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Data Shows Potential of CytRx Corporation's Oral Drug Candidate Arimoclomol As a Therapeutic for Type 2 Diabetes

Posted on: Tuesday, 11 January 2005, 09:00 CST

LOS ANGELES, Jan. 11 /PRNewswire-FirstCall/ -- CytRx Corporation today announced previously unreleased scientific data showing the potential of its oral drug candidate arimoclomol as a therapeutic for type 2 diabetes. The data will be presented in a poster entitled "The Broad Therapeutic Potential of Pharmaceuticals that Activate Molecular Chaperone Proteins" on January 11, 2005 at the Protein Folding Disorders Conference in San Diego, California.

"We previously announced data showing that arimoclomol restored normal serum glucose levels in an animal model when co-administered with a commonly prescribed drug, metformin," said Steven A. Kriegsman, President and Chief Executive Officer of CytRx. "The data that we are making public today, all of which was generated by Biorex Research and Development Company prior to CytRx's acquisition of arimoclomol, shows that arimoclomol alone also may have a therapeutic effect. We will continue to actively pursue the clinical development of this drug candidate and feel that it is important to make the data that supported our decision to acquire arimoclomol available to the scientific community."

Type 2 diabetes is a disease that results in abnormally poor metabolism of glucose. Patients with diabetes tend to accumulate more glucose in their bloodstream after eating (especially a diet high in sugar) than people without diabetes. When obese diabetic animals (Zucker diabetic fatty rats) were fed large amounts of glucose, the amount of glucose in their blood increased to a higher level, and was maintained longer than the corresponding glucose levels of non-diabetic animals. The data in the experiments made public today shows that treatment with arimoclomol significantly improved the ability of diabetic animals to remove glucose from the bloodstream after consuming large amounts of glucose.

"The data suggests that arimoclomol may have significant therapeutic benefits for patients with type 2 diabetes," said Dr. Louis Ignarro, a Noble Laureate and CytRx's Chief Scientific Spokesman. "This improved glucose tolerance is also seen with certain commonly prescribed diabetic drugs called thiazolidinediones, however these drugs have the unfortunate side effect of significantly increasing overall body weight. The animals treated with arimoclomol alone maintained normal weight."

In another experiment, rats were given diabetes by feeding them a high fat diet. It is believed that the accumulation of fat in internal organs ("visceral" fat), rather than overall body fat, may lead to type 2 diabetes. The tissues become less responsive to insulin signaling, causing "insulin resistance," one of the earliest signs of diabetes. The data that CytRx made public today shows that arimoclomol lowered the amount of fat in the serum of the rats that were fed a high fat diet and also inhibited the accumulation of fat in the liver and muscle tissue of these animals. Arimoclomol did not prevent overall weight gain during the high fat diet, but lowered the amount of visceral fat that accumulated, specifically in liver and muscle tissue. "If these results can be achieved in humans, it may help prevent the progression of type 2 diabetes in obese patients by preventing insulin resistance," according to Dr. Ignarro.

CytRx today is also making public data from another past experiment in which arimoclomol was tested for its ability to control the production of glucose in the liver of diabetic animals. Normal animals make less glucose in their livers than diabetic animals. The experiment was performed both in non-obese rats that were genetically predisposed to type 2 diabetes (Goto-Kakizaki diabetic rats) and in genetically normal rats made diabetic by inhibiting their ability to produce insulin with a toxin called streptozoticin. In both experimental models, arimoclomol significantly inhibited the production of glucose in the liver.

"The take-home message of all of these experiments, and the reason that we decided to acquire the drug based on these experiments, is that activation of molecular chaperone proteins, the mechanism by which arimoclomol is believed to work, may have very broad therapeutic potential," said Jack Barber, Ph.D., Senior Vice President Drug Development. "Since arimoclomol has already been shown to be well tolerated in human safety trials, we are anxious to begin determining their therapeutic potential in the months to come."

According to the Centers for Disease Control, there are approximately 18.2 million people in the United States diagnosed with diabetes. Of that 18.2 million, 90% of those suffer from type 2 diabetes. In 2002, direct medical and indirect expenditures attributable to diabetes were estimated at $132 billion by the American Diabetes Association.

About Arimoclomol

CytRx currently plans to initiate Phase II clinical trials for ALS (commonly known as Lou Gehrig's disease) in the second quarter of 2005. Arimoclomol is believed to function by a mechanism that stimulates 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 with arimoclomol could show therapeutic efficacy over a broad range of diseases.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company, based in Los Angeles with a subsidiary in Worcester, Massachusetts. The company is engaged in the development of products, primarily in the area of small molecules and ribonucleic acid interference (RNAi), in a variety of therapeutic categories. The company recently acquired 3 clinical stage compounds and a library of 500 small molecule drug candidates from Biorex Research & Development Company. The company 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 CMV using RNAi technology. CytRx also licensed from UMMS the rights to a DNA-based HIV vaccine technology currently in a Phase I clinical trial. The company also 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. For more information, visit CytRx's website at http://www.cytrx.com/.

This press release may contain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, that 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 or uncertainties related to the early stage of CytRx's diabetes, obesity, CMV and ALS research, the need for future clinical testing of any RNAi-based products and small molecules that may be developed by CytRx, uncertainties regarding the scope of the clinical testing that may be required by regulatory authorities for the products acquired from Biorex and other products and the outcomes of those tests, the significant time and expense that will be incurred in developing any of the potential commercial applications for CytRx's RNAi technology or small molecules, CytRx's need for additional capital to fund its ongoing working capital needs, including ongoing research and development expenses related to the drugs purchased from Biorex, risks relating to the enforceability of any patents covering CytRx's products and to the possible infringement of third party patents by those products, and the impact of third party reimbursement policies on the use of and pricing for CytRx's products. Additional uncertainties and risks are described in CytRx's most recently filed SEC documents, such as its most recent annual report on Form 10-K, all quarterly reports on Form 10-Q and any current reports on Form 8-K filed since the date of the last Form 10-K. 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.

CytRx Corporation

CONTACT: Edward Umali of CytRx Corporation, +1-310-826-5648,eumali@cytrx.com; or Gino De Jesus or John Nesbett, both of Investor RelationsGroup, +1-212-825-3210, for CytRx Corporation

Web site: http://www.cytrx.com/

Source: PRNewswire-FirstCall

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