Latest Methotrexate Stories

NUTLEY, N.J., Dec. 4 /PRNewswire/ -- Roche today announced that the U.S. Food and Drug Administration (FDA) has provided further guidance on the requirements for the Biologics License Application (BLA) for ACTEMRA(R) (tocilizumab), the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). As a result of the FDA's evolving Risk Evaluation and Mitigation Strategy (REMS)...

CHARLOTTE, N.C., Nov. 13, 2008 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) has begun dosing volunteers in the single ascending dose (SAD) study of its Phase I clinical program for CH-4051, the second drug candidate from its portfolio of orally available, non-metabolized antifolates engineered to provide potent anti-inflammatory activity without the liver and kidney toxicities or tolerability related side effects associated with chronic methotrexate (MTX)...

Spectrum Pharmaceuticals, Inc., (NasdaqGM:SPPI) announced today that the Centers for Medicare and Medicaid Services (CMS), under the Medicare Part B benefit, has assigned a unique, product-specific billing code, or J-code, for FUSILEV(TM) (levoleucovorin). FUSILEV(TM) is the only commercially available formulation comprised only of the pharmacologically active isomer of leucovorin. The J-code J06410 becomes effective on January 1, 2009, and will assist providers in obtaining reimbursement for...

Spectrum Pharmaceuticals, Inc., (NasdaqGM:SPPI) today announced that it has filed with the FDA the supplemental NDA for FUSILEV(TM) (levoleucovorin) for injection in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. FUSILEV is the only commercially available formulation comprised only of the pharmacologically active isomer of leucovorin. "Ninety percent of the more than 500 million milligrams of leucovorin used in the United States is for colorectal cancer,"...

Chelsea Therapeutics International has completed patient enrollment in its Phase II trial comparing the efficacy and tolerability of daily oral doses of CH-1504, a metabolically inert antifolate, to a standard weekly dose of methotrexate in rheumatoid arthritis patients. A total of 200 patients were enrolled in this 12-week, four-arm, parallel group Phase II clinical trial designed comparing 0.25mg, 0.5mg and 1mg once daily oral doses of CH-1504 versus a 20mg once weekly oral dose of...

CHARLOTTE, N.C., Oct. 28, 2008 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that it has completed patient enrollment in its Phase II trial comparing the efficacy and tolerability of daily oral doses of CH-1504, a novel metabolically inert antifolate, to a standard weekly dose of methotrexate in rheumatoid arthritis patients. "Having recently received a favorable recommendation from an independent data safety monitoring board and now having completed...

Hoffmann-La Roche has reported positive data from two Phase III studies which showed that patients who suffer from the debilitating and painful effects of rheumatoid arthritis achieved significant improvements in signs and symptoms when treated with Actemra alone or in combination with methotrexate compared with methotrexate alone. Results of the Radiate study, which evaluated difficult-to-treat patients who failed to respond to prior anti-tumor necrosis factor (TNF)-alpha therapies,...

US-based Cypress Bioscience, a developer of therapeutics and personalized medicine services, has launched its first two personalized medicine services. According to the company, the initial personalized medicine services facilitate improved diagnostic, prognostic and therapeutic decision making for rheumatologists treating patients with rheumatoid arthritis (RA). Avise PG is a test that supports dose optimization and therapeutic decision making for patients taking methotrexate (MTX), a...

A new study suggests a simple monthly injection of an antibody drug might stop the progression of rheumatoid arthritis (RA) in half of all patients. The new drug, known as tocilizumab, works with methotrexate, an existing RA treatment.  Rheumatoid arthritis is a potentially crippling condition in which the body attacks its own joints.  Although nothing can be done to reverse existing damage caused by RA, the new research shows the two drugs taken together can achieve remission by...

SAN FRANCISCO, Oct. 27 /PRNewswire/ -- Results from two Phase 3 studies showed that patients receiving every four week subcutaneous injections of golimumab (CNTO 148) 50 mg or 100 mg, an investigational therapy, experienced significant improvements in physical function, health-related quality of life (HRQOL) and fatigue. The data from the randomized, double-blind, placebo- controlled studies in patients with active moderate to severe rheumatoid arthritis (RA) were presented at the American...