Diffusion Pharma Selects Contract Research Organization For Phase III Clinical Trial Of Lead Compound TSC For Inoperable GBM Brain Cancer

Published: Jul 31, 2017

CHARLOTTESVILLE, Va., July 31, 2017 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals, Inc. (NASDAQ:DFFN), a clinical stage biotechnology company developing novel small molecule therapeutics for cancer and other hypoxia-related diseases, announced today that it has selected a premier Clinical Research Organization (CRO) to conduct a Phase 3 clinical trial of Diffusion's lead molecule, trans sodium crocetinate (TSC), in inoperable glioblastoma multiforme (GBM) patients. Diffusion also entered into agreements with top tier partners to manage the MRI imaging, clinical data management, drug supply and other functions related to the trial. Diffusion plans to initiate this Phase 3 clinical trial by the end of 2017.

“After reaching the critical milestone of manufacturing drug product for our Phase 3 trial earlier this month, we have now reached another major milestone with the selection of our full clinical trial team, including a leading global CRO and first-in-class providers of imaging and data management services,” said David Kalergis, Diffusion’s Chairman and CEO. “We are pleased to have engaged such skilled and experienced partners for this important endeavor.”

Diffusion is now interacting with the FDA on details regarding the design and execution of the planned Phase 3 study. The study will focus on treating newly diagnosed GBM patients who have been judged by their medical team to be inoperable, usually because of the size or location of the tumor. Due to their poor prognosis, these patients are often excluded from participation in other GBM clinical trials. In the Company’s Phase 2 GBM trial, the TSC-treated inoperable group showed a nearly four-fold increase in survival at two years, compared to the control.

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 almost four fold 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 the final protocol design focusing on 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 Phase 2 trials in pancreatic cancer and 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, 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,and the various risk factors (many of which are beyond Diffusion’s control) as described under the heading “Risk Factors” in Diffusions’s filings with the United States Securities and Exchange Commission. 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.

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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