CHARLOTTESVILLE, Va., Sept. 28 /PRNewswire/ -- Diffusion
Pharmaceuticals LLC, a clinical-stage drug development company
commercializing first-in-class drugs utilizing a novel mechanism of action
that enhances oxygen diffusion, today announced the results of a Phase I
safety trial of its lead drug candidate, trans sodium crocetinate (TSC). In
addition, the company announced the completion of a $4.5 million private
placement, the proceeds of which will support the company's overall growth
and advance TSC into Phase II clinical trials in early 2008.
Diffusion Pharmaceuticals' initial safety study was a double-blind,
placebo-controlled, dose-escalation study designed to evaluate the
tolerability and pharmacokinetics of a single intravenous bolus injection
of TSC in healthy human subjects. The study demonstrated that TSC is very
well-tolerated, raising no significant clinical issues in humans at doses
significantly higher than the doses to be used in upcoming clinical trials
in patients.
"Successful completion of this study is a key milestone in the clinical
development of TSC and significantly advances our lead product candidate
toward commercialization," said David G. Kalergis, Chief Executive Officer
of Diffusion Pharmaceuticals. "The results of our Phase I trial and recent
preclinical studies, coupled with completion of the private placement, will
enable us to move quickly into Phase II proof-of-concept studies with TSC
in two diverse patient populations -- peripheral vascular disease and
cancerous brain tumors -- both of which exhibit oxygen deprivation at the
cellular level," said Kalergis.
The company's next clinical study will examine the safety and effects
of TSC on oxygenation levels of cancerous tumor tissue in primary brain
tumor patients who have glioblastoma multiforme (GBM) and will be
undergoing a surgical procedure for tumor biopsy and/or tumor resection.
Further trials in GBM patients will examine the safety and effects of TSC,
including impact on patient survival, when combined with radiation therapy.
These clinical trials will be sponsored by Diffusion Pharmaceuticals LLC,
and conducted in collaboration with The Johns Hopkins University School of
Medicine and the New Approaches to Brain Tumor Therapy (NABTT) Central
Nervous System (CNS) Consortium.
Dr. Stuart Grossman, Director of Clinical and Laboratory Neuro-Oncology
Programs at Johns Hopkins and project leader for NABTT said, "TSC's novel
mechanism of action provides a whole new approach to enhancing radiation
therapy. We are excited by its prospects and intend to start clinical
trials in patients with primary brain tumors as soon as possible."
In addition, the company is planning a clinical trial in peripheral
vascular disease patients suffering from intermittent claudication (i.e.,
intense leg pain while walking) to evaluate the effect of TSC on tissue
oxygenation in these patients using a standardized treadmill test. Site
selection for this study is currently underway.
Diffusion Pharmaceuticals' pipeline of first-in-class small molecules
uses a novel mechanism of action allowing more oxygen to reach
oxygen-deprived (hypoxic) tissues in the body. The diffusion of oxygen
through blood plasma and into tissue is a critical step in delivering
oxygen to hypoxic tissue; Diffusion Pharmaceuticals' drugs affect this
process. In preclinical studies, TSC has been shown to increases the rate
of oxygen diffusion by about 30 percent. TSC has been shown in animal
models to increase the diffusion of oxygen into hypoxic cancerous tumor
tissue, making the cancer more susceptible to radiation therapy and
increasing survival. In addition, animals suffering severe blood loss have
a higher rate of survival if treated with TSC.
The ability to enhance oxygen diffusion into hypoxic tissue represents
a transformative technology, with potentially far-ranging implications for
human health and the practice of medicine. Diffusion Pharmaceuticals'
family of drugs can potentially be used in a broad range of conditions such
as cardiovascular disease, cancer, respiratory disorders and other serious
or life-threatening medical conditions. If approved for marketing by the
U.S. Food and Drug Administration (FDA), the patient population for
successful Diffusion-owned, patent-protected molecules such as TSC could be
in the millions.
To date, Diffusion Pharmaceuticals has raised $10.2 million in private
equity and has received $2.6 million in government research and development
funding from the Office of Naval Research (ONR), bringing the company's
total funding to $12.8 million.
About Diffusion Pharmaceuticals LLC
Diffusion Pharmaceuticals LLC is a clinical-stage drug-development
company commercializing a family of first-in-class drug candidates to treat
serious or life-threatening medical conditions. These proprietary small
molecules use a novel method of action to enhance oxygen diffusion to
oxygen deprived (hypoxic) tissue. Potential clinical applications include
critical care uses such as trauma, hemorrhage, stroke and heart attack, as
well as chronic conditions such as cardiovascular disease, respiratory
disorders and peripheral vascular disease. Additionally, enhanced diffusion
of oxygen into hypoxic tissue also has an important application in oncology
by improving the efficacy of radiation therapy in cancerous tumors. The
Company's first Phase I clinical trial for its lead molecule, trans sodium
crocetinate (TSC), shows the drug is well-tolerated in healthy human
subjects at doses significantly higher than the estimated efficacious human
dose. Clinical trials will begin in early 2008 in cancer patients
undergoing radiation therapy and in peripheral vascular disease patients
suffering from intermittent claudication. Diffusion Pharmaceuticals, which
is privately held, is located in Charlottesville, Virginia. For more
information, visit http://www.diffusionpharma.com.
SOURCE Diffusion Pharmaceuticals LLC
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Related links:
http://www.diffusionpharma.com
CONTACT:
Tracey Linkous, Director of Communications,
+1-434-220-0718, tlinkous@diffusionpharma.com
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