Methotrexate is an antimetabolite and antifolate agent with antineoplastic and immunosuppressant activities. Methotrexate binds to and inhibits the enzyme dihydrofolate reductase, resulting in inhibition of purine nucleotide and thymidylate synthesis and, subsequently, inhibition of DNA and RNA syntheses. Methotrexate also exhibits potent immunosuppressant activity although the mechanism(s) of actions is unclear.
Methotrexate is approved by the Food and Drug Administration (FDA) to be used by itself to treat the following types of gestational trophoblastic tumors, Chorioadenoma destruens, Choriocarcinoma, Hydatidiform mole. Methotrexate is also approved to be used alone or with other drugs to treat acute lymphoblastic leukemia (ALL) that has spread to the central nervous system (CNS) or to keep it from spreading there, and to treat the following, breast cancer, certain types of head and neck cancer, lung cancer, advanced non-Hodgkin lymphoma (NHL), advanced mycosis fungoides (a type of cutaneous T-cell lymphoma), osteosarcoma that has not spread to other parts of the body, following surgery to remove the primary tumor. Methotrexate is also approved to treat the following non-cancer conditions, rheumatoid arthritis, severe psoriasis.
The American College of Rheumatology has developed new guidelines for starting and monitoring treatments for children with juvenile idiopathic arthritis. These are the first JIA guidelines endorsed by the ACR, with the goal of broad acceptance within the rheumatology community.
A recent trial of rituximab in combination with a tumor necrosis factor inhibitor and methotrexate in patients with active rheumatoid arthritis found the safety profile to be consistent with other RA trials with TNF inhibitors.
Protalex, Inc, a clinical stage biopharmaceutical company which is engaged in developing a class of drugs for treating autoimmune and inflammatory diseases, today announced enrollment of the first patients in the 3rd cohort of its ongoing multicenter Phase 1b dose escalation clinical study of PRTX-100 in adult patients with active Rheumatoid Arthritis (RA) being conducted in South Africa. The dose was increased by a factor of two from the 2nd cohort.
4SC AG, a drug discovery and development company focused on autoimmune and cancer indications, announces the final data from the ENTRANCE Phase IIa trial in inflammatory bowel disease with vidofludimus, an oral inhibitor of interleukin-17 release and DHODH, including the secondary endpoints comprising the analysis of CDAI and CAI disease scores, change of prednisolone intake and threshold doses, safety, pharmacokinetics and biomarkers.
NMS Labs launches another unique test suitable for the evaluation of toxicity vs. efficacy and helping physicians with therapeutic drug monitoring of patients for the therapeutic agent, Methotrexate.
UCB SA, on behalf of its affiliate UCB Pharma S.A., and PDL BioPharma, today jointly announced that the companies have entered into a definitive settlement agreement that resolves all legal disputes between them, including those relating to UCB's pegylated humanized antibody fragment, Cimzia, and PDL's patents known as the Queen et al. patents.
Amgen and Pfizer Inc. today announced results from a new trial that demonstrated Enbrel significantly improved scalp involvement in adult patients with moderate to severe plaque psoriasis, compared with placebo. The data will be presented today at the 69th Annual American Academy of Dermatology meeting in New Orleans, La.
Antares Pharma, Inc. today announced that the first patient has been dosed in a clinical study evaluating the VIBEX™ MTX product which is being developed for the treatment of rheumatoid arthritis. The clinical study will evaluate several dose strengths of VIBEX MTX delivered with a proprietary autoinjector versus conventional needle and syringe administration by a healthcare professional.
Genentech, a member of the Roche Group, and Biogen Idec today announced the U.S. Food and Drug Administration approved Rituxan as a maintenance treatment for patients with advanced follicular lymphoma who responded to initial treatment with Rituxan plus chemotherapy.
In a previous study, rheumatoid arthritis (RA) patients who failed to respond to methotrexate were shown to experience positive results with fostamatinib disodium (R788), an oral spleen tyrosine kinase (Syk) inhibitor that is thought to block immune cell signaling involved with bone and cartilage destruction. In the current study, RA patients who failed to respond to biologic agents were studied.
AB Science SA, a pharmaceutical company specialising in the research, development and commercialisation of protein kinase inhibitors (PKIs), announced today the recruitment of the first patient in the phase 3 study evaluating masitinib in severe persistent asthma.
RNL BIO CO., LTD, a leading biopharmaceutical company specialized in adult stem cell therapeutics, announced on January 21, 2011 another successful patient report utilizing stem cell therapy on a leading US orthopedic spine surgeon who suffered from Autoimmune Arthritis.
Chelsea Therapeutics International, Ltd. reported new 12-month data from Study 303, a safety extension study from its Phase III NORTHERA™ (droxidopa) registration program in symptomatic neurogenic orthostatic hypotension (NOH). Preliminary, top-line results demonstrate Northera provides clinically meaningful and durable symptomatic improvements in patients with NOH throughout a one-year observation period.
Genentech, Inc., a member of the Roche Group, today announced that the United States Food and Drug Administration has extended the ACTEMRA (tocilizumab, RoACTEMRA in the European Union) label to include inhibition and slowing of structural joint damage, improvement of physical function, and achievement of major clinical response in adult patients with moderately to severely active rheumatoid arthritis, when given in combination with methotrexate.
Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced it submitted a supplemental New Drug Application with the U.S. Food and Drug Administration (FDA) for a Ready-to-Use formulation of FUSILEV (levoleucovorin) for Injection.
Patients with early rheumatoid arthritis (RA) who are current smokers were less likely to achieve good response to methotrexate (MTX) and tumor necrosis factor (TNF) inhibitors than those who never smoked. The study by researchers from Sweden also found that RA patients who smoked in the past did not experience a lower response to these therapies. Results of the 10-year study appear in the January 2011 issue of Arthritis & Rheumatism, a journal published by Wiley-Blackwell on behalf of the American College of Rheumatology (ACR).
Centocor Ortho Biotech Inc. announced today that it has filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) requesting the approval of REMICADE® (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.
Research led by St. Jude Children-s Research Hospital investigators will likely impact how acute lymphoblastic leukemia is treated in young adults and shows older adolescent age does not dictate worse outcomes against the most common childhood cancer.
Chelsea Therapeutics International, Ltd. announced it has completed a pre-NDA assessment with the U.S. Food and Drug Administration (FDA) and intends to accelerate its new drug application (NDA) for NORTHERA™(droxidopa) for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH), a chronic and potentially debilitating drop in blood pressure upon standing commonly associated Parkinson's disease, multiple system atrophy and pure autonomic failure.
4SC AG, a drug discovery and development company focused on autoimmune and cancer indications, today reported that it has completed enrolment of its COMPONENT Phase IIb study with vidofludimus, an oral inhibitor of IL-17 release, in rheumatoid arthritis (RA) patients. Data from the trial are expected to be announced in Q2 2011.
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