Press Release

Diffusion Pharmaceuticals Appoints Dr. Robert Ruffolo to Board of Directors

Company Release - 7/6/2017 8:00 AM ET

CHARLOTTESVILLE, Va., July 06, 2017 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN), a clinical stage biotechnology company focused on the development of novel small molecule therapeutics for cancer and other hypoxia-related diseases, today announced the appointment of Robert R. Ruffolo, Jr., Ph.D., to its Board of Directors, effective immediately.

“We are delighted to welcome Bob to the Board,” stated David Kalergis, Chairman and Chief Executive Officer. “His comprehensive pharmaceutical industry experience and drug development knowledge will add real value to Diffusion.”

Dr. Ruffolo currently serves as President of Ruffolo Consulting, LLC, and sits on the Boards of Directors for numerous biotechnology companies, in addition to several non-profit charitable organizations. He previously served as President of Research and Development of Wyeth Pharmaceuticals and Corporate Senior Vice President of Wyeth (now Pfizer). Previously Dr. Ruffolo spent 17 years at SmithKline Beecham Pharmaceuticals (now GlaxoSmithKline) as Senior Vice President and Director of Biological Sciences, Worldwide, and before that, he was Chairman of the Cardiovascular Research Committee at Lilly Research Laboratories.

During his distinguished career in the pharmaceuticals industry, Dr. Ruffolo played a significant role in the discovery and/or development of marketed products such as Carvedilol for the treatment of heart failure and acute myocardial infarction, Ropinirole for Parkinson’s disease, Dobutamine for congestive heart failure and Eprosartan for hypertension. He has authored nearly 500 full-length publications and over 200 abstracts, in addition to editing 15 books. Dr. Ruffolo was Editor-in-Chief of four international scientific journals, and has served on the editorial board of 29 international scientific journals. He has received numerous prestigious awards throughout his career, including the Discoverers Award for Carvedilol in heart failure. Dr. Ruffolo received a B.S. degree in pharmacy and his Ph.D. degree in pharmacology from The Ohio State University.  Thereafter, he spent two years as a postdoctoral fellow at the National Institutes of Health.

About Diffusion Pharmaceuticals Inc.

Diffusion Pharmaceuticals Inc. 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. Diffusion is developing its lead product candidate, trans sodium crocetinate (TSC), for use in the many cancer types in which tumor hypoxia (oxygen deprivation) 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, including a 37% improvement in overall survival over the control group at two years.  A particularly strong efficacy signal was seen in the subset of inoperable patients where survival of TSC-treated patients at two years was increased by almost fourfold over the controls. At an End-Of-Phase 2 Meeting, the U.S. Food and Drug Administration provided Diffusion with extensive guidance on the design for a Phase 3 trial of TSC in newly diagnosed GBM patients.   Assuming FDA sign-off on our final protocol design, focusing on the inoperable patients, the study is planned to initiate by the end of 2017.  Due to its novel mechanism of action, TSC has safely re-oxygenated a range of tumor types in our preclinical and clinical studies.  Diffusion 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.  Additional planned studies include a Phase 2 trial in pancreatic cancer and a study in brain metastases, with study initiation subject to receipt of additional funding or collaborative partnering.  The Company also believes that TSC has potential application in other indications involving hypoxia, such as neurodegenerative diseases and emergency medicine, and an in-ambulance trial of TSC in stroke is under consideration.

Forward-Looking Statements

To the extent any statements made in this news release deal with information that is not historical, 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 anticipated timing of future clinical trials and protocol review, the anticipated financial position, operating results and growth prospects of the company and other statements that are not historical in nature, particularly those that utilize terminology such as "would," "will," "plans," "possibility," "potential," "future," "expects," "anticipates," "believes," "intends," "continue," "expects," other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. 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; and the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance. All forward-looking statements in this news release speak only as of the date of this news release and are based on management's current beliefs and expectations. Diffusion undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

This announcement is neither an offer to sell, nor a solicitation of an offer to buy, any securities and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful. Any such offer must be made pursuant to the registration requirements of the Securities Act of 1933, as amended, or any state securities laws, and unless so registered, may not be offered or sold in the United States except pursuant to an exemption therefrom.

 

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

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Source: Diffusion Pharmaceuticals, Inc.