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 Canadian Agency for Drugs and Technologies in Health's (CADTH) Therapeutic Review Panel released last week their recommendations for Biologic Response Modifier Agents for Adults with Rheumatoid Arthritis (RA).
The Food and Drug Administration (FDA) received reports of malignancies in children using tumor necrosis factor (TNF) blockers, raising concerns of an associated risk and prompting an investigation. Researchers from the FDA set out to identify all reports of malignancy in children using infliximab, etanercept, and adalimumab and their report is published in the August issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology.
The Food and Drug Administration (FDA) received reports of malignancies in children using tumor necrosis factor a (TNF) blockers, raising concerns of an associated risk and prompting an investigation.
Bristol-Myers Squibb Company today reported results for the second quarter of 2010 which featured data on key marketed and investigational compounds in its oncology, diabetes and cardiovascular franchises, and growth in sales and EPS. The company also confirmed guidance for 2010 and minimum guidance for non-GAAP EPS in 2013.
Bristol-Myers Squibb Company has today announced that on 1 July 2010 the European Commission approved a new indication for ORENCIA® (abatacept), in combination with methotrexate (MTX), for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including MTX or a TNF-alpha inhibitor.
Chelsea Therapeutics International, Ltd. announced the completion and favorable outcome of an independent Data Monitoring Committee (DMC) review of the safety and efficacy data from approximately half the target enrollment in Chelsea's Phase II trial of droxidopa in fibromyalgia.
Chelsea Therapeutics International, Ltd. has successfully reached its target enrollment of 150 patients in its Northera™ (Droxidopa) pivotal Phase III Study 301 for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH). Results from the trial are expected in September 2010 and the full registration program is on track to initiate a new drug application (NDA) in the first half of 2011.
Chelsea Therapeutics International, Ltd. announced the initiation of Study 306, a pivotal Phase III trial evaluating the efficacy of NORTHERA™, an oral synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) associated with Parkinson's disease.
The Multiple Sclerosis Research Center of New York (MSRCNY), together with the International Multiple Sclerosis Management Practice (IMSMP), today announced that results from its Intrathecal Methotrexate Treatment in Multiple Sclerosis study have been published in this month's issue of Journal of Neurology. This study reports on the feasibility of using intrathecal methotrexate (ITMTX) in treatment unresponsive multiple sclerosis (MS) patients with progressive forms of the disease.
Disease-modifying antirheumatic drugs should be used early and aggressively at the first sign of rheumatoid arthritis. The results of an 11-year trial, published in BioMed Central's open access journal Arthritis Research & Therapy, demonstrate that active treatment from the very beginning pays off, even in the long run.
Chelsea Therapeutics International, Ltd. announced that data from its pivotal studies of Northera™ (droxidopa) in symptomatic neurogenic orthostatic hypotension was presented during a poster session and featured in a symposium highlighting the role of norepinephrine (NE) deficiency in Parkinson's disease at the 14th International Congress on Parkinson's Disease and Movement Disorders in Buenos Aires, Argentina.
Bristol-Myers Squibb Company and Alder Biopharmaceuticals today announced that new data from a dose-ranging Phase 2a trial support further development of BMS-945429/ALD518, an investigational monoclonal antibody directed against interleukin-6 (IL-6), as a potential treatment for rheumatoid arthritis (RA). The Phase 2a data will be presented in a scientific session on June 18, 2010, at the Annual Congress of the European League against Rheumatism (EULAR).
Trubion Pharmaceuticals, Inc. today announced Pfizer's decision to discontinue development of TRU-015 (PF-05212374), an investigational drug in Phase 2 evaluation for the treatment of rheumatoid arthritis (RA) developed under the companies' CD20 collaboration. However, Pfizer has confirmed that it will continue to develop SBI-087 (PF-05230895), Trubion's next-generation, humanized, subcutaneous CD20 RA product candidate also in Phase 2 clinical evaluation.
Allos Therapeutics, Inc. today announced updated data from its ongoing dose finding Phase 1 study of FOLOTYN (pralatrexate injection) in patients with relapsed or refractory cutaneous T-cell lymphoma, a group of often slow-growing non-Hodgkins lymphomas that primarily manifest in the skin. These data were presented during a poster presentation at the European Hematology Association meeting being held June 10-13, 2010 in Barcelona, Spain.
Chelsea Therapeutics International, Ltd. announced that during a teleconference yesterday, the U.S. Food and Drug Administration requested that the company delay the initiation of its proposed Phase II clinical study of CH-4051 in rheumatoid arthritis and indicated that the agency is requesting additional detail from the preclinical studies previously submitted as part of the company's investigational new drug application.
Abraxis BioScience, Inc. presented abstracts describing 10 trials of nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension), for the treatment of breast cancer at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
Genmab A/S announced today that data from the pivotal trial of zalutumumab in refractory head and neck cancer patients will be presented today at the 2010 American Society of Clinical Oncology Annual Meeting, which will be held June 1-8 in Chicago, Illinois. This is the first controlled study to demonstrate that an EGFr-targeted antibody given as monotherapy induces a clinically meaningful improvement in progression free survival in patients with refractory head and neck cancer who have failed platinum-based chemotherapy.
Can-Fite BioPharma Ltd, a biotechnology company traded on the Tel Aviv Stock Exchange, announced today that it has opened Investigational New Drug application (IND) with the United States Food and Drug Administration (US FDA). The IND is for Can-Fite's lead compound, CF101, for the treatment of patients with psoriasis. This is the third US IND for CF101, and the fourth for Can-Fite.
The John Theurer Cancer Center at Hackensack University Medical Center announced today important research findings that will be presented at the American Society of Clinical Oncology annual meeting taking place June 4 - 8, 2010 in Chicago. Research highlights include a comparison of first-line treatments for an aggressive form of lymphoma, the efficacy and safety of a new genetically engineered cancer therapy, and the value of a commonly used tool for staging lymphoma.
The John Theurer Cancer Center at Hackensack University Medical Center announced today that its physicians and researchers will present 16 abstracts on treatment and diagnostic progress in many different areas of oncology during the Annual Meeting of American Society of Clinical Oncology in Chicago, IL from June 4-8.
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