PRINCETON, N.J., June 2 /PRNewswire-FirstCall/ -- Medarex, Inc.
(Nasdaq: MEDX) today announced preliminary data from an ongoing Phase 1
study of MDX-1106 (ONO-4538: development code of Ono Pharmaceutical Co.,
Ltd.), a fully human anti-PD-1 antibody. Data presented from patients with
recurrent or treatment-refractory cancer in the study included the safety,
tolerability and pharmacokinetic profile of single-dose MDX-1106. In
addition, preliminary evidence of anti-tumor activity was observed,
including one patient with colorectal carcinoma who experienced a confirmed
partial response that has been durable for more than 6 months. Tumor
regressions (tumor shrinkage that did not meet the criteria for partial
response) were also observed in four additional patients, including two
patients with melanoma, one patient with non-small cell lung cancer, and
one with renal cell carcinoma. These preliminary study results were
presented in an oral presentation by investigator Julie Brahmer, M.D.,
Assistant Professor of Oncology from the Sidney Kimmel Cancer Comprehensive
Center at Johns Hopkins University at the annual meeting of the American
Society of Clinical Oncology (ASCO) being held in Chicago. (Abstract #3006)
"We are pleased with the safety profile and preliminary evidence of
anti- tumor activity from this first human clinical trial of MDX-1106,"
said Geoffrey M. Nichol, MBChB, Senior Vice President of Product
Development at Medarex. "We look forward to the further development of this
novel immunotherapy, and plans are underway to initiate a Phase 2 trial of
MDX-1106 in cancer this year."
In the single-dose Phase 1 trial, 24 patients initially enrolled in the
dose-escalation portion of the trial, and an additional 15 patients are now
fully enrolled in the expansion cohort at the highest dose. Eligible
patients with recurrent or treatment-refractory solid tumors (including
non-small cell lung cancer, renal, colon, melanoma, and hormone-refractory
prostate cancer) received single-dose treatment of 0.3, 1, 3 or 10 mg/kg of
MDX-1106 and were allowed re-treatment with multiple doses. All doses were
well-tolerated with no observed severe immune-related adverse events and no
dose-limiting toxicities within the first four weeks following single-dose
therapy. Two patients with histories of arthritis that were not disclosed
to the investigator prior to enrollment in the trial (history of autoimmune
disease requiring treatment is an exclusion criterion for the trial)
developed low grade arthritic symptoms that responded to oral
corticosteroid treatment. Of the 11 patients that were eligible for
re-treatment, one patient with ocular melanoma developed colitis 3 weeks
after receiving a fifth dose of 1 mg/kg (over 9 months), and is improving
with medical treatment of this immune- related adverse event after
discontinuation of MDX-1106 dosing. In the 21 patients who have received 10
mg/kg of MDX-1106, including 3 patients who have received at least 3 doses,
no serious immune-related adverse events have been observed.
About MDX-1106/ONO-4538
MDX-1106/ONO-4538 is a novel fully human antibody designed to target
and inhibit the function of PD-1 (programmed cell death 1), a receptor
expressed on the surface of activated lymphocytes (T-cells) that is
involved in the system of negative regulation for the suppression of
activated lymphocytes. Preclinical studies suggest that blockade of the
PD-1 signaling pathway by MDX-1106/ONO-4538 activates T-cell responses and
promotes an immune response to fight tumors and infectious diseases.
Medarex and Ono Pharmaceutical are investigating the potential of
MDX-1106/ONO-4538 in ongoing Phase 1 trials for the treatment of cancer and
hepatitis C.
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, the statements
relating to MDX-1106 in this press release 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. Medarex disclaims,
however, any intent or obligation to update these forward-looking
statements. Risks and uncertainties include risks associated with product
discovery and development of MDX-1106, 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; Nichol Harber, Corporate Communications
(media), +1-609-430-2880, x2214, both of Medarex, Inc.
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