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MEDAREX PLANS EXPANDED PHASE II BONE MARROW PURIFICATION TRIALS

Executive Summary

MEDAREX PLANS EXPANDED PHASE II BONE MARROW PURIFICATION TRIALS in 1992 for the treatment of acute myeloid leukemia. The Princeton, N.J.-based biopharmaceutical R&D firm presented Phase II data at the Dec. 9 meeting of the American Society of Hematology in support of its claim that its monoclonal antibody bone marrow purification technique significantly increased the survival rate of patients with AML. The company is currently enrolling patients for further Phase II studies, but final trial size has not yet been determined. The firm may seek expedited review by FDA, given the relatively short median survival rate of AML patients -- one year for those treated with conventional therapies (chemotherapy and allogeneic bone marrow transplants). In the study of 55 AML patients reported at the hematology meeting, four of seven patients in first remission were disease free for 14 to 61 months after treatment, a 67% two-year actuarial survival rate. The normal survival rate for AML patients in first remission receiving just chemotherapy is 25%, Medarex said. In addition, the 43 patients in second or third remission periods achieved a two-year survival rate of 35%, compared to less than 5% for patients not receiving a bone marrow transplant. The remaining five patients in the trial were in first relapse and three of them survived disease free. Medarex believes its bone marrow purification technique is more effective than chemotherapeutic methods used to purge leukemia cells from extracted bone marrow. Medarex' purification process uses a group of endogenous protein factors and enzymes called the "complement system," which can be mediated by a pair of Medarex monoclonal antibodies to kill tumors or pathogens. Although the marrow purification technique is the company's lead product, it does not use the company's core technology of Bispecific antibodies. Bispecific antibodies are two monoclonal antibodies bound together, one a "targeting antibody" and the other a proprietary "Trigger" antibody, which was patented in September 1990. The Trigger antibody is said by the company to avoid the problem of "antibody blockade," in which all Fc receptors of a macrophage, which trigger cell destruction, are occupied by other antibodies. Medarex binds monoclonal antibodies that target specific pathogens, including HIV and cancer, to its Trigger antibody, which then provokes an immune response against the pathogen. An in vivo treatment for AML and small cell carcinoma of the lung, MDX-11, is the farthest along of the company's Bispecific antibody products. The treatment incorporates one of the two antibodies used in the purification product, fused with the Trigger antibody. An IND was filed on Jan. 13 for the product's use against AML. INDs for the treatment of AIDS and ovarian cancer will be filed later in 1992, the company said. Medarex went public in June 1991, raising over $14 mil. from the sale of 2.3 mil. shares. The company emerged from a 1987 joint venture between Dartmouth Medical School and Essex Chemical Corp. and became independent in 1989. Dartmouth Medical School assigned the patent and rights to the use of the Trigger antibody to Medarex on a royalty-free basis, in return for a 9% equity stake in the company. Medarex is developing its AIDS treatment in collaboration with the French Centre National de Transfusion Sanguine, which has agreed to provide $3.2 mil. in funding and a license to its HIV- targeting antibody. Medarex' AIDS therapy would use the CNTS antibody linked to the Trigger antibody. In return for funding and the antibody, CNTS receives marketing rights outside of North America to any AIDS treatment using the Trigger antibody. Medarex also has research agreements with SmithKline Beecham and Upjohn for the development of AIDS treatments. The Medarex management team is led by President and CEO Donald Drakeman, formerly Essex Chemicals VP. Charles Schaller, another former Essex Chemicals topsider, is chairman. Nathan Dinces, PhD, Genzyme's former director of development and a scientific officer at Applied DNA Systems, is VP-operations. Medarex' founders are Dartmouth Medical School's Michael Fanger, PhD, and Paul Guyre, PhD, and University of Pittsburgh's Edward Ball, MD, formerly of Dartmouth Medical.

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