Maxim's Ceplene Featured in Six Articles in Seminars in Oncology Supplement
Articles Highlight Ceplene's Potential Innovative Role in Cancer Therapy
SAN DIEGO--(BW HealthWire)--July 8, 2002--Maxim Pharmaceuticals Inc. (Nasdaq\NM:MAXM)(SSE:MAXM) announced that more than 20 years of research and clinical testing of its lead drug candidate Ceplene(TM) (histamine dihydrochloride) are the subject of a series of six scientific articles included in the Seminars in Oncology supplement entitled "New Applications of Cancer Immunotherapy" (vol 29, no 3, supp 7).
The Seminars in Oncology supplement is comprised of 10 articles discussing current trends and innovations in the use of immunotherapy, a treatment approach designed to enhance and exploit the immune system's ability to combat cancer and infectious diseases. As described in the series of articles, Ceplene is designed to protect key immune cells at the tumor site through a novel mechanism of action involving reduction of oxidative stress created by free radicals. This universal mode of action gives Ceplene the potential to be used in a broad range of life-threatening cancers as an adjuvant to existing treatments. To date, more than 1,300 patients have participated in 15 completed and/or ongoing clinical trials of Ceplene in several cancers and in hepatitis C.
Ceplene is currently being tested in a Phase 3 clinical trial in North America and Europe for the treatment of advanced metastatic melanoma with liver metastases, the most deadly form of skin cancer and the most rapidly growing cancer in the developed world. This ongoing trial complements a U.S. Phase 3 trial of Ceplene in advanced metastatic melanoma completed in 2000, a trial that demonstrated a significant increase in survival for patients treated with the combination of Ceplene and interleukin-2 (IL-2). Ceplene is also being tested in a Phase 3 trial for the treatment of acute myeloid leukemia, the most common acute adult leukemia, and has been tested in Phase 2 trials in renal cell carcinoma, a serious cancer of the kidneys. Based upon the fundamental immune mechanism of action, Ceplene is also being tested in ongoing clinical trials and research studies in hepatitis C and other chronic liver diseases. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency.
Key Ceplene research presented in the Seminars in Oncology publication included the following articles:
"New Applications of Cancer Immunology" by Dr. Sanjiv S. Agarwala from the University of Pittsburgh Cancer Institute. The article highlights the fact that the outlook is dismal for patients with Stage-IV melanoma, and states that recent clinical trials using chemotherapy in combination with cytokines have produced marginal benefits with extreme toxicity for the patients. The article provides an overview of the first Phase 3 study of the combination of Ceplene and the cytokine IL-2 completed in 2000. "This is the first large, controlled, randomized trial that shows a statistically significant survival advantage for any subgroup of patients with malignant melanoma," said Dr. Agarwala. "Importantly, this benefit was achieved with a regimen that produced less toxicity than typically seen with IL-2, and was self-administered at home."
"Therapeutic Options in the Management of Renal Cell Carcinoma" by Dr. John A. Glaspy from the University of California, Los Angeles, School of Medicine. Among the therapeutic approaches discussed in the article is treatment of advanced-stage renal cell carcinoma patients with the triple-drug combination of Ceplene, IL-2 and interferon-alpha. The Phase 2 trial reported concluded that the Ceplene triple-drug therapy was safe and suggested a prolonged survival for those patients treated with the combination therapy.
"Histamine Dihydrochloride and Interleukin-2 in the Treatment of Acute Myeloid Leukemia" by Dr. Edward A. Stadtmauer, from the Hematologic Malignancies Program, University of Pennsylvania Cancer Center. The article described favorable Phase 2 studies of the combination of Ceplene and IL-2 in the treatment of AML, and provides the details of a 320-patient Phase 3 trial that completed enrollment in October 2000. The data for this Phase 3 trial may be available in the second half of 2004.
"Histamine in Cancer Immunotherapy" by Dr. Kristoffer Hellstrand, Department of Virology. University of Goteborg, Sweden. The article outlines the preclinical research into the role of histamine that commenced in the mid 1980s and has continued to the current time. Among many other findings, this research elucidated how Ceplene can prevent or reverse damage associated with oxidative stress, thereby protecting immune cells and other critical cells and tissue. This research forms the basis for the clinical development underway or planned in multiple life-threatening cancers, hepatitis C and chronic liver disease.
"Dr. Hellstrand's article describes his team's two decades of preclinical research and provides insight into the innovative, breakthrough nature of the efforts that resulted in the discovery of Ceplene's mechanism, providing the basis for the extensive human studies underway today," said Larry G. Stambaugh, Maxim's chairman and chief executive officer. "This leading-edge work continues through a combination of research being conducted today by Maxim's scientific team, Dr. Hellstrand and his colleagues, and other leading scientists throughout the world. Much attention today is focused on our later-stage clinical testing of Ceplene. However, our understanding of Ceplene's potential role and benefits continues to grow as a result of this basic research, and the additional insights that have resulted from this work have led us to expand the development of the drug candidate into new high-need diseases such as chronic liver disease."
Maxim Overview
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers, hepatitis C and chronic 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 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, 858/453-4040
or
John Nugent, 212/213-0006 (Investors)
or
Coffin Communications Group
Sean Collins / Valerie Bent, 818/789-0100 (Media) |
