Vical Licensee Sanofi-aventis Initiates Phase 3 Trial to Reduce Amputations
- Category: Antibodies
- Published on Friday, 21 September 2007 04:00
- Hits: 1842
SAN DIEGO, CA, USA | September 20, 2007 | Sanofi-aventis, a licensee of Vical Incorporated (Nasdaq: VICL), announced on Monday the initiation of a 500-patient Phase 3 clinical trial of its NV1FGF angiogenesis therapy, which is based on Vical's non-viral DNA delivery technology. Assuming successful completion of the trial, called TAMARIS, sanofi-aventis expects to file for marketing approval in 2010.
The plasmid DNA (pDNA) therapy encodes Fibroblast Growth Factor 1 (FGF-1), a growth factor that stimulates the growth of blood vessels, and is intended to reduce the need for amputations in patients suffering from critical limb ischemia. Sanofi-aventis previously reported results from a Phase 2 trial in 107 patients demonstrating a statistically significant reduction in the rate of both major amputations and all amputations in patients receiving NV1FGF compared with those receiving placebo.
"In addition to DNA vaccines for infectious diseases and cancer, angiogenesis is among the most promising applications of our DNA delivery technology," said Vijay B. Samant, Vical's President and Chief Executive Officer. "The ability of pDNA to induce production of a protein locally at the site of injection ideally matches the desired treatment profile for critical limb ischemia, and perhaps for earlier stages of peripheral vascular disease. We are pleased that sanofi-aventis, one of our two partners in this field, has advanced into Phase 3 testing of this novel therapy addressing a major unmet medical need, and we look forward to successful completion of the trial."
The TAMARIS study is a double-blind, placebo-controlled Phase 3 trial in approximately 500 patients with critical limb ischemia. Four doses of 4 mg each will be administered by intramuscular injection at two-week intervals, and follow-up will continue for one year. The primary endpoint is the prevention of major amputation or of death. Additional information on the trial is available at http://en.sanofi-aventis.com/index.asp.
About Critical Limb Ischemia
Critical limb ischemia is a severe and costly condition. In the twelve months following the first episode of critical limb ischemia, 55% of patients either require amputation or die. In the United States and Europe, there are more than 150,000 amputations each year due to critical limb ischemia, with a direct cost of nearly $6 billion and a total cost of more than $8 billion. No disease-modifying therapy for critical limb ischemia is currently available.
Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at http://www.vical.com.
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected, including: whether sanofi-aventis will continue development of NV1FGF as planned; whether NV1FGF or any other product candidates will be shown to be safe and effective in clinical trials; whether Phase 3 trial results will support filing for marketing approval by 2010, if at all; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market NV1FGF or any other product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
SOURCE: Vical Incorporated