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Biotech / Medical : Stressgen (VSE: SSB) -- Ignore unavailable to you. Want to Upgrade?

To: Heat Shock who wrote (158)	4/2/2001 5:40:58 PM
From: Heat Shock	Read Replies (1) \| Respond to of 236

To all: Stressgen's HspE7 receives orphan drug status for recurrent respiratory papillomatosis. The ability of HspE7 to cause the immune system to act against multiple subtypes of the human papillomavirus allows this indication to be added to the list. VICTORIA, BC, March 29 /CNW/ - Stressgen Biotechnologies Corporation (TSE: SSB) announced today that the United States Food and Drug Administration (FDA) has granted orphan drug status for HspE7, a novel immunotherapeutic, for the treatment of a human papillomavirus (HPV)-related disease called recurrent respiratory papillomatosis (RRP). The FDA grants orphan drug designations to provide economic incentives to stimulate the research, development and approval of products that treat rare diseases. Stressgen Biotechnologies is evaluating the potential of HspE7 as a broad based therapeutic for diseases caused by HPV. The Company currently has a number of clinical trials ongoing, including one Phase III trial and several Phase II trials. "The orphan designation will help us investigate the potential of HspE7, our immunotherapy for HPV, in addressing this important unmet medical need," said John R. Neefe, M.D., Vice President, Clinical Research and Regulatory Affairs for Stressgen Biotechnologies. RRP is caused by HPV types six and eleven - the same types of HPV that cause genital warts. In a small subset of susceptible individuals, HPV causes tumor-like lesions to grow on the larynx and, in some cases, in the trachea and lungs. Left untreated, these tumors can cause suffocation and death. The incidence of RRP is spread evenly between children and adults. Lesions in RRP tend to recur, even after numerous and repeated surgical interventions. It is estimated that there are between 5,000 and 25,000 people in the United States who suffer from RRP. "RRP can be a tragic disease, especially in children, and we believe that HspE7 offers hope in the treatment and management of this disease," said Daniel L. Korpolinski, President and Chief Executive Officer of Stressgen Biotechnologies. "We view the FDA's decision as a significant milestone for the Company, and as an opportunity to further realize the potential for HspE7 as a cornerstone treatment for a wide variety of HPV infections." Under the Orphan Drug Act (ODA), sponsors are encouraged to conduct open protocols allowing patients to be added to ongoing studies. Grant funding is available to defray costs of qualified clinical testing expenses incurred in connection with the development of orphan drug products. In addition, the ODA enables companies to apply for research funding, tax credits for certain research expenses and a waiver from the FDA's application user fee. HspE7, a recombinant fusion product created with Stressgen's proprietary Hsp fusion technology, is composed of heat shock protein 65 (Hsp65) from Mycobacterium-bovis BCG and the protein E7. As a member of the family of stress proteins, Hsp65 is known to elicit a powerful immune response. The E7 protein is derived from the HPV and is involved in the malignant transformation of epithelial cells. E7 is a tumor-specific antigen and represents a precise target for the immune system attack on abnormal cells. newswire.ca Heat.