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CytRx Provides Update on Stroke Recovery Research Plans

Posted on: Monday, 18 December 2006, 09:01 CST

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: Business Wire

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