Data Safety Monitoring Board Recommends Continued Conduct of Study with Highest Dose of TSC

CHARLOTTESVILLE, Va., July 23, 2019 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions, today reported that based on favorable safety data in a 19-patient dose-escalation run-in study, the Data Safety Monitoring Board (DSMB) has recommended the continuation of the Company’s Phase 3 clinical trial with trans sodium crocetinate (TSC) in inoperable glioblastoma multiforme (GBM) patients. In addition, the DSMB has recommended that the highest dose administered, 1.5 mg/kg of TSC, be used during the adjuvant treatment period of the Phase 3 INTACT trial. The INTACT (INvestigating Tsc Against Cancerous Tumors) trial is comparing standard of care (SOC) radiation therapy and chemotherapy plus TSC against SOC alone.

The dose-escalation run-in study explored four doses of TSC:  0.25, 0.5, 1.0 and 1.5 mg/kg. Patients received SOC radiation therapy and temozolomide chemotherapy with an intravenous injection of TSC administered before those treatments. Adverse events seen were consistent with the natural history of newly diagnosed inoperable GBM patients.  

The DSMB concluded that no adverse safety signal had been observed, and unanimously recommended continuing the study as planned using the 1.5 mg/kg dose of TSC during the adjuvant chemotherapy period.

“We are pleased this run-in study is consistent with our previous findings as to the safety of TSC,” said David Kalergis, Diffusion’s chief executive officer. “We are hopeful these run-in safety data, along with compelling data from our Phase 2 study showing a nearly four-fold improvement in survival at two years with TSC when used with radiation therapy in the inoperable GBM patient subgroup, will attract the attention of potential partners for continuing the development of the GBM indication. GBM patients have a poor prognosis and limited treatment options. We believe TSC has great potential to improve these patients’ outcomes and extend survival.”

About the INTACT Trial

The INTACT clinical trial is an open-label, randomized, controlled, Phase 3 safety and efficacy registration trial in inoperable GBM patients.  It will screen 300 patients and enroll 264, with the expectation that results from 236 patients will be available for analysis.  Enrolled patients will be randomized in a 1:1 ratio into control and treatment groups. Patients in the control group will receive SOC radiation and chemotherapy, including the standard temozolomide injections. Patients in the treatment group will receive injections of TSC prior to these SOC treatments. The SOC regimen for GBM is temozolomide plus radiation therapy for 6 weeks followed by 28 days of rest, followed by 6 cycles of high-dose temozolomide treatment.

The study will compare overall survival at two years between the two groups. Up to 100 clinical sites are expected to participate.

Further details about the trial protocol are available at www.clinicaltrials.gov.

About Diffusion Pharmaceuticals Inc.

Diffusion Pharmaceuticals Inc. is an innovative biotechnology company developing new treatments to bring oxygen to the areas where it is needed most, offering new hope for the treatment of life-threatening medical conditions.

Diffusion’s lead drug TSC was originally developed with aid from the U.S. Office of Naval Research, which was seeking a way to treat casualties from massive blood loss on the battlefield. 

Evolutions in research have led to Diffusion’s focus today, Fueling Life, by taking on some of the most intractable and difficult-to-treat diseases, including stroke and GBM brain cancer. In each of these diseases, hypoxia – oxygen deprivation of essential tissue in the body – has been a significant obstacle for previous treatments and is the target for TSC’s novel mechanism.

In January 2018 the Company began enrolling patients in the lead-in safety testing of its Phase 3 INTACT program, using TSC to target inoperable GBM brain cancer. The Company is seeking to partner this indication prior to initiation of the randomization stage. Diffusion’s highest-priority program, the on-ambulance PHAST-TSC acute stroke protocol, has been granted FDA clearance to proceed and work is underway to begin enrolling patients later this year.  Additional preclinical data supports the potential use of TSC as a treatment for other conditions where hypoxia plays a significant role, such as myocardial infarction, respiratory diseases such as COPD, peripheral artery disease, and neurodegenerative conditions such as Alzheimer’s and Parkinson’s disease.

In addition, RES-529, the Company’s PI3K/AKT/mTOR pathway inhibitor that dissociates the mTORC1 and mTORC2 complexes, is in the preclinical testing phase.

Diffusion is headquartered in Charlottesville, Virginia – a hub of advancement in the life science and biopharmaceutical industries – and is led by CEO David Kalergis, a 30-year industry veteran and company co-founder. 

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 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 Diffusion’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Particular uncertainties and risks include: the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; general business and economic conditions; the company's need for and ability to obtain additional financing or partnering arrangements; and the various risk factors (many of which are beyond Diffusion’s control) as described under the heading “Risk Factors” in Diffusion’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.

Contacts:
David Kalergis, CEO
Diffusion Pharmaceuticals Inc.
(434) 220-0718
dkalergis@diffusionpharma.com

LHA Investor Relations
Kim Sutton Golodetz
(212) 838-3777
kgolodetz@lhai.com

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