To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Europe Grants Orphan Drug Designation to Proxinium for Treatment of Head and Neck Cancer URL: http://www.pslgroup.com/dg/24DC8A.htm Doctor's Guide June 1, 2005
TORONTO, ON -- June 1, 2005 -- Viventia Biotech Inc. (TSX:VBI) today announced that its lead anti-cancer drug, Proxinium(TM), has been designated an Orphan Drug for the treatment of Head and Neck cancer by the European Medicines Agency (EMEA) for the Evaluation of Medical Products. "Proxinium has produced positive efficacy results in patients with refractory head & neck cancer and is on track to commence late-stage clinical trials this year," said Dr. Nick Glover, President and CEO of Viventia. "Orphan drug status provides Proxinium with up to ten years of market exclusivity in Europe and will ensure that our regulatory strategy for the EU is supported." In Europe, head and neck cancer is the 6th most common form of cancer, accounting for more than 100,000 new cancer cases each year and more than 40,000 deaths. About Proxinium Proxinium 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 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 has completed two Phase I exploratory human clinical rials. In one, 20 patients received direct intratumoral injection of the drug n a weekly basis for 4 weeks as a monotherapy. Of the 18 patients who were considered evaluable at the end of the trial, final efficacy analysis showed hat: 25% of patients who expressed the therapeutic target for Proxinium had a complete response to therapy (complete disappearance of treated tumor); 3% had an objective response (significant or partial shrinkage of treated tumor); and 88% had tumor growth control (objective response or stabilization f disease). In a 24 patient Phase I dose-escalation trial, Proxinium injected intratumorally on a monthly schedule yielded an objective response rate of 43% and a tumor growth control rate of 71% from those patients that expressed the EpCAM antigen. The median survival rate for EpCAM positive patients who showed a response to Proxinium reported from this study was 301 days, compared to a median survival of 125 days for those patients that were EpCAM negative (the expected median survival is approximately 120-150 days). Proxinium received U.S. Orphan Drug designation from the FDA for the treatment of head and neck cancer in January 2005. SOURCE: Viventia Biotech Inc. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.