Poster Presentation to Focus on Phase 3 GBM Brain Cancer Clinical Trial;
40 Percent Survival Rate for Biopsy-only Patients in Phase 2 Represents Fourfold Increase
Above Historical Average For Those Facing Inoperable GBM Cancer
CHARLOTTESVILLE, Va., Nov. 15, 2018 (GLOBE NEWSWIRE) — Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN), 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’s needed most, announced today that Chief Scientific Officer Dr. John L. Gainer will join leading clinicians and researchers from around the world in presenting a poster at the 2018 Annual Meeting of the Society for NeuroOncology (SNO) on Saturday, November 17, 2018 from 5:00-7:00pm EST.
SNO’s 23rd Annual Scientific Meeting and Education Day will be held from Thursday, November 15, 8:00am through Sunday, November 18, 1:00pm at the Marriott Hotel, New Orleans, Louisiana. SNO is a “multidisciplinary organization dedicated to promoting advances in neuro-oncology through research and education” whose annual conference is an opportunity for top health care professionals who specialize in central nervous system tumors to gather and present the latest advancements to fellow researchers, hospital administrators, and potential investors.
Dr. Gainer, who in addition to serving as the Chief Scientific Officer of Diffusion is also the inventor of Trans Sodium Crocinate (TSC), will present a poster on the Company’s Phase 3 INTACT (INvestigation of TSC Against Cancerous Tumors) clinical trial for the treatment of glioblastoma multiforme (GBM) brain cancer in biopsy-only patients. Phase 2 of Diffusion’s INTACT trial showed potentially breakthrough results in the use of TSC in treatment: a fourfold increase in the two-year survival rate of biopsy-only patients, which jumped from 10 percent to 40 percent. This result is especially promising for these patients and their families: biopsy-only patients have historically faced lower survival rates than patients for whom resection (surgery for removal of the tumor) is an option.
“Dr. Gainer’s focus on innovation is what drew me to his research in the first place, and resulted in our co-founding of Diffusion, where we continue our efforts to find new and effective treatments for life-threatening diseases like GBM brain cancer,” said David Kalergis, Chairman and CEO of Diffusion. “At the 2018 Annual Meeting of the Society of NeuroOncology, Dr. Gainer will have an opportunity to present the exciting results from our Phase 2 GBM cancer trial and share our continued Phase 3 efforts for biopsy-only participants – work which represents real potential and promise for patients and their families”
“Finding effective and life-saving treatment for patients living with biopsy-only GBM brain cancer has long been a significant challenge for researchers, scientists, and physicians, so I’m looking forward to my poster presentation at the 2018 Annual Meeting of the Society of NeuroOncology, as it’s a chance to share the progress we’ve made on this front,” said Dr. John L. Gainer, Chief Scientific Officer of Diffusion. “Hypoxic tumors are resistant to radiation therapy, and our Phase 2 results showed that using TSC – which was developed to fight hypoxia by bringing oxygen to the areas where it’s needed most – in conjunction with radiation and temozolomide (TMZ) treatment led to a significant increase in survival for biopsy only patients. Our Phase 3 study will focus on these biopsy-only patients, and I am eager to share that work with my colleagues from around the world at SNO’s 2018 Annual Meeting.”
Diffusion’s Phase 3 INTACT program is using TSC to target inoperable GBM brain cancer. Historically, these biopsy-only patients have faced lower survival rates and increased obstacles to inclusion in clinical trials. Current standard of care for these GBM patients following diagnosis involves 6 weeks of radiation therapy along with daily temozolomide (TMZ), followed by six 4-week chemotheraphy sessions which include a high dosage of TMZ. Phase 2 of INTACT saw treatment with TSC added to the initial six weeks of radiation therapy and TMZ treatment. Phase 3 of INTACT will include treatment with TSC during the initial six week of radiation therapy and TMZ treatment, but will also include administration of TSC during the six months of chemotheraphy. The Company is currently engaged in an FDA-requested, 8-patient lead-in, scheduled to complete in January 2019. Randomization can begin following read out and reporting of that data.”
Dr. Gainer’s presentation at SNO is just the latest development for Diffusion, which recently received FDA approval to enroll patients in an ambulance-based Phase 2 clinical trial testing TSC for the treatment of both ischemic and hemorrhagic stroke. The Company also recently appointed William “Bill” Hornung to the position of Chief Financial Officer.
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’s needed most —offering new hope for the treatment of life-threatening medical conditions.
Diffusion’s lead drug, Trans Sodium Crocinate (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, GBM brain cancer, pancreatic cancer, and brain metastases. In each of these diseases, hypoxia – when essential tissue in your body is deprived of oxygen – has proved to be a significant obstacle for medical providers and the target for TSC’s novel mechanism.
In 2018, the Company began enrolling patients in its Phase 3 INTACT program, using TSC to target inoperable GBM brain cancer. Its on-ambulance Phase 2 acute stroke protocol was granted FDA clearance to proceed in September, 2018. Additional pre-clinical 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.
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 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.
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 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 or partnering arrangement; 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 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.
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