SAN DIEGO, Aug. 30, 2011 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today provided an update on its planned meetings with the U.S. Food and Drug Administration (FDA) regarding its three late-stage programs:
Exelbine (vinorelbine injectable emulsion)
- Type A meeting with FDA has been requested. This meeting is to discuss the complete response letter regarding the Company’s New Drug Application (NDA) for Exelbine. The Company will present information that it believes demonstrates the authenticity of study drugs used in the pivotal study.
ANX-514 (docetaxel for injectable emulsion)
- Type B clinical meeting with FDA has been requested. This meeting is to discuss the pivotal safety study that FDA recommended at a meeting earlier this year. The Company is proposing a randomized, open-label study designed to descriptively evaluate the safety of ANX-514 without corticosteroid premedication and Taxotere® with corticosteroid premedication in non-small cell lung cancer.
- Type B CMC meeting with FDA has been requested. This meeting is to discuss the manufacture of ANX-514 for clinical trial material in connection with the planned pivotal safety study and for commercial product.
ANX-188 (purified poloxomer 188)
- Type B clinical meeting with FDA is planned for the fourth quarter of 2011. This meeting will be to confirm prior agreements with FDA, reach agreement on key aspects of the planned phase 3 pediatric study in sickle cell crisis and discuss the overall development plan.
- Type B CMC meeting with FDA is planned for the first quarter of 2012. This meeting will be to discuss the manufacture of ANX-188 for clinical trial material in connection with the planned phase 3 study and for commercial product.
“Frequent contact with FDA is critical to the success of our clinical programs, and the number of our upcoming meetings with FDA demonstrates our commitment in this regard. Following these meetings, we intend to provide updates with respect to key events for each of our programs, including timelines for study initiation, study completion and NDA submission,” said Brian M. Culley, Chief Executive Officer of ADVENTRX. “In the meantime, we continue to prepare to initiate the ANX-188 and ANX-514 pivotal studies next year. Our cash and equivalents, which were $40.7 million at July 31, allow us to make substantial progress on these programs,” Mr. Culley added.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a specialty pharmaceutical company focused on developing proprietary product candidates. The Company’s current lead product candidates are ANX-188, a novel, purified, rheologic and antithrombotic compound initially being developed as a first-in-class treatment for pediatric patients with sickle cell disease in acute crisis, and ANX-514, a detergent-free reformulation of the blockbuster drug Taxotere, which recently went off-patent. The Company is evaluating its Exelbine program following the complete response letter it received from the FDA. More information can be found on the Company’s web site at www.adventrx.com.
Forward Looking Statements
ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that are based on ADVENTRX’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements regarding ADVENTRX’s expectations regarding its meetings with the FDA, including the timing and outcome of each of those meetings, ADVENTRX’s belief that information it will present to the FDA demonstrates the authenticity of the drugs used in its bioequivalence study of Exelbine, and the nature and timing of the ANX-188 and ANX-514 development programs, including anticipated timing for initiation of pivotal clinical studies. Actual events or results may differ materially from those expressed or implied by the forward-looking statements in this press release due to a number of risks and uncertainties, including, without limitation: the risk that meetings with the FDA do not take place on the timelines anticipated by ADVENTRX and, as a result, decisions regarding its Exelbine program and initiation of its anticipated clinical studies of ANX-188 and ANX-514 are delayed; the potential for the FDA to impose further requirements, including clinical studies, before or after approval of Exelbine; the potential for ADVENTRX to discontinue its investment in the Exelbine program and instead pursue partnership opportunities for Exelbine; the risk that the FDA does not grant market approval of Exelbine, whether submitted by ADVENTRX or a future partner, on a timely basis, or at all; difficulties or delays in reaching agreement with the FDA on the clinical development of ANX-188 and ANX-514; the potential for the FDA to require significant additional clinical and/or nonclinical studies of ADVENTRX’s lead product candidates, in addition to its planned clinical trials of ANX-188 and ANX-514, and that ADVENTRX consequently determines to discontinue one or more of its development programs; difficulties or delays in manufacturing material for clinical studies; ADVENTRX’s reliance on third parties to assist in the conduct of important aspects of its product candidates’ development programs, and that such third parties may fail to perform as expected; the potential for ADVENTRX to raise additional capital to acquire new technologies, product candidates or products and/or to fund development and/or commercialization activities for current and/or future product candidates; the risk that ADVENTRX will pursue acquisition and/or development activities at levels on timelines, or will incur unexpected expenses, that shorten the period through which its operating funds will sustain it; and other risks and uncertainties more fully described in ADVENTRX’s press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX’s public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date hereof, except as may be required by law.
SOURCE ADVENTRX Pharmaceuticals, Inc.
