News for 'CYTR' - (CytRx Provides Update on Stroke Recovery Research Plans Further Preclinical Stroke Studies with Arimoclomol Slated for 1st Quarter 2007)
LOS ANGELES, Dec 18, 2006 (BUSINESS WIRE) -- CytRx Corporation (Nasdaq:CYTR), a
biopharmaceutical company engaged in the development and commercialization of
human therapeutics, today announced plans to initiate additional animal stroke
functional recovery studies with its lead oral drug candidate arimoclomol,
currently being evaluated as a therapeutic for amyotrophic lateral sclerosis
(ALS or Lou Gehrig's Disease). The animal studies are expected to begin in the
first quarter of 2007, and CytRx anticipates results of the studies will be
announced in the second quarter of 2007. In November 2006, CytRx presented data
at the Rodman & Renshaw 8th Annual Healthcare Conference demonstrating for the
first time that arimoclomol improved the functional recovery of motor skills in
an experimental rat model of stroke.
According to CytRx President and CEO Steven A. Kriegsman, "Our decision to
further study arimoclomol as a therapeutic for stroke recovery is based on the
promising results of this early-stage animal study. In addition, we have already
shown in our ALS clinical trial that arimoclomol can cross the human blood:brain
barrier, which is an important attribute for any potential stroke recovery
therapeutic."
In the recently completed rat study, stroke was induced by blocking blood flow
to parts of the brain causing cerebral oxygen deprivation. A subgroup of the
study rats were then dosed orally with arimoclomol daily for 28 days, beginning
one hour after stroke was induced. Recovery from stroke was measured by
monitoring sensory motor skills. While motor skills declined dramatically in all
study rats, those treated with arimoclomol recovered faster and more completely
than those untreated. In one functional capacity test, arimoclomol treated
animals were completely restored to normal non-stroke levels, indicating a
complete recovery using this particular measurement of stroke.
"The improvement in functional recovery from stroke observed with arimoclomol in
this initial preclinical study provides additional scientific support for the
broad therapeutic potential of the underlying mechanism of action of
arimoclomol," said CytRx Senior Vice President of Drug Development Jack Barber,
Ph.D. "CytRx will only initiate clinical development of arimoclomol for stroke
recovery if the subsequent planned studies demonstrate a substantial advantage
over other companies' drugs that were not successful in the clinic." Dr. Barber
added, "I am optimistic that the planned studies will support the potential of
arimoclomol for stroke recovery and look forward to sharing the upcoming results
with our investors."
About Stroke
According to the American Heart Association, 700,000 Americans each year
experience a new or recurrent stroke and, on average, every 45 seconds someone
in the United States has a stroke. Stroke is the third leading cause of death in
the U.S. and is the number one cause of long-term disability among Americans.
According to the American Heart Association, stroke cost almost $57 billion in
both direct and indirect costs in 2005.
About Arimoclomol
Arimoclomol is believed to function by stimulating a normal cellular protein
repair pathway through the activation of "molecular chaperones." Since damaged
proteins called aggregates are thought to play a role in many diseases, CytRx
believes that activation of molecular chaperones could have therapeutic efficacy
for a broad range of diseases.
In September 2006, CytRx announced that arimoclomol was shown to be safe and
well tolerated at all three doses tested in its Phase IIa clinical trial in
patients with amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). The
Company plans to enter a Phase IIb clinical trial with arimoclomol in ALS in the
3rd quarter of 2007, subject of U.S. Food and Drug Administration (FDA)
approval. The FDA has granted Fast Track designation and Orphan Drug status and
the European Commission has granted orphan medicinal product status to
arimoclomol for the treatment of ALS.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company
engaged in the development of high-value human therapeutics. The Company owns
three clinical-stage compounds based on its small molecule "molecular chaperone"
co-induction technology. In September 2006, CytRx announced receipt of $24.5
million in a non-dilutive agreement with the privately-funded ALS Charitable
Remainder Trust to fund continued arimoclomol development for the treatment for
ALS in return for a one percent royalty from potential worldwide sales of
arimoclomol for the treatment of ALS. The Greater Los Angeles Chapter of The ALS
Association is the charitable beneficiary of the ALS Charitable Remainder Trust.
CytRx has a broad-based strategic alliance with the University of Massachusetts
Medical School to develop novel compounds in the areas of ALS, obesity, type 2
diabetes and cytomegalovirus (CMV) using RNAi technology. The Company has a
research program with Massachusetts General Hospital, Harvard University's
teaching hospital, to use RNAi technology to develop a drug for the treatment of
ALS. CytRx's Drug Discovery division, located in Worcester, Mass., focuses on
the use of RNAi technologies to develop small molecule and RNAi therapeutics to
treat obesity and type 2 diabetes. For more information, visit CytRx's Web site
at www.cytrx.com.
Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of
Section 21E of the Securities Exchange Act of 1934, as amended. Such statements
involve risks and uncertainties that could cause actual events or results to
differ materially from the events or results described in the forward-looking
statements, including risks or uncertainties related to the outcome or results
of any future pre-clinical testing of arimoclomol on animal models of stroke
recovery, and other risk and uncertainties described in CytRx's most recently
filed SEC documents, such as its most recent annual report on Form 10-K, all
quarterly reports on Form 10-Q and any current reports on Form 8-K filed since
the date of the last Form 10-K. All forward-looking statements are based upon
information available to CytRx on the date the statements are first published.
CytRx undertakes no obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise.
SOURCE: CytRx Corporation
CONTACT: CEOcast, Inc.Dan Schustack, 212-732-4300dschustack@ceocast.com
Copyright Business Wire 2006
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