Diffusion Pharmaceuticals Announces Publication of RES-529 Review Article in Anti-Cancer Drugs

CHARLOTTESVILLE, Va., March 15, 2016 -- Diffusion Pharmaceuticals Inc. (OTCQX:DFFN), a clinical stage biotechnology company focused on the development of novel small molecule therapeutics for cancer, today announced the online publication of a reviewed article on RES-529 ahead of print in Anti-Cancer Drugs.  

Diffusion Pharmaceuticals recently acquired RES-529, a novel PI3K/AKT/mTOR pathway inhibitor that targets both mTORC1 and mTORC2 through mTOR complex dissociation, from RestorGenex Corporation at the closing of its reverse merger on January 8, 2016. RES-529 is being developed for oncology and ophthalmology with a primary focus in the treatment of glioblastoma multiforme (GBM). Orphan drug designation has been granted by the FDA for this indication.

The article entitled “RES-529: a PI3K/AKT/mTOR pathway inhibitor that dissociates the mTORC1 and mTORC2 complexes,” reviews the potential of RES-529 to inhibit tumorigenesis in glioblastoma, prostate cancer, and breast cancer. RES-529 treatment has been shown to be effective in preclinical models of glioblastoma as well as synergistic with radiation therapy in these models.  In preclinical models of prostate cancer, RES-529 has been shown to be synergistic with all three common modalities of treatment: radiation therapy, chemotherapy, and hormonal therapy. The article was authored by Mark Weinberg, MD, MBA, who was previously Senior VP of Clinical Development at RestorGenex.

David Kalergis, Chairman and Chief Executive Officer of Diffusion Pharmaceuticals, said, “The acquisition of RES-529 has strengthened our oncology pipeline. Concurrent with our primary focus of advancing our lead candidate, trans sodium crocetinate (TSC), into a Phase III clinical program in GBM and a Phase II/III trial in pancreatic cancer, we are also assessing the future opportunities and plans for RES-529.”

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.  Diffusion is developing its lead drug, 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.  TSC has potential application in other indications involving hypoxia, such as stroke and neurodegenerative diseases.

A Phase II clinical program, completed in the second quarter of 2015, evaluated 59 patients with newly diagnosed glioblastoma multiforme (GBM).  The 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 III trial in newly diagnosed GBM.  Additional planned studies include a Phase II/III trial in pancreatic cancer and a Phase II/III study in brain metastases.  Due to its novel mechanism of action, TSC safely re-oxygenates a range of tumor types. Its therapeutic potential is not limited to specific tumors, thereby making it potentially useful to improve current standard-of-care treatments of many life-threatening cancers.

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 combined company’s technology and product candidates, the anticipated timing of future clinical trials, the anticipated financial position, operating results and growth prospects of the combined 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 Company management’s current beliefs and expectations.  Diffusion Pharmaceuticals undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

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]