CHARLOTTESVILLE, Va., Sept. 29, 2016 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals Inc. (OTCQX:DFFN), a clinical stage
biotechnology company focused on the development of novel small molecule therapeutics for the treatment of cancer and various
hypoxia-related conditions, today announced the establishment of a new Scientific Advisory Board (“SAB”) of distinguished
scientists and clinicians. The SAB will serve as a resource to Diffusion in the continued development of its lead drug candidate,
trans sodium crocetinate (TSC), in its many areas of therapeutic use for indications involving hypoxic conditions.
David G. Kalergis, Diffusion’s Chairman and Chief Executive Officer, said, “The newly assembled SAB is comprised
of distinguished leaders in their respective fields, all of whom share the common objective of developing therapeutics to treat
hypoxia-induced maladies and address selected unmet medical needs. The SAB includes expertise in brain cancer, stroke, peripheral
artery disease, and Alzheimer’s disease. The composition of this board demonstrates the high level of interest in the significant
therapeutic potential of TSC from scientific leaders across a wide array of disciplines.”
The newly formed SAB consists of the following distinguished members:
Guy M. Chisolm, PhD, Chair of Diffusion Pharmaceuticals’ SAB
Guy M. Chisolm III, Ph.D. was Professor in the Department of Cellular and Molecular Medicine and Vice Chair of the Lerner Research
Institute at Cleveland Clinic prior to his recent retirement. He also previously served on Cleveland Clinic’s Board of Governors
and Board of Trustees. He also held an appointment as Professor of Biomedical Engineering at Case Western Reserve University. He
served on numerous editorial boards and peer review study sections at NIH and American Heart Association. He received a BS from the
University of Pennsylvania, MS and PhD from the University of Virginia and postdoctoral research training from the Karolinska
Institute (Stockholm) and MIT. He has published over 100 articles on vascular cell biology and atherosclerosis.
Gene H. Barnett, MD., MBA, FACS
Dr. Gene H. Barnett serves as Director, Rose Ella Burkhardt Brain Tumor and Neuro-Oncology Center of the Cleveland Clinic
Neurological Institute. He has authored more than 210 articles published in leading medical journals and has a particular
interest in the areas of neuro-oncology, computer-assisted surgery and stereotactic radiosurgery. Dr. Barnett created the Center
for Computer-Assisted Neurosurgery at Cleveland Clinic, and established Cleveland Clinic's innovative neurosurgery program. He
holds several patents and continues work on the development of technology in neurosurgery including laser lesioning systems for
brain tumors. He graduated summa cum laude from Case Western Reserve University with a B.A. in Biology and Chemistry, and received
his M.D. from Case Western Reserve University School of Medicine. He did his residency in neurosurgery and a fellowship in
neurology at Cleveland Clinic, served as an honorary registrar at the University of Edinburgh in Scotland, and completed a clinical
and research fellowship at Harvard Medical School and Massachusetts General Hospital. In addition, he completed the executive MBA
program at the Weatherhead School of Management of Case Western Reserve University.
Connie Hess, MD, MHS
Dr. Hess is an interventional Cardiologist at the University of Colorado where she serves as an Assistant Professor of Medicine.
She also serves as a Clinician Scientist for CPC Clinical Research, a university-affiliated, non-profit cardiovascular and clinical
trials research organization. Previously, Dr. Hess was an Assistant Professor in the Department of Medicine, Division of Cardiology
at Duke University Medical Center and was a faculty member of the Duke Clinical Research Institute (DCRI). She received her medical
degree from Harvard Medical School and completed her internship and residency in internal medicine at Massachusetts General
Hospital. Dr. Hess completed fellowships in cardiology and interventional cardiology at Duke University Medical Center, where she
also earned a Master of Health Science degree.
William R. Hiatt, MD
Dr. Hiatt is an endowed professor for cardiovascular research at the University of Colorado School of Medicine, Division of
Cardiology with a clinical and research focus in vascular medicine. He is president of CPC Clinical Research, a
university-affiliated, non-profit cardiovascular and clinical trials research organization. Research activities include studies
evaluating the pathophysiology and epidemiology of peripheral artery disease and related disorders. He received his medical degree
cum laude from the University of Colorado School of Medicine, and was elected to the Alpha Omega Alpha medical society. Dr. Hiatt
completed his residency training at Boston University Hospital and the University of Colorado Health Sciences Center. He was a
fellow in internal medicine and vascular medicine at the University of Colorado before joining the University of Colorado faculty.
CPC Clinical Research currently is running several large cardiovascular outcome trials.
Karen C. Johnston, MD, MSc
Dr. Johnston is the Harrison Distinguished Professor and Chair of Neurology and Professor of Public Health Sciences at the
University of Virginia. Dr. Johnston’s research has focused on the design and execution of middle phase and phase III clinical
trials. She is currently leading the NIH-NINDS funded Phase III Stroke Hyperglycemia Insulin Network Effort (SHINE) trial in
acute ischemic stroke. Dr. Johnston graduated AOA from the University of Rochester School of Medicine, where she also did her
internal medicine and neurology residency training. She did a vascular neurology fellowship at UVA and obtained a master’s
degree in outcomes and clinical investigation at UVA.
Jeffrey L. Saver, MD, FAHA, FAAN, FANA
Dr. Saver has been Director of the UCLA Stroke Unit since its inception, and Professor and SA Vice-Chair of Neurology at the David
Geffen School of Medicine. He is a leader in cerebrovascular research and clinical care. Dr. Saver has published more than 500
original articles, more than 30 book chapters, and two edited volumes and has been the principal investigator of more than 50
clinical research studies. His research focuses on stroke prevention, acute stroke treatment, stroke diagnosis, and neurocognitive
and neurobehavioral consequences of stroke. Dr. Saver received his medical degree from Harvard Medical School, and is a graduate of
the Harvard-Longwood Neurology Training Program, the University of Iowa Fellowship Program in Behavioral Neurology and Cognitive
Neuroscience, and the Brown University Fellowship Program in Vascular Neurology. Dr. Saver did his internship at Brigham & Women's
Hospital and his residency at Brigham & Women's Hospital.
Kathleen A. Welsh-Bohmer, Ph.D., ABPP-CN
Dr. Welsh-Bohmer is the Director of the Joseph and Kathleen Bryan Alzheimer’s Disease Research Center (Bryan ADRC) at Duke
University Medical Center, which focuses on basic science discovery and clinical care programs for patients with Alzheimer’s
disease and other similar memory complaints. Under Dr. Welsh-Bohmer’s leadership, the Bryan ADRC has established broad
collaborative ties regionally, nationally and internationally. She also serves as Professor, Department of Psychiatry and
Behavioral Sciences, Division of Medical Psychology and has a joint appointment with the Department of Neurology at Duke
University. She holds a BS in Psychology from Duke University and a PhD in Psychology from University of Virginia. She completed a
postdoctoral clinical training fellowship in Clinical Neuropsychology at University of Iowa. She is board certified through the
American Board of Professional Psychologists in the practice of clinical neuropsychology.
About Diffusion Pharmaceuticals
Diffusion Pharmaceuticals is a clinical stage biotechnology company focused on extending the life expectancy of cancer patients by
improving the effectiveness of current standard-of-care treatments including radiation therapy and chemotherapy. The Diffusion
technology is a paradigm shift in the approach to the treatment of cancer and other diseases involving hypoxia, or oxygen
deprivation, in that it facilitates the diffusion of oxygen to hypoxic tissues. Diffusion is developing its lead drug, trans
sodium crocetinate (TSC), for use in the many cancer types in which tumor hypoxia is known to diminish the effectiveness of
current treatments. TSC targets the cancer’s hypoxic micro-environment, re-oxygenating treatment-resistant tissue and making the
cancer cells more vulnerable to the therapeutic effects of treatments such as radiation therapy and chemotherapy, without the
apparent addition of any serious side effects.
A Phase 2 clinical program, completed in the second quarter of 2015, evaluated 59 patients with newly diagnosed
glioblastoma multiforme (GBM). This open label, historically controlled study demonstrated a favorable safety and efficacy profile
for TSC combined with standard of care. The U.S. Food and Drug Administration has guided the design of a Phase 3 trial in newly
diagnosed GBM. Additional planned studies, subject to receipt of necessary financing, include a Phase 2 trial in pancreatic cancer
and a study in brain metastases. Due to its novel mechanism of action, TSC has safely re-oxygenated a range of tumor types in our
preclinical and clinical studies. The Company believes its therapeutic potential is not limited to specific tumors, thereby making
it potentially useful to improve standard-of-care treatments of other life-threatening cancers and multiple hypoxia-linked
disorders.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that are not historical facts,
these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are
not limited to, statements about the company’s plans, objectives, expectations and intentions with respect to future operations and
products, the potential of the company’s technology and product candidates, the continued development of TSC in GBM, pancreatic
cancer and possibly other indications, and other statements that are not historical in nature, including those that utilize
terminology such as “would,” “will,” “plans,” “possibility,” “potential,” “future,” “expects,” “anticipates,” “believes,”
“intends,” “continue,” “estimates,” “targets,” “projects,” “intends,” and similar expressions, derivations of such words and the
use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain and
involve both known and unknown risks. These uncertainties and risks may cause the Company’s actual results to be materially
different than those expressed in or implied by such forward-looking statements. Particular uncertainties and risks include:
general business and economic conditions; the Company’s need for and ability to obtain additional financing; the Company’s ability
to satisfy regulatory requirements with respect to its product candidates; the Company’s ability to maintain and defend its
intellectual property; the conduct and success of the Company’s clinical trials, including successful enrollment in those trials;
the safety and efficacy of the Company’s product candidates; the Company’s ability to retain and recruit qualified personnel; the
difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; and the
other factors discussed in the Company’s public filings, including the risk factors included in the Company’s most recent Annual
Report on Form 10-K. All forward-looking statements in this news release speak only as of the date of this news release and are
based on Company management’s current beliefs and expectations. Investors, potential investors and other readers are urged
to consider these factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on
such forward-looking statements. The Company undertakes no obligation to update or revise any forward-looking statement,
whether as a result of new information, future events or otherwise after the date of this release, except as required
by applicable law.
Diffusion Pharmaceuticals Contacts David Kalergis Chief Executive Officer Diffusion Pharmaceuticals Inc. (434) 220-0718 dkalergis@diffusionpharma.com Stephanie Carrington ICR Inc. (646) 277-1282 Stephanie.Carrington@icrinc.com
