• 2/4/2005
  • Toronto, Ontario, Canada
  • pharmalive.com

Viventia Biotech Inc. announced today that its lead drug candidate Proxinium(tm) has been granted orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of advanced, recurrent head and neck cancer.

The US Orphan Drug Act provides financial, regulatory and marketing incentives to companies to help facilitate the development and marketing of drugs for the treatment of rare diseases or conditions that affect fewer than 200,000 patients in the United States. Orphan drug designation entitles Viventia to various incentives, including seven years of exclusive marketing rights if Proxinium(tm) receives marketing approval by the FDA. Historically, many orphan drugs have received expedited regulatory review because they have been developed to treat serious or life-threatening illnesses, leading to more rapid approval times.

About head and neck cancer:
Head and neck cancer, comprising cancers of the larynx, tongue, mouth, oral cavity, and pharynx, is the sixth most common form of cancer globally. In the United States alone over 50,000 new cases of head and neck cancer are diagnosed annually. Despite aggressive measures, such as radical surgery, radiation and/or chemotherapy, as well as concerted efforts from clinicians to eradicate these tumors, long-term survival rates have not improved in the last 30 years and the five year survival rate remains less than 40%. As more than two-thirds of patients will present with advanced disease, curative treatments are often not possible. Compounding the poor prognosis for survival are the often devastating effects these tumors and their treatment can have on quality of life outcomes.

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