Adventrx Asks FDA to Approve Its Formulation of Anti-Cancer Drug

Xconomy San Diego — 

San Diego-based Adventrx Pharmaceuticals (AMEX: ANX), which reduced its workforce to just five executives and announced plans last March to “substantially end” its drug development and business operations, sprang back to life today. The company says it has submitted a new drug application, or NDA, to the Food and Drug Administration for ANX-530, a formulation of the anti-cancer drug vinorelbine the company has developed.

Adventrx says ANX-530 is its proprietary emulsion formulation of vinorelbine chemotherapy that is intended to reduce the incidence and severity of vein irritation and blistering associated with intravenous delivery of the approved drug Navelbine. Adventrx says it acquired ANX-530 in 2006, and its NDA includes data from a clinical bioequivalence study. The company holds exclusive worldwide rights to its formulation of the drug, except in China, Hong Kong, Macau, and Taiwan.

In a related announcement, Adventrx says it plans to fund the commercial launch of ANX-530 at least partly from $19 million in gross proceeds raised through the private placement of convertible preferred shares of its stock with institutional investors. The offering is expected to close by Thursday.

In a statement issued by the company, Brian Culley, the principal executive officer of Adventrx, says, “ANX-530 has the potential to offer important benefits to cancer patients, and we look forward to working with FDA towards its approval. The ANX-530 NDA submission is a key step in our strategy to create valuable products that improve the performance of currently approved drugs.”