Press Release

Diffusion Pharmaceuticals’ TSC Phase 1/2 Glioblastoma Multiforme Clinical Trial Results Published in February 2017 Edition of Journal of Neurosurgery

Company Release - 2/8/2017 8:00 AM ET

CHARLOTTESVILLE, Va., Feb. 08, 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 that the data from the Phase 1/2 clinical trial evaluating the safety and efficacy of trans sodium crocetinate (TSC) in newly diagnosed glioblastoma multiforme (GBM) has been published in the print edition of the peer-reviewed Journal of Neurosurgery (“JNS”) (Volume 126, February 2017).  Results from the Phase 1/2 clinical trial in 59 patients showed that 36.3% of the full TSC dose patients were alive at two years, compared to historical two-year survival rates ranging from 27% to 30%. TSC, the Company’s lead product candidate, is designed to target the tumor’s reduced oxygen microenvironment. TSC re-oxygenates cancerous tissue, thus making the cancer cells more susceptible to current radiation therapy and chemotherapy. 

“The publication of the article in the JNS provides peer-reviewed validation and raises the visibility of Diffusion across key stakeholder audiences,” stated David Kalergis, Chairman and Chief Executive Officer.  “The very encouraging data from our Phase 1/2 clinical trial supports our strategy to advance into Phase 3 clinical development.”

The article, entitled, “Trans sodium crocetinate with temozolomide and radiation therapy for glioblastoma multiforme,” outlines the results of a Phase 1/2 trial designed to evaluate the therapeutic effect of adding TSC to radiation therapy in 59 newly diagnosed GBM patients.  In this trial, all patients received radiation with the drug temozolomide beginning either after surgery or biopsy of the tumor. TSC was administered around 45 minutes before each radiation session three days per week during the 6 weeks of radiation therapy.  Considerable tumor shrinkage was seen in many patients, with tumors in 11 patients disappearing completely.

JNS is the official peer-reviewed publication of the American Association of Neurological Surgeons.  Diffusion’s data was previously published in the online edition of JNS in May 2016 and was originally released in July 2015. 

About Treatment-Resistant Cancers and TSC
Oxygen deprivation at the cellular level (“hypoxia”) is the result of rapid tumor growth, causing the tumor to outgrow its blood supply.  Cancerous tumor cells thrive with hypoxia and the resultant changes in the tumor microenvironment cause “treatment-resistance” to radiation therapy and chemotherapy.  Using a novel, proprietary mechanism of action, Diffusion’s lead drug TSC counteracts tumor hypoxia – and therefore treatment-resistance – by safely re-oxygenating tumor tissue, thus enhancing tumor kill and potentially prolonging patients’ life expectancy.  Oxygen levels of normal tissue remain unaffected upon administration of TSC, thereby avoiding the introduction of harmful side effects.

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 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.

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 provided guidance on the design of a Phase 3 trial in newly diagnosed GBM. Additional planned studies may 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 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. The Company also believes that TSC has potential application in other indications involving hypoxia, such as stroke and neurodegenerative diseases.

Forward-Looking Statements
To the extent any statements made in or in connection with 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 Diffusion’s technology and product candidates and significance of its clinical data to date, 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," "continue," “estimates,” “targets,” “projects,” “intends,” other words or expressions of similar meaning, derivations of such words or expressions 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 Diffusion'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; Diffusion’s need for and ability to obtain additional financing; Diffusion’s ability to satisfy regulatory requirements with respect to its product candidates and obtain regulatory approval for its proposed clinical pathways; Diffusion’s ability to maintain and defend its intellectual property; the conduct and success of Diffusion’s clinical trials, including successful enrollment in those trials; the safety and efficacy of Diffusion’s product candidates; Diffusion’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 Diffusion’s public filings, including the risk factors including in Diffusion’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 Diffusion’s management's current beliefs and expectations. Investors, potential investors and other reads 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.  Diffusion 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

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Source: Diffusion Pharmaceuticals, Inc.