ImClone Systems Inc. is beginning Phase Ib/IIa clinical trials ofits malignant melanoma vaccine MelVax. The safety and dosingtrial will include 36 to 39 patients at three centers.

MelVax is a proprietary anti-idiotypic monoclonal antibodydesigned to mimic GD3, an antigen found on the surface ofmelanoma tumor cells (as well as other tumor cells) that elicitsan immune response. New York-based ImClone said last weekthat in previous pilot studies conducted with cancer patients"MelVax has been shown to evoke a humoral response againstGD3."

The current safety and dosing trial will be conducted atMemorial Sloan-Kettering Cancer Center in New York, thePittsburgh Cancer Institute at the University of PittsburghMedical Center and the Thomas Jefferson University Hospital inPhiladelphia. A Phase I physician-sponsored trial initiated atMemorial Sloan-Kettering earlier this year is ongoing.

ImClone's (NASDAQ:IMCL) anti-idiotypic monoclonal antibodyis also being tested in the same formulation as a vaccine forsmall-cell lung cancer. The vaccine for this indication is calledLuVax. A Phase I pilot study for the product was initiated inFebruary under an investigational new drug applicationassigned to the Memorial Hospital affiliate of Memorial Sloan-Kettering. -- Brenda Sandburg

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