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| |  CMV Retinitis and Anti-Inflammatory Drugs Safe and Effective CARLSBAD, Calif., Feb. 6, 1997 -- Speaking at the International Business Communications Meeting on Antisense Therapeutics in San Diego, Daniel Kisner, M.D., President and Chief Operating Officer of Isis Pharmaceuticals (Nasdaq: ISIP) presented data today showing that fomivirsen (ISIS 2922) continues to demonstrate an attractive safety profile and rapid and long-term control of CMV retinitis in AIDS patients, including patients who have failed newer CMV retinitis agents such as Vitrasert and Vistide, as well as standard agents. Isis expects to complete Phase III of fomivirsen trials later in 1997. Dr. Kisner also discussed the positive efficacy results from the recently completed Phase IIa study of ISIS 2302 in Crohn's disease and the company's decision to initiate a large-scale, pivotal quality study in this indication. Results from the Phase IIa study in Crohn's disease will be presented at the end of February at the Canadian Digestive Diseases Week conference in Quebec. Fomivirsen (ISIS 2922) is an antisense drug in randomized, pivotal Phase III trials as a treatment for CMV retinitis in AIDS patients. Dr. Kisner presented data from an open-label, uncontrolled study of patients with advanced CMV retinitis whose disease had progressed with other CMV retinitis therapies including Vitrasert and Vistide. When treated with fomivirsen, many patients achieved significant therapeutic utility including extended progression-free periods, some for as long as 12-18 months, despite the advanced stage of their CMV retinitis. Dr. Kisner said because of the drug's safety, convenient dosing, and effectiveness, support among Phase III clinical investigators is strong. The safety profile of fomivirsen continues to be attractive, characterized by no systemic toxicities. ISIS 2302 is an antisense inhibitor of ICAM-1 gene expression, currently in Phase II trials in Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriasis and kidney transplant rejection. Dr. Kisner said that the safety profile of the drug is highly acceptable. Isis and its partner Boehringer Ingelheim continue to be excited about the potential of ISIS 2302 in Crohn's disease. Plans are underway to initiate a Phase IIb study in this indication in the early second quarter. Dr. Kisner said that results from Phase IIa trials of ISIS 2302 in four additional inflammatory conditions will be available in 1997, and will form the basis for further development in additional indications. Dr. Kisner concluded his presentation with a preview of ISIS 3521/CGP64128A and ISIS 5132/CGP69846A, two antisense anticancer compounds that are completing Phase I trials in patients with a broad range of solid tumors. These compounds are demonstrating a high level of safety and tolerability and have demonstrated in preclinical studies the potential to be important cancer therapeutics. Isis and its partner Novartis (formed from the merger of Ciba and Sandoz) are planning to initiate Phase II trials in these compounds later in 1997 to fully evaluate their potential efficacy. A third antisense anticancer compound, ISIS 2503, an inhibitor of Ha-ras gene expression, is scheduled to enter Phase I clinical trials in the second half of 1997. This press release contains forward-looking statements concerning Isis' portfolio of antisense compounds currently in clinical development. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Actual results could differ materially from those projected in this release. As a result, the reader is cautioned not to rely on these forward-looking statements. These and other risks are described in additional detail in Isis' Annual Report on Form 10-K for the year ended December 31, 1995 and in the Company's most recent quarterly report on Form 10-Q filed with the Securities and Exchange Commission, copies of which are available from the company. Isis Pharmaceuticals, based in northern San Diego County, is engaged in the discovery and development of novel human therapeutic compounds. Isis has five compounds in human clinical trials: ISIS 2922, to treat CMV-induced retinitis in AIDS patients, is in Phase III clinical trials; ISIS 2302, an inhibitor of ICAM-1, is in Phase II clinical trials for renal transplant rejection, rheumatoid arthritis, psoriasis, Crohn's disease and ulcerative colitis; ISIS 3521/CGP64128A and ISIS 5132/CGP69846A, both anticancer compounds, are in Phase I clinical trials; and ISIS 5320, a combinatorially-derived anti-HIV compound, is in Phase I clinical trials. The company also has several additional compounds in preclinical development. Isis' broad medicinal chemistry and biology research programs support efforts in both antisense and combinatorial drug discovery.
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