• 10/22/2004
  • no attribution
  • Datamonitor NewsWire

Biopharmaceutical oncology therapeutics developer Viventia Biotech has filed for orphan drug designation with the FDA for its lead armed antibodies drug candidate, Proxinium, for the treatment of head and neck cancer.

Proxinium is a targeted therapeutic consisting of a proprietary antibody fragment conjugated with a cancer-killing payload. It targets a cell surface protein found on most head and neck cancers and has been designed to deliver a therapeutically potent anticancer payload directly to tumors, avoiding healthy, normal tissue.

If the application is approved by the FDA, under the US Orphan Drug Act, Proxinium will be entitled to various incentives, which may include a waiver of regulatory filing fees, access to potential grant funding for non-clinical and clinical research, and seven years of market exclusivity if it is subsequently approved by the FDA

In addition, many orphan drugs receive expedited regulatory review because they have been developed to treat serious or life-threatening illnesses, and as such the approval time for orphan drugs has historically been considerably shorter than for other drugs.

“Obtaining orphan drug designation from the FDA is an important step in Viventia’s strategy to rapidly develop Proxinium as a treatment for patients with advanced head and neck cancer,” said Dr Glover, president and CEO of Viventia Biotech.