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Viventia Biotech Inc. (VBI.TO) Reports Synergystic Effect of its Proxinium(TM) Antibody in Combinaton with Chemotherapy and Radiation


4/18/2007 12:33:00 PM

TORONTO, April 18 /PRNewswire/ - Viventia Biotech Inc., a privately held biopharmaceutical company advancing a portfolio of novel antibody products focused on cancer, today announced results of in vitro cytotoxicity and in vivo pharmacokinetic studies conducted to evaluate the potential for combining its phase III anti-cancer antibody therapeutic, Proxinium(TM), with first-line standard of care therapy for squamous cell carcinoma of the head & neck (SCCHN). The data were presented at the Annual Meeting of the American Association for Cancer Research (AACR), which runs from April 14-18, 2007 in Los Angeles, California.

Viventia's lead product, Proxinium(TM), is being developed to treat late stage, locally advanced head and neck cancer and is currently enrolling patients in its TARGET trial, a pivotal Phase III global clinical trial that is expected to complete accrual by the end of 2007. Proxinium(TM) targets the cancer antigen EpCAM.

The combination of Proxinium(TM) with cisplatin, carboplatin, paclitaxel, 5-fluorouracil, and docetaxel resulted in a significant additive cytotoxic effect (p < 0.05) as compared to the chemotherapeutic agents administered alone. The sequence of drug administration did not influence the outcome. The combination of Proxinium(TM) with radiotherapy led to a synergistic cytotoxic effect when Proxinium(TM) was administered after radiotherapy or additive effects when Proxinium(TM) was administered before or at the same time as radiotherapy.

"The data from these studies clearly demonstrate the additive cytotoxic effect of Proxinium(TM) when used either in combination with chemotherapeutic agents or with radiation therapy," said Dr. Barry Wenig, Head of Otolaryngology - Head and Neck Cancer at Evanston Northwestern Healthcare Centre. "These data offer exciting possibilities for the use of Proxinium(TM) not solely as a local immunotherapy, but more importantly as an adjunct to the current first-line therapies and even as a precursor to surgery."

Dr. Nick Glover, President and CEO of Viventia Biotech Inc. commented: "Our development strategy for Proxinium(TM) is to aggressively pursue initial approval for the treatment of late stage, palliative head and neck cancer, to be followed by a broad clinical program intended to support the addition of Proxinium(TM) to standard chemotherapy, radiotherapy and chemoradiotherapy regimens for earlier lines of treatment. These data presented at AACR clearly show the significant promise of adding Proxinium(TM) to other treatment modalities in head and neck cancer. Our goal is to establish Proxinium(TM) as a key component in the multidisciplinary treatment of this devastating disease."

In vitro cytotoxicity was evaluated pre-, concurrent and post-treatment with Proxinium(TM) in SCCHN cell lines CAL 27 and SCC-15. Cell growth inhibition, in combination with various chemotherapeutic agents (cisplatin, carboplatin, paclitaxel, 5-fluorouracil, docetaxel, bleomycin, and methotrexate) was assessed using an MTS assay. Growth inhibition, in combination with radiotherapy, was assessed using a clonogenic assay. In vivo pharmacokinetic profiles generated from drug administration to Sprague-Dawley rats indicated that the pharmacokinetics of cisplatin, paclitaxel, and 5-fluorouracil was not affected when administered in combination with Proxinium(TM). In summary, no antagonism was observed in in vitro or in vivo studies with Proxinium(TM) in combination with either chemo- or radiotherapy. The additive and synergistic cytotoxic effects demonstrated in this study indicate the potential utility of Proxinium(TM) in conjunction with more conventional treatment modalities for patients with SCCHN and suggest that Proxinium(TM) in conjunction with first line standard of care therapy may be of greater benefit than standard care alone.

Viventia Biotech retains full global product rights to Proxinium(TM). The Company is seeking partners for Proxinium(TM) capable of complementing Viventia's development expertise with their global sales, marketing and commercial capabilities.

About Viventia Biotech:

Viventia Biotech Inc. is a biopharmaceutical company generating a pipeline of fully human antibodies and identifying novel targets for the treatment of cancer. Its lead products have been further developed into Armed Antibodies(TM); powerful and precise anti-cancer drugs that combine cytotoxic protein payloads with the highly precise tumor-targeting characteristics of monoclonal antibodies to overcome various forms of cancer. Viventia's lead product, Proxinium(TM), is undergoing a global Phase III clinical trial - TARGET - for the treatment of head and neck cancer. Viventia is also developing Vicinium(TM), which is in a Phase II clinical study for the treatment of bladder cancer, and VB6-845, beginning a Phase I/II clinical trial for the treatment of solid tumors. The Company has created a portfolio of follow-on fully human antibody drug candidates and has a discovery engine to provide a rich and sustainable long-term pipeline.

Viventia Biotech Inc.

CONTACT: James Smith, Tel. (416) 815-0700 x 229, Fax. (416) 815-0080,Email: jsmith@viventia.com, www.viventia.com, www.proxinium.com



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