DFFN Diffusion Pharmaceuticals Inc

Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) (“Diffusion” or “the Company”), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body’s ability to bring oxygen to the areas where it is needed most, today announced receipt from the European Patent Office of a Notice of Intention to Grant a patent related to the use of the Company’s lead compound trans sodium crocetinate (“TSC”) in combination with the leading thrombolytic, tissue plasminogen activator (“tPA”), in the treatment of ischemic stroke. The patent claim covers administration of TSC within three or four hours of the onset of stroke symptoms in combination with tPA administered within nine to 12 hours of the onset of stroke symptoms.

The European Patent Office has also granted two additional patents to Diffusion. Patent, No. EP1667954B1 entitled “Bipolar Trans Carotenoid Salts and Their Uses” covers the use of bipolar trans-carotenoids, including TSC, to treat acute lung injury, congestive heart failure, and pretreatment or treatment during or after surgery. Patent No. EP 1487774B1, also entitled “Bipolar Trans Carotenoid Salts and Their Uses,” relates to methods of synthesizing bipolar trans carotenoid salts, including TSC. Similar patents were previously issued in the U.S.

“We are building an important portfolio of intellectual property on a global scale and are pleased with our continued progress to protect TSC in multiple indications,” said David Kalergis, Chief Executive Officer of Diffusion Pharmaceuticals. “As we prepare to begin our Phase 2 on-ambulance trial for the treatment of stroke this summer, we are heartened to receive additional protection in Europe for our proprietary compound in combination with tPA.  

“tPA is used to break down blood clots in patients suffering from ischemic stroke and is the only FDA-approved stroke treatment. While tPA has shown efficacy in ischemic stroke, it may not be used in hemorrhagic stroke and precious time may be lost before the determination is made as to which type of stroke a patient is experiencing.  TSC may provide an important solution as our preclinical work has shown that TSC in combination with tPA may extend the timeframe wherein tPA may be administered.

“More than 40 patents related to TSC have either been allowed or issued in various geographies, including the U.S. and the EU, the world’s two largest markets for pharmaceutical products, which collectively account for approximately 80% of the world’s pharmaceutical market,” Mr. Kalergis added.  

About Diffusion Pharmaceuticals Inc.

Diffusion Pharmaceuticals Inc. is an innovative biotechnology company developing new treatments that improve the body’s ability 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 in conjunction with the Office of Naval Research, which was seeking a way to treat hemorrhagic shock caused by massive blood loss on the battlefield. 

Evolutions in research have led to Diffusion’s focus today: Fueling Life by taking on some of medicine’s 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 proved to be a significant obstacle for medical providers and the target for TSC’s novel mechanism.

In January 2018 the Company began enrolling patients in the lead-in phase to its Phase 3 INTACT program, using TSC to target inoperable GBM brain cancer. In September 2018 its on-ambulance PHAST-TSC acute stroke protocol was granted FDA clearance to proceed.  Additional preclinical data supports the potential use of TSC as a treatment for other conditions where hypoxia plays a major 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 preclinical testing for GBM.

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, CEODiffusion Pharmaceuticals Inc.(434) 220-0718dkalergis@diffusionpharma.comorLHA Investor RelationsKim Sutton Golodetz(212) 838-3777kgolodetz@lhai.com