Avigen Initiates AV650 Clinical Development
June 22 2006 - 9:00AM
PR Newswire (US)
Phase I Study Will Assess the Safety, Pharmacokinetics and Lack of
Sedation of AV650 ALAMEDA, Calif., June 22 /PRNewswire-FirstCall/
-- Avigen, Inc. (NASDAQ:AVGN) today announced it was given approval
from the U.S. Food and Drug Administration to commence its initial
clinical trial of AV650. AV650 is a New Chemical Entity (NCE) in
the U.S. The initial clinical trial will be a Phase I study to
assess the safety and pharmacokinetic profile, as well as AV650's
lack of sedation in normal volunteers. Avigen plans to initiate
clinical development in the second half of 2006. AV650 is being
developed in the North American market for the treatment of
disabling neuromuscular spasticity and spasm under a license and
supply agreement with Sanochemia Pharmazeutika AG. AV650 is an
orally administered centrally acting small molecule marketed for
the treatment of neuromuscular spasticity and spasm in Europe and
Asia. Avigen's development program will build on the extensive
ex-U.S. safety and efficacy experience with this compound. Avigen
President and Chief Executive Officer Ken Chahine commented, "We
are excited to initiate our U.S. clinical development program with
AV650 as planned. The European experience with tolperisone
indicates it has the promise to provide better tolerability than
current agents, and we are eager to see this demonstrated in its
development in the U.S. In particular, AV650 has the potential of
being non-sedative, an attribute that would clearly differentiate
it from current treatments, and which we also plan to assess in
this initial safety trial." Patricia Nance, M.D., Clinical
Professor, Department of Physical Medicine and Rehabilitation,
University of California Irvine noted, "There continues to be an
unmet need in the treatment of patients with neuromuscular
disorders. We are encouraged to see the development of tolperisone
and hope that it can help address the quality-of-life issues that
impair the lives of many patients suffering from these disorders."
About Neuromuscular Spasm and Spasticity Chronic or recurrent
muscle spasm is a sudden, violent, painful contraction of muscles
typically associated with serious neurological disorders such as
Lou Gehrig's disease (ALS), multiple sclerosis, stroke, spinal cord
injury, and cerebral palsy. These painful muscle spasms are often,
but not always, associated with spasticity, an abnormality in
muscle "tone." Spastic limbs become stiff and rigid because the
muscles fail to relax, lacking normal regulation by the damaged
nervous system. Both spasticity and sudden, painful muscle spasms
can occur as complications of the neurological disorders mentioned
above. About Avigen Avigen is a biopharmaceutical company focused
on unique small molecule therapeutics and biologics to treat
serious neurological disorders, including neuropathic pain and
neuromuscular spasm and spasticity. Avigen's strategy is to
complete the requirements of clinical development for each of the
candidates in its product pipeline, and continue to look for
opportunities to expand its pipeline through a combination of
internal research, acquisitions and in-licensing, with the goal of
becoming a fully integrated commercial biopharmaceutical company
committed to its small molecule and biologics neurology products.
The company is currently developing AV650 for spasticity and
neuromuscular spasm and two candidates for neuropathic pain, AV411
and AV333. Additionally, the company is advancing toward clinical
trials a novel therapy for the treatment of multiple bleeding
disorders, including hemophilia A and B, AV513. For more
information about Avigen, consult the company's website at
http://www.avigen.com/. This press release contains forward-looking
statements, including Avigen's belief that it will be able to
initiate clinical development for AV650 in the second half of 2006,
that AV650 may provide better tolerability than current agents,
that Avigen will be able to expand its pipeline through internal
research, acquisitions, and/or in-licensing, and its belief that it
will be able to develop, commercialize or obtain value from its
current drug candidates for any indication. These statements are
subject to risks and uncertainties that could cause actual results
to differ materially from those projected in these forward-looking
statements. These risks and uncertainties include, among others,
the fact that development of small molecule therapeutics and other
therapeutic discovery and development is a time- and
resource-intensive process, which may result in the expenditure of
a significant amount of time and resources with no marketable
product resulting from the effort. Other risks and uncertainties
relating to Avigen are detailed in reports filed by Avigen with the
Securities and Exchange Commission, including Avigen's quarterly
report on Form 10-Q for the period ended March 31, 2006, under the
caption "Risk Factors" in Item 1 of Part 1A of that report, which
was filed with the SEC on May 9, 2006. DATASOURCE: Avigen, Inc.
CONTACT: Michael Coffee, Chief Business Officer of Avigen, Inc.,
+1-510-748-7372, or Web site: http://www.avigen.com/
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