Maxim's Ceplene Improves Human Immune Cell Activation by Interferon-Alpha in Preclinical Study
Findings Presented at the European Association for the Study of the Liver Conference
SAN DIEGO--(BW HealthWire)--April 22, 2002-- Maxim Pharmaceuticals Inc. (Nasdaq:MAXM - news; SSE:MAXM) announced today that its lead drug candidate Ceplene(TM) (histamine dihydrochloride) was shown in a preclinical study to potentiate and improve the activation of critical immune cells by interferon-alpha.
Interferon-alpha is an agent used as a standard treatment for patients with chronic hepatitis C. Data from this and other work highlighting the impact of histamine dihydrochloride on the immune system were presented this weekend by scientists at the European Association for the Study of the Liver (EASL) conference in Madrid, Spain.
At the conference, Dr. Ana Romero and co-researchers of the Sahlgrenska University Hospital, Goteborg, Sweden, presented the results of in vitro tests evaluating histamine's ability to improve the interferon-alpha-induced activation of two types of immune cells that are critical for the defense against hepatitis C, natural killer cells (NK cells) and cytotoxic T cells. In this preclinical study, human NK cells and cytotoxic T cells were treated in vitro with interferon-alpha, with or without Ceplene. The NK and T cells were tested in an environment containing mononuclear phagocytic cells to mimic the oxidative stress associated with hepatitis C-infected liver tissue. Ceplene was found to markedly improve immune cell activation by interferon-alpha. Specifically, the addition of Ceplene resulted in a greater than 400-percent improvement of interferon-alpha-induced activity in both NK cells and cytotoxic T cells.
``The finding that Ceplene potentiates interferon-alpha-induced activation of these critical immune cells may help to explain the positive results achieved to date in the clinical testing of Ceplene in hepatitis C and cancer,'' said Kurt R. Gehlsen, Ph.D., Maxim's senior vice president, research and chief technical officer. ``These results are consistent with the established mechanism of action for Ceplene, specifically that the compound protects NK cells and cytotoxic T cells from oxidative stress, thereby allowing for a more efficient activation of these critical immune cells that can target cancer cells and virally infected cells.''
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 C 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.
In the case of cancer and hepatitis, oxygen free radicals may induce apoptosis (programmed cell death) in NK cells and T cells, both of which are critical immune cells with the ability to kill cancerous or virally infected cells. By preventing the production and release of oxygen free radicals, Ceplene may protect NK and T cells. For the treatment of hepatitis and cancer, Ceplene is administered in combination with cytokines such as interferon-alpha and interleukin-2, proteins that stimulate these same immune cells.
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. The company is also developing MaxDerm(TM), a technology platform 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 |
