Arimoclomol Significantly Inhibits Progression of Amyotrophic Lateral Sclerosis
Apr 20, 2005 - 9:24:00 AM, Reviewed by: Dr.
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Arimoclomol provides cellular protection from abnormal proteins by activating molecular "chaperone" proteins that can repair or degrade the damaged proteins that are believed to cause many diseases, including ALS.
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By CytRx Corporation,
CytRx Corporation (Nasdaq: CYTR - News) today announced the completion of a meeting with representatives of the U.S. Food and Drug Administration (FDA) prior to the submission of the Company's Investigational New Drug (IND) application for its lead small molecule drug candidate arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease). The FDA's pre-IND meeting programs are designed to provide sponsors with advance guidance and input on drug development programs.
Jack Barber, Ph.D., CytRx's Senior Vice President, Drug Development, stated, "The purpose of our meeting was to seek guidance from the FDA concerning the upcoming submission of our IND application for arimoclomol. We plan to file an IND application with the FDA and expect to begin a Phase II clinical trial for the treatment of ALS in the current quarter."
Arimoclomol provides cellular protection from abnormal proteins by activating molecular "chaperone" proteins that can repair or degrade the damaged proteins that are believed to cause many diseases, including ALS.
Arimoclomol was previously shown to be well tolerated in two Phase I clinical trials in healthy volunteers. Originally developed to treat diabetic complications, arimoclomol was recently discovered to significantly inhibit progression of ALS in an experimental animal model of the disease (Kierin et al., Nature Medicine, April 2004, Vol. 10(4), 402-5).
According to the ALS Survival Guide, 50% of ALS patients die within 18 months of diagnosis and 80% of ALS patients die within five years of diagnosis. Approximately 30,000 people are living with ALS and nearly 6,000 new cases are diagnosed each year in the U.S. alone, according to the ALS Association. There are over 120,000 people living with ALS worldwide.
CytRx Corporation makes no representation that the FDA will allow any clinical trial to take place upon the filing of the IND, or take any other action to allow arimoclomol to be studied or marketed. 
- U.S. Food and Drug Administration (FDA)
www.cytrx.com
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 owns three clinical-stage compounds based on its molecular "chaperone" co-induction technology, as well as a targeted library of 500 small molecule drug candidates that may be used to screen for new drug candidates. CytRx has a broad-based strategic alliance with the University of Massachusetts Medical School (UMMS) to develop novel compounds in the areas of ALS, obesity, type 2 diabetes and cytomegalovirus (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 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 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, 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 its molecular chaperone co-induction drug candidates 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 its molecular chaperone co-induction drug candidates, 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.
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