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REPLIGEN’s ANTI-CD11b MAb TO BEGIN PHASE I/II TRIALS IN EARLY 1993

Executive Summary

REPLIGEN's ANTI-CD11b MAb TO BEGIN PHASE I/II TRIALS IN EARLY 1993, Repligen Chief Operating Officer John Kenward told a recent Oppenheimer & Co. health care conference in New York City. Repligen met with FDA to discuss clinical development plans for the anti-inflammatory monoclonal antibody on Sept. 2, Kenward said. "We plan to file an IND for the molecule by the end of 1992 and to begin clinical trials in first quarter 1993," he added. "Initial studies will target diseases with clear endpoints," which will help Repligen "to well delineate clinical toxicities," Kenward said during the Oct. 22 meeting with the financial community. Early studies could involve patients suffering inflammation associated with ideopathic pulmonary fibrosis, hypersensitive pneumonitis or Pneumocystis carinii infections. Ultimately, Repligen plans to move the anti-CD11b MAb into a more difficult patient population: "trauma shock will be our target indication for final licensing," Kenward said. Other possible targets include transplantation, myocardial infarction, cardiopulmonary bypass and adult respiratory distress syndrome, he indicated. Repligen CEO Sandford Smith outlined the financial details of Repligen's partnership with Lilly for the CD11b project ("The Pink Sheet" May 25, T&G-8). Lilly will pay R&D revenues "in excess of $30 mil." over the three years of the deal, Smith said, plus "premarketing milestones in the neighborhood of $15 mil." Repligen also will be reimbursed for "all clinical supplies at cost plus 5%." The development program thus will be at "no cost to Repligen," Smith said. A Phase I/II study of Repligen's recombinant platelet factor four (PF4 or Replistatin) in Kaposi's sarcoma patients is expected to be completed in November, Kenward said. Repligen began the placebo-controlled multi-dose trial at San Francisco General Hospital on July 9. "We have observed no reportable toxicity in any patient at any dose level," Kenward said. Data from the trial will be analyzed in time for the May 1993 American Society of Clinical Oncology meeting, he added. The firm has begun planning "multiple systemic Phase II anticancer studies that will probably begin in the second half of 1993," Kenward said. Possible disease targets include malignant melanoma, renal cell carcinoma and colorectal cancer, he added. A "short term and potentially not so arduous" development program for Replistatin for heparin neutralization is also under way, Kenward said. "We've been encouraged by FDA to test PF4's heparin neutralizing abilities in post-angiography and [post-] angioplasty populations," Kenward said. "We're planning to initiate a Phase I/II clinical trial early in 1993....If there are no adverse findings, we are planning to move into full Phase II dose determination studies for cardiopulmonary bypass later in 1993." Replistatin's development is being funded by a limited partnership created in March ("The Pink Sheet" March 16, T&G-6). Repligen's third development project, a multivalent AIDS vaccine collaboration with Merck, is nearing the clinical stage as well. "Clinical protocols have been finalized" for the multivalent vaccine, Smith said. "We would expect to begin this trial in the first quarter of next year." The "plan is that this prototype would be tested in both infected and noninfected individuals," Smith added. He acknowledged that Repligen has not "moved as aggressively into the clinic" as some AIDS vaccine manufacturers, explaining that the firm wanted to be sure that its vaccine "can be more broadly neutralizing" of different strains of the AIDS virus.
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