Benlysta could become first lupus treatment in 50 years
ROCKVILLE, Md. An investigational drug for lupus that could become the first new treatment for the disease in decades produced significant results in patients, compared with standard treatments, according to results of a late-stage clinical trial set for presentation Saturday.
GlaxoSmithKline and Human Genome Sciences said Thursday that Benlysta (belimumab) significantly reduced symptoms of systemic lupus erythematosus when added to standard treatments compared with standard treatments alone in the placebo-controlled phase 3 “BLISS-52” study. Results of the study will be presented at the 2010 Congress of the European League against Rheumatism.
“The BLISS-52 phase 3 results presented at EULAR demonstrate that the efficacy of treatment in this study with belimumab plus standard of care was superior to that of placebo plus standard of care,” HGS EVP research and development David Stump stated. “Belimumab has met the primary endpoint in both of its pivotal phase 3 trials.”
Based on the results, HGS and GSK have submitted regulatory approval applications for the drug. If approved, it could become the first new treatment in more than 50 years for lupus, a potentially life-threatening disease that affects around 1.5 million Americans and 5 million people worldwide.
‘Battle of the bulge’ solved with Perfect Fit Button
FAIRFIELD, N.J. Need a quick fix for pants that just don’t fit right? Look no further than the Perfect Fit Button, an innovative new product that helps prolong the comfortable fit of pants, jeans or skirts by creating an easy way to adjust the waistband.
Made by TeleBrands, the company behind such products as storage solution Shoes Under and PedEgg, the Perfect Fit Button is the newest way to get pants and skirts to fit without having to spend extra money. It retails for $9.99 for a set of eight.
Patient enrollment complete for lung cancer treatment trial
SOUTH SAN FRANCISCO, Calif. Drug maker OXiGENE has finished enrolling patients for a mid-stage clinical trial of a lung cancer treatment, the company said Wednesday.
OXiGENE announced that it had enrolled 60 patients in “FALCON,” a phase 2 trial of the drug Zybrestat, a treatment for non-small cell lung cancer. The trial comprises two arms, a study arm with patients taking Zybrestat with Genentech’s Avastin (bevacizumab) and chemotherapy, and a control arm with patients taking Avastin and chemotherapy alone. OXiGENE said some preliminary results from the trial presented at the recent meeting of the American Society of Clinical Oncology have indicated that the drug is safe and effective.
“We look forward to presenting a more complete analysis of the FALCON trial later in 2010 at a scientific meeting,” OXiGENE CEO Peter Langecker said. “If the encouraging positive trends in terms of progression-free survival and overall survival that we presented at ASCO are maintained, they will underscore Zybrestat’s utility in non-small cell lung cancer and potentially pave the way toward embarking upon a registration pathway.”