ASPERVA REPORTS ON PHASE III TRIAL FOR MYASTHENIA GRAVIS.Aspreva Pharmaceuticals Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ASPV; TSX: ASV), an emerging pharmaceutical company focused on increasing the pool of evidence-based medicines available for patients living with less common diseases today announced that based on a preliminary review of the data, CellCept(R) (mycophenolate mofetil or MMF See multimode fiber. ) in treating myasthenia gravis myasthenia gravis (mīəsthē`nēə grä`vĭs), chronic disorder of the muscles characterized by weakness and a tendency to tire easily. (MG) failed to meet both primary and secondary endpoints in its phase III trial. 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. , double-blind, placebo-controlled clinical trial was designed to evaluate the efficacy and safety of MMF in maintaining or improving symptom control with reduced doses of corticosteroids in patients with myasthenia gravis over a treatment period of 36 weeks. The primary endpoints in the trial included minimal disease activity while maintaining a designated low steroid and cholinesterase inhibitor doses. The preliminary analysis of the results from Aspreva's phase III trial indicates that MMF failed to meet both the primary and secondary endpoints. Aspreva's analysis also showed that MMF appeared to be generally well tolerated by the patients in the study. The most frequent adverse events were diarrhea, muscle spasms and other symptoms related to the disease. About CellCept CellCept is Roche's leading immunosuppressant or "anti-rejection" drug used in combination with other immunosuppressive drugs (cyclosporine and corticosteroids) for the prevention of rejection in patients receiving heart, kidney and liver transplants. CellCept was first approved for use in combination therapy for the prevention of acute organ rejection in kidney transplantation in 1995 and has since been approved worldwide for prevention of organ rejection in adult kidney, heart and liver transplantation. In some countries, it has also been approved for paediatric kidney transplantation. This therapeutic success in the prevention of organ rejection in adult kidney, heart and liver transplantation represents 11 years of clinical experience and patient benefits, including reduced toxicities and prolonged graft and patient survival. In July 2003, Aspreva signed a collaboration agreement with Roche for the exclusive worldwide rights to develop and, upon regulatory approval, commercialize CellCept for all autoimmune disease applications. It is important to note that CellCept 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. for the treatment of any autoimmune disease. There are no adequate and well-controlled studies of CellCept in pregnant women. As CellCept has been shown to have teratogenic effects in animals at subclinical subclinical /sub·clin·i·cal/ (sub-klin´i-k'l) without clinical manifestations. sub·clin·i·cal adj. Not manifesting characteristic clinical symptoms. Used of a disease or condition. doses on a body surface area basis, it may cause fetal harm when administered to a pregnant woman. CellCept should not be used in pregnant women unless the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within one week prior to beginning therapy even where there has been a history of infertility, unless due to hysterectomy. Women of childbearing potential must use effective contraception before beginning CellCept therapy, during therapy and for six weeks following discontinuation of therapy. Two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method. If pregnancy occurs during treatment, the physician and patient should discuss the desirability of continuing the pregnancy (see complete product information). Adverse events reported in >30% of renal, cardiac or liver transplant patients receiving CellCept (in combination with cyclosporine and corticosteroids) were pain, fever, headache, asthenia, anemia, leucopenia leu·co·pe·ni·a n. Variant of leukopenia. (patients should be monitored for neutropenia; dosing should be interrupted or the dose reduced if neutropenia develops), thrombocytopenia Thrombocytopenia Definition Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets. , leukocytosis Leukocytosis Definition Leukocytosis is a condition characterized by an elevated number of white cells in the blood. Description Leukocytosis is a condition that affects all types of white blood cells. , urinary tract infection urinary tract infection (UTI), n infection in one or more of the structures that make up the urinary system. Occurs more often in women and is most commonly caused by bacteria. , hypertension, hypotension, peripheral edema, hypercholesteremia, hypokalemia Hypokalemia Definition Hypokalemia is a condition of below normal levels of potassium in the blood serum. Potassium, a necessary electrolyte, facilitates nerve impulse conduction and the contraction of skeletal and smooth muscles, including the heart. , hyperglycemia hyperglycemia: see diabetes. , creatinine, BUN and cough increased, hypomagnesemia hypomagnesemia /hy·po·mag·ne·se·mia/ (-mag?nes-em´e-ah) abnormally low magnesium content of the blood. hy·po·mag·ne·se·mi·a n. An abnormally low level of magnesium in the blood. , diarrhea, constipation, nausea, vomiting, respiratory infection, dyspnea, lung disorder, pleural effusion, tremor and insomnia. Patients receiving immunosuppressant regimens are at increased risk of developing lymphomas and other malignancies, particularly of the skin. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of renal, cardiac or hepatic transplant patients should use CellCept. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient. For full prescribing information on CellCept, please visit: www.rocheusa.com/products/cellcept. About Aspreva Pharmaceuticals Aspreva is an emerging pharmaceutical company focused on identifying, developing and, upon regulatory approval, commercializing new indications for approved drugs and late stage drug candidates for patients living with less common diseases. Aspreva is listed on the Nasdaq Global Select Market under the trading symbol "ASPV" and on the Toronto Stock Exchange Toronto Stock Exchange (TSE) Canada's largest stock exchange, trading approximately 1,200 company stocks and 33 options. under the trading symbol "ASV". For more information, call 250/744-2488 ext. 84270. or visit http://www.aspreva.com. |
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