CytRx Announces Significant Efficacy Results In A Pre-Clinical Trial With Iroxanadine For Diabetic Peripheral Neuropathy

Main Category: Diabetes
Also Included In: Neurology / Neuroscience
Article Date: 20 Mar 2009 - 2:00 PDT

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CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, announced that its molecular chaperone amplifying drug candidate iroxanadine has been shown to be effective in protecting against diabetic peripheral neuropathy (DPN) in animals. DPN is one of the earliest complications of diabetes and damages the nerves in arms, legs, hands and feet, resulting in a loss of normal sensory function, which then results in numbness, tingling, or pain. Since nerves are also necessary to sense the need for and then control local blood flow, DPN is considered to be a primary factor leading to the generation and persistence of intractable diabetic foot ulcers.

"This is another successful demonstration of the broad therapeutic potential of our chaperone amplifying drugs," said Steven Kriegsman, CytRx President and CEO. "DPN is an important therapeutic target in its own right, and the involvement of neuropathy in diabetic foot ulcers gives us additional confidence in the potential of iroxanadine for that indication. These data could make this program an even more attractive partnering opportunity."

In the trial, 40 adult male rats were administered a single injection of the drug streptozotocin to induce experimental diabetes. Ten additional animals served as the non-diabetic control group. After confirmation of elevated blood glucose in the diabetic rats, one of three dosages of iroxanadine (10, 20 or 50 mg/kg) or a vehicle control lacking iroxanadine was administered orally on a daily basis to these diabetic animals. At various intervals, DPN was measured by well-established tests, namely sensory nerve conduction velocity (SNCV), latency of compound muscle action potential (CMAP), and the number of intra-epidermal nerve fibers (IENF).

Animals treated with iroxanadine showed statistically significant improvement in DPN as assessed by SNCV and CMAP latency. Additionally, iroxanadine completely prevented the dramatic decrease in IENF seen in the diabetic control group not receiving iroxanadine. There was an equivalent level of neuroprotective activity regardless of the iroxanadine dose level, suggesting that the biological effect was maximal even at the lowest dose tested in this trial. Further, during the duration of this trial, iroxanadine did not affect blood glucose levels compared to diabetic control animals not receiving iroxanadine. This means that iroxanadine improved DPN per se independent of the metabolic factors of the disease that lead to neuropathy in this animal model.

"Most experts agree that the two most important disease-related aspects of diabetes that lead to the persistence of diabetic foot ulcers are DPN and damage to the endothelial cells that line the internal surface of blood vessels," according to Jack Barber, Ph.D., CytRx's Chief Scientific Officer. "We have previously announced results demonstrating both the protective role of iroxanadine on endothelial cells and an iroxanadine-mediated acceleration of wound healing in diabetic animals. We believe that the combination of these previous results with the present neuropathy results with iroxanadine presents a strong mechanistic basis for the treatment of diabetic foot ulcers and clearly distinguishes it's mechanism from that of other pharmaceuticals previously or currently being tested clinically," added Dr. Barber.

About Diabetic Peripheral Neuropathy

According to the Centers for Disease Control, diabetes now affects nearly 24 million people, or eight percent of the population, in the United States. The World Health Organization estimates the number of diabetics worldwide will exceed 350 million by 2030. Complications due to diabetes are widespread, and approximately 60% to 70% of people with diabetes will experience some form of nervous system damage. Diabetic peripheral neuropathy includes impaired sensation or pain in the hands or feet and severe cases are the major contributing factor to lower-extremity amputation. The American Diabetes Association stated that about 71,000 non-traumatic lower-limb amputations were performed in 2007 in people with diabetes. In 2007, the diabetes treatment market worldwide was reported to be worth over $25 billion.

About Iroxanadine

CytRx believes that iroxanadine represents a potentially powerful breakthrough in the treatment of vascular diseases. 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. Preclinical and clinical studies, including a Phase II trial in patients with chronic hypertension, with orally available iroxanadine indicate that it has therapeutic potential for the treatment of cardiovascular atherosclerosis, as well as various vascular diseases or their complications including diabetic ulcers, thrombosis, retinopathy and peripheral artery disease. As a result, the Company believes that iroxanadine presents a significant opportunity for a partnership and is actively pursuing potential transactions.

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. 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 http://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 timing, outcome or results of any future pre-clinical or clinical testing of iroxanadine for peripheral neuropathy or diabetic foot ulcers, the potential need to conduct additional toxicology or human studies with iroxanadine, which could result in substantial additional expenses and delay the initiation of any future clinical trials, risks related to CytRx's ability to enter into partnerships to advance the clinical development of iroxanadine, 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.

Source
CytRx Corporation

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