SAN DIEGO, Aug. 8, 2011 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today reported financial results for the periods ended June 30, 2011.
"As we head into the second half of the year, we are taking steps to prepare for our launch of Exelbine™ into the U.S. market, should it be approved on or around FDA's PDUFA goal date of September 1, 2011," said Brian M. Culley, Chief Executive Officer of ADVENTRX. "Having a commercial infrastructure will expand our strategic options and increase stockholder value."
"In parallel, we are working to finalize the protocol for a phase 3 pediatric study of ANX-188, our first-in-class treatment for sickle cell crisis, for which FDA has granted orphan drug designation. We plan to initiate this study in 2012. There are no FDA-approved drugs designed to treat patients in crisis, making this an area of significant unmet need," Mr. Culley continued.
"We also are excited about ANX-514, our detergent-free reformulation of the blockbuster drug Taxotere®, which recently went off-patent. We plan to meet with FDA in the next quarter to discuss a single, additional study in which we compare the safety profiles of Taxotere with corticosteroid premedication and ANX-514 without corticosteroid premedication. We believe this single study will provide sufficient clinical data to support a new drug application, should the study demonstrate comparable safety profiles between ANX-514 and Taxotere, and a competitive advantage over Taxotere and other detergent-containing formulations of docetaxel," Mr. Culley concluded.
Second Quarter 2011 Operating ResultsADVENTRX's net loss applicable to common stock for the second quarter of 2011 was $4.4 million, or $0.17 per share, compared to a net loss applicable to common stock of $5.0 million, or $0.39 per share, for the same period in
|SOURCE ADVENTRX Pharmaceuticals, Inc.|
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