LOS ANGELES, Dec. 6 /PRNewswire-FirstCall/ -- CytRx Corporation today announced that its drug candidate arimoclomol, for which CytRx intends to initiate a Phase II clinical trial for ALS ("Lou Gehrig's disease") in the second quarter of 2005, accelerated the regeneration of damaged nerves in experimental animals.
"These are highly interesting data that show that the drug can significantly improve nerve function in rats that have artificially had their spinal or sciatic nerves damaged by cutting or freezing," said Louis Ignarro, Ph.D., Nobel Laureate and CytRx's Chief Scientific Spokesman. "This acceleration of nerve repair provides additional evidence that the drug might ultimately be effective as a treatment for Lou Gehrig's disease and potentially other neurodegenerative diseases as well."
"Our interest in arimoclomol as a therapeutic began with the previously published results that the drug could delay the progression of ALS in a mouse model of the disease," said Steven A. Kriegsman, President and CEO. "The experiments that we are now announcing show that the drug also improves nerve healing after physical damage in other experimental models. If similar effects of the drug are found in humans, it is possible that the drug might not only prevent the progression of ALS, but may ultimately reverse some of the nerve damage already caused by the disease," said Mr. Kriegsman.
Arimoclomol is thought to function by activating "molecular chaperone" proteins, normally found in all cells of the body. According to Jack Barber, Ph.D., CytRx's Senior Vice President, Drug Development, "these results support our belief that arimoclomol, by activating the molecular chaperones, enhances the cell's natural ability to 'fix whatever is broken' at the cellular level through its natural repair mechanisms. Given that the drug was well tolerated in two prior Phase I clinical trials, we are looking forward to initiating our Phase II clinical trial for ALS next year."
Lou Gehrig's disease is a progressive and invariably fatal disease causing motor neuron degeneration, skeletal muscle atrophy, and paralysis. According to the ALS Association, in the U.S. alone, approximately 30,000 people are living with ALS and almost 6,000 new cases are diagnosed each year. The International Alliance of ALS/MND Association estimates that more than 120,000 cases of ALS are diagnosed worldwide annually.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company, based in Los Angeles with a subsidiary in Worcester, Massachusetts. The company is engaged in the development of products, primarily in the area of small molecules and ribonucleic acid interference (RNAi), in a variety of therapeutic categories. The company recently acquired 3 clinical stage compounds and a library of 500 small molecule drug candidates from Biorex Research & Development Company. The company 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 CMV using RNAi technology. CytRx also licensed from UMMS the rights to a DNA-based HIV vaccine technology currently in a Phase I clinical trial. The company also 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. For more information, visit CytRx's website at http://www.cytrx.com/.
This press release may contain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, that 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 early stage of CytRx's diabetes, obesity, CMV and ALS research, the need for future clinical testing of any RNAi-based products and small molecules that may be developed by CytRx, uncertainties regarding the scope of the clinical testing that may be required by regulatory authorities for the products acquired from Biorex and other products and the outcomes of those tests, the significant time and expense that will be incurred in developing any of the potential commercial applications for CytRx's RNAi technology or small molecules, CytRx's need for additional capital to fund its ongoing working capital needs, including ongoing research and development expenses related to the drugs purchased from Biorex, risks relating to the enforceability of any patents covering CytRx's products and to the possible infringement of third party patents by those products, and the impact of third party reimbursement policies on the use of and pricing for CytRx's products. Additional uncertainties and risks are 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.