Kinex Pharmaceuticals was
notified today, by the U.S. Food and Drug Administration, that its
Investigational New Drug, KX2-391, can proceed into Phase 1 Clinical
Trials.
"The rapid progress we have made in advancing this novel compound into
human trials is extraordinary," said Dr. Allen Barnett, Chief Executive
Officer of Kinex Pharmaceuticals. Barnett, a pharmaceutical industry
veteran who played key roles in the development of four marketed drugs,
including two blockbusters, further added that, "This is a very dynamic
time for Kinex as we continue to transition from a Drug Discovery company
into a vertically integrated Discovery/Development organization. We have
successfully navigated KX2-391 through the IND process, and have positioned
the company to continue to develop the necessary pipeline to go public in
the next few years."
Phase 1 trials on KX2-391 will begin at two prominent U.S. Cancer
Centers, in September 2007 in patients with lymphoma or solid tumors. The
goal of these studies is to generate human safety data and to look at
potential efficacy using biomarkers.
KX2-391 is an orally active Src kinase inhibitor with excellent
bioavailability. It is a first-in-class drug because it is the first
non-ATP competitive kinase inhibitor to enter human trials, thereby
providing a highly selective mechanism of action that should have a
decreased likelihood of inducing resistance in patients. Src kinase is a
key regulator of tumor growth, tumor vascularization and metastasis. In
pre-clinical animal models, KX2-391 inhibits the growth of both primary
tumors and metastasis. The compound is a potent inhibitor of a wide range
of human tumor cells, including cells that are resistant to currently
available cancer therapies.
About Kinex Pharmaceuticals
Kinex Pharmaceuticals is a biopharmaceutical company focused on the
discovery and development of novel non-ATP competitive small molecule
inhibitors for therapeutically relevant tyrosine kinases and phosphatases.
Mimetica(TM), the Company's platform discovery technology is used to design
and synthesize orally bioavailable small molecules that are highly
selective for their target. This technology was originally developed in the
laboratory of Dr. David Hangauer at the University of Buffalo; Kinex has an
exclusive world-wide license to Mimetica(TM) and to early compounds which
formed the basis for the KX2-391 development program.
In addition to KX2-391, Kinex is currently developing Src inhibitors
for ophthalmic indications and hearing loss. Discovery programs are focused
on the use of Mimetica(TM) and the Company's compound libraries to identify
lead compounds for cancer and other medical conditions where unmet medical
needs exist.
Forward-Looking Statements
This press release may contain forward-looking statements that involve
substantial risks and uncertainties. Kinex may not actually achieve the
plans, intentions or expectations contained in such forward-looking
statements. Actual results or events could differ materially from plans,
intentions and expectations contained in such forward-looking statements.
Kinex does not assume any obligation to update any such forward-looking
statements.
Kinex Pharmaceuticals
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