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|  |  Viventia Receives FDA Clearance to Initiate Phase II Cancer Trial for ProxiniumPress Release September 19, 2005 TORONTO, September 19, 2005 /PRNewswire-FirstCall/ - Viventia Biotech Inc. today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to begin a Phase II study evaluati ng Proxinium(TM) for the treatment of patients with chemotherapy-refractory recurrent head and neck cancer. "While there are limited treatment options for patients with recurrent, refractory head and neck cancer, previous clinical data suggest that Proxinium(TM) therapy may be associated with an improvement in survival in this patient population," said Dr. Nick Glover, Viventia's President and CEO. "This trial, which will be initiated in 2005 and will involve more than 10 sites across North America, will be important to further establishing the potential of our lead drug." Information for physicians and patients will be made available on the Company's website, www.viventia.com. About Proxinium(TM) Proxinium(TM) combines a powerful cytotoxic protein payload with the highly precise tumour-targeting characteristics of a monoclonal antibody. A single molecule of the cytotoxic protein payload, Pseudomonas exotoxin, is capable of killing a cancer cell. The antibody fragment of Proxinium(TM) targets EpCAM - an antigen that is highly expressed on many epithelial cancers including head & neck cancer, ensuring that the payload is delivered directly to the tumour. Proxinium(TM) has been designated an Orphan Drug for the treatment of head and neck cancer in the U.S. and EU. Head and neck cancer is the 9th most common cancer in North America, with approximately 55,000 new cases diagnosed annually in the U.S. alone, leading to 14,000 deaths annually. Head and neck cancer recurs in 60 - 70% of patients. About Viventia Biotech Viventia Biotech Inc. is a biopharmaceutical company developing Armed Antibodies(TM), powerful and precise anti-cancer drugs designed to overcome various forms of cancer. Viventia's lead product is Proxinium(TM), which combines a cytotoxic protein payload significantly more powerful than traditional chemotherapies with the highly precise tumour-targeting characteristics of a monoclonal antibody. Proxinium(TM) is in clinical development for the treatment of head and neck cancer and bladder cancer, and is expected to enter advanced clinical trials in 2005. This press release contains forward-looking statements, which are subject to risks and uncertainties inherent to the process of developing and commercializing human therapeutic products. Actual results could differ materially from those projected in this release. Certain statements included in this press release constitute forward-looking statements. When used in this press release, the words "anticipate", "believe", "plan", "estimate", "expect", "intend", "will", "may", "should" and similar expressions, as they relate to us or our management, are intended to identify forward-looking statements. These forward-looking statements are not historical facts but reflect our current expectations concerning future results and events. These statements include, without limitation, statements with respect to the clinical and developmental timelines associated with Proxinium. The Toronto Stock Exchange has neither approved nor disapproved the information contained herein. CONTACT: James Smith, Tel. (416) 815-0700 x 229, Fax. (416) 815-0080,Email: jsmith@viventia.com
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