Maxim Announces Preclinical Research Suggesting Ceplene May Prevent Liver Damage Caused by Alcohol
Results Presented at the Digestive Disease Week -DDW- Conference
SAN DIEGO--(BW HealthWire)--May 21, 2002--Maxim Pharmaceuticals Inc. (Nasdaq\NM:MAXM)(SSE: MAXM) announced that researchers presented yesterday the results from three preclinical studies suggesting that Ceplene(TM) (histamine dihydrochloride) provides protection against alcohol-induced liver injury, and may assist in reversing alcohol-induced liver damage, in animal models of alcoholic liver disease (ALD). The results were presented at the Digestive Disease Week (DDW) conference in San Francisco.
In the United States alone, approximately 25 million people -- one in every ten -- have been afflicted with chronic liver, bile duct or gallbladder diseases. More specifically, liver cirrhosis resulting from alcohol abuse is one of the ten leading causes of death in the United States. Last month the company presented the results of the first studies evaluating the ability of Ceplene to protect against alcohol-induced liver injury in a rat model of alcohol hepatitis. These results suggested that Ceplene provided significant protection against early alcohol-induced liver injury in this animal model.
Yesterday at the DDW conference, Maxim scientists Stephen C. Hornyak, MS and Tapio Haaparanta, Ph.D. presented the results of three studies in which liver injury was induced through the administration of a single dose of ethanol once per day for up to eight weeks in rats. Animals were divided into groups in which some were treated with Ceplene and others were left untreated, while all animals were on a high-fat diet and given ethanol. The animals in the untreated group had significantly higher levels of the liver enzymes ALT and AST, markers that are elevated when there is damage to the liver. In contrast, animals that were treated with Ceplene showed normalized ALT and AST levels. The animals treated with Ceplene also showed pathology scores for inflammation, necrosis and total pathology that were significantly better (p less than 0.05) when compared to the untreated group.
These results suggest that Ceplene protected against early alcohol-induced liver injury in this animal model. These experiments also demonstrated that there is a dose-dependent effect of Ceplene on protection from liver damage, possibly related to the modulation of certain pro-inflammatory cytokines like tumor necrosis factor-alpha (TNF-alpha) and interferon-gamma.
"Interestingly, the active agent in Ceplene has been shown previously to modulate several key cytokines like TNF-alpha, IL-1b, IL-18 and INF-gamma, and certain of these cytokines have been shown to contribute to the liver damage in ALD," said Dr. Kurt Gehlsen, Senior Vice President and Chief Technical Officer. "Therefore, the protective mechanism of Ceplene may go beyond the established reduction in oxidative stress and may include modulation of key cytokines in the liver."
"The studies reported this week represent the commencement of research to evaluate the potential of Ceplene to be used in the treatment of alcohol-induced liver injury. This research includes ongoing studies to evaluate the ability of Ceplene to accelerate the healing of damaged liver tissue in animal models," added Dr. Gehlsen. "To date we have preliminary data suggesting that Ceplene may accelerate the healing of liver tissue damaged by alcohol and larger studies are underway to establish the healing effect of Ceplene and the role of cytokine modulation. Preclinical studies are also underway to further explore Ceplene's effect in the liver for several diseases including animal models for NASH, another widespread liver disease impacting many adults. These studies are designed to support the human clinical testing of Ceplene in alcoholic liver disease (ALD) and nonalcoholic steatohepatitis (NASH) planned to commence in 2002."
Ceplene Overview
Research has shown that oxygen free radicals released by certain immune cells can suppress the immune system and damage normal tissue, a process commonly referred to as oxidative stress. Oxidative stress, implicated in numerous diseases, is most pronounced in the liver and can damage or destroy liver tissue in patients with hepatitis and other chronic liver diseases.
Ceplene, based on the naturally occurring molecule histamine, has been shown in preclinical work to prevent the production and release of oxygen free radicals, thereby reducing oxidative stress. Accordingly, treatment with Ceplene has the potential to prevent or reverse damage induced by oxidative stress, thereby protecting critical cells and tissues, including the liver.
Ceplene is currently being tested in Phase 3 cancer clinical trials for advanced metastatic melanoma and acute myelogenous leukemia. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. More than 1,300 patients have participated in the Company's completed and ongoing clinical trials. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency.
Maxim Overview
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers and liver diseases. Maxim's research and development programs are designed to offer hope to patients by developing safe and effective therapeutic candidates that have the potential to extend survival while maintaining quality of life. Maxim has attracted an experienced international management group and a team of employees dedicated to commercializing life-enhancing product candidates. Joining this motivated team in its mission are world-leading scientific and clinical investigators and major pharmaceutical development partners.
In addition to Ceplene, Maxim is also developing small-molecule inhibitors and activators of programmed cell death, also known as apoptosis, that may serve as drug candidates for cancer, cardiovascular disease and other degenerative diseases. Lastly, the Company's MaxDerm(TM) technology is designed for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy and intended utilization of Ceplene, the apoptosis modulator technology and MaxDerm, and regarding the company's clinical trials. Such statements are only predictions and the company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials, the risk that the company will not obtain approval to market its products, and the risk that clinical trials may not commence when planned. These factors and others are more fully discussed in the company's periodic reports and other filings with the Securities and Exchange Commission.
Note: Ceplene(TM), MaxDerm(TM) and the Maxim logo are trademarks of the company.
Editor's Note: This release is also available on the Internet at maxim.com.
--------------------------------------------------------------------------------
Contact:
Maxim Pharmaceuticals
Larry G. Stambaugh or Dale A. Sander, 858/453-4040
or
Burns McClellan
Stephanie Diaz (Investors), 415/352-6262
or
Coffin Communications Group
Valerie Bent (Media), 818/789-0100 |
