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.