SOUTH SAN FRANCISCO, Calif. and PRINCETON, N.J., June 4
/PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE) and Medarex,
Inc. (Nasdaq: MEDX) today announced follow-up data from the ongoing Phase 1
clinical trial in patients with advanced prostate cancer receiving Cell
Genesys' GVAX immunotherapy for prostate cancer administered in combination
with ipilimumab (MDX-010), a fully human anti-CTLA-4 antibody that is being
jointly developed by Medarex and Bristol-Myers Squibb Company. The new data
reported today includes median follow-up of 18 months on the first twelve
patients enrolled in the trial, as well as immunologic and biochemical
analyses of the effects of the combination treatment. These data were
presented over the weekend by Winald Gerritsen, M.D., Ph.D., director of
the University Hospital Vrije Universiteit Cancer Center in Amsterdam, at
the annual meeting of the American Society of Clinical Oncology (ASCO)
being held in Chicago, IL.
In the ongoing Phase 1 combination therapy trial of GVAX immunotherapy
for prostate cancer and ipilimumab, twelve patients with advanced prostate
cancer have completed the combination regimen to date. Of the six patients
who have received the two highest doses, antitumor activity has been
observed in five patients, including prostate-specific antigen (PSA)
declines of greater than 50% that were maintained in four of these patients
for at least six months, with the longest response to date at approximately
16 months. Clinical evidence of antitumor activity has been observed in
four of these five PSA responders, including complete resolution of
multiple lesions on bone scan in two patients, and resolution of abdominal
lymph node disease by CT scan and improvement in bone pain in one patient
each. The five patients with PSA declines experienced either Grade 2 or 3
immune-mediated endocrine deficiencies similar in type to those previously
reported with ipilimumab therapy, and were successfully treated with
standard hormone replacement therapy. Importantly, the PSA declines could
not be consistently correlated with declines in adrenal androgens and there
was no induction of the alpha-21-hydroxylase auto-antibody that is seen in
90% of cases of auto-immune adrenal insufficiency. Two patients requiring
thyroid replacement therapy were successfully tapered off after recovery of
thyroid function, with one patient subsequently maintaining a PSA response.
One patient who received the highest dose of ipilimumab tested in the trial
developed a Grade 3 dose-limiting pulmonary alveolitis that responded to
steroid treatment. Immunomonitoring studies showed that the combination
therapy enhanced T cell and dendritic cell activity, which was more
pronounced at the higher dose levels. Evaluation of antibody responses
shows that the combination therapy can induce antibody responses to a broad
array of previously identified cancer-associated antigens including PSMA,
NY-ESO-1 and filamin-B, and that these responses were patient-specific with
respect to the pattern of antibodies detected in different patients.
"We continue to be encouraged by the frequency and durability of both
PSA and bone scan responses observed in the first twelve patients on this
trial, and look forward to the evaluation of the additional patients
currently being enrolled on this trial," stated Rob Dow, M.D., chief
medical officer of Cell Genesys. "We continue to believe that the clinical
evidence of antitumor activity seen in this combination immunotherapy trial
provides further support for our ongoing Phase 3 trials of GVAX
immunotherapy for prostate cancer."
"We are pleased with the data so far and look forward to analyzing
further data as additional patients enroll in the study," said Geoffrey M.
Nichol, M.B.Ch.B., senior vice president, Product Development at Medarex.
The ongoing Phase 1 combination therapy trial of GVAX immunotherapy for
prostate cancer and ipilimumab is expected to enroll a total of
approximately 25 to 30 patients with metastatic, hormone-refractory
prostate cancer (HRPC). The dose for GVAX immunotherapy for prostate cancer
is the same dose currently being tested in Cell Genesys' VITAL-1 Phase 3
trial. The dose for ipilimumab was escalated in sequential groups of three
patients and has now reached dose levels associated with therapeutic
activity. Additional patients are currently enrolling at a dose level at
which therapeutic effects have been seen.
About GVAX immunotherapy for prostate cancer
GVAX immunotherapy for prostate cancer is currently being studied as a
single agent and in combination with docetaxel chemotherapy in two Phase 3
clinical trials expected to enroll approximately 1200 patients with
metastatic HRPC. Cell Genesys received Special Protocol Assessments (SPA)
from the Food and Drug Administration (FDA) for each of the Phase 3 studies
and has also received Fast Track designation for the product. Cell Genesys'
ongoing Phase 3 program is designed to demonstrate an improvement in
survival for GVAX immunotherapy for prostate cancer and is supported by
consistent median survival results from two, independent, multi-center
Phase 2 clinical trials (median survival of 34.9 months and 35.0 months,
respectively, for the patients who received doses comparable to the Phase 3
dose), results that compare favorably to the previously published median
survival of 18.9 months for metastatic HRPC patients treated with
Taxotere(R) (docetaxel) chemotherapy plus prednisone, the current standard
of care. GVAX immunotherapy for prostate cancer is comprised of two
prostate cancer cell lines that have been modified to secrete GM-CSF
(granulocyte-macrophage colony stimulating factor), an immune stimulatory
hormone, and irradiated for safety. GVAX cancer immunotherapy for prostate
cancer is being developed as a non patient-specific, "off-the-shelf"
pharmaceutical product.
Clinical Trials Information for GVAX:
Patients seeking information about clinical trials of GVAX
immunotherapy for prostate cancer can obtain information by calling
1.800.648.6747 ext. 3210, and also by checking http://www.clinicaltrials.gov
(keyword: GVAX) and by visiting the company's website at
http://www.cellgenesys.com.
About Ipilimumab
Ipilimumab (also known as MDX-010) is a fully human antibody against
human CTLA-4, a molecule on T cells that is believed to be responsible for
suppressing the immune response. Medarex and Bristol-Myers Squibb are
investigating the potential of ipilimumab to enable the immune systems of
cancer patients to help suppress tumor growth. Ipilimumab is currently in
three separate registrational studies for metastatic melanoma as a
second-line monotherapy treatment, as a first-line treatment in combination
with dacarbazine, and as a second-line treatment in combination with a
melanoma-peptide vaccine. Ipilimumab is also involved in multiple Phase II
clinical trials to investigate the product's potential activity in other
tumor types, as well as in combination studies with chemotherapy,
immunotherapy and vaccines. Further information regarding the Medarex
ipilimumab program can be found in Medarex's public disclosure filings with
the U.S. Securities and Exchange Commission (SEC).
Clinical Trials Information for Ipilimumab:
For study enrollment information, in the United States and Canada
contact 1-866-892-1BMS Ext. 342 or http://www.clinicaltrials.gov. Outside of the
United States and Canada, call 1-941-906-4711 Ext. 342.
About Cell Genesys
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(TM) cancer
immunotherapies and oncolytic virus therapies. Ongoing clinical trials
include Phase 3 trials of GVAX immunotherapy for prostate cancer, Phase 2
trials of GVAX immunotherapies for pancreatic cancer and for 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.
About Medarex
Medarex is a biopharmaceutical company focused on the discovery,
development and potential commercialization of fully human antibody-based
therapeutics to treat life-threatening and debilitating diseases, including
cancer, inflammation, autoimmune disorders and infectious diseases. Medarex
applies its UltiMAb(R) technology and product development and clinical
manufacturing experience to generate, support and potentially commercialize
a broad range of fully human antibody product candidates for itself and its
partners. Over thirty of these therapeutic product candidates derived from
Medarex technology are in human clinical testing or have had INDs submitted
for such trials, with six of the most advanced product candidates currently
in Phase III clinical trials. Medarex is committed to building value by
developing a diverse pipeline of antibody products to address the world's
unmet healthcare needs. For more information about Medarex, visit its
website at http://www.medarex.com.
Cautionary Statements
For Cell Genesys: Statements made herein about the company, other than
statements of historical fact, including statements about the company's
progress, financial results, timing and results 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 funding.
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, 2006 filed on March 1, 2007 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.
For Medarex: Except for the historical information presented herein,
matters discussed herein may constitute forward-looking statements that are
subject to certain risks and uncertainties that could cause actual results
to differ materially from any future results, performance or achievements
expressed or implied by such statements. Statements that are not historical
facts, including statements preceded by, followed by, or that include the
words "potential"; "believe"; "anticipate"; "intend"; "plan"; "expect";
"estimate"; "could"; "may"; or similar statements are forward-looking
statements. Medarex disclaims, however, any intent or obligation to update
these forward-looking statements. Risks and uncertainties include risks
associated with product discovery and development, uncertainties related to
the outcome of clinical trials, slower than expected rates of patient
recruitment, unforeseen safety issues resulting from the administration of
antibody products in patients, uncertainties related to product
manufacturing as well as risks detailed from time to time in Medarex's
public disclosure filings with the U.S. Securities and Exchange Commission
(SEC), including its Annual Report on Form 10-K for the fiscal year ended
December 31, 2006. There can be no assurance that such development efforts
will succeed or that other developed products will receive required
regulatory clearance or that, even if such regulatory clearance were
received, such products would ultimately achieve commercial success. Copies
of Medarex's public disclosure filings are available from its investor
relations department.
Cell Genesys(R) and the Cell Genesys logo are registered trademarks of
Cell Genesys, Inc. All rights are reserved.
Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks
of Medarex, Inc. All rights are reserved.
Contacts: Ina Cu Laura Choi (Investor Relations)
Cell Genesys, Inc. Medarex, Inc.
650-266-3200 609-430-2880, x2216
Jean Mantuano (Corporate Communications)
Medarex, Inc.
609-430-2880, x2221
SOURCE Genesys, Inc.; Medarex, Inc.
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Related links:
http://www.cellgenesys.com
http://www.medarex.com
CONTACT:
Ina Cu of Cell Genesys, Inc.,
+1-650-266-3200; Laura Choi, Investor Relations, +1-609-430-2880,
x2216, or Jean Mantuano, Corporate Communications,
+1-609-430-2880, x2221, both of Medarex, Inc.
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