Maxim Announces Completion of Enrollment of Phase 2 Hepatitis C Clinical Trial.Business Editors/Health/Medical Writers BIOWIRE2K SAN DIEGO--(BUSINESS WIRE)--July 29, 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 it has completed enrollment of a Phase 2 trial of its drug candidate Ceplene(TM) (histamine dihydrochloride) for the treatment of hepatitis C Hepatitis C Definition Hepatitis C is a form of liver inflammation that causes primarily a long-lasting (chronic) disease. Acute (newly developed) hepatitis C is rarely observed as the early disease is generally quite mild. nonresponder patients. The M0406 Phase 2 trial includes 302 hepatitis C patients who failed to respond to prior therapy with the combination of interferon-alpha and ribavirin ribavirin /ri·ba·vi·rin/ (ri?bah-vi´rin) a broad-spectrum antiviral used in the treatment of severe viral pneumonia caused by respiratory syncytial virus, particularly in high-risk infants; also used in conjunction with interferon . The randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , controlled Phase 2 trial is designed to compare the treatment of nonresponder hepatitis C patients with a triple-drug combination of Ceplene, Peg-Intron(R) (peginterferon alfa-2b) and Rebetol(R) (ribavirin, USP USP - unique sales point ) versus treatment with the Peg-Intron and Rebetol combination. "Enrollment of this trial was one of our key corporate objectives for 2003, and we are pleased to have reached this milestone," said Larry G. Stambaugh, Maxim's Chairman and Chief Executive Officer. "Current treatments are ineffective for approximately half of the patients with hepatitis C, and in particular there are a lack of effective treatment options for patients that have failed prior treatment. The M0406 trial is one of the programs that we have underway to advance the potential use of histamine therapy in chronic liver disease Chronic liver disease is a liver disease of slow process and persisting over a long period of time, resulting in a progressive destruction of the liver. It includes amongst others:
In the M0406 trial, patients will be treated for up to 48 weeks and followed for an additional 24 weeks after completion of treatment. The primary measures of efficacy in the study are sustained complete viral response and sustained biochemical response (normalization In relational database management, a process that breaks down data into record groups for efficient processing. There are six stages. By the third stage (third normal form), data are identified only by the key field in their record. of the liver enzyme ALT, a standard measure of liver function) at 72 weeks. The trial is being conducted in North America, Western Europe and Israel. Overview of Ceplene and Histamine Therapy 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 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 and can damage or destroy liver tissue in patients with hepatitis and other chronic liver diseases. 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 histamine has the potential to prevent or reverse damage induced by oxidative stress and to protect critical cells and tissues, including the liver. Research regarding histamine and related clinical results has been the subject of more than 80 presentations at major scientific and clinical meetings, and has been published in more than 300 scientific and clinical articles. Phase 3 clinical trials of Ceplene, the injectable form of histamine dihydrochloride, have been conducted in Stage IV malignant melanoma and acute myeloid leukemia. Ceplene has also been tested in Phase 2 trials in 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. . Nearly 2,000 patients have participated in the Company's completed and ongoing clinical trials. Testing of histamine therapy has been expanded beyond oncology as it has shown the potential to prevent or inhibit oxidative stress, a condition associated with most acute and chronic liver diseases. Based upon the basic mechanism of action of histamine therapy, and the results seen in clinical and preclinical testing, Maxim intends to further explore the testing and development of histamine in chronic liver diseases such as hepatitis C and nonalcoholic non·al·co·hol·ic adj. A beverage usually containing less than 0.5 percent alcohol by volume. steatohepatitis (NASH Nash , Ogden 1902-1971. American writer known for his droll epigrammatic verse, much of which appeared in the New Yorker. Noun 1. Nash - United States writer noted for his droll epigrams (1902-1971) Ogden Nash ). "Initial testing in hepatitis C has been conducted with the Ceplene injectible drug candidate," said Kurt R. Gehlsen, Ph.D., Maxim's Chief Scientific Officer. "We expect that an alternative formulation, such as the oral formulation of histamine currently under development, most likely will be integrated into further testing of histamine in chronic liver disease." 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. 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. Ceplene, the apoptosis inducers, and MX8899 are investigational drugs and have not been approved by the U.S. Food and Drug Administration (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. 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, the risk that the Company will not obtain approval to market its products, and the risks and costs associated with litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. . 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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