PRINCETON, N.J., April 15 /PRNewswire-FirstCall/ -- Medarex, Inc.
(Nasdaq: MEDX) announced today interim results from two ongoing Phase 1
trials in hormone refractory prostate cancer (HRPC) demonstrating
dose-dependent T-cell activation and clinical activity of ipilimumab, an
investigational anti-CTLA-4 antibody. These studies were done in
combination with antigen-releasing immunotherapies based on GM-CSF, a
cytokine that stimulates the proliferation of white blood cells and
augments immune responses, and results were presented in two separate oral
presentations by investigators at the Annual Meeting of the American
Association for Cancer Research (AACR), being held April 12-16, 2008 in San
Diego.
"The interim results demonstrating clinical activity in these ongoing
trials lend additional support to the concept of ipilimumab as part of a
therapeutic regimen in treating prostate cancer," said Geoffrey M. Nichol,
M.B.Ch.B., Senior Vice President of Product Development at Medarex. "We
will continue to explore the prospects of ipilimumab in HRPC, and we expect
further data in prostate cancer for ipilimumab monotherapy and in
combination with other antigen-releasing agents at this year's ASCO
conference in June."
-- "Dendritic and T cell functions in patients with metastatic
hormone-refractory prostate cancer treated with GVAX immunotherapy for
prostate cancer and ipilimumab" (Abstract #2538)
Interim data from the ongoing Phase 1 study of escalating doses of
ipilimumab in combination with the Cell Genesys, Inc. GVAX
immunotherapy for prostate cancer (an investigational agent comprised
of whole tumor cells modified to secrete GM-CSF) were presented by
Saskia JAM Santegoets, Ph.D., from the Department of Medical Oncology
and Pathology of Vrije Universiteit Medical Center located in
Amsterdam, Netherlands. The data suggested an ipilimumab dose-related
association with increased T-cell activation, as well as associated
anti-tumor activity from the initial 12 patients that was previously
reported at the June 2007 American Society of Clinical Oncology (ASCO)
meeting.
In the Phase 1 clinical trial, 28 patients with metastatic HRPC have
been enrolled, including 12 patients in the dose-escalation cohort
(0.3, 1, 3 or 5 mg/kg ipilimumab) and 16 patients in the expansion
cohort (3 mg/kg ipilimumab). The dose of GVAX immunotherapy for
prostate cancer used in this combination trial is comparable to that
currently being evaluated in Cell Genesys' ongoing Phase 3 program. The
treatment combination was generally well-tolerated. Adverse events
associated with this regimen are consistent with data previously
reported from this study.
-- "CTLA-4 blockade for hormone refractory prostate cancer: dose-dependent
induction of CD8+ T cell activation and clinical responses" (Abstract
#2539)
Preliminary data from an ongoing Phase 1 study of escalating doses of
ipilimumab in combination with GM-CSF (sargramostim) were presented by
Lawrence Fong, Ph.D., from the University of California, San Francisco,
San Francisco. Of the six patients treated at 3 mg/kg ipilimumab, three
experienced confirmed decreases in prostate-specific antigen (PSA)
serum levels of over 50%, and one of these patients experienced a
partial response in hepatic metastases.
In the Phase 1 clinical trial, 26 patients with HRPC received treatment
with a 28-day cycle of daily doses of 250 mg/m2 of GM-CSF for 14 days
in combination with ipilimumab administered on the first day of the
28-day cycle for up to four cycles. Ipilimumab dosing initially ranged
from 0.5 mg/kg to 3 mg/kg. Additional patients are now being treated
with higher doses (5 mg/kg and 10 mg/kg) of ipilimumab. The treatment
combination was generally well-tolerated. Adverse events associated
with ipilimumab treatment are consistent with data previously reported
from this study and from other clinical trials of ipilimumab.
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. More than 40 of these therapeutic product candidates derived from
Medarex technology are in human clinical testing or have had INDs submitted
for such trials, with seven of the most advanced product candidates
currently in Phase 3 clinical trials or the subject of regulatory
applications for marketing authorization. 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.
Medarex Statement on Cautionary Factors
Except for the historical information presented herein, matters
discussed herein relating to the interim data from ongoing ipilimumab
combination Phase 1 studies 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 "preliminary"; "interim"; "potential"; "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
development, unforeseen safety issues resulting from the administration of
antibody products in humans, 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, 2007 and its quarterly reports on Form 10-Q. There
can be no assurance that future milestone payments will be paid, whether
the product development efforts will succeed, or whether 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.
Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks
of Medarex, Inc. All rights are reserved.
SOURCE Medarex, Inc.
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CONTACT:
Laura S. Choi, Investor Relations,
+1-609-430-2880, ext. 2216, or Nichol Harber, Corporate
Communications (media), +1-609-430-2880, ext. 2214, or Jean
Mantuano, Corporate Communications (media), +1-609-430-2880, ext.
2221, all of Medarex, Inc.
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