EntreMed, Inc (ROCKVILLE, Maryland), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, announced preclinical results for 2ME2 (Panzem^® or 2-methoxyestradiol) in rheumatoid arthritis (RA). The results of the study demonstrated that 2ME2 involutes rat collagen-induced arthritis and suppresses synovial VEGF and bFGF gene expression.

Results from treatment studies in a preclinical model of established RA demonstrated that daily oral administration of 2ME2 suppressed both clinical and radiographic indicators of joint inflammation and damage, including soft tissue swelling and bone erosion. The treatment benefits of 2ME2 were dose-dependent and associated with reduced joint expression of the prominent angiogenic growth factors, FGF-2 and VEGF, as well as decreased angiogenesis. Data demonstrated both a delay in onset and a decrease in severity of arthritis if 2ME2 treatment is started prior to disease initiation. These results indicate that 2ME2 may represent a novel agent for treatment of inflammatory autoimmune diseases such as RA and identify 2ME2 as a disease modifying anti-rheumatic drug (DMARD).

2ME2 has an excellent safety profile established through daily dosing in more than 300 cancer patients, some for over 5 years. EntreMed has initiated clinical activities to support 2ME2 in RA, including the completion of a healthy volunteer study. Results of the healthy volunteer study have been submitted to the US FDA and, once feedback has been received, EntreMed will determine the appropriate next steps for continuing the 2ME2 RA clinical program.