Isis Reports Preclinical Data Supporting Liver Safety of ISIS 301012- Results of animal studies distinguish liver effects of apoB inhibition from MTP inhibition and support liver safety of ISIS 301012
CARLSBAD, Calif., October 06, 2007 /PRNewswire-FirstCall/ -- Isis Pharmaceuticals, Inc. announced new results of preclinical studies reaffirming the safety profile of ISIS 301012 and enhancing the understanding of its activity in the liver presented by Richard Lee, Ph.D. of Isis in a 3:45 p.m. oral session today at the Drugs Affecting Lipid Metabolism (DALM) XVI International Symposium in New York City. Isis will host a conference call Monday morning at 8:00 a.m. E.T. to discuss these results along with results of Phase 2 studies of ISIS 301012 presented at DALM.
The preclinical data presented provide a mechanistic explanation for Isis' previous observations that, in mice and monkeys, treatment with antisense inhibitors of apolipoprotein B-100 (apoB) is associated with reduced liver fat content. This observation is in contrast to the effects of either small molecule or antisense inhibitors of microsomal triglyceride transfer protein (MTP), another component of the cholesterol export pathway, which cause severe liver fat accumulation in the same animal models.
In the study reported today at DALM, Isis demonstrated that apoB inhibition led to compensatory changes in liver fat metabolism including reduced fat production and increased fat breakdown. These changes were documented in metabolic indicators measured in the blood serum and were accompanied by consistent changes in liver gene expression profiles. Having now developed the appropriate tests and demonstrated that serum metabolites are relevant indicators of liver fat metabolism in preclinical studies, Isis plans to incorporate similar measurements in its future clinical trials of ISIS 301012.
ABOUT ISIS 301012 AND CHOLESTEROL
ISIS 301012 is a second-generation antisense drug that reduces the production of apoB-100, a protein critical to the synthesis and transport of "bad" cholesterol and a target that has proved to be undruggable using traditional, small-molecule approaches. Cholesterol can be carried in the bloodstream in a variety of forms, with high-density lipoprotein, or HDL-C, being the good form, and low-density lipoproteins, or LDL-C, and very low-density lipoproteins, or VLDL-C, being bad forms directly involved in heart disease. Collectively, LDL-C, VLDL-C, and other bad forms of cholesterol are referred to as "non-HDL-C." The lowering of non-HDL-C is a key component in the prevention and management of cardiovascular disease. Isis plans to develop ISIS 301012 as the drug of choice for patients who are unable to achieve target cholesterol levels with statins alone or who are intolerant of statins. Isis has selected 200 mg/week as its development dose for future studies, including the registration studies for FH and the long-term coadministration study planned for patients with routine high cholesterol, both expected to begin this year.
Conference Call Information
At 8:00 a.m. Eastern Time Monday, October 8, Isis will conduct a live webcast conference call to discuss ISIS 301012 results. Interested parties may access the webcast at http://www.isispharm.com or listen to the call by dialing 888-211-7384 (U.S.) / 913-312-0380 (International). A replay will be available for a limited time.
ABOUT ISIS PHARMACEUTICALS, INC.
Isis is exploiting its expertise in RNA to discover and develop novel drugs for its product pipeline and for its partners. The Company has successfully commercialized the world's first antisense drug and has 17 drugs in development. Isis' drug development programs are focused on treating cardiovascular and metabolic diseases. Isis' partners are developing drugs for a wide variety of diseases. Ibis Biosciences, Inc., Isis' wholly owned subsidiary, is developing and commercializing the Ibis T5000(TM) Biosensor System, a revolutionary system to identify infectious organisms. As an innovator in RNA-based drug discovery and development, Isis is the owner or exclusive licensee of over 1,500 issued patents worldwide. Additional information about Isis is available at http://www.isispharm.com.
This press release includes forward-looking statements regarding the development, activity, therapeutic potential and safety of ISIS 301012 in treating patients with high cholesterol. Any statement describing Isis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement, including those statements that are described as Isis' goals or projections. 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, in developing and commercializing systems to identify infectious organisms that are effective and commercially attractive, and in the endeavor of building a business around such products. Isis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward- looking statements. Although Isis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Isis' programs are described in additional detail in Isis' annual report on Form 10-K for the year ended December 31, 2006, and its quarterly report on Form 10-Q for the quarter ended June 30, 2007, which are on file with the SEC. Copies of this and other documents are available from the Company.
In this press release, unless the context requires otherwise, "Isis," "Company," "we," "our," and "us" refers to Isis Pharmaceuticals and its subsidiaries.
Isis Pharmaceuticals, Ibis Biosciences and Ibis T5000 are registered trademarks or trademarks of Isis Pharmaceuticals, Inc.
CONTACT: Kristina Lemonidis, Associate Director, Investor Relations,+1-760-603-2490, or Amy Blackley, Ph.D., Manager, Corporate Communications,+1-760-603-2772, both of Isis Pharmaceuticals, Inc.
Web site: http://www.isispharm.com/
Ticker Symbol: (NASDAQ-NMS:ISIS)
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Posted: October 2007