ADVENTRX Pharmaceuticals (ANX) Says FDA Accepts INDA for Clinical Development of ANX-530
More News related to ANX
- ADVENTRX Pharmaceuticals Reports Third Quarter Financial Results
- Trading Review for Adventrx Pharmaceuticals Inc. Issued by Beacon Equity
- ADVENTRX Pharmaceuticals to Present at the BIO Investor Forum on October 29
- Adventrx (ANX) Comments on Recent Financial Activity, AMEX Listing, and Denner Resignation
- ADVENTRX Provides Business Update Following Recent Financing Activity
More News related to FDA
- Kensey Nash (KNSY) Receives FDA Clearance for its First Extracellular Matrix Product, Medeor
- Teva Pharma (TEVA) Gets Final U.S. FDA Approval for Generic Prevacid
- Mylan (MYL) Gets FDA Ok for Generic Prevacid
ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) announced that its Investigational New Drug (IND) application for the clinical development of its proprietary cancer drug ANX-530 has been accepted by the United States Food and Drug Administration (FDA).
In taking this action, the FDA acknowledged the suitability of the Company's clinical study protocol to establish the bioequivalence of ANX-530, and Navelbine. Navelbine is an anti-cancer agent approved for use in non-small cell lung cancer.
Patient recruitment for this study is expected to begin in January 2007. The FDA has affirmed this 28-patient clinical study to be sufficient as a marketing-enabling trial.
"We believe ANX-530 will show bioequivalence to the marketed form of vinorelbine," said Evan M. Levine, chief executive officer of ADVENTRX. "Further, we anticipate filing a new drug application (NDA) by the end of 2007, potentially making ANX-530 the Company's first commercial oncology product."
Related Categories
FDAStocks Mentioned
+0.01Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
