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GENETICS INSTITUTE SUPPLYING RECOMBINANT REVERSE TRANSCRIPTASE TO NIH UNDER COOPERATIVE R&D AGREEMENT; FDA's BIOLOGICS GROUP IS PARTICIPANT

Executive Summary

Genetics Institute is supplying recombinant reverse transcriptase to investigators at the National Institutes of Health under a collaborative research agreement that will give the biotech firm rights to commercialize any resulting anti-AIDS products. "A complete understanding of the structure and functions of reverse transcriptase should enable investigators to develop safer and more effective anti-viral compounds free of the toxic side effects associated with existing anti-HIV drugs such as AZT," Genetics Institute President Gabriel Schmergel maintained in a March 10 press release. "The company is supplying quantities of recombinant reverse transcriptase to researchers at the NIH and has the right of first negotiation to commercialize any reverse transcriptase-based anti-AIDS product that emerges from this work." Part of the NIH Intramural AIDS Targeted Antiviral Program -- the cooperative R&D program -- is the first between Genetics Institute and NIH, and involves seven government research groups. Genetics Institute will not participate in research activities but will share resulting information, NIH said. Program participants include teams from FDA's Center for Biologics, the National Cancer Institute, the National Institute of Allergies & Infectious Diseases, the National Heart Lung & Blood Institute, the National Institue of Diabetes & Digestive and Kidney Diseases and the National Institute of Dental Research. Reverse transcriptase is the enzyme that enables the HIV virus to replicate in human cells. "The primary goal of the current research project with reverse transcriptase is to create a drug that would act specifically on the HIV virus," Genetics Institute Senior VP-Scientific Affairs Robert Kamen explained. "A major drawback of therapies using existing drugs is that although they are effective at inhibiting viral reverse transcriptase, they also interrupt the action of normal cellular enzymes and can thus be severely toxic. A drug that acts more specifically on reverse transcriptase should have fewer side effects." Noting that the R&D collaboration with NIH is dedicated to mapping the precise three-dimensional structure of the reverse transcriptase molecule, Genetics Institute said that the recent agreement expands on existing collaboration with x-ray crystallographers at Harvard University. One Genetics Institute product that has already been used to treat AIDS patients within a clinical setting is granulocyte macrophage colony stimulating factor (GM-CSF). A study published last year in The New England Journal of Medicine reported dose-related increases in the white blood cell count of AIDS patients treated with recombinant GM-CSF. At a recent analyst presentation, Genetics Institute reported preliminary results of two ongoing Phase II studies of GM-CSF. A trial near completion at the Dana Farber Cancer Institute examined GM-CSF's potential in preventing neutropenia secondary to cancer chemotherapy. "The most salient features of this particular study were that the duration of neutropenia or myelosuppression was decreased with GM-CSF in cycles in which the compound was given compared to cycles in which the compound was not given and the blood cell counts with GM-CSF were much higher compared to those patients not receiving GM-CSF," VP-Clinical Development Marc Garnick, MD, said. Garnick also described a second, "relatively mature" study at Duke University. "In this study using GM-CSF in the setting of bone marrow transplantation with intensive doses of chemotherapy, the time for the bone marrow to take successfully was much shorter, and the organ toxicity . . . was markedly lessened with GM-CSF compared to historical controls," he said.

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