domingo, 2 de octubre de 2011

ViaCell Announces Completion Of CB001 Phase I Clinical Trial

ViaCell, Inc.
(Nasdaq: VIAC) today announced that it has enrolled and treated the last
patient in the CB001 Phase I clinical trial and has begun the 100-day
post-transplant follow-up. CB001 is an investigational therapy being
studied as a potential therapeutic option for people who need stem cell
transplants, such as bone marrow, for hematopoietic recovery after
chemo-radiation therapy or chemotherapy in the treatment of a variety of
blood cancers. The Phase I clinical trial is a safety study of CB001 using
stem cells that have been isolated from umbilical cord blood and expanded
using ViaCell's proprietary expansion technology. Ten patients received
treatment in the study. A preliminary data review indicates that there were
no infusion toxicity events related to CB001. ViaCell expects to announce
top-line results from the Phase I clinical trial in the fourth quarter of
2006 and, if positive, the Company intends to advance the product into a
Phase II clinical trial.


Umbilical cord blood stem cells are an important source of
hematopoietic cells and often the preferred source of stem cells for
transplants, especially in children. A single umbilical cord blood unit is
generally too small to be suitable to treat an adult patient. CB001
consists of donor cord blood stem cells expanded using ViaCell's Selective
Amplification technology, a proprietary approach to control and optimize
growth of the stem cell population.


"There is an important medical need for patients who are unable to find
a suitable bone marrow donor and we believe an expanded umbilical cord
blood derived stem cell product has the potential to be a therapeutic
alternative," said Marc D. Beer, President and Chief Executive Officer of
ViaCell. "We are pleased to have completed the treatment phase of this
study and look forward to reporting results later this year."


The Phase I clinical trial is primarily designed to evaluate safety in
patients with advanced hematologic cancers in need of a hematopoietic stem
cell transplant and who are unable to find a suitable bone marrow donor.
Patients requiring this type of therapy are typically very sick with few
therapeutic options. Patients participating in the study receive CB001 plus
a standard cord following full myeloablative therapy. Patients are followed
for 100 days post-transplant. ViaCell also expects to generate preliminary
data on the clinical activity of CB001 including rate and durability of
blood and immune system reconstitution. Additional background information
on the clinical trial protocol is available online at clinicaltrials.



About ViaCell


ViaCell is a biotechnology company focused on enabling the widespread
use of human cells as medicine. The Company is developing a pipeline of
proprietary stem cell product candidates intended to address cancer,
cardiac disease, and diabetes. CB001, its lead cord blood derived stem cell
therapy product candidate, is being developed for hematopoietic stem cell
transplantation in patients affected by a variety of cancers. In addition
to its therapeutic development programs, ViaCell's reproductive health
business commercializes ViaCord(R), a product that offers expecting
families the option of preserving their baby's umbilical cord blood. The
Company is working to leverage its commercial infrastructure and product
development capabilities by developing ViaCyte(SM), its investigational
product intended to broaden reproductive choices for women through the
cryopreservation of human unfertilized eggs. ViaCell is headquartered in
Cambridge, Massachusetts with a processing and storage facility in Kentucky
and additional research and development operations in Singapore. Additional
information about ViaCell is available online at viacellinc.















This press release contains forward-looking statements regarding the
potential for CB001 and the possibility of advancing to Phase II trials if
the Phase I data is positive. Such statements are based on management's
current expectations, and are subject to a number of risks and
uncertainties which could cause actual results to differ materially from
the Company's current expectations. There is no assurance that the Company
will advance CB001 into Phase II clinical trials or be successful with
development efforts. The Company may decide that the data from the Phase I
clinical trial does not warrant further clinical development or requires
changes in the program that cause there to be a need for additional
preclinical testing or another Phase I clinical trial. Later stage clinical
trials of CB001 may fail to show the desired safety and efficacy. The
Company may also encounter other unexpected technical, regulatory or
manufacturing hurdles and issues. For example, the FDA may view CB001 made with an improved Selective Amplification process as sufficiently different
from the product candidate being used in our current Phase 1 clinical trial
so as to warrant a new Phase 1 clinical trial. The Company may need to
repeat trials for CB001 to incorporate new procedures such as
mini-transplants. Repeating clinical trials for any reason would
significantly delay the Company's development efforts related to CB001.
Drug development involves a high degree of risk. For more information on
the risks and uncertainties associated with the Company and its products
and programs, see the factors set forth under the heading "Risk Factors" in
the Company's report on Form 10-Q for the quarter ending March 31, 2006,
which is on file with the Securities and Exchange Commission and which
factors are incorporated herein by reference. ViaCell does not undertake
any obligation to update forward-looking statements.


ViaCell(R) and ViaCord(R) are federally registered trademarks and
ViaCyte(SM) is a service mark of ViaCell, Inc.


ViaCell, Inc.

viacellinc

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