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CytRx Phase IIa Arimoclomol Data to Be Presented at the 17th International Symposium on ALS/MND.


LOS ANGELES -- CytRx Corporation (Nasdaq:CYTR CYTR Canadian Yorkshire Terrier Rescue
CYTR Constant Yield Tax Rate (property tax) 
), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced that Merit Cudkowicz, M.D. and Jeremy Shefner, M.D. will be presenting previously-released data from the Company's Phase IIa trial with its lead small molecule product candidate arimoclomol for the treatment for amyotrophic lateral sclerosis amyotrophic lateral sclerosis (ALS) (ā'mīətrōf`ik, sklĭrō`sĭs) or motor neuron disease,  (ALS Als (äls), Ger. Alsen, island, 121 sq mi (313 sq km), Sønderjylland co., S Denmark, in the Lille Bælt, separated from the mainland by the narrow Alensund.  or Lou Gehrig's disease Lou Geh·rig's disease
n.
See amyotrophic lateral sclerosis.
) at the 17th International Symposium on ALS/MND ALS/MND Amyotrophic Lateral Sclerosis / Motor Neurone Disease  being held November 30 through December 2, 2006 in Yokohama, Japan. Drs. Cudkowicz and Shefner are co-principal study investigators of the trial.

A poster presentation titled "A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in ALS" will be available on Thursday, November 30, and on Saturday, December 2. Dr. Cudkowicz will deliver a 15-minute closing slide presentation on the same topic beginning at 2:15 p.m. local time.

In September 2006, CytRx announced that primary endpoints were met in its Phase IIa double-blind, placebo-controlled, clinical trial of the safety and tolerability of arimoclomol compared with placebo over 12 weeks of treatment in patients with ALS. Initial Phase IIa data suggests the achievement of a secondary endpoint that includes drug absorption, distribution and elimination. Subject to U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) approval, CytRx plans to initiate a Phase IIb clinical trial with arimoclomol for the treatment of ALS in the 3rd quarter of 2007.

About Arimoclomol

Arimoclomol is one of CytRx's three orally-administered, small molecule compounds. This small molecule drug candidate 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.

The FDA has granted Fast Track designation and Orphan Drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the  status to arimoclomol for the treatment of ALS. Fast Track is designed to facilitate the development and expedite the regulatory review of a new drug that demonstrates the potential to address a significant unmet medical need for the treatment of a serious or a life-threatening condition. Orphan Drug status holds numerous potential benefits, including opportunities for grant funding towards clinical trial costs, tax advantages, FDA user-fee benefits, seven years of U.S. market exclusivity should the FDA grant marketing approval for the drug and an added mechanism for more frequent communication with the FDA.

Arimoclomol has also been granted orphan medicinal product medicinal product,
n a substance administered to humans or animals through injection, application, oral ingestion, inhalation, and so forth, whose purpose is to ultimately restore health or eliminate disease in an individual.
 status for the treatment of ALS by the European Commission. This orphan medicinal product status grants CytRx market exclusivity in the European Union for 10 years in the event that arimoclomol receives marketing approval, and provides for incentives such as reduced fees for protocol assistance and scientific advice.

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 chaperone /chap·er·one/ (shap´er-on) someone or something that accompanies and oversees another.

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 charitable remainder trust (Charitable Remainder Irrevocable Unitrust) n. a form of trust in which the donor (trustor or settlor) places substantial funds or assets into an irrevocable trust (a trust in which the basic terms cannot be changed or the gift withdrawn)  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 UMMS is ranked fourth in primary care education among the nation’s 125 medical schools in the 2006 U.S.News & World Report annual guide, “America’s Best Graduate Schools”. UMMS is also a major center for research.  to develop novel compounds in the areas of ALS, obesity, type 2 diabetes type 2 diabetes
n.
See diabetes mellitus.
 and cytomegalovirus cytomegalovirus (sī'təmĕg'əlōvī`rəs), member of the herpesvirus family that can cause serious complications in persons with weakened immune systems.  (CMV CMV cytomegalovirus.

CMV
abbr.
1. controlled mechanical ventilation

2. cytomegalovirus


Cytomegalovirus (CMV) 
) using RNAi technology. The Company has a research program with Massachusetts General Hospital Massachusetts General Hospital Health care The major teaching hospital for Harvard Medical School, widely regarded as one of the best health care centers in the world , 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, Massachusetts, 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 contains forward-looking statements, including those related to the results and achievements of CytRx's clinical Phase IIa trial for arimoclomol, which involve known and unknown risks and uncertainties that may cause actual future results and achievements of CytRx to be materially different from those expressed or implied by these forward-looking statements. In particular, the results and achievements described may not be supported by further analysis of the Phase IIa trial data or by the results of any subsequent clinical trials. These risks and uncertainties also include risks and uncertainties regarding CytRx's ability to obtain regulatory approvals for further clinical testing of arimoclomol, the scope of clinical testing that may be required by regulatory authorities and the timing and outcome of further clinical trials. Additional uncertainties and risks regarding regulatory approval of CytRx's drug candidates, financing needs, reliance upon strategic relationships, intellectual property protections and other relevant matters are described in CytRx's reports filed with the Securities and Exchange Commission, including 10-K, 10-Q and 8-K reports. All forward-looking statements in this press release are based upon information available to CytRx as of the date of this press release. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
COPYRIGHT 2006 Business Wire
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Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Nov 28, 2006
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