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CuraGen's CR011-vcMMAE Starts Phase I Clinical Trial for Metastatic Melanoma

Strategic Insights

— 1 min read

CuraGen Corporation's Investigational New Drug Application (IND) for CR011-vcMMAE, a fully-human monoclonal antibody-drug conjugate, has been cleared by the FDA and dosing of patients has begun in a Phase I clinical trial. The trial will evaluate the safety and potential activity of CR011-vcMMAE in patients with metastatic melanoma, a deadly form of skin cancer. Dr. Mario Sznol, co-principal investigator, commented, "We are very excited to begin evaluating CR011-vcMMAE as a potential treatment for metastatic melanoma." The open-label, multi-center, dose-escalation study will assess patient response and determine the maximum tolerated dose (MTD) of CR011-vcMMAE.

Key Takeaways:

  • CuraGen has initiated a Phase I clinical trial for CR011-vcMMAE in metastatic melanoma patients, with preliminary results expected in Q4 2007.
  • The trial will evaluate the safety, tolerability, and pharmacokinetics of CR011-vcMMAE in patients with unresectable Stage III or Stage IV melanoma who have failed no more than one prior line of cytotoxic therapy.
  • CR011-vcMMAE targets GPNMB, a protein predominantly expressed on the surface of melanoma cells, using a fully-human monoclonal antibody and a potent cell-killing drug, monomethyl-auristatin E (MMAE).
  • The ADC technology was licensed from Seattle Genetics, and the ADC is designed to be stable in the bloodstream, releasing MMAE from CR011 to produce a cell-killing effect upon internalization into the targeted cell.
  • Preclinical studies demonstrate that CR011-vcMMAE produces strong and reproducible effects against tumors in animal models of melanoma.

Statistics:

  • Approximately 30 patients will be enrolled in the trial after the maximum tolerated dose (MTD) is determined.
  • The study will evaluate cohorts of patients receiving increasing doses of CR011-vcMMAE to determine the MTD.

Sources:

  • CuraGen Corporation
  • U.S. Food & Drug Administration (FDA)
  • Health & Medicine Week editors
  • Seattle Genetics, Inc.
  • Abgenix, now Amgen Fremont, a wholly-owned subsidiary of Amgen

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