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Biotech / Medical : Ionis Pharmaceuticals (IONS) -- Ignore unavailable to you. Want to Upgrade?

To: TomOrt who wrote (2561)	5/10/1999 9:09:00 AM
From: Mailbu	Read Replies (1) \| Respond to of 4676

Monday May 10, 6:00 am Eastern Time Company Press Release SOURCE: Isis Pharmaceuticals Isis Begins Phase II Testing of Third Anticancer Drug, Isis 2503 CARLSBAD, Calif., May 10 /PRNewswire/ -- Isis Pharmaceuticals (Nasdaq: ISIP - news) announced today the initiation of Phase II clinical testing of ISIS 2503, its third antisense anticancer compound in clinical development. In Phase I testing, ISIS 2503 demonstrated an encouraging safety profile in patients with solid tumors. In Phase II trials of ISIS 2503, the compound will be evaluated as a single-agent in patients with colon, breast, pancreatic and non-small cell lung cancers. These trials will provide preliminary data on the anti-tumor activity of ISIS 2503 against these common tumor types. Approximately ten sites in the United States and Europe will enroll 15-30 patients per tumor type in these trials. Phase I trials examining the use of ISIS 2503 in combination with approved chemotherapies are also planned in 1999. In Phase I studies, ISIS 2503 was well-tolerated, with no clinically significant toxicities observed among 22 patients with a variety of solid tumors who received the drug by 14-day continuous infusion repeated every 21 days. This schedule will be used in the Phase II trials. Prolonged stable disease was observed in 4 patients on this trial, including one patient with pancreatic cancer who had disease stabilization for 8 treatment courses administered over 6 months. ISIS 2503 is a potent, selective antisense inhibitor of H-ras gene expression. H-ras is one of a family of ras genes that are involved in the process by which cells receive and send signals that affect their behavior. Substantial evidence exists to support a direct role for the ras gene products in the development and maintenance of human cancers. ISIS 2503 is being developed by Isis Pharmaceuticals. This press release contains forward-looking statements pertaining to the therapeutic potential of ISIS 2503, an antisense anticancer compound in clinical development. Vitravene(TM), an antisense drug in development as a treatment for CMV retinitis in AIDS patients. 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 concerning the therapeutic potential of ISIS 2503 are described in additional detail in Isis' Annual Report on Form 10-K for the year ended December 31, 1998 which is on file with the U.S. Securities 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 six compounds in human clinical trials: Vitravene(TM) (fomivirsen), to treat CMV-induced retinitis in AIDS patients, has been approved for marketing by the FDA and has recently received a positive recommendation by the EMEA for European marketing; ISIS 2302, an inhibitor of ICAM-1, is in a pivotal quality trial for Crohn's disease, Phase II clinical trials for renal transplant rejection and is being explored as an enema formulation for ulcerative colitis, a topical administration for psoriasis and an aerosol administration for asthma; ISIS 3521 is in Phase II trials as a treatment for cancer; ISIS 5132 is in Phase II clinical trials as a treatment for cancer: ISIS 2503 has entered Phase II trials as a treatment for cancer and ISIS 13312 is in Phase I/II clinical trials for the treatment of CMV retinitis in AIDS patients. The company also has several additional compounds in preclinical development. ISIS' broad medical chemistry and biology research programs support efforts in both antisense and small molecule drug delivery. Vitravene(TM) is a trademark of Novartis AG. SOURCE: Isis Pharmaceuticals More Quotes and News: ISIS Pharmaceuticals Inc (Nasdaq:ISIP - news) Related News Categories: biotech, medical/pharmaceutical