Maxim Scientists Present Preclinical Research Highlighting Ceplene Protection Against Alcohol-Induced Liver Injury
Results Presented at the European Association for the Study of the Liver Conference
SAN DIEGO--(BW HealthWire)--April 18, 2002-- Maxim Pharmaceuticals Inc. (Nasdaq:MAXM - news; SSE:MAXM) announced that researchers will present today the first results from a series of preclinical studies showing that Ceplene(TM) (histamine dihydrochloride) protected against alcohol induced liver injury in an animal model.
The results are being presented today at the European Association for the Study of the Liver (EASL) conference in Madrid, Spain.
These studies are among the body of research underway designed to support the human clinical testing of Ceplene in chronic liver diseases such as alcoholic liver disease (ALD) and nonalcoholic steatohepatitis (NASH) planned to commence in 2002. 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.
``These data represent the first evaluation of the use of Ceplene as a single-agent therapy in chronic liver disease, and we are pleased with the results in this alcohol protection model,'' said Dr. Kurt Gehlsen, senior vice president, research and chief technical officer. ``A series of follow-on preclinical studies are ongoing to evaluate the potential of Ceplene to reverse the tissue damage caused by alcohol damage. Preclinical studies are also underway to assess the potential of Ceplene in animal models related to NASH, another widespread liver disease impacting many adults. Results from these studies are expected to be available for presentation at upcoming scientific presentations.''
Alcohol Liver Injury Research
To examine the potential role of Ceplene in preventing oxidative damage in chronic liver diseases, Ceplene was studied in an alcohol-induced liver injury hepatitis model in rats. Animals were divided into three groups:
Control Group: Administered no alcohol and received no Ceplene.
Untreated Group: Administered a single dose of ethanol (5 g/kg) once per day for six weeks, but received no treatment with Ceplene.
Treatment Group: Administered the same dose of ethanol and also received treatment with Ceplene twice daily for six weeks.
Animals receiving ethanol but not treated with Ceplene developed steatosis (fatty degeneration of liver tissue), and inflammation and necrosis of liver tissue. The animals in the untreated group also had elevated levels of the liver enzymes ALT and AST, two standard measures of liver function. Animals that were administered the same dose of ethanol but were treated with Ceplene had livers that were comparable in appearance to the control group, and had normal ALT and AST levels (statistically significant at p less than 0.05). The animals treated with Ceplene also had statistically significant better scores (p less than 0.05) for inflammation, necrosis and total pathology score compared to the untreated group. These results suggest that Ceplene protected against early alcohol-induced liver injury in this animal model.
``The expansion of the clinical testing of Ceplene into chronic liver diseases represents a natural evolution of the scientific understanding and the clinical development of this drug candidate resulting from the extensive body of research and clinical testing completed to date,'' said Larry G. Stambaugh, Maxim's Chairman and Chief Executive Officer. ``Our discussions with doctors and patients emphasize the need for a successful therapy for certain diseases of the liver like alcoholic liver disease and NASH, and we are committed to the commencement of human clinical trials in this area. With nearly one in ten Americans afflicted with some form of chronic liver disease, this area represents one of the largest unmet medical needs and may ultimately represent the most important advancement in the development of Ceplene.''
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.
A human clinical study of Ceplene in NASH patients is expected to commence in the first half of 2002. A human clinical study of Ceplene in alcoholic liver disease patients is expected to commence in late 2002. Presentation of additional preclinical research is planned for the Digestive Disease Week meeting in May 2002 in San Francisco.
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.
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Contact:
Maxim Pharmaceuticals Inc.
Larry G. Stambaugh, Chairman, President and CEO /
Dale A. Sander, Chief Financial Officer
858/453-4040
or
Burns McClellan
Stephanie Diaz (Investors) / Kathy Jones, Ph.D. (Media)
415/352-6262 / 212/213-0006 |
