CEL-SCI WILL FILE IND FOR IL-2 MALIGNANT MELANOMA TRIALS IN U.S.
CEL-SCI WILL FILE IND FOR IL-2 MALIGNANT MELANOMA TRIALS IN U.S. as soon as the company completes a secondary stock offering, according to a Dec. 23 preliminary prospectus. Phase II trials of Cel-Sci's "cocktail" interleukin-2 product for treatment of head and neck cancer already are under way in Florida, under approval from the state's Department of Health and Rehabilitative Services. Cel-Sci also is studying the IL-2 product in Phase II trials in the U.K. focusing on malignant melanoma. Once the stock sale goes through, Cel-Sci will file an IND for broad solid state tumor indications in this country. The prospectus notes that additional studies may be needed to support the IND request. However, given the early "positive" results from the Florida study, the company will ask for permission to gather any supporting information concurrently with, rather than prior to, Phase II trials. If FDA grants the IND, Cel- Sci will request Treatment IND status, the prospectus adds. To date, two patients have been treated at the H. Lee Moffitt Cancer Research Center in Tampa. After two treatment cycles, both patients demonstrated "significant reduction of tumor volume," "leukocyte infiltration into the tumor sites indicating an intense immune reaction" and a doubling of blood lymphocyte counts, Cel- Sci says. Cel-Sci defines its "cocktail" product as "an IL-2 rich mixture of certain lymphokines" of which IL-2 is only one component. The Alexandria, Va.-based company produces both IL-2 and its IL-2 product via cell-culture technology using mammalian cells, an approach which the firm claims may offer certain advantages over genetically engineered, bacteria-produced products. For example, Cel-Sci researchers are applying the "cocktail" in small dosages, versus the "huge dosages" required for the administration of bacteria-produced, single substance IL- 2. The prospectus registers 900,000 units for sale, each unit consisting of five shares of common stock and five common stock purchase warrants. Underwritten by Kober Financial, the sale is expected to net Cel-Sci about $12.4 mil. While the bulk of the proceeds (75%) will go to support proprietary Cel-Sci projects -- Phase II clinicals, construction of a plant, general and administrative expenses and repayment of debt -- the remaining 25% is slated for Cel-Sci's AIDS vaccine joint venture with Alpha 1 Biomedicals. The joint venture, Viral Technologies, currently is in Phase I trials with a prototype AIDS vaccine based on HGP-30, a synthesized component of the p-17 gag protein thought to be an internal region within the HIV-1 virus. As of Nov. 30, 19 healthy HIV-negative volunteers at sites in Los Angeles and San Francisco had been vaccinated with doses of HGP-30 with no clinically significant adverse effects. Viral Technologies expects to complete Phase I trials by autumn 1992; following the stock sale, the company plans to seek an IND for additional Phase I trials in HIV-positive volunteers. Viral Technologies also is seeking permission to study HIV- positive patients in the U.K.
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