ADVENTRX Announces Establishment Of Regulatory Advisory Board
SAN DIEGO, April 9, 2012 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced the establishment of a Regulatory Advisory Board (RAB). The RAB will provide drug development and regulatory affairs guidance to Company management in its interactions with the U.S. Food and Drug Administration (FDA). Frank J. Sasinowski, M.S., M.P.H., JD, who is rendering legal advice to Company management, and in that capacity also will advise the RAB, is a Director at Hyman, Phelps & McNamara, P.C., a law firm with one of the most extensive food and drug practices in the United States, and a current At Large member and a former Chair of the Board of Directors of the National Organization for Rare Disorders (NORD).
"As a Director of NORD, I have worked closely with the rare disease community, as well as lawmakers, to raise awareness for the over 7,000 rare diseases that affect nearly 30 million Americans," stated Mr. Sasinowski. "I believe that ANX-188 has significant potential to ease the suffering of patients with sickle cell disease. I look forward to advising the Company as it develops this important new product candidate."
"Our ability to attract these experienced industry veterans reflects favorably on the potential of ANX-188," stated Brian M. Culley, Chief Executive Officer of ADVENTRX. "The establishment of this RAB also highlights our commitment to frequent and open communication with the Agency. We look forward to advancing ANX-188 into a phase 3 clinical trial later this year, and bringing the hope of a new therapy for sickle cell patients one step closer to fruition."
Frank J. Sasinowski, M.S., M.P.H., JDIn his practice at Hyman, Phelps & McNamara, P.C., Mr. Sasinowski assists sponsors in developing new medicines and has helped secure FDA approval for hundreds of new drugs including more than 45 novel therapies for serious and rare diseases. Mr. Sasinowski joined FDA in 1983 as regulatory counsel in the Center for Drugs and Biologics, where he had a key role in implementing both the 1983 Orphan Drug law and the 1984 Hatch-Waxman law. He twice received the FDA Award of Merit. In 1987, Mr. Sasinowski left the FDA as Deputy Director of the health policy staff in the Commissioner's office and joined Hyman, Phelps & McNamara, P.C.
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