CuraGen Announces Expansion of CR011-vcMMAE Phase II Trial in Advanced Breast Cancer
June 17 2009 - 6:30AM
PR Newswire (US)
- 12 week progression free rate supports advancement into second
stage of Simon 2-Stage designed trial - BRANFORD, Conn., June 17
/PRNewswire-FirstCall/ -- CuraGen Corporation (NASDAQ:CRGN)
announced today that its Phase I/II Trial evaluating CR011-vcMMAE
for the treatment of patients with advanced breast cancer has met
the efficacy criteria for advancement to the second stage of
enrollment. To date, 29 patients have been enrolled in this trial,
including 15 in the Phase II portion. Two of the first four
evaluable Phase II patients were progression-free at 12 weeks,
therefore, as part of the Simon 2-Stage design, the Phase II trial
will now advance to the second stage and enroll a total of
approximately 25 patients. The principal investigator of the study
is Dr. Linda Vahdat, Medical Director of the Breast Cancer Research
Program and Associate Professor of Clinical Medicine, /Weill
Cornell. CuraGen anticipates presenting updated results from this
study during the second half of 2009. About CR011-vcMMAE
CR011-vcMMAE is an antibody-drug conjugate (ADC) being developed by
CuraGen that consists of a fully-human monoclonal antibody, CR011,
linked to a potent cell-killing drug, monomethyl-auristatin E
(MMAE). The ADC technology, comprised of MMAE and a stable linker
system for attaching it to CR011, was licensed from Seattle
Genetics, Inc. The ADC is designed to be stable in the bloodstream.
Following intravenous administration, CR011-vcMMAE targets and
binds to GPNMB, a specific protein that is predominantly expressed
on the surface of cancer cells, including melanoma, breast cancer
and glioma. Upon internalization by the targeted cell, CR011-vcMMAE
is designed to release MMAE from CR011 to produce a cell-killing
effect. CR011-vcMMAE is currently in two Phase II trials assessing
its safety and efficacy in the treatment of melanoma and for the
treatment of metastatic breast cancer, and in a Phase I trial to
evaluate the safety and activity of alternate dosing schedules.
About Breast Cancer Breast cancer is the most common cancer in
women and a leading cause of death in the United States. According
to the American Cancer Society, more than 180,000 women will be
diagnosed with invasive breast cancer in 2009 with more than 40,000
deaths attributed to this disease. Despite recent advances in
therapy, the median survival of patients with metastatic breast
cancer is 2 to 3 years, while patients with "triple-negative" or
"basal-like" breast cancer have limited treatment options and
poorer outcomes. Therefore, a significant unmet need remains for
novel therapeutic approaches for patients with locally advanced and
metastatic breast cancer who have failed other therapies. About
CuraGenCuraGen Corporation (NASDAQ:CRGN) is a clinical-stage
biopharmaceutical company developing promising approaches for the
treatment of cancer. CuraGen Corporation is headquartered in
Branford, Connecticut. For additional information please visit
http://www.curagen.com/. Forward-Looking Statements Statements in
this press release regarding management's future expectations,
beliefs, intentions, goals, strategies, plans or prospects,
including statements relating to CuraGen's development program for
CR011-vcMMAE, including CuraGen's ability to advance CR011-vcMMAE
through Phase II clinical trials for melanoma and metastatic breast
cancer, to explore additional doses and schedules of this
antibody-drug conjugate, and to explore the potential of
CR011-vcMMAE in a patient population in need of new therapies may
constitute forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by terminology such as "anticipate,"
"believe," "could," "could increase the likelihood," "estimate,"
"expect," "intend," "is planned," "may," "should," "will," "will
enable," "would be expected," "look forward," "may provide,"
"would" or similar terms, variations of such terms or the negative
of those terms. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors including the risk
that any one or more of CuraGen's drug development programs will
not proceed as planned for technical, scientific or commercial
reasons or due to patient enrollment issues or based on new
information from nonclinical or clinical studies or from other
sources, the success of competing products and technologies,
CuraGen's stage of development as a biopharmaceutical company,
government regulation and healthcare reform, technological
uncertainty and product development risks, product liability
exposure, uncertainty of additional funding, CuraGen's history of
incurring losses and the uncertainty of achieving profitability,
reliance on research collaborations and strategic alliances,
competition, patent infringement claims against CuraGen's products,
processes and technologies, CuraGen's ability to protect its
patents and proprietary rights and uncertainties relating to
commercialization rights, as well as those risks, uncertainties and
factors referred to in CuraGen's Quarterly Report on Form 10-Q for
the period ended March 31, 2009 filed with the Securities and
Exchange Commission under the section "Risk Factors," as well as
other documents that may be filed by CuraGen from time to time with
the Securities and Exchange Commission. As a result of such risks,
uncertainties and factors, CuraGen's actual results may differ
materially from any future results, performance or achievements
discussed in or implied by the forward-looking statements contained
herein. CuraGen is providing the information in this press release
as of this date and assumes no obligations to update the
information included in this press release or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise. Contacts: Sean Cassidy Chief Financial
Officer Ronit Simantov, M.D. Chief Medical Officer (888) 436-6642
CRGN-P DATASOURCE: CuraGen Corporation CONTACT: Sean Cassidy, Chief
Financial Officer, , or Ronit Simantov, M.D., Chief Medical
Officer, , both of CuraGen Corporation, +1-888-436-6642 Web Site:
http://www.curagen.com/
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