CuraGen Corporation
(Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused on
oncology, announced today the treatment of the first patient in its
CR011-vcMMAE Phase II breast cancer study.
The Phase II trial is an open-label, multi-center study of CR011-vcMMAE
administered intravenously once every three weeks to patients with
locally-advanced or metastatic breast cancer who have received prior
therapy. This study will enroll up to approximately 40 patients to confirm
the maximum tolerated dose (MTD) in this population and to assess efficacy
using a Simon 2-Stage design with an endpoint of progression-free rate at
12 weeks. The principal investigator is Dr. Linda Vahdat, Medical Director
of the Breast Cancer Research Program and Associate Professor of Clinical
Medicine, NewYork-Presbyterian Hospital/Weill Cornell.
"We believe that GPNMB is a promising target in breast cancer, and we
look forward to better understanding how CR011-vcMMAE could be used in the
treatment of this disease," commented Dr. Timothy Shannon, President and
Chief Executive Officer of CuraGen Corporation. "We are confident in our
ability to continue the rapid development of this program and look forward
to providing updated CR011-vcMMAE results for the treatment of melanoma by
the end of 2008 and the presentation of preliminary results from this newly
initiated study in breast cancer during the first half of 2009."
CR011-vcMMAE targets a protein known as glycoprotein NMB (GPNMB), which
is overexpressed in a variety of cancers including breast cancer, melanoma,
and brain tumors. CR011-vcMMAE is an antibody-drug conjugate comprised of a
fully-human monoclonal antibody against GPNMB linked to a potent tubulin
stabilizing agent, monomethyl auristatin E (MMAE). The enzyme-sensitive
linker, which was licensed from Seattle Genetics, is designed to be stable
in the bloodstream and to release MMAE inside tumor cells, resulting in
cancer cell death.
Dr. Ronit Simantov, Vice President and Chief Medical Officer commented,
"Preclinical studies have shown that GPNMB is expressed in aggressive
breast cancers and is believed to play a role in promoting invasion and
metastasis of breast cancer cells. Furthermore, conjugating an antibody
against this biologically relevant target with MMAE, a cytotoxic drug that
belongs to a class of therapeutics known to be active against breast
cancer, represents a novel approach to treating this disease."
Objective responses have been observed in patients with advanced
melanoma treated with CR011-vcMMAE. A Phase II study of CR011-vcMMAE in
patients with melanoma is currently enrolling patients, and preclinical
studies with CR011-vcMMAE for the treatment of gliomas are ongoing.
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 2008
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 CuraGen
CuraGen Corporation (Nasdaq: CRGN) is a dedicated clinical-stage
biopharmaceutical company developing diverse approaches for the treatment
of cancer. CuraGen Corporation is headquartered in Branford, Connecticut.
For additional information please visit curagen.
Safe Harbor
Statements in this press release regarding management's future
expectations, beliefs, intentions, goals, strategies, plans or prospects,
including statements relating to the effectiveness of antibody-drug
conjugates and CuraGen's CR011-vcMMAE program, including the use of
CR011-vcMMAE for breast cancer, melanoma and gliomas, and the timeframe of
initiating clinical trials and presenting results on CR011-vcMMAE 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
quarter ended March 31, 2008, 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.
CuraGen Corporation
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