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

San Diego-based Adventrx Pharmaceuticals (AMEX: [[ticker: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.”

Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.