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CLINICAL RESULTS ON VESTAR'S DAUNOXOME IN AIDS-RELATED KAPOSI'S SARCOMA PRESENTED AT AIDS CONFERENCE

 CLINICAL RESULTS ON VESTAR'S DAUNOXOME IN AIDS-RELATED
 KAPOSI'S SARCOMA PRESENTED AT AIDS CONFERENCE
 AMSTERDAM, The Netherlands, July 20 /PRNewswire/ -- Clinical results presented today at the VIII International Conference on AIDS in Amsterdam demonstrate that the drug DaunoXome(R) has the potential to produce a high response rate with a low incidence of side effects in treating AIDS-related Kaposi's sarcoma (KS). DaunoXome, Vestar, Inc.'s (NASDAQ: VSTR) liposomal formulation of the anti-cancer drug daunorubicin, offers promise as a treatment for KS that can be safely administered in conjunction with anti-viral therapies for the primary treatment of AIDS.
 Results from a Phase I trial indicate that it is possible to safely administer doses of DaunoXome that are much higher than previously reported, in patients with advanced cases of KS. These doses of DaunoXome are also much higher than conventional doses of free daunorubicin and other chemotherapies. The higher doses of DaunoXome may also accelerate the clinical benefit of the drug, and may increase the percentage of complete responses without provoking serious side effects.
 Michael Ross, M.D., executive vice president medical/regulatory affairs at Vestar, presented data on 31 KS patients who received and tolerated doses of up to 60 mg/m2 of DaunoXome every two weeks, substantially higher than the usual doses of conventional (free) daunorubicin. At this higher dose, investigators reported that the drug was well tolerated, myelosuppression (bone marrow toxicity) was tolerable, and no new side effects were seen. Dr. Ross noted that the higher doses of DaunoXome induced responses more rapidly than the 40 mg/m2 dose previously administered in Phase I studies, and that the percentage of complete responders at the higher dose may also be increased.
 In a separate presentation, results were shown for the first time from a Phase II trial underway at the HIVCare program at Saint Francis Memorial Hospital in San Francisco, in which 21 KS patients were treated, of whom 20 responded favorably based on objective criteria. Many of these patients had advanced cases of the disease and had failed on other therapies, including doxorubicin. One patient had a complete response, 19 patients had partial responses, and one patient had stable disease. Eleven of the 21 patients have maintained their response, with a treatment duration of three to 16 months, and continue to receive DaunoXome treatment. Treatment for Kaposi's Sarcoma
 "Based on our clinical results to date, we believe that DaunoXome is an effective treatment for Kaposi's sarcoma compared with other currently available agents," said Dr. Terrence Chew, the lead investigator of the Phase II study, who is medical director of clinical research of HIVCare at Saint Francis Memorial Hospital. "Treatment of advanced Kaposi's sarcoma has been extremely difficult until now, because patients are often receiving other therapy for their underlying disease which makes them more susceptible to serious toxicities, and which can force us to discontinue the therapy for KS. In contrast, we found that toxicity from DaunoXome was mild and infrequent. Perhaps most importantly, the drug was well tolerated in combination with other drugs used to treat AIDS," Dr. Chew stated.
 Dr. Ross also presented a compilation of the most updated results of multicenter Phase II trials of DaunoXome, encompassing a total of 87 patients and more than 500 patient treatment cycles. Of the 56 patients evaluated in the Phase II trials, 95 percent showed clinical benefit. More than 60 percent of the patients showed either a complete or partial response, and another 35 percent showed stabilization of disease. There was no evidence of cardiotoxicity. Other common side effects of chemotherapy, such as nausea, vomiting and fatigue, were generally mild and occurred in less than 10 percent of the treatment cycles. There was no baldness. These Phase II trials are still underway at centers in Los Angeles and San Francisco, and in London, Paris and Berlin. The investigators from Paris to Berlin also presented abstracts of their interim Phase II results at the conference.
 "As we expanded the trials to treat more patients, we have been extremely gratified to see repeated confirmation of the emerging safety and efficacy profile of the drug," said Dr. Ross. "We are particularly delighted that patients can tolerate much higher doses of this drug than would have been predicted, allowing us to control their KS and improve their quality of life. We believe the DaunoXome will play a major role in the treatment of Kaposi's sarcoma," Dr. Ross added. Dr. Ross presented the updated Phase II results at the AIDS Conference on behalf of all the investigators in the multicenter trials.
 Kaposi's sarcoma is the most common of the cancers that afflict AIDS patients, causing a wide spectrum of serious and debilitating symptoms. The disease affects an estimated 15 percent or more of AIDS patients. It is characterized by lesions of the skin, mucous membranes and lymph nodes, and often progresses rapidly to internal organs, including the lungs and gastrointestinal tract.
 A number of therapeutic treatment modalities have been used to control KS. Alpha-Interferon is valuable for patients with a limited disease burden, and an intact immune system. Most patients, however, do not fit into this category. For patients with advanced disease, cytotoxic chemotherapy is usually the treatment of choice. Response rates have been 30-75 percent for chemotherapy. Vincristine, vinblastine, methotrexate, bleomycin, doxorubicin and etoposide all have been used in KS. These agents are limited by their toxicities, however, including cardiotoxicity, and by the fact that they cannot be safely administered in conjunction with the primary therapies for AIDS. DaunoXome Background
 DaunoXome is comprised of daunorubicin encapsulated inside microscopic spheres known as liposomes, with walls similar to those of cell membranes. Once entrapped inside the liposomes, DaunoXome is selectively taken up by cancer cells, resulting in a 10-fold increase in the amount of active drug accumulated in the tumors, as demonstrated in preclinical studies published last month in Cancer Research. The selective killing of cancer cells by DaunoXome is not accompanied by an increase of drugs in normal cells, and therefore leads to clinical benefit without toxicity.
 Vestar, headquartered in San Dimas, California, develops, manufactures and markets pharmaceuticals to treat patients with cancer and serious infections, including AIDS. Among the company's proprietary drug delivery technologies are liposomes to encapsulate pharmaceuticals, and lipid prodrug technology for the development of orally active compounds. Since 1989, Vestar has been marketing in Europe AmBisome(R), a lipisomal formulation of amphotericin B, to treat systemic fungal infections. DaunoXome(R), a liposomal formulation of the chemotherapeutic agent daunorubicin, is in development as Vestar's second major product.
 -0- 7/20/92
 /CONTACT: Roger J. Crossley, M.D., president and CEO of Vestar, 714-394-4000; Jannine Howard, Saint Francis Memorial Hospital, 415-353-6640; or Marcia Kean of Feinstein Partners, 617-577-8110, for Vestar/
 (VSTR) CO: Vestar, Inc.; Saint Francis Memorial Hospital ST: IN: MTC SU:


CN -- NE003 -- 0560 07/20/92 08:31 EDT
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Date:Jul 20, 1992
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