mutation that disables a tumor suppressor called PTEN. Now researchers at Washington University School of Medicine in St. Louis have shown why inactivation of PTEN allows tumors to resist radiation therapy.


The PTEN gene produces a protein found in almost all tissues in the body. This protein acts as a tumor suppressor by preventing cells from growing and dividing too rapidly. Mutations in PTEN are frequently found in prostate cancer and endometrial cancer, melanoma and certain aggressive brain tumors.


Tumors with PTEN mutations are often resistant to radiation therapy, and Tej K. Pandita, Ph.D., a researcher with the Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital, and his colleagues have been trying to find out why. That information could enable researchers to develop drugs that overcome that resistance and increase the effectiveness of radiation treatments.


In an article to be published July 15, 2009, in the journal Cell Cycle and now available online, they demonstrate that PTEN-deficient cells have defective checkpoints. As cells grow and divide, they pass through several phases. Checkpoints operate during each phase and assess whether a cell is healthy enough to continue growing and dividing. If not - for example, if there is damage to genetic material resulting from radiation treatments signals from checkpoints should tell the cell to wait until repairs are made or should induce the cell to die.


The finding that checkpoints are affected in PTEN-deficient cells is contrary to some previous research, which had suggested instead that cells with PTEN mutations had defective DNA repair mechanisms. But Pandita showed that DNA repair is independent of PTEN function in tumor cells grown in the laboratory. That indicated that defective DNA repair is not the cause of the unstable genomes frequently seen in PTEN-deficient tumor cells and not the explanation for radiation resistance in these tumors.


"The defective checkpoints contribute to radioresistance," says Pandita, associate professor of radiation oncology and of genetics. "When a cell gets damaged by radiation, normally checkpoints will make it stop growing to repair the damage. If the checkpoints are working but the cell has a defective DNA repair system, the cell will be radiosensitive. But if the checkpoints don't operate, the cell can bypass DNA repair and continue to grow and divide. Then the cells are radioresistant."


The results indicate that to increase radiation sensitivity in tumors with PTEN mutations it will be necessary to develop drugs that correct for the faulty checkpoint processes, Pandita says. Work continues in the laboratory to further unravel the details of the checkpoint system and its role in radiation therapy resistance.


Gupta A, Yang Q, Pandita RK, Hunt CR, Xiang T, Misri S, Zeng S, Pagan J. Jeffrey J, Puc J, Kumar R, Feng Z, Powell SN, Bhat A, Yaguchi T, Wadhwa R, Kaul SC, Parsons R, Khanna KK, Pandita TK. Cell cycle checkpoint defects contribute to genomic instability in PTEN deficient cells independent of DNA repair. Cell Cycle. 2009 July 15;14(8):1-13.


Funding from National Institutes of Health supported this research.


Washington University School of Medicine's 2,100 employed and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children's hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked third in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children's hospitals, the School of Medicine is linked to BJC HealthCare.


Siteman Cancer Center is the only federally designated Comprehensive Cancer Center within a 240-mile radius of St. Louis. Siteman Cancer Center is composed of the combined cancer research and treatment programs of Barnes-Jewish Hospital and Washington University School of Medicine. Siteman has satellite locations in West County and St. Peters, in addition to its full-service facility at Washington University Medical Center on South Kingshighway.


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