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CETUS' BETA INTERFERON IS NOW IN PHASE II CLINICALS

Executive Summary

CETUS' BETA INTERFERON IS NOW IN PHASE II CLINICALS, company President and CEO Robert Fildes, PhD, reported on April 16 at the annual Alex Brown & Sons Health Care Seminar in Baltimore. He indicated that targets for Phase II tests would include skin cancer, renal cancer, cell carcinoma and hairy cell leukemia. In Phase I trials, all four cancers showed signs of responding to interferon tests, Fildes said. Betaseron, Cetus trade name for its interferon, is the result of a joint venture between Cetus and Triton Biosciences, a Shell Oil Company subsidiary. Fildes noted that the company is currently finishing Phase I clinicals for its interleukin-2 product and hopes to begin Phase II studies by the middle of this year. Cetus is also looking at the product's potential in combination with certain other drugs, interferon, and antiviral drugs, according to Fildes. The firm sees possibilities for these types of immunoregulators in combination therapy for AIDS, leukemia, ovarian carcinoma and melanoma, Fildes said. Last February, the company announced that it had been granted patent approval by the U.S. Patent and Trademark Office for its rDNA interleukin-2 muteins, the first such product patents issued in the U.S. on a recombinant IL-2 composition ("The Pink Sheet" Feb. 11, T&G-1). Muteins, or mutationally altered proteins, are a key element of the overall Cetus business strategy. "The strategy we have taken has been to look for improvements and come up with unique molecules which we can patent and get a separate proprietary position on," Fildes emphasized. "Our position is that patents on natural proteins will be relatively narrow because one of the things you can't show is clear structure/activity relationships." Fildes noted that the firm's interleukin-2 patents were "specifically on muteins and on formulation of muteins." He continued, "We believe . . . we will be outside the Japanese patents on IL-2. So there are only two games in town -- either it's Hoffmann-LaRoche or it's us, that's the way we see the world on IL-2." In the immunotoxin area, Cetus has developed target-specific monoclonal antibodies and linked them to toxins which will kill those targets. According to Fildes, the monoclonal furthest in development in pre-clinicals for breast cancer. Clinicals are expected to begin within the next 12 months. Cetus continues to maintain a relatively strong cash position. At the end of 1984, the firm had $88 mil. in the bank. Fildes indicated that overall the company has access to $200 mil. "to complete the tasks we have set out." While other small biotechnology companies find diagnostic products attractive because they can be brought to market more rapidly than therapeutic products, Cetus views its diagnostics business as secondary to its therapeutics operations. Noting that the diagnostics market is small compared to therapeutics, as well as overcrowded, Fildes commented, "We don't really see it [diagnostics] as being the major opportunity for us. The major opportunity for us is going into business in therapeutics."
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