CytRx To Present Stroke Recovery Data At The Sixth International Workshop On The Molecular Biology Of Stress Responses

Main Category: Stroke
Also Included In: Biology / Biochemistry
Article Date: 28 Mar 2008 - 5:00 PDT

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CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, announced that Shi Chung Ng, Ph.D., CytRx's Senior Vice President of Research and Development, will present previously reported positive results of several animal stroke studies with the Company's lead molecular chaperone amplification drug candidate arimoclomol at the Sixth International Workshop on The Molecular Biology of Stress Responses being held at the Chulabhorn Research Institute in Bangkok, Thailand.

In his presentation, Dr. Ng will discuss study data indicating that while motor skills declined dramatically in study rats immediately after stroke was induced, those treated orally with arimoclomol recovered dramatically faster and more completely than untreated animals, regardless of whether arimoclomol treatment was initiated six, 12, 24 or even 48 hours after stroke was induced. Animals treated 48 hours post-stroke-inducement were approximately half-way to complete recovery within seven days after stroke, while motor skills of untreated animals had not improved.

"We believe that stroke recovery with arimoclomol represents a new paradigm in stroke pharmaceutical intervention that we refer to as 'neurorestoration,'" said Dr. Ng. "Most of the previous-generation stroke drug candidates that have been tested in recent years were designed to prevent brain cells from dying in the acute stage of ischemic stroke, either by re-establishing the flow of blood (fibrinolytics or clot busters) or by protecting the cells from the absence of oxygen (neuroprotectants). The results of our studies presented at this meeting suggest that arimoclomol improves recovery from stroke not by decreasing the number of brain cells that die, but by repairing the brain cells that survived but that were otherwise too injured to function normally. This may explain why arimoclomol demonstrated statistically significant improvement in recovery even when the drug was administered well after the event. We are pleased to share the results of our study at this important workshop that attracts scientific thought-leaders from around the world."

"On average, every 40 seconds someone in the U.S. has a stroke, and stroke is the number one cause of long-term disability among Americans, according to the American Heart Association," added CytRx's Chief Scientific Officer Jack Barber, Ph.D. "The results from these rat studies with arimoclomol in stroke recovery are sufficiently compelling that we are working toward entering a Phase II clinical trial in stroke recovery in the second half of this year, subject to U.S. Food and Drug Administration (FDA) clearance."

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 amplification" technology. 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 ALS. The Company's Phase IIb clinical trial with arimoclomol for ALS was placed on clinical hold in January 2008, and the Company has announced its intention to work diligently with the FDA to reach resolution. The FDA has granted Fast Track designation and Orphan Drug status to arimoclomol for the treatment of ALS, which has also been granted orphan medicinal product status for the treatment of ALS from the European Medicines Agency. The Company has announced plans to commence a Phase II clinical trial for arimoclomol in stroke recovery in the second half of 2008, subject to FDA clearance. The Company has also announced plans to commence a Phase II clinical trial with its next drug candidate, iroxanadine, for diabetic foot ulcers in the second half of 2008, subject to FDA clearance. CytRx has recently opened a research and development facility in San Diego. For more information on the Company, visit http://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 or clinical testing of arimoclomol for stroke recovery, uncertainties related to the impact of the FDA's clinical hold on our clinical program for arimoclomol for the treatment of amyotrophic lateral sclerosis on the timing and ability to initiate the planned Phase II clinical trial for stroke recovery, the risk that any requirements imposed on our planned clinical trial design for stroke recovery by the FDA as a result of the concerns expressed in their clinical hold of our ALS program might adversely affect our ability to demonstrate that arimoclomol is efficacious in treating stroke patients or cause us to cancel the trial, the potential need to conduct additional toxicology or human studies which could result in substantial additional expenses and delay the resumption of the clinical trial, as well as other risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx's most recent annual report. 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.

CytRx Corporation