BRANFORD, Conn., June 25 /PRNewswire-FirstCall/ -- 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.
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 http://www.curagen.com.
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
Glenn Schulman, PharmD
Director of Medical Communications
|SOURCE CuraGen Corporation|
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