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.
Many patients seen at a rheumatology clinic—including some with a long history of rheumatoid arthritis (RA)—don't recognize important terms related to their health and medical treatment, reports a study in the December issue of JCR: Journal of Clinical Rheumatology.
Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced top-line results from a recently completed Phase 2a study of LX2931 in patients with rheumatoid arthritis (RA). LX2931 is an orally-delivered, small molecule drug candidate that inhibits sphingosine-1-phosphate (S1P) lyase, an enzyme important for modulating the immune system by controlling S1P levels in lymphoid tissues.
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for the subcutaneous formulation of ORENCIA® (abatacept), a treatment for adult patients with moderate to severe rheumatoid arthritis (RA) administered through an injection into the skin. Bristol-Myers Squibb submitted the sBLA to the FDA for the subcutaneous formulation of ORENCIA and received confirmation of its receipt on October 4, 2010.
Genentech, Inc., a member of the Roche Group, and Biogen Idec announced today positive data from a Phase III study of Rituxan (rituximab) in patients with advanced follicular lymphoma who did not have symptoms of disease (asymptomatic disease).
Allos Therapeutics, Inc. today reported updated results from the Company's Phase 1 dose-finding study of FOLOTYN® (pralatrexate injection) which supports the selection of 15 mg/m2 weekly for three weeks out of a four-week cycle as the optimal starting dose and schedule for further evaluation in patients with relapsed or refractory cutaneous T-cell lymphoma. Data were presented at the 52nd American Society of Hematology Annual Meeting in Orlando, Florida.
Magnetic resonance imaging (MRI) analyses from two Phase 3 clinical trials showed that once every four week subcutaneous injections of golimumab 50 mg plus methotrexate resulted in statistically significant improvements in markers of inflammation and structural damage in patients with active rheumatoid arthritis (RA) compared with placebo plus methotrexate.
Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the complete response regarding its supplemental New Drug Application (sNDA) for FUSILEV® (levoleucovorin) for Injection for treatment of patients with advanced metastatic colorectal cancer.
Incyte Corporation announced the presentation of final six-month clinical data from the dose ranging, placebo-controlled Phase IIa trial of its orally available janus kinase (JAK) inhibitor INCB28050 in patients with active rheumatoid arthritis (RA).
Today, Abbott presents results from a pooled analysis of two pivotal HUMIRA® (adalimumab) studies, which look at patients with early and long-standing moderate to severe rheumatoid arthritis (RA), at the American College of Rheumatology meeting in Atlanta.
People with rheumatic diseases don't take their medication on a regular basis, and this leads to poor outcomes in their disease treatment, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta.
Children with juvenile idiopathic arthritis have a two to threefold increased risk of developing cancer compared to similarly-aged children without JIA, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta. The same study also reported no cases of cancer in children with JIA who were exposed to anti-TNF therapy.
Pfizer Inc. today announced results of ORAL Solo (1045), a Phase 3 study that showed tasocitinib (CP-690,550), an investigational, novel, oral JAK inhibitor, administered as monotherapy met two primary endpoints, demonstrating a statistically significant reduction in signs and symptoms of moderately to severely active rheumatoid arthritis (RA) and improvement in physical function as measured by ACR20 response rates and mean change in HAQ-DI, respectively, versus placebo at three months.
People with newly-developed rheumatoid arthritis or undifferentiated arthritis may be able to achieve remission, with continued drug therapy, after four months of treatment with methotrexate and prednisone, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta.
Magnetic resonance imaging (MRI) analyses from two Phase 3 clinical trials showed that once every four week subcutaneous injections of SIMPONI (golimumab) 50 mg plus methotrexate resulted in statistically significant improvements in markers of inflammation and structural damage in patients with active rheumatoid arthritis (RA) compared with placebo plus methotrexate.
Anti-TNF therapies commonly used to treat rheumatoid arthritis have been found to potentially reduce the risk of developing Alzheimer's dementia among people with rheumatoid arthritis, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta.
Alder Biopharmaceuticals Inc. today announced that data from two clinical studies of its ALD518 investigational antibody therapeutic will be presented at the Annual Meeting of the American College of Rheumatology in Atlanta.
Genentech, Inc., a member of the Roche Group today announced updated data from a Phase III study (ROSE) that showed rheumatoid arthritis (RA) patients receiving ACTEMRA (tocilizumab) experienced a rapid, measured response as early as one week after beginning ACTEMRA, and improvement in disease activity within four weeks.
4SC AG, a drug discovery and development company focused on autoimmune and cancer indications, today announced positive preliminary results of a Phase IIa study in inflammatory bowel disease (IBD) with its lead autoimmune compound vidofludimus, an oral inhibitor of interleukin-17 (IL-17) release.
Researchers from the Cincinnati Children's Hospital Medical Center observed a statistically significant increase in mean height, weight, and body mass index (BMI) percentiles in patients with juvenile idiopathic arthritis (JIA) who were treated with etanercept or etanercept plus methotrexate (MTX). JIA patients treated with MTX alone did not display an increase in growth percentiles.
Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced that on Friday, October 29, 2010 it submitted a complete response to the "Complete Response" letter issued by the U.S. Food and Drug Administration (FDA), regarding its supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for Injection for treatment of patients with advanced metastatic colorectal cancer.
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