BRANFORD, Conn., June 22 /PRNewswire-FirstCall/ -- CuraGen Corporation announced today its Investigational New Drug Application (IND) for CR011-vcMMAE, a fully-human monoclonal antibody-drug conjugate (ADC), has been cleared by the U.S. Food & Drug Administration (FDA) and dosing of patients has begun in a Phase I clinical trial evaluating the safety and potential activity of CR011-vcMMAE for the treatment of metastatic melanoma, a deadly form of skin cancer. CuraGen anticipates preliminary results from this Phase I trial will be available in the fourth quarter of 2007.
“We are very excited to begin evaluating CR011-vcMMAE as a potential treatment for metastatic melanoma. Currently, patients with this type of cancer have limited treatment options,” commented Dr. Mario Sznol, co-Principal Investigator, Head of the Melanoma Program at the Yale University School of Medicine, at the Yale Cancer Center in New Haven, CT. “In addition to evaluating the safety of CR011-vcMMAE, we will also assess patient response to see whether tumors shrink following treatment with this novel therapeutic.”
The open-label, multi-center, dose-escalation study will evaluate the safety, tolerability and pharmacokinetics 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. The first part of the trial will evaluate cohorts of patients receiving increasing doses of CR011-vcMMAE to determine the maximum tolerated dose (MTD). After determination of the MTD, up to approximately 30 additional patients will be enrolled and treated at the MTD to further define safety and efficacy in this Phase I trial.
“CR011-vcMMAE targets GPNMB, a protein discovered through CuraGen’s internal R&D efforts, which appears to be predominantly expressed on the surface of melanoma cells. We believe the disease specificity and targeted nature of CR011-vcMMAE will accelerate the evaluation of this therapeutic in the clinic, where we hope to replicate the activity we saw with this agent in preclinical studies,” stated Dr. Frank M. Armstrong, President and Chief Executive Officer of CuraGen. “CR011-vcMMAE also represents the third oncology product from CuraGen to be advanced into clinical trials in the past three years, highlighting our commitment to developing promising novel therapeutics that aim to address the unmet needs of cancer patients.”
About CR011-vcMMAE
CR011-vcMMAE is an 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 fully-human monoclonal antibody was generated with Xenomouse(R) technology by Abgenix, now Amgen Fremont, a wholly-owned subsidiary of Amgen. 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 primarily located on the surface of melanoma cells. 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 melanoma.
About Melanoma
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 2006. 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. No significant advances in the treatment of metastatic melanoma have occurred over the past thirty years underscoring the need for novel therapeutics to address the unmet medical need in this patient population.
About CuraGen
CuraGen Corporation is a biopharmaceutical company developing diverse approaches, including novel protein, antibody, and small molecule therapeutics that aim to offer hope for patients with cancer, inflammatory diseases, and diabetes. CuraGen’s strategic alliances have resulted in a deep pipeline of potential therapeutics that is being developed by the Company’s experienced research and development teams. By leveraging the drug development strengths cultivated over the years, CuraGen expects to make a difference in the lives of patients by bringing forward promising therapeutics that address unmet medical needs. To further capitalize on CuraGen’s extensive research and development expertise, CuraGen founded a majority-owned subsidiary, 454 Life Sciences, which has developed and is commercializing advanced technologies for the sequencing of DNA. CuraGen and 454 Life Sciences are headquartered in Branford, Connecticut. For additional information on the companies please visit http://www.curagen.com and http://www.454lifesciences.com.
SAFE HARBOR
This press release may contain forward-looking statements, including statements that this clinical trial with CR011 will be completed during the fourth quarter of 2007, that GPNMB appears to be predominantly expressed on the surface of melanoma cells, that the disease specificity and targeted nature of CR011-vcMMAE will accelerate the evaluation of this therapeutic in the clinic and that we will be able to replicate in the clinic the activity we saw with this agent in preclinical studies. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. CuraGen cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors, including, but not limited to, the following: CuraGen’s stage of development as a biopharmaceutical company, uncertainties of clinical trials, 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. Please refer to our Annual and Quarterly Reports on Forms 10-K and 10-Q for a description of these risks. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.
Contact: Glenn Schulman, Pharm.D. Assistant Director of Investor Relations gschulman@curagen.com (888) 436-6642
CuraGen Corporation
CONTACT: Glenn Schulman, Pharm.D. of CuraGen, +1-888-436-6642,gschulman@curagen.com
Web site: http://www.curagen.com//
