Human Testing Expected to Begin in Early 2007
CHARLOTTESVILLE, Va., Oct. 17 /PRNewswire/ -- Diffusion Pharmaceuticals
LLC, a drug discovery and development company pioneering a revolutionary
mechanism of action to treat life-threatening diseases, today announced
that it has completed all animal toxicology studies required by the U.S.
Food and Drug Administration (FDA) to file an investigational new drug
(IND) application for its lead compound trans sodium crocetinate (TSC). The
company also announced that it has completed a private financing round of
$1.5 million, the proceeds of which will be used to support the company's
overall growth and move TSC into Phase I clinical trials in early 2007.
The recently completed toxicology tests were conducted at independent
research laboratories, and were funded in part by a grant from the Office
of Naval Research. The no adverse effect level (NOAEL) was about 500 times
the efficacious dose in those animals, which is substantially higher than
the proposed dose to be examined in humans.
"These studies show no appreciable toxicity of TSC, even at doses much
greater than the proposed human dose," said David G. Kalergis, Diffusion's
Chief Executive Officer. "Reaching this critical milestone has positioned
us to prepare and file our IND application, which is currently being
assembled by a team of Diffusion staff members and expert consultants," he
continued.
Assuming no significant FDA objections after filing, the company can
proceed with its plans to initiate testing in healthy human volunteers.
These studies are expected to begin in early 2007. Completion of these
Phase I clinical trials will provide the foundation for further testing of
TSC in populations suffering from such life-threatening conditions as
hemorrhagic shock, stroke, respiratory disorders and cancer.
Additionally, Diffusion announced that it has closed a financing round
in which it raised its target of $1.5 million in private equity, primarily
from existing shareholders.
"These funds help move TSC into human testing, where we will have the
opportunity to demonstrate the drug's safety in humans and show proof of
principal for the company's novel technology," said Kalergis. "Over the
past 18 months, the company has also solved complex technical formulation
issues, manufactured TSC to GMP (human) quality standards, and enhanced its
intellectual property portfolio, all of which add value to the company and
its platform technology."
About Diffusion Pharmaceuticals LLC
Diffusion Pharmaceuticals LLC is a 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 could be used to
treat life-threatening conditions, such as trauma, stroke, cardiovascular,
respiratory, and other conditions characterized by oxygen deprivation at
the cellular level. The company's pipeline drugs, known as trans bipolar
carotenoid or TBC molecules, are currently in the preclinical stage.
Clinical trials are planned to support the use of TSC in ischemic
indications. 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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