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Biopharma Forms Scientific Advisory Board to Provide Additional Scientific and Pharmaceutical Expertise
August 19, 2016 - Hemispherx Biopharma (NYSE MKT: HEB) announced that it has formed a scientific advisory board (SAB). The
purpose of the SAB is to leverage its member's scientific and pharmaceutical expertise and advice to advance the Company's
drug development programs by providing guidance on steering the company forward and capitalizing on business opportunities as
well as interactions with the Food and Drug Administration. The Board consists of William Mitchell, M.D., Ph.D., Ronald Brus,
M.D., W. Neal Burnette, Ph.D., and Christopher Nicodemus, M.D., F.A.C.P.
Mitchell, M.D., Ph.D., Chairman of the Board of Directors of Hemispherx, will chair the SAB. Dr. Mitchell has served as a Director
on the Hemispherx Board since 1998, becoming chairman earlier this year. Dr. Mitchell is Professor of Pathology, Microbiology
& Immunology at Vanderbilt University School of Medicine and is a board certified physician. Dr. Mitchell earned a M.D. from
Vanderbilt and a Ph.D. from Johns Hopkins University, where he served as House Officer in Internal Medicine (Osler Service), followed
by a Fellowship at its School of Medicine. Dr. Mitchell has published over 200 papers, reviews and abstracts that relate to the
pathogenesis of obligate intracellular pathogens, innate and adaptive immune responses, and liquid biopsy cancer (chromosomal
instability) diagnostics. He is the inventor or co-inventor of 14 issued US patents as well as derivative foreign patents. Dr.
Mitchell has worked with many professional scientific societies that have included the American Society of Investigative Pathology
(ASIP), the International Society for Antiviral Research (ISAR), the American Society of Biochemistry and Molecular Biology (ASBMB),
the American Society of Microbiology (ASM), the American Chemical Society (ACS), and the American Society of Clinical Oncology
(ASCO). Dr. Mitchell is a member of the American Medical Association (AMA). He has served on numerous review committees for the
National Institutes of Health (NIH), the Centers for Disease Control (CDC), the European Union (EU), and the College of American
Pathology (CAP). He is an independent director of Chronix Biomedical, a genetics based cancer diagnostic company.
Brus is the founder and chief executive officer of myTomorrows.com, a web-based early access program designed to assist seriously
ill patients obtain the latest drug innovations. Hemispherx recently initiated an early access program through myTomorrows.com
for Ampligen in Europe. Dr. Brus has more than 25 year of experience in the industry. Prior to founding myTomorrows.com,
he held several executive positions at Crucell, a vaccine company, including chief executive officer. Crucell was acquired by
Johnson & Johnson for $2.8 billion in 2011. He has served as director of Galapagos, a clinical stage biotech focused on developing
novel mode of action medicines and was the product planning physician at Forest Laboratories. Dr. Brus obtained his M.D. at the
University of Groningen.
Burnette is an experienced biomedical research scientist focused on molecular biology and vaccine development in academia, industry,
and the military. He is the inventor of the "Western Blot" that remains one of the most used techniques in the medical
and biological sciences. He was a senior scientist at Amgen where he developed the first "genetic toxoids" for pertussis
and cholera vaccines. Following 9/11, he returned to active US Army duty and served as the deputy joint program executive officer
for Chemical and Biological Defense and as a senior infectious disease consultant to the U.S. Army Medical Research and Materiel
Command. Colonel Burnette was also a member of the President's Interagency Working Group for Weapons of Mass Destruction.
He received his Ph.D. in retrovirology at Vanderbilt University School of Medicine, was a postdoctoral fellow in molecular biology
and infectious diseases at Albert Einstein College of Medicine, and was on the research staffs of the Fred Hutchinson Cancer Research
Center and the Salk Institute. Dr. Burnette has served as a consultant, acting senior executive, and board member for a wide variety
of early-stage biomedical companies that ranged broadly in focus from vaccines and immunobiologics to the treatment of retinal
Nicodemus has been a collaborator and advisor to Hemispherx since 2008. He is founder, president and chief scientific officer
of AIT Strategies a firm focusing on biomedical research and development with a special interest in immunotherapeutics. Prior
to founding AIT Strategies, he served as chairman and chief scientific officer of Advanced Immune Therapeutics, Inc. Nicodemus
focus of interest is enhancing anti-tumor immunity and is an expert on toll-like receptor 3 (TLR3). He has led teams working on
three successful NDA's registrations of Zyrteck , Acutect and Neotect . His work in ovarian cancer and immunology
has resulted in multiple patent applications. He has extensive FDA and international regulatory experience and has published more
than 40 papers, chapters and reviews and numerous abstracts and is a fellow of the American College of Physicians. Dr. Nicodemus
received undergraduate training at Harvard College and received his M.D. degree from Upstate Medical University in Syracuse, NY.
company is engaged in a number of development initiatives for both Alferon N Injection and our experimental drug, Ampligen ,"
said Thomas Equels, chief executive officer of Hemispherx. "The SAB's expertise and advice will be invaluable as
we move forward with both of these products."
Hemispherx Biopharma:
Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug
entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection
and the experimental therapeutics Ampligen and Alferon LDO. Ampligen is an experimental RNA nucleic acid being
developed for globally important debilitating diseases and disorders of the immune system, including Chronic Fatigue Syndrome.
Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening
diseases. Because both Ampligen and Alferon LDO are experimental in nature, they are not designated safe and effective
by a regulatory authority for general use and are legally available only through clinical trials. Hemispherx has patents comprising
its core intellectual property estate and a fully commercialized product (Alferon N Injection ), approved for sale in the
U.S. and Argentina. The FDA approval of Alferon N Injection is limited to the treatment of refractory or recurrent external
genital warts in patients 18 years of age or older. The Company's Alferon N Injection approval in Argentina includes
the use of Alferon N Injection (under the brand name "Naturaferon") for use in any patients who fail, or become
intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. The Company wholly owns and
exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information,
please visit www.hemispherx.net.
the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are
made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "potential,"
"potentially," "possible," and similar expressions are intended to identify forward-looking statements.
The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that any of its plans will
be achieved. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a
variety of risks and uncertainties, many of which are beyond Hemispherx's control, which could cause actual results to differ
materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include those
set forth in the Disclosure Notice, below, as well as the risks described in Hemispherx's filings with the Securities and
Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K. You are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligation to update
or revise the information contained in this press release, whether as a result of new information, future events or circumstances
or otherwise revise or update this release to reflect events or circumstances after the date hereof.
contained in this news release, other than historical information, should be considered forward-looking and is subject to various
risk factors and uncertainties including, but not limited to, general industry conditions and competition; general economic factors;
the Company's ability to adequately fund its projects; the impact of pharmaceutical industry regulation and healthcare legislation
in the United States and internationally; trends toward healthcare cost containment; technological advances, new products and
patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the
Company's ability to accurately predict the future market conditions; manufacturing difficulties or delays; dependence on
the effectiveness of the Company's patents and other protections for products; and the exposure to litigation, including
patent litigation, and/or regulatory actions; and numerous other factors discussed in this release and in the Company's
filings with the Securities and Exchange Commission. The production of new Alferon API inventory will not commence until
the validation phase is complete. While the facility is approved by FDA under the Biological License Application ("BLA")
for Alferon , this status will need to be reaffirmed by a successful Pre-Approval Inspection by the FDA prior to commercial
sale of newly produced inventory product. The validation phase is delayed until we are able to repair the damage caused by a flood
that occurred on January 5, 2016 at the facility. While we have made progress in repairing the damage at the facility, we cannot
assure when all repairs required to be made prior to seeking Pre-Approval Inspection by the FDA. If and when we obtain a reaffirmation
of FDA BLA status and have begun production of new Alferon API, we will need FDA approval as to the quality and stability
of the final product to allow commercial sales to resume. With regard to our NDA for Ampligen to treat CFS, we note that
there are additional steps which the FDA has advised us to take in our seeking approval. The final results of these efforts and/or
any other activities could vary materially from Hemispherx's expectations. Any failure to satisfy the FDA regulatory requirements
or the requirements of other countries could significantly delay, or preclude outright, approval of Ampligen in the United
States and other countries. No evidence is suggested that Ampligen will be commercially approved for any treatment or that
Alferon N Injection will be commercially approved for potential new treatment indications or for new manufacturing procedures.