Viventia receives FDA fast track and orphan drug designations for cancer drug Proxinium

By Angela McDaniels

Seattle, Nov. 10 - Viventia Biotech Inc. said the U.S. Food and Drug Administration has granted fast track and orphan drug designations to Proxinium for the treatment of patients with recurrent squamous cell carcinoma of the head and neck.

The FDA will provide input into product development plans and may accept portions of Viventia's marketing application prior to the completion of the final registration package, the company said.

"Recurrent, refractory head and neck cancer is a devastating and aggressive disease for which there are limited treatment options," said Viventia president and chief executive officer Nick Glover in a company press release.

"We look forward to working with the FDA to further advance our clinical strategy for Proxinium, which has shown promising early-stage efficacy results in patients with this form of cancer."

Viventia has been cleared by the FDA and Health Canada to initiate a phase-2 trial of Proxinium, which the company plans to begin by the end of the year.

Toronto-based Viventia Biotech is a biopharmaceutical company that develops anti-cancer drugs.

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