CytRx to Present Statistically Significant Evidence of Arimoclomol's Ability to Protect Experimental Animals from the Effects of Hypoxia at the 2009 International Society on Oxygen Transport to Tissue Conference
Data Provide Indirect Support of Potential in Stroke Recovery
LOS ANGELES--(BUSINESS WIRE)--Jun 25, 2009 - CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced that an experimental animal trial produced statistically significant evidence that the company's chaperone amplifying drug candidate arimoclomol provided protection from the detrimental cognitive and sensorimotor effects of low atmospheric oxygen (hypoxia) that occurs at high altitudes. Data from this trial will be presented in a poster, “A heat-shock protein co-inducer treatment improves behavioral performance in rats exposed to hypoxia,” on July 9 at the 37th Annual International Society on Oxygen Transport to Tissue (ISOTT) Conference, being held in Cleveland, Ohio.
“The ability to help people adapt more readily and rapidly to extreme environmental conditions, such as high altitude, without loss of cognitive function has a number of important applications. This is particularly important to those who travel to high altitudes to accomplish tasks and require the maintenance of good judgment and rational thinking that is usually lost during the adjustment period,” said Steven Kriegsman, CytRx President and CEO. “Importantly, we believe these animal data provide indirect added support for arimoclomol as a potential treatment for stroke recovery, since damage during stroke is caused by a lack of oxygen, and are yet another example of arimoclomol's broad therapeutic potential and its value as a possible partnership candidate.”
The brain is physiologically vulnerable to hypoxia due to its high demand for oxygen. Accordingly, hypobaric hypoxia (high altitude exposure) results in stress-related damage to the brain and leads to impaired behavioral performance. This can often lead to tragic results as highlighted by the recent and widely reported death of climber Frank Ziebarth, 29, who reached the summit of Mount Everest without the use of supplemental oxygen, but was exhausted and confused, and ultimately perished during his descent due to lack of oxygen.
The trial was conducted under the supervision of Joseph C. LaManna, Ph.D., chairman of the Anatomy Department and Professor in the Neurology, Physiology/Biophysics and Neuroscience departments at the Case Western Reserve University School of Medicine (Cleveland, Ohio). Twenty-four rats were randomly assigned to four drug- and vehicle-treated groups (six rats per group) and exposed to either normal atmospheric oxygen or hypobaric hypoxia for 10 days. Drug-treated rats were administered intraperitoneal (abdominal) injections of arimoclomol daily, while control rats were given only the solution in which arimoclomol was dissolved. Hypoxic rats were kept in hypobaric chambers at a constant pressure equivalent to one-half of sea level (0.5 atmospheres), with the exception of approximately three hours daily in which they were returned to normal atmospheric pressure for behavioral tests. Normoxic rats were housed in the same room to ensure identical ambient conditions. Tissues from all trial rats were valuated for markers of hypoxic damage.
Trial data indicated that arimoclomol improved both cognitive and motor performance during the adaptation to simulated high-altitude exposure. These results included improved ability to explore a maze, and ability to recognize and explore a novel object, which was evaluated through memory tests. In addition, signs of programmed cell death, or apoptosis, in the brain during hypoxic exposure were diminished and hypoxia-induced inflammatory responses were also suppressed by arimoclomol.
About Arimoclomol
Arimoclomol, a molecular chaperone regulator drug candidate, is being considered as a treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) and stroke recovery. Arimoclomol has been studied in seven Phase 1 and two Phase 2 clinical trials without any significant adverse events. CytRx's Phase 2b clinical trial with arimoclomol as a treatment for ALS was placed on clinical hold by the FDA in January 2008, unrelated to any data generated by human studies, and CytRx expects to submit this quarter to the FDA data from additional preclinical toxicology studies to potentially resolve this issue. The Company anticipates a response from the FDA in the third quarter. In February 2009, CytRx announced the commencement of a Phase 2/3 adaptive clinical trial to study arimoclomol in a subset of patients with the inherited or familial form of ALS or Lou Gehrig's disease.
About Molecular Chaperone Regulation
CytRx is a leader in molecular chaperone regulation technology. The Company currently has two orally administered, clinical-stage drug candidates and recently discovered a series of additional compounds that may provide a pipeline for additional drug candidates. The Company's drug candidates are believed to function by regulating a normal cellular protein repair pathway through the activation or inhibition of “molecular chaperones.” Because damaged proteins are thought to play a role in many diseases, activation of molecular chaperones that help to reduce the accumulation of misfolded proteins may have therapeutic efficacy in a broad range of disease states. Similarly, CytRx believes that the inhibition of molecular chaperones that normally help protect cancer cells from toxic misfolded proteins may result in the selective destruction of cancer cells.
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). 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. 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 risks relating to the predictive power of this or any other animal model to humans, the outcome or results of any future pre-clinical or clinical testing of arimoclomol for hypoxia or stroke recovery, uncertainties related to the impact of the FDA's clinical hold on our clinical program for arimoclomol for the treatment of amyotrophic lateral sclerosis on the timing and ability to initiate further clinical development for stroke recovery or any other indication, risks related to CytRx's ability to enter into partnerships to advance the clinical development 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.
Contact: Legend Securities, Inc.
Thomas Wagner
800-385-5790 x152
718-233-2600 x152
twagner@legendsecuritiesinc.com
