ImClone Systems Inc. of New York announced Friday plans toexpand a pilot study to treat malignant melanoma patientswith the company's MelVax monoclonal anti-idiotypic antibody.
In a continuing physician-directed Phase I clinical trial atMemorial Sloan-Kettering Cancer Center in New York, sixmelanoma patients are to receive a 10-week regimen ofMelVax combined with an adjuvant to boost the patients'response against melanoma tumor cells. The adjuvant, BacilleCalmette Guerin (BCG), has already been approved by the FDAfor use in bladder carcinoma therapy.
ImClone (NASDAQ:IMCL) intends to file an investigational newdrug (IND) application with the FDA this year, said HarlanWaksal, ImClone's chief operating officer. It is developingMelVax in collaboration with E. Merck AG of Germany.
MelVax, previously known as BEC-2, was shown in a priorstudy to induce an immunoglobulin G (IGG) response to a non-protein cancer antigen in one of seven patients.
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