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The study was published in the September issue of Blood (volume 96, no. 5, pp 1961-68), which is the official journal of The American Society of Hematology (ASH). The results were also presented at the Society of Biological Therapy (SBT) conference in Berlin, Germany.
"We are pleased by these preclinical data as they further support the benefit that Maxamine may provide in cancer therapy by preventing suppression of key elements of the immune system," said Dr. Kurt R. Gehlsen, Maxim's vice president. "Cancer cells can sometimes escape the immune system by suppressing natural killer cells and cytotoxic T-cells, and it is encouraging that Maxamine was found to protect these cells against inhibition in this CML study, consistent with the results of our research in other cancers."
"We are pleased by these preclinical data as they further support the benefit that Maxamine may provide in cancer therapy by preventing suppression of key elements of the immune system."
In the Blood paper, Dr. Ulf-Henrik Mellqvist and co-workers at the University of Goteborg, Sweden, reported that cancer cells recovered from patients with CML, a common form of leukemia, inhibit two type of cells, natural killer (NK) cells and T cells, both of which are key in the defense against cancer cells. NK cells and T cells normally attack and destroy cancer cells, but the authors found that this anti-tumor function was strongly compromised by CML cells. The study concluded, however, that the addition of Maxamine completely restored the anti-tumor functions of NK cells and T cells.
"We are pleased with the rapidly growing awareness and acceptance of the important advancement that Maxamine may represent in the treatment of cancer and infectious diseases," said Larry G. Stambaugh, Maxim's chairman and chief executive officer. "During the SBT conference this week, results are being presented from our U.S. Phase III study in advanced metastatic melanoma, our Phase II dose-ranging study in hepatitis C, and the recently published preclinical study in CML. The results from these three studies further highlight Maxamine's potential broad applicability to immunotherapy and biotherapy."
Maxamine OverviewTreatment with Maxamine is based upon the discovery of a universal mechanism that suppresses the capacity of the immune system to detect and destroy tumor cells or virally infected cells in many patients with cancer and chronic infectious diseases. Maxamine is designed to reverse this immune suppression, thereby enhancing the effectiveness of immunotherapy, a class of therapies that employ the body's immune system to fight cancer and certain infectious diseases. Maxamine protects critical immune cells and is administered in combination with cytokines such as interleukin-2 (IL-2) and interferon-alpha, a class of proteins that stimulate these same immune cells. More than 1,200 patients have been treated in the company's completed and ongoing clinical trials in advanced malignant melanoma, acute myelogenous leukemia, hepatitis C and renal cell carcinoma. Maxamine is an investigational drug and has not been approved by the FDA or any international regulatory agency. However, clinical trial results to date suggest that Maxamine Therapy, the administration of Maxamine in combination with cytokines, is a safe, at-home treatment that may improve patient survival. Maxim Pharmaceuticals is a late-stage biopharmaceutical company developing advanced drugs and therapies for cancer, infectious diseases, degenerative diseases and topical disorders. In July 2000 the company submitted a New Drug Application (NDA) to the FDA seeking approval to market Maxamine in the United States as an adjuvant to IL-2 for the treatment of advanced metastatic melanoma. In September 2000 the FDA has informed the company that the NDA had been accepted for review as filed, and that the NDA had been granted priority review status and would be reviewed under the accelerated approval statutes. In addition, Maxamine is also currently being tested in two additional Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukemia. Phase II trials of Maxamine are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. The company has also developed product candidates based on its MaxDerm(TM) technology that are 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. Furthermore, Maxim is developing small-molecule inhibitors and activators of caspases, key enzymes that modulate and carry out the cellular signaling pathways involved in programmed cell death, also known as apoptosis. Compounds that can either inhibit caspases or induce caspases may form the basis for important new drugs for a wide variety of disease targets, such as cancer, cardiovascular disease and other degenerative diseases.
Source: Maxim Pharmaceuticals
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