BRANFORD, Conn., June 1 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN) today presented encouraging results from the ongoing Phase I/II study of CR011-vcMMAE for the treatment of unresectable Stage III or Stage IV melanoma. The results were presented by Dr. Patrick Hwu, Co-Principal Investigator, and Professor, Chairman, Dept. of Melanoma Medical Oncology at The University of Texas, M.D. Anderson Cancer Center.
"In this heavily pretreated group of patients with primarily Stage IV disease, the observation of dose-dependent objective responses, tumor shrinkage, and encouraging early progression-free rate at 12 weeks at doses in the anticipated active range, leads us to believe that CR011-vcMMAE could be a potentially useful treatment for patients with advanced melanoma," commented Dr. Timothy Shannon, President and Chief Executive Officer of CuraGen Corporation. "Based on these promising results in melanoma we have expanded the CR011-vcMMAE development program to include a Phase II trial in metastatic breast cancer, and are also exploring additional doses and schedules to further optimize the activity of this antibody-drug conjugate."
As of April 4, 2008, forty patients were treated in this first-in-man Phase I/II study including a total of 32 patients in the Phase I dose-escalation portion of the trial that aimed to identify the safety and maximum tolerated dose (MTD) of CR011-vcMMAE and 8 patients in the ongoing Phase II portion of the study. During Phase I, doses of CR011-vcMMAE between 0.03 mg/kg to 2.63 mg/kg were evaluated and generally well tolerated, with rash and neutropenia emerging at higher doses. A total of 130 treatment cycles were administered (range 2 - 19+ cycles per patient). Two dose-limiting toxicities, consisting of rash, were reported at the highest dose evaluated, and therefore the per-protocol MTD was determined to be 1.88 mg/kg administered intravenously (IV) once every three weeks.
Over 80% of the patients treated had Stage IV disease and had received a median of 2 prior therapies (range 0 - 6). A total of 37 patients from both Phase I and the ongoing Phase II were evaluable for tumor response by RECIST criteria. The activity of CR011-vcMMAE was dose dependent with 50% of those patients treated with doses at or above 1.34 mg/kg exhibiting tumor shrinkage and 64% progression-free at 12 weeks compared to 17% with tumor shrinkage seen and 28% progression-free at 12 weeks for patients treated at lower doses. In the Phase I portion of the study, 13 evaluable patients were treated with doses at or above 1.34 mg/kg of which one confirmed partial response and six patients with stable disease were reported. In the Phase II portion of the study evaluating CR011-vcMMAE 1.88 mg/kg, there were six evaluable patients of which one partial response (confirmatory visit pending at time of presentation) and three patients with stable disease were reported.
"The overexpression of the GPNMB protein by melanoma makes it an intriguing and novel therapeutic target. The antibody-drug conjugate CR011-vcMMAE, which targets GPNMB, has shown some encouraging activity in this ongoing study, and we look forward to continuing to explore the potential of this drug in this patient population in need of new therapies," commented Dr. Hwu.
In addition to M.D. Anderson Cancer Center, other study sites in the melanoma trial include Yale Cancer Center, New Haven, CT; The Angeles Clinic and Research Institute, Santa Monica, CA; and New York University Medical Center, New York, NY. This Phase II trial is evaluating the safety and efficacy of CR011-vcMMAE for patients with unresectable Stage III or Stage IV melanoma who have failed no more than one prior line of cytotoxic therapy.
Reprints of the poster presentation will be made available on CuraGen's website at http://www.curagen.com or can be requested by emailing [email protected]
A replay of the conference call will be available starting at 12:00 p.m. Eastern time on Wednesday, June 4, 2008 through Friday, July 4, 2008 by dialing 800-642-1687 (domestic) or 706-645-9291 (international). The passcode for the replay is 50070965. An archive of the webcast will be available for 30 days at http://www.curagen.com
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. (Nasdaq: SGEN). 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 gliomas. Upon internalization into the targeted cell, CR011-vcMMAE is designed to release MMAE from CR011 to produce a cell-killing effect. Preclinical studies conducted with this potential therapeutic demonstrate that CR011-vcMMAE produces strong, reproducible and durable effects against tumors in animal models of human cancer. CR011-vcMMAE is currently in a Phase II trial assessing the safety and efficacy in the treatment of melanoma and will enter Phase II during the third quarter of 2008 for the treatment of metastatic breast cancer.
Melanoma is a very serious form of skin cancer that accounts for the majority of skin-cancer related deaths each year. The number of people diagnosed with melanoma is rapidly increasing with more than 62,000 new cases expected to be diagnosed in the U.S. during 2008. While the chance of developing melanoma increases with age, it remains one of the most common cancers in young adults. This type of cancer begins in specific cells in the skin and can metastasize, or spread, throughout the body to many organ systems. Patients with Stage IV metastatic melanoma typically have a median survival of less than nine months despite current standard therapies, underscoring the need for novel therapeutics to address the unmet medical need in this patient population.
CuraGen 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
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, 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.
SOURCE CuraGen Corporation