CytRx Announces Discovery of Novel Compounds that Amplify Chaperone Response to Cell Stress

LOS ANGELES--(BUSINESS WIRE)--CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced that scientists at its San Diego laboratory have discovered a novel series of compounds that amplify the natural cellular chaperone response to toxic misfolded proteins in cell culture, providing potential pipeline leads for next generation drug candidates in a number of disease indications, including cancer, cardiovascular disease, diabetes and neurodegenerative diseases.

Shi Chung Ng, Ph.D., CytRx Senior Vice President Research and Development said, “We are excited by the rapid progress made in our laboratory in the short time since September 2007 when we started operations in our San Diego facility. Before this discovery could result in any clinical candidates, we plan to file a patent application for these compounds, followed by submission of our study results for publication in a peer-reviewed journal, while we continue the process of compound characterization and lead optimization.”

During conditions that are stressful to cells, such as during certain disease states, proteins can fold into inappropriate, toxic shapes. These misfolded proteins are recognized to be undesirable by a group of proteins called molecular chaperones, and consequently are either re-folded or directed to protein degradation machinery in the cell. Small molecule amplifiers of the chaperone response, as CytRx’s clinical candidates arimoclomol and iroxanadine are believed to be, have shown promising results in animal models of neurological impairment and diabetic complications.

Using sophisticated, image-based high-content screening technologies developed at the Company’s San Diego laboratory, CytRx scientists have identified a novel series of compounds that by themselves have shown no effect on normal, unstressed cells culture, but can amplify the chaperone response in the presence of stress that leads to the generation of toxic misfolded proteins. As expected due to the known cytoprotective properties of molecular chaperones, these compounds also significantly protected cultured cells exposed to stress such as heat shock or oxygen and glucose deprivation, the latter of which is a cell-based model for stroke.

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 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 by the FDA in January 2008. 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 with its next drug candidate, iroxanadine, for diabetic foot ulcers in the second half of 2008, subject to FDA clearance. The Company has also announced plans to commence a Phase II clinical trial for arimoclomol in stroke recovery 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 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 ability to replicate in humans the chaperone amplification shown in cell culture, uncertainties related to the outcome or results of any future identification, development or testing of product candidates based on new molecular chaperone amplification compounds, including their safety and efficacy, the potential inability to obtain patents that provide commercially significant protection for any new molecular chaperone amplification compounds, the outcome or results of any future pre-clinical or clinical testing of arimoclomol for ALS and stroke recovery, and of iroxanadine for diabetic foot ulcers, uncertainties related to the impact of the FDA's clinical hold on the Company's arimoclomol clinical trial for ALS on the timing and ability to resume and continue that clinical trial at the desired dosage of arimoclomol, and the impact of that clinical hold on the timing and ability to initiate the planned Phase II clinical trial of arimoclomol for stroke recovery, the risk that any requirements imposed on the Company's planned clinical trial designs for ALS or stroke recovery by the FDA as a result of the concerns expressed in their clinical hold of the Company's ALS program might adversely affect the Company's ability to demonstrate that arimoclomol is efficacious in treating ALS or stroke patients or cause the Company to cancel one or both of those trials, the potential need to conduct additional toxicology or human studies with arimoclomol or iroxanadine, which could result in substantial additional expenses and delay the initiation or resumption, as applicable, of the Company's planned clinical trials, CytRx's need for additional capital to fund its ongoing working capital needs, as well as other risks or uncertainties described in CytRx's most recently filed SEC documents, such as its most recent annual report on 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.