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