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Executive Summary

LYNX' AML SYSTEMIC ANTISENSE THERAPY APPROVED TO TREAT 15 PATIENTS under a non-IND protocol at the University of Nebraska Medical Center. The university said that it began treating the first patient, a 19-year-old male with acute myelogenous leukemia, on June 19. He has completed the first 10-day infusion of the antisense oligonucleotide and may receive a second course later this month. Lynx Therapeutics, a newly-formed subsidiary of Applied Biosystems, has exclusive rights to the compound which targets the messenger RNA coded by the p53 gene. UNMC and Lynx are preparing a formal IND for the compound which they expect to file "by late 1992," Lynx said. Because the University of Nebraska and FDA have been working closely together on preparing the IND, Lynx said, the agency was prepared to grant "emergency approval" to use the compound on a case-by-case basis in up to 15 patients prior to the IND submission. The first patient treated had relapsed following an autologous bone marrow transplant. The UNMC researchers believed that he might not have survived for the three-to-six months necessary to find an unrelated bone marrow donor. Lynx believes that the trial involves "the first... antisense compounds administered systemically to humans." At least two other antisense trials have been initiated: one, under an IND held by Isis, involves in situ injection of a compound to treat human papilloma virus ("The Pink Sheet" March 9, In Brief); the other, under an IND held by Genta, involves the ex vivo treatment of bone marrow in chronic myelogenous leukemia patients ("The Pink Sheet" Jan. 27, In Brief). The p53 gene targeted by the compound "has been linked to many forms of human cancer," the university said. "The team of physicians and researchers believe that if the treatment proves effective in treating leukemia, it will nave a much wider use in treating other cancers." The compound "appears to have virtually no toxic effect on normal cells," UNMC added. Foster City, Calif.-based Applied Biosystems announced the formation of Lynx on July 8. The new subsidiary will be headed by ABI founder and former CEO Sam Eletr. "Lynx plans to raise capital and seek corporate partners in order to expedite and expand its collaborations with university and government laboratories," ABI said. ABI, a biotech systems supplier, formed a therapeutic group to develop antisense compounds in 1987. The firm supplied Isis with the ISIS 2105 compound used in the papilloma virus trials under a collaboration that has since been terminated. ABI said it will receive royalties on 2105 if it is commercialized.

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