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 devel
|SOURCE Vical Incorporated|
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