Diffusion Pharmaceuticals Successfully Completes Animal Toxicity Studies in Preparation for Phase 3 Pivotal Trial of TSC in New Diagnosed Glioblastoma Patients

CHARLOTTESVILLE, Va., Sept. 19, 2016 -- Diffusion Pharmaceuticals Inc. (OTCQX:DFFN), a clinical stage biotechnology company focused on the development of novel small molecule therapeutics for cancer and other hypoxia-related diseases, today reported the successful completion of dosing of two animal toxicology studies required by the U.S. Food and Drug Administration (FDA) to support Diffusion’s planned Phase 3 clinical trial testing its lead molecule trans sodium crocetinate (TSC) in newly diagnosed Glioblastoma (GBM) patients.

As outlined at the end of Phase 2 FDA meeting, the number of TSC dosing exposures per patient will double in the planned Phase 3 trial as compared to the Phase 2 trial.  As part of the agreement reached on a trial design for the Phase 3 study, the FDA requested that Diffusion augment its existing TSC toxicology studies with additional three month TSC toxicology data in both rats and dogs. The animal dosing for these three month studies has now been successfully completed.

David G. Kalergis, Diffusion’s Chairman and Chief Executive Officer, said, “The successful completion of dosing for these three month animal toxicology studies is an important milestone in support of Diffusion’s ability to conduct a Phase 3 pivotal trial of TSC in newly diagnosed GBM patients.”

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 the 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 agreed upon the design of a Phase 3 trial in newly diagnosed GBM.  Additional planned studies, subject to receipt of necessary financing, include the 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.

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
[email protected]

Stephanie Carrington
ICR Inc.
(646) 277-1282
[email protected]