Advertisement
"We are very pleased with the clinical progress achieved withCR011-vcMMAE. Completing enrollment in this melanoma study ahead of schedulehighlights the external support for this novel antibody-drug conjugate fromour investigators," commented Dr. Timothy Shannon, President and ChiefExecutive Officer of CuraGen. "We expect that treatment of patients will stillbe ongoing in this Phase II trial at the time of iSBTc, and therefore lookforward to presenting the first data from all treated patients in November,and anticipate that final results from the study will be available during thefirst half of 2009."
Advertisement
A total of 36 patients were enrolled in this Phase II open-label,multi-center trial evaluating the efficacy and safety of CR011-vcMMAE 1.88mg/kg administered intravenously once every three weeks in patients withunresectable Stage III or Stage IV melanoma. Eligible patients had progressivedisease at trial entry and may have received one prior cytotoxic regimen andany number of prior immunotherapies. Clinical efficacy endpoints includeobjective response rate, progression free rate, time to response and durationof response.
CuraGen is also continuing the Phase I portion of the trial evaluating theuse of a weekly as well as a two out of every three week regimen ofCR011-vcMMAE to explore the optimal dose and schedule of administration.Results from these more frequent dosing schedules are expected to be availablein the first half of 2009.
In addition, CR011-vcMMAE is being studied in an ongoing Phase II trial inpatients with metastatic breast cancer who have received previouschemotherapy. It is anticipated that preliminary results from the breastcancer trial will be presented in the first half of 2009.
CR011-vcMMAE targets glycoprotein NMB (GPNMB), which is overexpressed in avariety of cancers including melanoma, breast cancer and brain tumors.CR011-vcMMAE is an antibody-drug conjugate comprised of a fully-humanmonoclonal antibody against GPNMB linked to a potent tubulin destabilizingagent, monomethyl auristatin E (MMAE). The enzyme-sensitive linker, which waslicensed from Seattle Genetics, is designed to be stable in the bloodstreamand to release MMAE inside tumor cells, resulting in cancer cell death.
About Melanoma
According to the American Cancer Society, it is expected thatapproximately 60,000 new cases of melanoma will be diagnosed, including nearly11,000 patients diagnosed with Stage III or Stage IV disease, and an estimated8,000 people in the U.S. will die of the disease during 2008. The prognosisfor patients with advanced melanoma is poor, and studies have shown that themedian survival is less than nine months.
About CuraGen
CuraGen Corporation (Nasdaq: CRGN) is a dedicated clinical-stagebiopharmaceutical company developing diverse approaches for the treatment ofcancer. CuraGen Corporation is headquartered in Branford, Connecticut. Foradditional information please visit http://www.curagen.com.
Forward-Looking Statements
Statements in this press release regarding management's futureexpectations, beliefs, intentions, goals, strategies, plans or pros
