Maxim Announces Preclinical Study Showing Synergy of Ceplene and Chemotherapy in Cancer Treatment.Business Editors/Health/Medical Writers BIOWIRE2K European Cancer Conference SAN DIEGO--(BUSINESS WIRE)--Oct. 1, 2003 Maxim Pharmaceuticals (Nasdaq NM: MAXM, SSE (1) An earlier full-screen editor in OS/2. (2) (Streaming SIMD Extensions) A series of additional instructions built into Pentium CPU chips for improved multimedia performance by performing mathematical operations on multiple sets of data at the : MAXM) announced that researchers presented at the European Cancer Conference (ECCO An earlier Windows PIM from NetManage, Inc., Cupertino, CA (www.netmanage.com). ECCO provided a phone book, calendar, to-do list, outlining and notetaking. It was noted for its tightly integrated and sophisticated functions. ) the results of preclinical research that suggested that the combination of Ceplene(TM) (histamine dihydrochloride) and chemotherapy has synergistic anti-tumor activity in the treatment of soft tissue sarcomas. In the preclinical study there were higher tumor response rates among animals treated with histamine in combination with chemotherapy, and in animals treated with histamine alone, compared to the response rates in animals treated with chemotherapy alone. Ceplene has been tested in multiple Phase 3 and Phase 2 human clinical trials in cancer in combination with immunotherapeutic agents, but has not yet been tested in combination with chemotherapy. The results were presented at the ECCO conference by Dr. Flavia Brunstein, Surgical Oncology surgical oncology Oncological surgery The field of surgery dedicated to the operative ablation of neoplasia, generally, 'solid' tumors , Erasmus University Medical Center Rotterdam. In the study conducted by Dr. Brunstein and colleagues at the Erasmus University Medical Center Rotterdam, groups of rats with established BN-175 soft tissue sarcoma tumors were treated with isolated limb perfusion Isolated limb perfusion is a chemotherapeutic technique used to deliver high doses of cancer drugs directly into the bloodstream. A tourniquet is used to cut off blood flow of the arm or leg of a patient, which isolates the circulation of the limb. with either a sham control, the chemotherapeutic agent chemotherapeutic agent An agent used to treat CA, administered in 'regimens'-one or more 'cycles' that combine 3 or more agents over wks; CAs are toxic to any cell with a high rate of proliferation–the CA itself, the GI tract–causing N&V, melphalan, histamine alone, or the combination of histamine and melphalan. The best tumor response rate among all four groups was achieved with the histamine / melphalan combination. Treatment with histamine alone achieved a tumor response rate similar to the response mediated by melphalan alone. Among the results reported by the researchers was that the increase in the uptake of melphalan in tumors was up to three times higher in the group treated with the histamine/melphalan combination than in the group treated with melphalan alone. The researchers concluded that the histamine / melphalan combination was synergistic as a result of both direct and indirect anti-tumor effects (reference: EJC EJC European Journalism Centre (Maastricht, Netherlands) EJC European Jewish Congress EJC European Journal of Cancer EJC Electronic Journal of Communication EJC Equal Justice Coalition EJC European Junior Championships Supplements, 2003;1(5):699). "The combination of histamine and melphalan showed a dramatic effect on tumor response in the isolated limb perfusion setting that has not been previously reported," said Dr. Alexander M.M. Eggermont, Department of Surgical Oncology, University Hospital Rotterdam - Den Hoed Cancer Center. "The above findings seem promising as a potential alternate treatment alternate treatment, n the contract provisions that authorize the insurance carrier to determine the amount of benefits payable, giving consideration to alternate procedures, services, or courses of treatment that may be performed to accomplish the for patients who show no response to standard treatment for sarcoma sarcoma (särkō`mə), highly malignant tumor arising in connective- and muscle-cell tissue. It is the result of oncogenes (the cancer causing genes of some viruses) and proto-oncogenes (cancer causing genes in human cells). , and also suggested that further testing of Ceplene in combination with chemotherapeutic agents is warranted." Overview of Ceplene Natural Killer (NK) cells and cytotoxic T cells possess an ability to kill and support the killing of cancer cells and virally infected cells. Much of the current practice of immunotherapy is based on treatment with cytokines Cytokines Chemicals made by the cells that act on other cells to stimulate or inhibit their function. Cytokines that stimulate growth are called "growth factors. such as interleukin-2 (IL-2) or interferon, proteins that stimulate NK and T cells T cells A type of white blood cell produced in the thymus gland. T cells are an important part of the immune system. Infants born with an underdeveloped or absent thymus do not have a normal level of T cells in their blood. . However, research has shown that oxygen free radicals released by certain immune cells can suppress NK and T cells and damage normal tissue, a process commonly referred to as oxidative stress oxidative stress, n an imbalance of the prooxidant antioxidant ratio in which too few antioxidants are produced or ingested or too many oxidizing agents are produced. . Oxidative stress, implicated im·pli·cate tr.v. im·pli·cat·ed, im·pli·cat·ing, im·pli·cates 1. To involve or connect intimately or incriminatingly: evidence that implicates others in the plot. 2. in numerous diseases, is most pronounced in the liver. Ceplene, based on the naturally occurring molecule histamine, has been shown to reduce oxidative stress. Accordingly, treatment with Ceplene may prevent the production and release of oxygen free radicals, thereby protecting NK cells and T cells and facilitating their activation by cytokines such as IL-2, interferon or other immunomodulators and protecting other critical cells and tissues, including the liver. Research regarding histamine, the active agent underlying Ceplene, and related clinical results has been the subject of more than 80 presentations at major scientific and clinical meetings, and have been published in more than 300 scientific and clinical articles. A three-minute animation of Ceplene's mechanism of action can be viewed on the Company's website at www.maxim.com. Ongoing or completed Phase 3 combination studies of Ceplene have been conducted in Stage IV malignant melanoma and acute myeloid leukemia. Maxim plans to file an application for market authorization in Europe in November 2003 for approval to market Ceplene for the treatment of advanced malignant melanoma. Ceplene has also been tested in Phase 2 trials in hepatitis C and advanced renal cell carcinoma renal cell carcinoma or hypernephroma Malignant tumour of the cells that cover and line the kidney. It usually affects persons over age 50 who have vascular disorders of the kidneys. It seldom causes pain, unless it is advanced. . Over 2,000 patients have participated in the Company's 17 completed and ongoing clinical trials in 19 countries for cancer and hepatitis C. Ceplene is an investigational drug and has not been approved by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. or any international regulatory agency. Maxim Overview Maxim Pharmaceuticals is a global biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening cancers and chronic liver diseases. Maxim's research and development programs are designed to deliver safe and effective drugs that possess the potential to extend survival while maintaining quality of life. In addition to Ceplene, Maxim is developing small-molecule inhibitors and activators of programmed cell death pro·grammed cell death n. See apoptosis. programmed cell death proposed system of cell death, often including poly(ADP)-ribosylation, ensures that a cell will not survive if it is so badly damaged that its recovery would harm the , also known as apoptosis, which may serve as drug candidates for cancer, cardiovascular disease and other degenerative diseases. The Company's third technology platform, the MX8899 topical gel, is being tested in an attempt to help patients who suffer from oral mucositis and radiation dermatitis, both of which are debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction side effects of certain cancer therapies. This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy, safety and intended utilization of Ceplene, the oral histamine formulation, the apoptosis inducers, and MX8899, and the conduct, results and timelines associated with 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, and the risk that the Company will not obtain approval to market its products. These factors and others are more fully discussed in the Company's periodic reports and other filings with the Securities and Exchange Commission. Note: The Maxim logo is a trademark of the Company. Editor's Note: This release is also available on the Internet at http://www.maxim.com. |
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