CuraGen Completes Enrollment in Phase II Trial of CR011-vcMMAE in Metastatic Melanoma
Thursday September 11, 6:30 am ET
- Preliminary results to be presented on November 1, 2008 at 2008 iSBTc Annual Meeting -
BRANFORD, Conn., Sept. 11 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused on oncology, today announced that it has completed the enrollment of patients into its Phase II trial evaluating CR011-vcMMAE for the treatment of advanced melanoma. CuraGen also announced today that Phase II results from this trial will be presented during an oral session at the 23rd Annual Meeting of the International Society for Biological Therapy of Cancer (iSBTc), being held October 31 -- November 2, 2008, in San Diego, CA. The trial will be presented by Dr. Patrick Hwu, Co-Principal Investigator and Professor and Chairman of the Department of Melanoma Medical Oncology at The University of Texas, M.D. Anderson Cancer Center.
"We are very pleased with the clinical progress achieved with CR011-vcMMAE. Completing enrollment in this melanoma study ahead of schedule highlights the external support for this novel antibody-drug conjugate from our investigators," commented Dr. Timothy Shannon, President and Chief Executive Officer of CuraGen. "We expect that treatment of patients will still be ongoing in this Phase II trial at the time of iSBTc, and therefore look forward to presenting the first data from all treated patients in November, and anticipate that final results from the study will be available during the first half of 2009."
A total of 36 patients were enrolled in this Phase II open-label, multi-center trial evaluating the efficacy and safety of CR011-vcMMAE 1.88 mg/kg administered intravenously once every three weeks in patients with unresectable Stage III or Stage IV melanoma. Eligible patients had progressive disease at trial entry and may have received one prior cytotoxic regimen and any number of prior immunotherapies. Clinical efficacy endpoints include objective response rate, progression free rate, time to response and duration of response.
CuraGen is also continuing the Phase I portion of the trial evaluating the use of a weekly as well as a two out of every three week regimen of CR011-vcMMAE to explore the optimal dose and schedule of administration. Results from these more frequent dosing schedules are expected to be available in the first half of 2009.
In addition, CR011-vcMMAE is being studied in an ongoing Phase II trial in patients with metastatic breast cancer who have received previous chemotherapy. It is anticipated that preliminary results from the breast cancer trial will be presented in the first half of 2009.
CR011-vcMMAE targets glycoprotein NMB (GPNMB), which is overexpressed in a variety of cancers including melanoma, breast cancer and brain tumors. CR011-vcMMAE is an antibody-drug conjugate comprised of a fully-human monoclonal antibody against GPNMB linked to a potent tubulin destabilizing agent, monomethyl auristatin E (MMAE). The enzyme-sensitive linker, which was licensed from Seattle Genetics, is designed to be stable in the bloodstream and to release MMAE inside tumor cells, resulting in cancer cell death.
iSBTc Presentation Details
Title: Phase I/II Study of CR011-vcMMAE, an Antibody-Drug Conjugate
targeting GPNMB, for the Treatment of Patients with Advanced
Melanoma
Type: Oral presentation
Presenter: Dr. Patrick Hwu
Session: Tumor Targeting Monoclonal Antibodies
Date/Time: November 1, 2008 from 2:45 p.m. to 4:15 p.m.
surf's up......crikey
