ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX), with its leading innovations in anti-cancer drug development has just announced that they’ve been successful in sending their ANX-530 (Exelbine™) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date of September 1, 2011.
Adventrx, based in San Diego, CA, focuses on acquiring developing and commercializing pharmaceuticals, proprietary product candidates for the treatment of cancer by improving the performance of existing drugs concerning principally with their safety and use.
With exclusive world wide rights to Exelbine, except in certain asian countries, Adventrx stays on course to bring about new anti-Cancer drugs
Exelbine™ is a treatment for non-small cell lung cancer and advance or metastatic breast cancer. The available version of vinorelbine in the U.S. since 2003 is Navelbine® (vinorelbine tartrate) Injection and Taxotere® (docetaxel) Injection Concentrate. However, Taxotere is not as affordable and available for healthcare use. Navelbine is often associated with injection site reactions, in as much as one-third of their patients.
Exebine was designed with these solutions in mind, to improving their pharmacoeconomics and convenience to healthcare practitioners and patients and also to reduce irritation while delivering the drug. By emulsifying vinorelbine into a homogeneous suspension of nanoparticles that is designed to protect the venous endothelium, to alleviates the irritation, during drug administration into a peripheral vein.
Upon multiple injections, Anx-530 will greatly reduce the irritation by a huge fraction of the current Navelbine, by almost 50%.
Exelbine also cures non-small cell cancer, lymphomas, metastatic breast cancer, ovarian cancer, esophageal cancer, and prostate cancer.
A press release was issued on 1/19/2011 concerning the 9/1/2011 as the goal date for the FDA to complete its review of Exelbine NDA.
Brian Culley, CEO of Adventrx stated in the press release, “we look forward to… moving Exelbine toward approval this year.”