Clinical trial expanded to further evaluate activity of CR011-vcMMAE for advanced melanoma
BRANFORD, CN, USA | April 9, 2008 | CuraGen Corporation (Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused on oncology, announced today that it has advanced CR011-vcMMAE, an antibody-drug conjugate (ADC), into Phase II for the treatment of patients with unresectable Stage III and Stage IV melanoma. CuraGen also announced today that updated data from the ongoing Phase I/II trial with CR011-vcMMAE will be presented at the 2008 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 30 – June 3, 2008 in Chicago, IL.
"We are pleased with the progress achieved in the CR011-vcMMAE clinical program," commented Dr. Ronit Simantov, Vice President of Medical Development and Chief Medical Officer. "Advancing this program into Phase II is an important development milestone as we look to establish the role of CR011-vcMMAE in the treatment of patients with advanced melanoma."
"Antibodies have made a significant impact in cancer treatment, and we believe that ADCs represent the next generation of antibody technologies. Over the last year, ADCs have demonstrated proof-of-concept activity against both solid tumors and hematologic malignancies," said Dr. Timothy M. Shannon, President and Chief Executive Officer of CuraGen. "We are encouraged by the activity observed to date with CR011-vcMMAE and are looking forward to reporting updated results at ASCO in June."
CR011-vcMMAE is an ADC comprised of a fully-human monoclonal antibody against glycoprotein NMB (GPNMB) attached to a potent, synthetic drug monomethyl auristatin E (MMAE), using Seattle Genetics’ proprietary technology. The ADC recognizes GPNMB, a novel, selective target that plays a role in the ability of cancer cells to invade and metastasize. CR011-vcMMAE contains an enzyme-cleavable linker designed to be stable in the bloodstream and to release MMAE after internalization into tumor cells that express GPNMB, resulting in cancer cell death.
ASCO Presentation Details
A poster entitled "A phase I/II study of CR011-vcMMAE, an antibody toxin conjugate drug in patients with unresectable stage III/IV melanoma," is scheduled to be presented by Patrick Hwu, M.D., Ph.D., Professor and Chairman of the Department of Melanoma Medical Oncology at M.D. Anderson Cancer Center, on Sunday, June 1, 2008 from 2:00 – 6:00 p.m. The poster session will be followed by a poster discussion from 5:00 – 6:00 p.m.
About Melanoma
The number of people diagnosed with melanoma is rapidly increasing. It is expected that approximately 60,000 new cases of melanoma will be diagnosed and an estimated 8,000 people in the U.S. will die of the disease during 2008. The prognosis for patients with advanced melanoma is poor, and studies have shown that the median survival is less than nine months.
About CuraGen
CuraGen Corporation (Nasdaq: CRGN) is a dedicated clinical-stage biopharmaceutical company developing diverse approaches for the treatment of cancer including belinostat and CR011-vcMMAE. By leveraging drug development strengths cultivated over the years, CuraGen expects to make a difference by advancing its promising therapeutics to address the unmet medical needs of cancer patients. CuraGen Corporation is headquartered in Branford, Connecticut. For additional information please visit http://www.curagen.com.
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 metastatic melanoma and the timeframe and presentation of clinical trial results of 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 Annual Report on Form 10-K for the year ended December 31, 2007, 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
Post Views: 109
Clinical trial expanded to further evaluate activity of CR011-vcMMAE for advanced melanoma
BRANFORD, CN, USA | April 9, 2008 | CuraGen Corporation (Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused on oncology, announced today that it has advanced CR011-vcMMAE, an antibody-drug conjugate (ADC), into Phase II for the treatment of patients with unresectable Stage III and Stage IV melanoma. CuraGen also announced today that updated data from the ongoing Phase I/II trial with CR011-vcMMAE will be presented at the 2008 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 30 – June 3, 2008 in Chicago, IL.
"We are pleased with the progress achieved in the CR011-vcMMAE clinical program," commented Dr. Ronit Simantov, Vice President of Medical Development and Chief Medical Officer. "Advancing this program into Phase II is an important development milestone as we look to establish the role of CR011-vcMMAE in the treatment of patients with advanced melanoma."
"Antibodies have made a significant impact in cancer treatment, and we believe that ADCs represent the next generation of antibody technologies. Over the last year, ADCs have demonstrated proof-of-concept activity against both solid tumors and hematologic malignancies," said Dr. Timothy M. Shannon, President and Chief Executive Officer of CuraGen. "We are encouraged by the activity observed to date with CR011-vcMMAE and are looking forward to reporting updated results at ASCO in June."
CR011-vcMMAE is an ADC comprised of a fully-human monoclonal antibody against glycoprotein NMB (GPNMB) attached to a potent, synthetic drug monomethyl auristatin E (MMAE), using Seattle Genetics’ proprietary technology. The ADC recognizes GPNMB, a novel, selective target that plays a role in the ability of cancer cells to invade and metastasize. CR011-vcMMAE contains an enzyme-cleavable linker designed to be stable in the bloodstream and to release MMAE after internalization into tumor cells that express GPNMB, resulting in cancer cell death.
ASCO Presentation Details
A poster entitled "A phase I/II study of CR011-vcMMAE, an antibody toxin conjugate drug in patients with unresectable stage III/IV melanoma," is scheduled to be presented by Patrick Hwu, M.D., Ph.D., Professor and Chairman of the Department of Melanoma Medical Oncology at M.D. Anderson Cancer Center, on Sunday, June 1, 2008 from 2:00 – 6:00 p.m. The poster session will be followed by a poster discussion from 5:00 – 6:00 p.m.
About Melanoma
The number of people diagnosed with melanoma is rapidly increasing. It is expected that approximately 60,000 new cases of melanoma will be diagnosed and an estimated 8,000 people in the U.S. will die of the disease during 2008. The prognosis for patients with advanced melanoma is poor, and studies have shown that the median survival is less than nine months.
About CuraGen
CuraGen Corporation (Nasdaq: CRGN) is a dedicated clinical-stage biopharmaceutical company developing diverse approaches for the treatment of cancer including belinostat and CR011-vcMMAE. By leveraging drug development strengths cultivated over the years, CuraGen expects to make a difference by advancing its promising therapeutics to address the unmet medical needs of cancer patients. CuraGen Corporation is headquartered in Branford, Connecticut. For additional information please visit http://www.curagen.com.
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 metastatic melanoma and the timeframe and presentation of clinical trial results of 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 Annual Report on Form 10-K for the year ended December 31, 2007, 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
Post Views: 109
