Data Presented at American Society of Clinical Oncology
PRINCETON, N.J., June 5 /PRNewswire-FirstCall/ -- Medarex, Inc.
(Nasdaq: MEDX) today announced interim data based on median follow-up of 12
months of extended dosing with ipilimumab (also known as MDX-010) indicated
that the treatment regimen was generally well-tolerated in 25 patients with
resected Stage IIIc or Stage IV melanoma treated with ipilimumab and a
multi- peptide melanoma vaccine in the adjuvant setting. All patients have
survived to date. The Phase II clinical trial results were presented by
Jeffrey S. Weber, M.D., Ph.D., Chief of Oncology at the Keck School of
Medicine at the University of Southern California at the 42nd Annual
Meeting of the American Society of Clinical Oncology, June 2-6, 2006, in
Atlanta, GA (Abstract #2510).
The Phase II clinical trial was designed to establish a dose and
regimen of ipilimumab suitable for extended dose treatment and involved 25
patients with surgically resected Stage IIIc (10 patients) or Stage IV (15
patients) melanoma who received 3.0 mg/kg of ipilimumab continually every
eight weeks, co-administered with a multi-peptide melanoma vaccine given 12
times over 12 months for up to one year. To date, all 25 patients are still
living with 12 months of median follow-up, and six of the patients have
relapsed.
Twelve of 25 patients experienced Grade II or Grade III colitis, rash
or hypopituitarism events that are consistent with an immune-based
mechanism of action due to ipilimumab mediated CTLA-4 blockade (also termed
Inflammatory Breakthrough Events, or IBEs), and which have correlated, in
short-term treatment of patients with advanced metastatic melanoma, with
anti-tumor response. The IBEs induced by longer-term treatment were either
reversible following discontinuation of treatment or did not require
discontinuation of therapy. Eighteen patients (72%) were able to continue
the therapy without discontinuation of treatment due to adverse events. To
date, only two of 12 patients experiencing IBEs have relapsed, in
comparison to four of 13 patients without IBEs, supporting a possible
association between IBEs and anti-tumor response. Patients will continue to
be followed to relapse.
"We are pleased to observe well-tolerated longer-term dosing with
ipilimumab that is associated with some evidence of tolerable immune
activation, with possible relapse prevention, in the adjuvant setting,"
said Donald L. Drakeman, President and CEO of Medarex. "We will continue to
follow the patients to further evaluate relapse-free and survival durations
with melanoma in this treatment setting, a setting that could considerably
expand therapeutic opportunities for ipilimumab."
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
two registrational studies as second-line therapy for metastatic melanoma
under two separate Special Protocol Assessment (SPA) agreements with the
Food and Drug Administration (FDA). One is a recently initiated monotherapy
study that is expected to be completed this year, and the other is in
combination with MDX-1379 (a melanoma peptide vaccine). A front-line
dacarbazine combination registrational study is also expected to initiate
this year. 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 Medarex's ipilimumab program can be
found in Medarex's public disclosure filings with the U.S. Securities and
Exchange Commission (SEC).
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. Thirty-two of these therapeutic product candidates derived from
Medarex technology are in human clinical testing or have had INDs submitted
for such trials, with four 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"; "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, 2005 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.
 back to top
Related links:
http://www.medarex.com
http://www.prnewswire.com/comp/108265.html /
CONTACT:
Laura S. Choi, Investor Relations, x2216, or
Jean Mantuano, Corporate Communications, media, x2221,
+1-609-430-2880
|
