BRANFORD, Conn., June 11 CuraGen Corporation(Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused ononcology, announced today that its Phase II Trial evaluating CR011-vcMMAE forthe treatment of patients with unresectable Stage III or Stage IV melanoma hasmet the efficacy criteria for advancement to the second stage of enrollment.Of the first six evaluable patients in this Phase II trial one patient has hada confirmed objective response, as measured by RECIST criteria. As part ofthe Simon 2-Stage design the trial will now expand to enroll a total of 32patients.
"We are very encouraged by the emerging clinical efficacy of CR011-vcMMAE.We believe that this objective response confirms the initial activity observedin the Phase I trial, the results of which were reported earlier this month atASCO," commented Dr. Timothy Shannon, President and Chief Executive Officer ofCuraGen Corporation. "This trial is enrolling well, and we expect the data toquickly mature allowing us to provide further updates from the study later inthe second half of this year."
Dr. Ronit Simantov, Vice President and Chief Medical Officer commented,"There remains a substantial unmet need for patients with advanced melanoma.As we continue to evaluate CR011-vcMMAE 1.88 mg/kg given once every threeweeks in this ongoing Phase II trial, we are also looking to further optimizethe activity of CR011-vcMMAE by actively exploring alternative dosingschedules including more frequent intravenous administration of this novelagent."
This ongoing open-label, multi-center Phase II study evaluating CR011-vcMMAE in patients with advanced melanoma utilizes a Simon 2-Stage design witha primary endpoint of objective response rate. Patients enrolled in the studymay have received no more than one prior cytotoxic regimen, but may havereceived an unlimited number of prior cytokine, immune or vaccine therapies.Enrollment in the study is expected to be completed by the end of 2008.
CR011-vcMMAE targets a protein known as GPNMB, which has been shown to beoverexpressed in melanoma, breast cancer and brain tumors. Based on theclinical activity observed in the treatment of melanoma, CuraGen anticipatesinitiating a Phase II trial evaluating CR011-vcMMAE for the treatment ofpatients with metastatic breast cancer in the third quarter of 2008.Furthermore, CuraGen is conducting preclinical research to determine theoptimal approach for utilizing CR011-vcMMAE as a potential treatment of braintumors, including glioblastoma multiforme.
CR011-vcMMAE is an antibody-drug conjugate (ADC) comprised of a fully-human monoclonal antibody against glycoprotein NMB (GPNMB) attached to apotent, synthetic drug monomethyl auristatin E (MMAE), using Seattle Genetics'proprietary technology. GPNMB is a novel, selective target that plays a rolein the ability of cancer cells to invade and metastasize. CR011-vcMMAEcontains an enzyme-cleavable linker designed to be stable in the bloodstreamand to release MMAE after internalization into tumor cells that express GPNMB,resulting in cancer cell death.
The number of people diagnosed with melanoma is rapidly increasing. It isexpected that approximately 60,000 new cases of melanoma will be diagnosed andan 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 haveshown that the median survival is less than nine months.
CuraGen Corporation (Nasdaq: CRGN) is a dedicated clinical-stagebiopharmaceutical company developing diverse approaches for the treatment ofcancer. CuraGen expects to make a difference by advancing its promisingtherapeutics to address the unmet medical needs of cancer patients. CuraGenCorporation is headquartered in Branford, Connecticut. For additionalinformation please visit http://www.curage