SOUTH SAN FRANCISCO, Calif., June 5 /PRNewswire-FirstCall/ -- Cell
Genesys, Inc. (Nasdaq: CEGE) today provides a recap of clinical data
reports from two GVAX(R) cancer immunotherapy programs that were presented
this past weekend at the 2006 American Society of Clinical Oncology (ASCO)
Annual Meeting being held in Atlanta, GA.
In the first oral presentation entitled, "A dose-escalation trial of
GM-CSF-gene transduced allogeneic prostate cancer cellular immunotherapy in
combination with a fully human anti-CTLA-4 antibody (MDX-010, ipilimumab)
in patients with metastatic hormone-refractory prostate cancer (HRPC),"
(Abstract #2500), Cell Genesys and collaborator, Medarex, Inc., presented
encouraging data from a Phase 1 clinical trial of the company's' GVAX(R)
immunotherapy for prostate cancer, administered in combination with
Medarex's fully human anti-CTLA-4 antibody, ipilimumab (MDX-010), in
patients with advanced prostate cancer. Twelve patients have been treated
to date, including six patients who received the combination therapy at the
therapeutic doses currently being evaluated in both GVAX and ipilimumab
Phase 3 clinical trials. Antitumor activity has been observed in five of
these six patients including reductions in prostate-specific antigen (PSA)
levels that are ongoing at two months or longer and qualify in all five
patients as partial responses (greater than 50% sustained reduction) by the
National Cancer Institute (NCI) Working Group criteria with two patients
having greater than 95% reductions. Moreover, clinical evidence of
antitumor activity has been observed in three of these five PSA responders,
including improvement of multiple lesions on bone scan, resolution of
abdominal lymph node disease by CT scan, and improvement in pain due to
bone metastases, respectively. In addition to these findings, four of the
six remaining patients who received the two lower doses of ipilimumab were
noted to have stable disease by PSA with at least two months of follow-up.
There have been no dose-limiting toxicities seen to date with the
combination therapy. All five patients with PSA partial responses have
experienced grade 2 or 3 immune-mediated endocrine deficiencies similar in
type to those previously reported with ipilimumab therapy which have been
successfully treated with standard hormone replacement therapy.
In the second oral presentation entitled, "K562/GM-CSF vaccination
reduces tumor burden, including achieving molecular remissions in chronic
myelogenous leukemia (CML) patients with residual disease on imatinib,"
(Abstract #6509), the company reported encouraging long-term follow-up data
from a Phase 2 trial of GVAX(R) immunotherapy for chronic myelogenous
leukemia (CML). A total of 19 CML patients with molecular evidence of
persistent leukemia following at least one year of Gleevec(R) (imatinib
mesylate) therapy were treated with GVAX immunotherapy while continuing to
receive Gleevec. Updated results show that the addition of GVAX
immunotherapy to Gleevec therapy reduced persistent leukemic disease in 10
of 19 patients as demonstrated by a complete disappearance (five patients)
or a greater than one log (90%) reduction (five patients) in bcr-abl -- a
validated genetic marker found on the leukemic cells. The new findings
reported today also show that with a median follow up from treatment
initiation of 14 months for all patients, the molecular responses are
ongoing in the five patients showing a one log or greater reduction in
bcr-abl. In addition, four of the 5 patients with a complete disappearance
of bcr-abl continue to have undetectable values at the most recent follow
up. Of the remaining 10 patients, only one patient has developed
cytogenetic progression on therapy and this patient had the highest level
of disease burden at study entry. To date all patients have tolerated
treatment well and completed the planned follow-up period.
Clinical trials of GVAX(R) cancer immunotherapies are under way for
multiple types of cancer including prostate cancer, pancreatic cancer, and
leukemia. These products are whole-cell immunotherapies which are designed
to stimulate an immune response against the patient's tumor. The products
are comprised of tumor cells that have been irradiated and genetically
modified to secrete GM-CSF (granulocyte-macrophage colony stimulating
factor), an immune stimulatory hormone which plays a key role in
stimulating the body's response to such immunotherapies. GVAX cancer
immunotherapies are being developed as non patient-specific,
"off-the-shelf" pharmaceutical products.
Cell Genesys is focused on the development and commercialization of
novel biological therapies for patients with cancer. The company is
currently pursuing two clinical stage product platforms - GVAX(R) cancer
immunotherapies and oncolytic virus therapies. Ongoing clinical trials
include Phase 3 trials of GVAX immunotherapy for prostate cancer, Phase 2
trials of GVAX immunotherapy for pancreatic cancer and leukemia, and a
Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer. Cell
Genesys continues to hold an equity interest in its former subsidiary,
Ceregene, Inc., which is developing gene therapies for neurodegenerative
disorders. Cell Genesys is headquartered in South San Francisco, CA and has
its principal manufacturing operation in Hayward, CA. For additional
information, please visit the company's website at
http://www.cellgenesys.com.
Statements made herein about the company, other than statements of
historical fact, including statements about the company's progress, results
and timing of clinical trials and preclinical programs and the nature of
product pipelines are forward-looking statements and are subject to a
number of uncertainties that could cause actual results to differ
materially from the statements made, including risks associated with the
success of clinical trials and research and development programs, the
regulatory approval process for clinical trials, competitive technologies
and products, patents, continuation of corporate partnerships and the need
for additional financings. For information about these and other risks
which may affect Cell Genesys, please see the company's Annual Report on
Form 10-K for the year ended December 31, 2004 filed on March 14, 2005 as
well as Cell Genesys' reports on Form 10-Q and 8-K and other reports filed
from time to time with the Securities and Exchange Commission. The company
assumes no obligation to update the forward-looking information in this
press release.
Contact: Ina Cu
Investor Relations
650-266-3200
SOURCE Cell Genesys, Inc.
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Related links:
http://www.cellgenesys.com/
CONTACT:
Ina Cu, Investor Relations, Cell Genesys,
Inc., +1-650-266-3200
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