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BobbyB
11-01-2006, 10:48 AM
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




BobbyB
11-01-2006, 10:52 AM
FDA seeking more data on Avanir drug




Biotech's share price plunges after request
By Penni Crabtree
UNION-TRIBUNE STAFF WRITER
November 1, 2006



Shares of Avanir Pharmaceuticals lost almost half their value yesterday after U.S. regulators said they would need more data to approve a drug to treat emotional outbursts.

The San Diego biotechnology company received a so-called “approvable” letter from the Food and Drug Administration for Neurodex, which the company is renaming Zenvia. But Avanir indicated that additional clinical studies might be needed before the drug could reach the market.

Avanir also cautioned that it couldn't be certain it would choose to continue development of Zenvia once it had met with the FDA to discuss the approvable letter.

Avanir's stock fell 46 percent, or $3.42, to close at $3.98.

Some Wall Street analysts didn't hold out much hope yesterday for Zenvia, a drug that was designed to treat involuntary emotional expression disorder, or IEED. It is the money-losing biotech's only advanced drug candidate.

“The potential need for further efficacy data is surprising, given that the Phase 3 studies with Zenvia were highly statistically significant,” said Elemer Piros, an analyst with Rodman & Renshaw, who downgraded Avanir's stock to market perform. “Either the FDA is moving the goal posts or management didn't hear the FDA correctly.

“Until we see evidence to the contrary, we are assuming that Zenvia may never obtain FDA approval and therefore no longer ascribe value to this product candidate,” Piros said in a research note.
Avanir also is testing Zenvia in a late-stage Phase 3 study for treatment of painful diabetic neuropathy. Given the FDA's stance on the drug, some analysts predict that Avanir will halt that study and try to conserve its dwindling cash.

As of June, Avanir had about $38 million in cash and securities. The company employs about 75 people.

IEED, also known as emotional lability, is a neurologic disorder that causes unpredictable emotional displays, including uncontrollable crying and laughing, according to the company.

Some drug industry observers have criticized Avanir's development of Zenvia, dismissing it as an uninspired drug in search of a disease.

"There are a lot of good companies tackling important disease indications – Avanir is not among them,” said Harry M. Tracy, publisher of Cardiff-based NeuroInvestment, a drug industry newsletter that tracks the development of neurological drugs. “The company had a drug and they were searching for something they could treat.”

Tracy said emotional outbursts are a symptom of a number of diseases, but that in most cases they are the least of a patient's problems. Zenvia was tested in patients with Lou Gehrig's disease and multiple sclerosis to relieve bouts of unwanted crying and laughing.

“In Lou Gehrig's disease, you have the gradual loss of muscular control, the brain is functioning but you can't move muscles, and you die, usually because of respiratory failure,” Tracy said. “Now, whether or not you have a brief episode of teariness, in the vast realm of things, Zenvia is not a critical need.”

Avanir chief executive Eric Brandt said the company would work closely with the FDA to determine the next steps required to receive marketing approval for Zenvia.

“We believe Zenvia can significantly improve the lives of patients, their families and their caregivers by reducing the emotional and social toll taken by involuntary emotional expression disorder,” Brandt said in a written statement.

In May, Avanir announced it would move its headquarters to Orange County by the end of the year but would maintain a research unit in San Diego. Avanir sells one medication, a little-prescribed schizophrenia drug called FazaClo, which it obtained this year in the acquisition of a private Beverly Hills firm.

Avanir, founded as Lidak Pharmaceuticals in 1988, successfully developed the over-the-counter cold sore cream Abreva, but marketing partner GlaxoSmithKline reaps most of the revenue.

Avanir also has licensed a compound to reduce fatty deposits in blood vessels to AstraZeneca. The drug entered early Phase 1 studies in January.



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Penni Crabtree: (619) 293-1237; penni.crabtree@uniontrib.com



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