Healthcare Industry News: saphenous vein
News Release - November 30, 2006
Anesiva and Lumen Therapeutics Enter Agreement Granting Lumen Access to Data From Studies in Bypass ProceduresSOUTH SAN FRANCISCO, Calif. and MOUNTAIN VIEW, Calif., Nov. 30 (HSMN NewsFeed) -- Anesiva, Inc. and Lumen Therapeutics announced today that they have entered into an agreement which grants Lumen a non-exclusive license to clinical data and technical information relating to the prevention of saphenous vein graft disease (SVGD). Lumen will use this information in planning future clinical studies of its lead product, LT-1951, which is incorporated into coronary artery bypass graft (CABG) surgery as a one-time, ex vivo application to the saphenous vein bypass grafts. LT-1951 treatment is intended to suppress both early graft failure due to thrombosis and neointimal hyperplasia which, if unchecked, leads to late stage graft failure. Under the terms of the agreement, Anesiva will receive royalties on net sales of LT-1951 and an equity position in Lumen Therapeutics.
"The approach that Lumen is taking to enhance CABG surgeries is an exciting one, and we are hopeful that our clinical data and know-how will benefit Lumen's efforts with LT-1951," commented James Z. Huang, president of Anesiva.
LT-1951 was tested in the Lumen-sponsored placebo-controlled, double- blinded, and randomized Phase 1 trial performed at Toronto General Hospital (TGH). No serious drug related adverse events were seen. The improved early performance of treated grafts suggested an anti-thrombotic effect for poly-L- arginine consistent with the published biological effects of poly-L-arginine. A dramatic reduction of neointimal hyperplasia following treatment with LT- 1951 has been demonstrated in preclinical vein to artery interposition grafts in several animal models. Marked improvement following a single ex vivo application of LT-1951 in interposition grafts demonstrated that the beneficial effect of the drug was not dependent upon continued treatment of the grafted tissue. Thus LT-1951 may well treat both early and late events that lead to CABG failure.
"We intend to initiate the next phase of clinical development in the first part of 2007 using an alternative vehicle for the drug that will allow the full benefit of treatment to be realized," stated Dr. Garry Fathman, chairman of Lumen's scientific advisory board.
About Coronary Artery Bypass Graft Failure
CABG is a common surgical procedure in which a section of a patient's vein is used to bypass damaged coronary arteries of the heart. In 2003, approximately 30,000 patients in Canada and 268,000 in the U.S. underwent CABG surgery. Former-President Clinton's recent CABG surgery did much to promote public understanding of the procedure. While CABG surgery is a very effective procedure, the grafts may fail shortly after installation due to thrombosis and there is further attrition due to SVGD, a narrowing of the vein's internal diameter (lumen) characterized by neointimal hyperplasia and subsequent formation of atherosclerotic plaque. In the first month after surgery, up to 15 percent of patients will suffer thrombotic failures of one or more bypass graft, and in the first year after bypass surgery SVGD will claim another five to 15 percent of grafts for an overall failure rate of 20-35 percent at one year. The consequences of failure can include heart attacks, chest pain, congestive heart failure, irregular heartbeat, and death. The additional surgery required to repair a failed or failing graft is technically difficult and carries an increased risk of complications. There is no currently approved therapeutic for the prevention of SVGD following CABG.
LT-1951 is an aqueous solution of a short peptide comprised of repeating units (a polymer) of a natural amino acid, L-arginine. The drug efficiently penetrates vascular tissues including the saphenous vein and supplies the tissue with a sustained reservoir of L-arginine, required for production of nitric oxide. Nitric oxide (NO) is an important vasoactive and cell signaling compound implicated in suppression of thrombosis and neointimal hyperplasia. Some established vascular effects of NO include inhibition of monocyte chemotaxis and adherence, platelet adherence and aggregation, and vascular smooth muscle cell proliferation. NO also inhibits death of critical blood vessel (endothelial) cells that form the internal surface of the vein graft.
Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel therapeutic treatments for pain. The company has three drug candidates in development for multiple pain-related indications. A New Drug Application (NDA) has been submitted for the most advanced product, Zingo(TM). The second product in the pipeline, 4975, has been shown to reduce pain after only a single administration for weeks to months in multiple settings in numerous mid-stage clinical trials for site-specific, moderate-to-severe pain. A third product, 1207, is currently being evaluated in a Phase 1 clinical trial as a topical local anesthetic. Anesiva is based in South San Francisco, CA. For more information about Anesiva's leadership in the development of products for pain management, and an overview of the clinical challenges being addressed by its product candidates, go to www.anesiva.com.
About Lumen Therapeutics
Lumen Therapeutics is a biopharmaceutical company focused on the development and commercialization of proprietary biopharmaceuticals based on polymers of L-arginine. Lumen is researching a pipeline of novel therapeutics based on this proprietary technology. For more information on the company and its technology, go to www.lumentherapeutics.com.
Forward Looking Statements for Anesiva
This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions are intended to identify such forward-looking statements. Forward- looking statements in this press release include, without limitation, projected timing of clinical trials and other matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: whether Anesiva can successfully develop new products and the degree to which these gain market acceptance. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning these and other risk factors is contained in Anesiva's quarterly report on Form 10-Q for the quarter ended September 30, 2006.
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