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., JD
In 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.
NORD, an organization representing patients with orphan diseases, honored Mr. Sasinowski in 2000 with its Humanitarian Award. Later that year he was elected to its Board of Directors where he has served as Chair and as Vice Chair, and where he remains on the Board today.
Cindy Dinella, R.Ph. Pharm. D.
Dr. Dinella currently serves as Founder, President and Managing Partner at Advyzom, LLC, a leading boutique consulting company specializing in highly strategic regulatory and development advice and services for the pharmaceutical and healthcare industry.
Dr. Dinella was formerly the Vice President of Drug Regulatory Affairs, the Nutley Site Head for Global Development and Member of the CEO's North American Operating Committee at Hoffman La Roche Inc. She brings more than 20 years of Regulatory and Drug Development experience.
Dr. Dinella has provided oversight and filed over one hundred IND filings across various therapeutic areas for both drugs and biologics. She has filed and received approval for over thirty-five New Molecular Entities (NMES) and major efficacy supplements. She has developed and managed thirteen Risk Evaluation Mitigation Strategies (REMS) with Medguides, Communication Plans, and Elements to Assure Safe Use (ETASU). Dr. Dinella has led numerous milestone and critical issue FDA meetings across Divisions, Centers and with FDA Senior Management. She has led, presented, and managed oversight for thirteen FDA Public Advisory Committees for NME approvals, safety issues, and Risk Management. She is experienced with Special Protocol Assessments (SPAs), Orphan Drug Designation, Fast Track Designation, Accelerated Approval and Pediatric Plans (PREA, PIPs, Exclusivity). She has led the corporate Global Regulatory Forum to define, discuss, and align global strategic regulatory plans at key milestones in development, manage critical issues, define product risk assessment, and set direction for regulatory policy and external influencing.
Dr. Dinella has been recognized for her achievements in the industry; in 1990, she received both the Upjohn Pharmacy Research Award for Excellence in Clinical Research and the Sandoz Pharmacy Award for Superior Academic Achievement & Contribution to Health Care; in 2000, she graduated from the Leadership New Jersey program designed to take proven professional leaders and make them Leaders of State issues within health care, environmental, social services, education, politics, and racism; in 2001, she received the Tribute to Women in Industry (TWIN) Award (2001) in recognition of her significant contributions to her company as a professional woman.
Bonnie Hepburn, M.D.
Dr. Hepburn is a rheumatologist with more than 20 years of experience in drug development and was formerly chair of the FDA's Arthritis Advisory Committee. She currently serves as a Clinical Professor in the Department of Medicine, Division of Rheumatology/Allergy/Immunology, at the University of California San Diego and as a consultant to private and public pharmaceutical and biopharmaceutical companies. She has been directly involved in planning clinical and regulatory strategy for multiple products including new molecular entities, both xenobiotics and biologic agents, across different platforms and multiple therapeutic areas. She has had numerous opportunities to interact directly with the FDA, leading early and late stage development meetings and overseeing NDA submissions that resulted in approvals.
Prior to serving as an independent consultant, Dr. Hepburn served in a number of senior roles, most recently as Senior Vice President, Drug Development, at Santarus, Inc., a specialty biopharmaceutical company in San Diego, focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. At Santarus, Dr. Hepburn was responsible for the establishment of the team responsible for drug development, clinical research and regulatory affairs, which led to the approval of the Zegerid products. Prior to joining Santarus, she served in a variety of senior roles, including Vice President of Clinical Development at La Jolla Pharmaceutical Company, Director of Immunology Clinical Research and head of the infliximab development team at Centocor, Inc., and Head of Inflammation, Bone and Allergy Clinical Research, Executive Director of Anti-inflammatory Research and Director of Regulatory Affairs at Novartis.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical company focused on developing proprietary product candidates. The Company's lead product candidate is ANX-188, a rheologic, antithrombotic and cytoprotective agent that improves microvascular blood flow and has potential application in treating a wide range of diseases and conditions, such as complications arising from sickle cell disease. We also are developing ANX-514, a novel, detergent-free formulation of the chemotherapy drug docetaxel. 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 the RAB's potential impact on the success of ADVENTRX's drug development programs, ADVENTRX's development plans for ANX-188, including the nature and timing of future clinical studies, and ANX-188's potential as an effective treatment for sickle cell disease patients. Among the factors that could cause or contribute to material differences between ADVENTRX's actual results and those indicated from the forward-looking statements are risks and uncertainties inherent in ADVENTRX's business, including, but are not limited to: the potential for ADVENTRX to delay, reduce or discontinue current and/or planned development activities, partner its product candidates at inopportune times or pursue less expensive but higher-risk development paths if it is unable to raise sufficient additional capital as needed; ADVENTRX's ability to obtain additional funding on a timely basis or on acceptable terms, or at all; the potential for delays in the commencement or completion of its planned clinical studies including as a result of difficulties or delays in completing manufacturing process development activities and manufacturing clinical trial material; the risk of suspension or termination of a clinical study including due to lack of adequate funding; the risk that planned clinical studies of ADVENTRX's product candidates, including ANX-188, are not successful and, even if they are successful, that the FDA could determine they are not sufficient to support an NDAs for the product candidate; the risk that the FDA does not grant market approval of ADVENTRX's product candidates, including ANX-188, on a timely basis, or at all; ADVENTRX's reliance on third parties to assist in the conduct of important aspects of its product candidates' development programs, including the manufacture of clinical trial material, the conduct of clinical studies and regulatory submissions related to product approval, and that such third parties may fail to perform as expected; 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.