SAN DIEGO, March 28 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL) today announced the company's licensee, AnGes MG, Inc., reported submission on March 27, 2008, of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare for its angiogenesis product candidate, Collategene, for treatment of critical limb ischemia. The treatment uses Vical technology to deliver a gene encoding hepatocyte growth factor (HGF), a human protein that causes growth of blood vessels in areas of restricted blood flow.
"The Japanese NDA filing positions Collategene to be the first product based on our DNA delivery technology with the potential to be approved for human use," said Vijay B. Samant, President and Chief Executive Officer of Vical. "In the United States, where it is estimated that more than 10 million people have peripheral arterial disease (PAD), AnGes already has completed two Phase 2 clinical trials of Collategene in PAD patients. This product candidate offers a novel approach to addressing an important, unserved medical need in the Japanese market, and has the potential to expand into the much larger markets worldwide. This NDA filing by AnGes is an important milestone in advancing nonviral gene therapy toward regulatory and commercial acceptance."
The NDA submission follows positive results announced in June 2007 following interim analysis of data from the first 41 subjects to complete a Phase 3 trial of Collategene. Based on the findings that the primary efficacy endpoint in the trial had been achieved with statistical significance and that there were no major safety concerns related to treatment, an Independent Data Monitoring Committee recommended stopping the trial early to prevent potential ethical issues against the placebo group subjects.
In the trial, 40 subjects with critical limb ischemia (advanced peripheral arterial disease) were evaluated for efficacy. The primary endpoints, improvement of rest pain (Visual Analog Scale, or VAS) or ischemic ulcer size, at 12 weeks post dosing, showed 30.8% improvement in the placebo group and 70.4% improvement in the treatment group, a statistically significant difference (p=0.014).
The following English translation of the original Japanese news release was provided by AnGes.
AnGes Submits NDA for HGF Gene Therapy
AnGes MG, Inc.(TSE Mothers:4563, http://www.anges-mg.com) has submitted its New Drug Application (NDA) to MHLW (Japan) for HGF Gene Therapy (INN : beperminogene perplasmid, Brand Name : Collategene) to treat Critical Limb Ischemia (CLI) in Arteriosclerosis Obliterans (ASO) and Burger's disease, on March 27, 2008.
HGF Gene Therapy is a product, where a gene which induces HGF protein is injected to the ischemic lesion, leading to the formation of new blood vessels through the effect of the HGF protein, which results in improvement of the ischemic symptoms.
AnGes has developed this product for peripheral arterial diseases (ASO and Burger's Disease), which occurs by decreased blood flow caused by narrowing of blood vessels as a result of arteriosclerosis, and ischemic heart disease.
This is a product with a novel mechanism of action different from existing products, so that it may also be effective to patients in which existing therapeutics were not effective, or, surgical treatments can not be pursued. As for safety, we are using naked DNA delivery method instead of viral vectors to transfect genes, so that there won't be any safety concerns often caused by viral vectors in case of gene therapies.
HGF is a gene therapy product originally developed in Japan through the research at Academia, and development went ahead in Japan first.
Since last June, when we got the positive results at the interim analysis of our Phase III study in Japan for ASO patients with CLI, we have prepared for submission, and are pleased to be the first company in Japan to submit an NDA for a gene therapy product.
AnGes is aiming to provide this product to patients also worldwide. After approval, the brand name in Japan will be "Collategene". The name comes from the meaning of formation of "collateral vessels" by angiogenesis and improvement of ischemic symptoms by "gene therapy".
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. Forward-looking statements include statements about the potential approval of Collategene, as well as Vical's focus, collaborative partners, and product candidates. Risks and uncertainties include whether Collategene will be approved in Japan; whether AnGes will successfully expand into U.S. or worldwide markets with Collategene; whether gene therapy will gain regulatory and commercial acceptance; whether any product candidates under development by Vical or its collaborative partners will be shown to be safe and effective in clinical trials; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market 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.
Contact: Alan R. Engbring
|SOURCE Vical Incorporated|
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