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Biotech / Medical : Genta, Inc. (GNTA) -- Ignore unavailable to you. Want to Upgrade?

To: bob zagorin who wrote (1262)	12/15/1999 11:10:00 AM
From: bob zagorin	Read Replies (1) \| Respond to of 1870

GNTA may turn out to be the antisense leader afterall. check this out. Isis Announces Disappointing Results from Isis 2302 Clinical Trial In Crohn's Disease CARLSBAD, Calif., Dec. 15 /PRNewswire/ -- Isis Pharmaceuticals Inc. (Nasdaq: ISIP) announced today that the data from the clinical trial of its antisense ICAM-1 inhibitor, ISIS 2302, in Crohn's disease did not demonstrate efficacy and that the profile of the drug does not support an NDA filing. The efficacy demonstrated, using the combined primary end point of clinical remission plus complete steroid withdrawal, was approximately 20% in all three arms of the study. This negative outcome was unexpected. In late 1998, the company conducted an interim analysis of the first 150 patients enrolled in the study. Based on the positive data from the interim analysis, the company believed that the 300 patient study was likely to support an NDA filing. Despite this setback, Isis believes that its pipeline and technology remain valuable. To be able to continue to develop its clinical pipeline and technology platform, the company anticipates significant restructuring to reduce its burn rate and to ensure appropriate focus of its resources on its most valuable opportunities. In the trial, the effects of two weeks and four weeks of treatment with ISIS 2302 were compared to placebo. The analysis of the data from the study failed to demonstrate the same efficacy profile of ISIS 2302 seen in the interim analysis. At the interim analysis, ISIS 2302 induced steroid-free complete clinical remissions in 29% of the drug treated patients vs. a placebo response rate of 14%. This was statistically different (p=0.047). Both the 2- and 4-week dose groups had similar results. In the placebo group, 34% of the patients discontinued from the study prematurely because of lack of response, while only 16% of the ISIS 2302 treated patients discontinued early. This also was statistically significant (p=0.020). Other measures of efficacy also favored ISIS 2302 in the interim analysis. In the second half of the study, the results were significantly different than the interim analysis. Only 12% of the ISIS 2302 treated patients enrolled in the second half of the study achieved steroid-free remission. This differs from the results in the initial 150 patients (p=0.0047). In the second half of the study, only 6% of the placebo patients discontinued from the study prematurely because of lack of response. This differed significantly from the results in the first half of the study (p=0.0004). In contrast, the early discontinuation rate for lack of clinical response in the drug treated arms was 20%, not significantly different from the results in the first 150 patients. The safety database has not yet been fully analyzed; however, the drug was well tolerated. The company will continue to investigate why the second half of the study was so different from the first. Several variables are being explored which may help explain the final results. The company will make a final decision regarding the development of ISIS 2302 for Crohn's disease after a full investigation of these factors. The company intends to prioritize its R&D programs and initiate a plan to focus resources on its most valuable near-term opportunities. Corporate collaborations in place with large pharmaceutical partners will continue and will help to partially fund R&D efforts. The results presented here represent an initial analysis of the data. These data may change as the study is analyzed further. This press release contains forward-looking statements pertaining to Isis and its drugs in development, its research programs and its future plans. 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 drug discovery and development, and the business, plans and priorities of the company are described in additional detail in Isis' Annual Report on Form 10-K/A for the year ended December 31, 1998, which is on file with the U.S. 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 drugs. The company's first product, Vitravene(TM) (fomivirsen), to treat CMV-induced retinitis in AIDS patients, is being sold in the United States, Europe and Brazil. In addition, Isis has four compounds in human clinical trials: a Phase II of ISIS 2302 for the prevention of renal transplant rejection is near completion, Phase II studies with an enema formulation for ulcerative colitis and a topical formulation for psoriasis, are just beginning and an aerosol administration for asthma is being explored. In addition, Isis has three anticancer compounds: ISIS 3521, ISIS 5132 and ISIS 2503, in Phase II studies. The company also has several additional compounds in preclinical development. Isis' medicinal chemistry and biology research programs support efforts in both antisense and small molecule drug discovery. Vitravene(TM) is a trademark of Novartis AG. SOURCE Isis Pharmaceuticals Inc. CO: Isis Pharmaceuticals Inc. ST: California IN: MTC SU: 12/15/1999 11:00 EST prnewswire.com