Isis' Partners Present Clinical Data on Antisense Drugs at the American Society of Clinical Oncology
CHICAGO and CARLSBAD, Calif., June 02, 2008 /PRNewswire-FirstCall/ -- Isis Pharmaceuticals, Inc. announced today that two of the Company's partnered oncology drugs were highlighted during the American Society of Clinical Oncology (ASCO) meeting. Data from both drugs highlighted positive activity that supports the continuation of clinical development, and both drugs were well tolerated up to very high doses. Results from Eli Lilly's Phase 1 clinical trial evaluating LY2181308 in patients with cancer and updated data from OncoGenex's Phase 2 trial evaluating OGX-011 in patients with hormone refractory prostate cancer (HRPC) were presented yesterday, June 1, at the annual ASCO meeting in Chicago. Both Lilly and OncoGenex are developing additional anticancer drugs discovered by Isis.
In both presentations, antisense drugs being developed by Isis' partners OncoGenex and Lilly continue to demonstrate the potential of antisense technology to treat multiple cancers. OncoGenex presented Phase 2 data on OGX-011 demonstrating better than expected survival results in combination with chemotherapy, reduction in levels of clusterin (the target of OGX-011), durable reductions in pain, and a decline in PSA, a protein that is often elevated in patients with prostate cancer. Encouraging data from this trial support initiation of registration trials required for product approval. OGX-011 was jointly discovered and is being co-developed by Isis and OncoGenex. Lilly presented first-in-human data from LY2181308 that showed the drug distributed to tumor cells with evidence of reduced survivin protein levels in tumor cells, LY2181308's target and one of the most commonly elevated proteins in cancer. Lilly has selected a dose of 750 mg/week of LY2181308 for Phase 2 studies where LY2181308 will be evaluated in combination with other oncology agents.
"The progress our partners are making with our antisense drugs demonstrate the potential of antisense technology to provide new, first-in-class treatment options to treat a variety of cancers. Antisense drugs are highly selective for their targets which minimizes the off target interactions that are responsible for so many toxicities observed with traditional drugs in oncology studies," said Brett Monia, Ph.D., Vice President of Drug Discovery Research at Isis Pharmaceuticals. "The encouraging safety profiles observed in both Lilly's and OncoGenex's studies support further clinical evaluation of both drugs."
OGX-011 and LY2181308 are part of Isis' cancer portfolio of first-in-class drugs, which act upon biological targets associated with cancer progression and/or treatment resistance. The distribution of antisense drugs to tumor cells and the high degree of specificity of these drugs to their target make them attractive new treatment options for a broad range of cancers.
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 18 drugs in development. Isis' drug development programs are focused on treating cardiovascular and metabolic diseases. Isis' partners are developing antisense drugs invented by Isis to treat a wide variety of diseases. Ibis Biosciences, Inc., Isis' majority-owned subsidiary, is developing and commercializing the Ibis T5000(TM) Biosensor System, a revolutionary system to identify infectious organisms. Isis is a joint owner of Regulus Therapeutics LLC, a joint venture focused on the discovery, development and commercialization of microRNA therapeutics. 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 Isis' business, its drug discovery and development pipeline, and the therapeutic potential of LY2181308 and OGX-011 for the treatment of cancer. 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. 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, 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, 2007, and its quarterly report on Form 10-Q for the quarter ended March 31, 2008, 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 is a registered trademark of Isis Pharmaceuticals, Inc. Ibis Biosciences and Ibis T5000 are trademarks of Ibis Biosciences, Inc. Regulus Therapeutics is a trademark of Regulus Therapeutics LLC.
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: June 2008