PRINCETON, N.J., June 2 /PRNewswire-FirstCall/ -- Medarex, Inc.
(Nasdaq: MEDX) today announced interim results from a Phase 1/2 trial of
ipilimumab, an investigational oncology immunotherapy, as monotherapy or in
combination with radiotherapy in patients with metastatic castration
resistant prostate cancer (mCRPC). Data presented showed that ipilimumab
monotherapy or in combination with radiotherapy was clinically active and
generally well-tolerated. Preliminary evidence of anti-cancer activity
showed that 21 percent of patients (7 of 33) experienced decreases in
prostate-specific antigen (PSA) serum levels of over 50 percent, with
median duration of PSA responses of 4.8 months. This included one patient
treated at the highest dose with a complete response (measured by both PSA
and RECIST criteria) ongoing over one year. Two additional patients had PSA
reductions of more than 30 percent within 12 weeks of treatment. The
interim results were described in an oral presentation by investigator
Tomasz M. Beer, M.D., the Grover C. Bagby Endowed Chair for Prostate Cancer
Research and Associate Professor of Medicine from Oregon Health & Science
University Cancer Institute, at the annual meeting of the American Society
of Clinical Oncology (ASCO) being held in Chicago. (Abstract #5004)
"These initial data in patients with metastatic castration resistant
prostate cancer demonstrated preliminary anti-tumor activity, including
durable response, and is suggestive of a safety profile at the optimal
ipilimumab regimen similar to that observed in our melanoma program," said
Geoffrey M. Nichol, MBChB, Senior Vice President of Product Development at
Medarex. "Radiotherapy is routinely used for palliative treatment in
patients with metastatic castration resistant prostate cancer and bone
metastases, and these data encourage further exploration of the ability of
tumor antigen release by radiotherapy to serve as an immune-supportive
intervention in combination with ipilimumab as a potentially important
treatment option for these patients."
The Phase 1/2 trial was conducted to evaluate the safety and
preliminary anti-tumor activity of escalating doses of ipilimumab (3, 5 or
10 mg/kg) every three weeks for up to four doses, with and without a single
dose of focal radiotherapy administered to target bone lesion(s) prior to
the first dose of ipilimumab. The dose escalation portion of the trial
enrolled 33 patients with mCRPC and with bone metastases. Additional
patients are enrolling in the expansion cohort of 10mg/kg ipilimumab in
combination with radiotherapy.
Adverse events related to ipilimumab in this study were generally
manageable and consistent with those immune-related adverse events (irAEs)
previously reported in other clinical trials of ipilimumab. Grade 3/4
adverse events included diarrhea/colitis (5 patients), rash (1 patient) and
elevated liver enzymes (2 patients). No new patterns or frequency of
adverse events emerged in patients receiving the combination of ipilimumab
and radiotherapy.
About Ipilimumab
Ipilimumab is a fully human antibody that binds to CTLA-4 (cytotoxic T
lymphocyte-associated antigen 4), a molecule on T-cells that plays a
critical role in regulating natural immune responses. The absence or
presence of CTLA- 4 can augment or suppress the immune system's T-cell
response in fighting disease. Ipilimumab is designed to block the activity
of CTLA-4, thereby sustaining an active immune response in its attack on
cancer cells.
Comprehensive Clinical Trial Program for Ipilimumab
Bristol-Myers Squibb Company and Medarex remain committed to the
development of ipilimumab. The companies also have ongoing Phase 2 studies
in hormone-refractory prostate cancer and lung cancer as well as a Phase 3
study, to be initiated shortly, in adjuvant melanoma.
For further information about ipilimumab clinical trials, please visit
http://www.clinicaltrials.gov.
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 Web site at http://www.medarex.com.
Medarex Statement on Cautionary Factors
Except for the historical information presented herein, matters
discussed herein relating to the development of ipilimumab may constitute
forward- looking statements, as defined in the Private Securities
Litigation Reform Act of 1995, 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, such as statements
preceded by, followed by or including the words "preliminary"; "suggest";
or "potential"; 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 the development of ipilimumab, 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, 2007 and its quarterly reports on Form 10-Q. There can be no
assurance that such development efforts will succeed or that 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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Related links:
http://www.medarex.com
http://www.asco.org/ASCO/Meetings/ASCO+Annual+Meeting
http://www.prnewswire.com/comp/108265.html /
CONTACT:
Laura S. Choi, Investor Relations,
+1-609-430-2880, x2216; or Nichol Harber, Corporate
Communications (media), +1-609-430-2880, x2214, both of Medarex,
Inc.
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