CytRx Files Report with the FDA in Response to the Partial Clinical Hold on its Phase 2b Arimoclomol ALS Trial

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Tue Jun 30, 2009 8:30am EDT

LOS ANGELES--(Business Wire)--
CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development
company engaged in the development of high-value human therapeutics, has filed a
report with the U.S. Food and Drug Administrations (FDA) in response to the
Agency`s partial clinical hold on the Company`s Phase 2b efficacy clinical trial
with its molecular chaperone regulator drug candidate arimoclomol for the
treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig`s disease). 

"We have been working closely with the FDA throughout this process and we are
confident that the information included in this report, including results from a
detailed animal toxicology study, sufficiently addresses the Agency`s concerns,"
said Steven A. Kriegsman, President and CEO of CytRx. "Given the timing of this
submission, we anticipate that the FDA will review the report during the third
quarter of this year. Again, we emphasize that the FDA`s partial clinical hold
was unrelated to data generated by human studies and arimoclomol has been
studied in seven Phase 1 and two Phase 2 clinical trials without any significant
adverse events." 

"We were diligent in our design and implementation of a highly detailed animal
toxicology study that specifically responded to the issues raised by the FDA to
support the lifting of the partial clinical hold," said Jack Barber, Ph.D.,
CytRx`s Chief Scientific Officer. "We remain optimistic about the prospects of
arimoclomol as a treatment for the devastating consequences of neurodegenerative
diseases such as ALS, and continue to work towards a potential partnership to
help with further development." 

Arimoclomol is an orally administered molecular chaperone regulator drug
candidate that is being considered as a treatment for ALS and stroke recovery.
Molecular chaperone regulator drugs are believed to function by regulating a
normal cellular protein repair pathway through the activation or inhibition of
"molecular chaperones." Molecular chaperones detect proteins that are misfolded,
and have the ability to refold those proteins into the appropriate, non-toxic
shape. 

In February 2009, CytRx announced the commencement of a Phase 2/3 adaptive
clinical trial, sponsored by the ALS Association and the FDA`s Office of Orphan
Products Development OOPD, to study arimoclomol in a subset of patients with the
inherited or familial form of ALS. In March 2009, the Company reported that
arimoclomol had demonstrated statistically significant neurorestorative results
in a preclinical embolic stroke trial. This data supported previous preclinical
results indicating improvement in stroke recovery following oral arimoclomol
administration up to 48 hours post-stroke. 

About ALS

ALS is a progressive degeneration of the brain and spinal column nerve cells
that control the muscles that allow movement. ALS is a common neuromuscular
disease, affecting an estimated 120,000 people of all races and ethnic
backgrounds worldwide. 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 Association more than 5,600
people in the U.S. are diagnosed with ALS annually and an estimated 30,000
Americans have ALS at any given time. According to the National Institute of
Neurological Disorders and Stroke, most ALS patients die within three to five
years after the onset of symptoms. 

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company
engaged in the development of high-value human therapeutics. The CytRx drug
development pipeline includes programs in clinical development for cancer
indications, including tamibarotene in a registration study for the treatment of
acute promyelocytic leukemia (APL). In addition, CytRx is developing two drug
candidates based on its industry-leading molecular chaperone technology, which
aims to repair or degrade misfolded proteins associated with disease. The
Company owns and operates a research and development facility in San Diego.
CytRx also maintains a 45% equity interest in publicly traded RXi
Pharmaceuticals, Inc. (NASDAQ:RXII). For more information on the Company, visit
www.cytrx.com. 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of
Section 21E of the Securities Exchange Act of 1934, as amended. Such statements
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 the risk that the animal toxicology data submitted to the
FDA will not sufficiently address the Agency`s concerns expressed in their
clinical hold on the Company`s Phase 2b efficacy clinical trial with its
molecular chaperone regulator drug candidate arimoclomol for the treatment of
amyotrophic lateral sclerosis, uncertainties related the timing and ability to
resume that clinical testing at the desired dosage of arimoclomol, the risk that
any requirements imposed on the Company's planned clinical trial designs for ALS
by the FDA as a result of the original concerns expressed in their clinical hold
of the Company's ALS program might adversely affect the Company's ability
ultimately to demonstrate that arimoclomol is efficacious in treating ALS, risks
relating to the timing, outcome or results of future clinical testing of
arimoclomol, risks related to CytRx's need for additional capital or strategic
partnerships to fund its ongoing working capital needs and development efforts,
risks related to the future market value of CytRx's investment in RXi and the
liquidity of that investment, and the risks and uncertainties described in the
most recent annual and quarterly reports filed by CytRx with the Securities and
Exchange Commission and current reports filed since the date of CytRx's most
recent annual report. 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. 





Legend Securities, Inc.
Thomas Wagner
800-385-5790 x152
718-233-2600 x152
twagner@legendsecuritiesinc.com

Copyright Business Wire 2009

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