CytRx CEO Receives Lou Gehrig Memorial Award
Nov 1 2006, 7:30 AM EST
BIOWIRE


CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced that Company President and CEO Steven A. Kriegsman received the Lou Gehrig Memorial Award from the Muscular Dystrophy Association. The award was presented in recognition of CytRx's dedication to finding a cure for amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) at the Phil Villapiano Field of Hope Gala, A Celebrity Event to Benefit ALS Research, on October 28, 2006.

Former Super Bowl Champion Oakland Raider Phil Villapiano hosted the charity event he founded 11 years ago to raise funds for ALS research. Proceeds from this event are dedicated to the cutting-edge research funded by the Muscular Dystrophy Association, a pre-eminent leader in finding an ALS cure. For additional information visit: www.philsfieldofhope.com.

In September 2006, CytRx announced that its lead drug candidate arimoclomol was shown to be safe and well tolerated at all three doses tested in its Phase IIa clinical trial in patients with ALS. Based on these results, CytRx plans to proceed with activities associated with initiating a Phase IIb clinical trial with arimoclomol for the treatment of ALS in the third quarter of 2007, subject to U.S. Food and Drug Administration (FDA) approval.

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 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 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 ALS

ALS is a progressive degeneration of the brain and spinal column nerve cells that control the muscles that allow movement. Over a period of months or years, ALS causes increasing muscle weakness, inability to control movement and problems with speaking, swallowing and breathing. According to the ALS Survival Guide, 50% of ALS patients die within 18 months of diagnosis and 80% die within five years. More than 120,000 people are living with ALS worldwide.

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 receipt of $24.5 million in a non-dilutive agreement with the privately-funded ALS Charitable Remainder Trust 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 to develop novel compounds in the areas of ALS, obesity, type 2 diabetes and cytomegalovirus (CMV) using RNAi technology. 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. 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.

http://www.genengnews.com/news/bnitem.aspx?name=7938071