CHARLOTTESVILLE, Va., March 16 /PRNewswire/ -- Diffusion
Pharmaceuticals LLC, a clinical-stage drug discovery and development
company, today announced the initiation of human testing of trans sodium
crocetinate (TSC), its lead drug candidate. TSC, which uses a novel
mechanism of action to enhance the diffusion of oxygen into tissue, is
being studied as a potential treatment for numerous diseases involving
oxygen deprivation at the cellular level (hypoxia). The Phase I safety
trial began on March 12, 2007, following a successful review by the U.S.
Food and Drug Administration (FDA) of the Investigational New Drug (IND)
application for TSC, which was completed in February 2007.
"Commencement of human trials is the most important milestone for
Diffusion Pharmaceuticals to date, marking our transition from a
preclinical drug-development company to a clinical-stage company," says
David G. Kalergis, Chief Executive Officer of Diffusion Pharmaceuticals.
"We look forward to rapidly advancing TSC to Phase II trials later this
year after successful completion of this initial safety study."
Diffusion completed FDA-required IND-enabling animal toxicology studies
in the third quarter of 2006. These studies confirmed a safety profile for
TSC showing no appreciable adverse findings and documenting very high no
adverse effect levels (NOAEL). The on-going Phase I safety trial is a
double-blind, placebo-controlled, dose-escalation study in 48 normal
healthy volunteers to assess TSC's pharmacokinetics and tolerability.
In preclinical studies, TSC has been shown to increase the body's
ability to use oxygen by up to 30 percent, which is a therapeutically
significant result across a range of dangerous physical conditions
involving oxygen deprivation. In animals subjected to induced ischemic
stroke, the area of damaged brain tissue is significantly reduced in
TSC-treated animals compared to untreated (control) animals. Also, animals
suffering severe blood loss have a higher rate of survival if treated with
TSC. In addition, TSC has been shown in animal models to increase the
diffusion of oxygen into hypoxic cancerous tumor tissue, rendering the
cancer more susceptible to radiation therapy.
John A. Jane, MD, PhD, David W. Weaver Professor of Neurosurgery and
Director of Neurosurgical Training, University of Virginia and Editor,
Journal of Neurosurgery, has noted, "Diffusion's new pharmaceutical
technology will revolutionize healthcare by improving the management of
stroke, myocardial infarction, and respiratory disease."
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. If approved by the FDA, the
patient population for successful Diffusion-owned, patent-protected
molecules such as TSC could be well over 34 million patients per year in
the U.S. alone.
To date, Diffusion Pharmaceuticals, which is privately owned and
financed, has received $2.6 million in research grants from the Office of
Naval Research (ONR) to help fund TSC's development.
About Diffusion Pharmaceuticals LLC
Diffusion Pharmaceuticals LLC is a clinical-stage drug-discovery and
development company that owns a platform technology of patented
small-molecule therapeutics that enhance the diffusion of oxygen to hypoxic
(oxygen starved) tissues. By applying a revolutionary approach to increase
oxygen diffusion into tissue cells, Diffusion's lead molecule trans sodium
crocetinate (TSC) and other proprietary pipeline molecules (known as trans
bipolar carotenoid or TBC molecules) could be used to treat
life-threatening conditions, such as trauma, stroke, cardiovascular
diseases, respiratory disorders, and numerous other conditions
characterized by oxygen deprivation at the cellular level. A Phase I
clinical trial for TSC began in the first quarter of 2007 to support the
use of TSC in ischemic indications. Phase II studies for TSC are expected
to begin later this year. Several of the company's pipeline molecules are
currently in the preclinical stage. 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 of
Diffusion Pharmaceuticals LLC, +1-434-220-0718,
tlinkous@diffusionpharma.com
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