ADVENTRX Submits NDA for its lead drug candidate Print E-mail
By Staff and Wire Reports   
Wednesday, 03 November 2010 06:51

ADVENTRX Pharmaceuticals (AMEX: ANX), whose focus is on in-licensing, developing, and commercializing proprietary product candidates for the treatment of cancer who announced yesterday that it had been awarded a total of $488,958 in grants under the qualifying therapeutic discovery project ("QTDP") program has issued significant news this morning.

ANX has made it known that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for one of its leading drug candidates ANX-530, or Exelbine. ANX-530 is an emulsion formulation of chemotherapy drug vinorelbine to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin, as well as to treat advanced or metastatic breast cancer.

Brian M. Culley, Chief Executive Officer of ADVENTRX told investors via a press release that the Exelbine submission included twelve months of site-specific stability data from the company's intended commercial manufacturer, which fulfills a request communicated to the company by the FDA earlier this year.

"We believe this submission will be accepted for review in early 2011 and we look forward to working with the Agency toward our first product approval," said Culley.

In October 2010, patent claims related to Exelbine were allowed by the United States Patent and Trademark Office.  When they are finally issued, the claims should extend into 2024. The company retains exclusive worldwide rights to Exelbine, other than in China, Hong Kong, Macau and Taiwan.

Exelbine is set to target the same indications as NavelbineĀ®, a branded formulation of vinorelbine, including non-small cell lung cancer.  

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