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
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.
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 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.
Contact:
Rob Corradi Pen Public
Affairsrob@penpublicaffairs.com410-212-5483
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