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JOHNS HOPKINS' AMPLIGEN INTERFERON INDUCER INTO PHASE II

Executive Summary

JOHNS HOPKINS' AMPLIGEN INTERFERON INDUCER INTO PHASE II clinical trials starting June 1 at Hahnemann University (Philadelphia) under a three-year, $5.5 mil. Natl. Cancer Institute grant, officials from the school announced at a May 15 Capitol Hill press conference. The first patients treated will be those with chronic myelocytic leukemia, and similar trials will be proposed for the treatment of acquired immune deficiency syndrome, officials said. Ampligen was developed by researchers at Hahnemann and Johns Hopkins University, and Hopkins holds the patent on the drug. In Phase I studies, seven of 12 patients with advanced cancers showed "partial or more than partial tumor response" to Ampligen, Hahnemann's Institute for Cancer & Blood Diseases Director of Clinical Research William Carter, MD, said. "One was a patient with kidney cancer, and interferon, itself, will be effective at about 15% to 30% of patients with kidney cancer," Hahnemann Institute President Isadore Broadsky, MD, said. He added that Phase I trials showed that Ampligen is non-toxic in "very large doses," and that the drug produced no side effects. Hahnemann officials maintained that Ampligen can safely turn on the body's own immune system by stimulating the production of interferon and turn off abnormal cancer oncogenes. In addition, Ampligen can work directly on tumor cells or can work in combination with interferon to produce a "synergistic effect," Carter said. Johns Hopkins Div. of Biophysics Director Paul Ts'o, co-developer of the drug, noted that Ampligen can produce "all kinds of interferon, and is a much more powerful component than interferon." Ts'o asserted that "Ampligen is also less expensive than interferon, even considering that interferon can be manufactured now by genetic engineering techniques." A press handout from the Hahnemann University group added that Ampligen can "be handled and stored much more conveniently than interferon." "Kidney cancer and colon carcinoid cancer are the principal cancers for which Ampligen is used," Brodsky explained. Noting that the compound was initially tested in patients for whom chemotherapy had failed, Brodsky reported that the investigators "have received approval from FDA to use the drug earlier and earlier in the tumor process. Now in certain instances the drug can be used as what is termed first line therapy in kidney tumors and certain types of leukemia." Discussing their strategy for the clinical trials, the Hahnemann group noted that they will screen cancer patients for the studies through "extensive" use of clonogenic assays to determine which patients have tumor cells responding in vitro to Ampligen. "Clonogenic data from about 50 patients have now been obtained" with "at least half" of the tumor samples responding to the compound, the press release notes. The researchers indicated that other cancers seen as potential candidates for Ampligen therapy include hepatoma, inoperable gastric cancer, and cancers suspected to have viral etiology. Through the ability to identify ahead of time which type of interferon will be clinically promising and the ability to monitor oncogene activity, Hahnemann researchers will "try to treat cancer as early as we can, hopefully in the very early stages, even after the first fuse has been lit," Carter said. However, Carter stressed that Ampligen is "not a quick fix."

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