Addition of Hepatitis C Treatment to Ongoing Oncology Program for MDX-1106
PRINCETON, N.J., Oct. 29 /PRNewswire-FirstCall/ -- Ono Pharmaceutical
Co., Ltd. and Medarex, Inc. (Nasdaq: MEDX) announced today the allowance of
an investigational new drug application (IND) filed with the U.S. Food &
Drug Administration (FDA) for MDX-1106 (ONO-4538: development code of Ono
Pharmaceutical Co., Ltd.), a fully human anti-PD-1 antibody being
investigated for the treatment of chronic viral infections, with the first
trial to target hepatitis C. MDX-1106 was developed under the May 2005
collaborative research agreement between Ono and Medarex, and currently is
in a separate ongoing Phase I clinical study in patients with recurrent or
treatment- refractory cancer.
The new Phase I single-dose, dose-escalation trial with
MDX-1106/ONO-4538 is expected to enroll up to 34 patients with active
hepatitis C genotype 1 infection (HCV). The study is intended to evaluate
the safety, pharmacokinetics, and preliminary efficacy of single doses of
MDX-1106/ONO- 4538.
"Recently, involvement of PD-1 in hepatitis C has been reported in the
scientific literature," said Shozo Matsuoka, Ph.D., Senior Managing
Director of Ono Pharmaceutical, Co., Ltd. "ONO-4538/MDX-1106 aims to
improve the immune capacity of the body and treat hepatitis C with a novel
mechanism of action which inhibits the involvement of PD-1. We are seeking
to develop ONO- 4538/MDX-1106 to be a new treatment for hepatitis C."
"We value our partnership with Ono and are pleased with the progress to
study the potential of MDX-1106 in both oncology and infectious diseases,"
said Howard Pien, President and CEO of Medarex. "We believe that our
ongoing program in patients with cancer is currently progressing well and
that this exploratory Phase I study in HCV may be a step toward potentially
adding new infectious disease indications for therapeutic blockade of this
important T cell regulatory molecule."
About MDX-1106/ONO-4538
PD-1 (programmed cell death 1) is one of the receptors expressed on the
surface of activated lymphocytes (T-cells) and is involved in the system of
negative regulation for the suppression of activated lymphocytes. An
increasing number of studies have reported that tumor cells and certain
chronic viruses, including HCV, may use the PD-1 pathway to evade host
adaptive immune responses (which protect the host from both harmful
pathogens and tumors), suggesting that blockade of the negative regulatory
signal mediated by PD-1 may promote the host immune response to recognize
tumor cells as foreign and eliminate viral pathogens. Preclinical studies
suggest that blockade of the PD-1 signaling pathway by MDX-1106/ONO-4538, a
fully human anti-PD-1 antibody, activates T-cell responses and promotes an
immune response to fight tumors and infectious diseases. Medarex and Ono
Pharmaceutical continue to investigate the potential of MDX-1106/ONO-4538
for cancer in an ongoing Phase I clinical trial and for 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 30 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 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.
Medarex Statement on Cautionary Factors
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"; "plan"; "expect"; "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 MDX-1106 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 and subsequent Quarterly Reports on
Form 10-Q. 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.
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 Jean Mantuano, Corporate
Communications (media), +1-609-430-2880, Ext. 2221, both of
Medarex, Inc.
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