ASPERVA REPORTS ON PHASE III TRIAL FOR MYASTHENIA GRAVIS.
The randomized, 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.
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 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 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 (patients should be monitored for neutropenia; dosing should be interrupted or the dose reduced if neutropenia develops), thrombocytopenia, leukocytosis, urinary tract infection, hypertension, hypotension, peripheral edema, hypercholesteremia, hypokalemia, hyperglycemia, creatinine, BUN and cough increased, hypomagnesemia, 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 under the trading symbol "ASV".
For more information, call 250/744-2488 ext. 84270. or visit http://www.aspreva.com.
|Printer friendly Cite/link Email Feedback|
|Date:||Dec 1, 2006|
|Previous Article:||CRUCELL/AERAS START TURBERCULOSIS VACCINE CLINICAL TRIAL.|
|Next Article:||TARO GETS UK MARKETING AUTHORIZATION FOR ETOPAN XL.|