TORONTO, Nov. 10 /PRNewswire-FirstCall/ - Viventia Biotech Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s lead drug, Proxinium(TM), as a Fast Track Product for the treatment of patients with recurrent squamous cell carcinoma of the head and neck (SCCHN).
The Fast Track program facilitates the development and expedites the review of new therapeutics that are intended to treat serious or life threatening diseases and demonstrate the potential to address unmet medical needs. The Fast Track Program is intended to accelerate the filing of an NDA. The FDA will provide input into product development plans and may accept portions of the marketing application prior to the completion of the final registration package. Also most, but not all, drugs that are designated for the Fast Track Program are given priority review once the NDA is filed. The targeted date for drugs entitled to priority review is 6 months compared to the target of 10 months as set by the Food and Drug Modernization Act.
“Recurrent, refractory head and neck cancer is a devastating and aggressive disease for which there are limited treatment options,” said Dr. Nick Glover, President and CEO of Viventia. “We look forward to working with the FDA to further advance our clinical strategy for Proxinium(TM), which has shown promising early-stage efficacy results in patients with this form of cancer.”
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.
Viventia has been cleared by the FDA and Health Canada to initiate a Phase II trial of Proxinium(TM) for chemotherapy-refractory recurrent head and neck cancer. The Company anticipates initiating the trial by the end of 2005.
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 products, Proxinium(TM) and Vicinium(TM), combine a cytotoxic protein payload significantly more powerful than traditional chemotherapies with the highly precise tumour-targeting characteristics of a monoclonal antibody. Proxinium(TM) is entering Phase II clinical trials for the treatment of head and neck cancer, and Vicinium(TM) is currently enrolling patients in a Phase I/II clinical trial for the treatment of bladder cancer.
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.
Viventia Biotech Inc.
CONTACT: James Smith, Tel. (416) 815-0700 x 229, Fax. (416) 815-0080,Email: jsmith@viventia.com
