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.
Sandoz Inc. announced today it has initiated a voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate Injection, USP product ("methotrexate") to the consumer/user level. Consistent with its commitment to quality and patient safety, Sandoz is initiating this voluntary recall of all 24 lots of the affected product following the finding of small glass flakes by Sandoz quality control in a limited number of vials in four lots.
Findings from the PRECiSE 3 (P3) open label extension study for Cimzia, demonstrating the longest continuously running maintenance trial for an anti-TNF in Crohn's disease, will be exhibited at the 2010 Annual Scientific Meeting of the American College of Gastroenterology (ACG), taking place in San Antonio from October 15 – 20. Additionally, long-term efficacy data from the PRECiSE 4 (P4) clinical trial also will be presented at the meeting.
Elorac, Inc., a rapidly growing specialty pharmaceutical company focused on the treatment of dermatological disorders, is pleased to announce that it has acquired world-wide rights to the active agent Cidoxepin from Gideon Pharmaceuticals. Cidoxepin is the cis-isomer of the widely prescribed tricyclic compound doxepin.
Studies and analyses of the Crohn's disease (CD) treatment Cimzia (certolizumab pegol) will be exhibited at the 2010 Annual Scientific Meeting of the American College of Gastroenterology, taking place in San Antonio from October 15 – 20.
In four separate pivotal clinical studies presented on Friday, a greater percentage of moderate to severe chronic plaque psoriasis patients treated with briakinumab, Abbott's investigational IL-12/23 inhibitor (ABT-874), achieved 75 percent or better skin clearance rates than those treated with etanercept (Enbrel®), methotrexate or placebo. Abbott presented data from all briakinumab pivotal studies in psoriasis at the European Association of Dermatology and Venereology scientific sessions.
Rigel Pharmaceuticals, Inc. today announced that it has earned $25 million from AstraZeneca for the fulfillment of two major milestones in the agreement the two companies have regarding the clinical development of fostamatinib (R788), a novel oral syk inhibitor. The first milestone is for initiation of the phase 3 clinical program with fostamatinib in patients with rheumatoid arthritis (RA) that was announced by AstraZeneca earlier today.
A study conducted at Copenhagen University Hospital showed that treatment of rheumatoid arthritis (RA) with disease modifying antirheumatic drugs (DMARDs), glucocorticoids, biologic agents, or a combination of agents significantly reduced radiographic evidence of joint destruction, with a relative effect of 48%-72% as compared with placebo.
Results from a 12-month multi-center clinical trial did not show therapeutic benefit of abatacept over placebo in patients with non-life threatening systemic lupus erythematosus (SLE). Abatacept failed to prevent new disease flares in SLE patients tapered from corticosteroids in an analysis where mild, moderate and severe disease flares were evaluated together. Full details of the phase IIb clinical trial are published in the October issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology (ACR).
Galapagos NV announced today that it has started a Phase II clinical study for the Company's flagship program GLPG0259, a novel drug being developed for rheumatoid arthritis. In this clinical trial, the safety and efficacy of this novel candidate drug will be tested in RA patients. Galapagos plans to announce interim results by the middle of next year and complete the trial by the end of 2011.
Chelsea Therapeutics International, Ltd. has initiated enrollment in a multinational, 12-week, double-blind Phase II trial designed to compare the efficacy and tolerability of CH-4051 against methotrexate (MTX) in 250 patients with rheumatoid arthritis (RA) who are experiencing an inadequate response to MTX treatment.
Genta Incorporated today announced that the Company has initiated a new Phase 2 clinical trial of tesetaxel in patients with advanced bladder cancer. Tesetaxel is the leading oral taxane in clinical development. The new trial will be conducted at Memorial Sloan-Kettering Cancer Center, New York, NY, the Kimmel Cancer Center at Jefferson University, Philadelphia, PA, and at least one site in the EU.
Scientists are reporting the development and successful initial testing of a new form of methotrexate the mainstay anticancer drug designed to be given as nose drops rather than injected. It shows promise as a more effective treatment for brain cancer, they say. The report appears in ACS' Molecular Pharmaceutics, a bi-monthly journal.
AstraZeneca's new oral syk inhibitor, fostamatinib (R788), recently in-licensed from Rigel Pharmaceuticals, Inc., significantly improved outcomes of patients with rheumatoid arthritis who responded inadequately to ongoing treatment with methotrexate, according to phase II study data published in The New England Journal of Medicine today.
Chelsea Therapeutics International, Ltd. announced that preliminary analyses of its Phase III NORTHERA™ Study 301 met its primary endpoint. Treatment with Northera provided clinically meaningful and statistically significant improvement.
Chelsea Therapeutics International, Ltd. announced confirmation by the U.S. Food and Drug Administration (FDA) that its proposed Phase II protocol for CH-4051 in rheumatoid arthritis has been approved by the agency.
Protalex, Inc., a clinical stage biopharmaceutical company engaged in developing a class of biopharmaceutical drugs for treating autoimmune and inflammatory diseases, today announced the dosing of the first patient in a multicenter Phase 1b clinical study of PRTX-100 in adult patients with active Rheumatoid Arthritis (RA). The study is being conducted in South Africa.
Chelsea Therapeutics International, Ltd. announced that a new investigator-led phase II clinical study of Droxidopa, an oral synthetic precursor of norepinephrine, has been initiated in chronic fatigue syndrome (CFS).
For people living with rheumatoid arthritis (RA), the level of disease activity measured using the standard DAS 28 score is the factor most strongly affecting the level of RA-related disability, according to a study in Journal of Clinical Rheumatology.
Merck is pleased to announce that New Brunswick, Nova Scotia and Alberta are the first provinces in Canada to reimburse SIMPONI(golimumab) for the treatment of three different rheumatic conditions. SIMPONI, a subcutaneous anti-tumor necrosis factor therapy, is now reimbursed by the drug formularies of these three provinces for people living with moderately to severely active rheumatoid arthritis, moderately to severely active psoriatic arthritis and active ankylosing spondylitis.
Antares Pharma, Inc. today reported financial and operating results for the second quarter ended June 30, 2010.
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