November 2007
Application for Actemra Filed with the FDA
Posted 11/26/07
A biologics license application has been submitted to the FDA seeking approval for tocilizumab (Actemra) to reduce the signs and symptoms in adults with moderate to severe rheumatoid arthritis (RA). The submission is based on results from five international Phase III studies, which demonstrated tocilizumab as a monotherapy or in combination with disease-modifying antirheumatic drugs (DMARDs) significantly reduced the signs and symptoms of RA compared with DMARD therapies alone.
Investigational New Drug Application for LX2931
Posted 11/13/07
An investigational new drug (IND) application has been filed to the FDA for LX2931, an oral drug candidate for rheumatoid arthritis and other autoimmune conditions. LX2931 was developed as an inhibitor of a key enzyme in the sphingolipid pathway, which controls lymphocyte circulation and trafficking to peripheral sites in the body during an inflammatory response.
Phase I Trial for PN0621 Complete
Posted 11/12/07
The Phase I trial of PN0621, an anti-TNF compound for rheumatoid arthritis, has been completed. Data from 30 healthy volunteers indicated ascending single doses of PN0621 administered intravenously and subcutaneously were well tolerated in humans. The Phase II trials, slated to begin in the first half of 2008, will examine the safety and efficacy of PN0621 in the treatment of rheumatoid arthritis and other inflammatory diseases.
Oral Efficacy of Anti-Cytokine Semapimod
Posted 11/12/07
An orally active form of semapimod, a synthetic compound that inhibits signal transduction pathways and proinflammatory molecules, is being tested. Semapimod is a potential treatment for inflammatory and autoimmune diseases, including rheumatoid arthritis, Crohn’s and psoriasis. The compound has been tested in trials as an intravenous infusion, and the newly developed oral form should enhance its acceptability to patients.
New Pain Medication in Phase II
Posted 11/12/07
GRC 6211, a vanniloid receptor antagonist compound, is in Phase II development as a potential next-generation treatment for various pain conditions, including osteoarthritic pain.
Results of CAPRA-1 Study Presented
Posted 11/12/07
In the CAPRA-1 study, morning stiffness decreased on average by more than 50 percent in patients with rheumatoid arthritis treated with Lodotra for up to 12 months. Lodotra is an oral reformulation of prednisone that takes the form of a coated tablet which, once ingested, does not release the medication until approximately four hours later. Results also showed a statistically significant reduction in serum levels of the pro-inflammatory cytokine IL-6 after 12 months of treatment.
