About DOR BioPharma,DOR BioPharma, is a late-stage biopharmaceutical company the products to life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. DOR ‘s lead product, orBec , is a potent, locally acting corticosteroid for the treatment of gastrointestinal graft-versus-host disease , a common and potentially life-threatening complication developed hematopoietic stem cell. DOR expects a confirmatory Phase 3 clinical trial with orBec for the treatment of GI GVHD in 1H 2009 begin purchase bactrim . OrBec is currently the subject of an NIH – supported, Phase 2, randomized, double – blind, placebo – controlled trial for the prevention of acute GVHD. Oral BDP may also be applied in the treatment of other gastrointestinal disorders by severe inflammation. DOR additionally has a lipid polymer micelle ) technology for drug delivery, oral administration of leuprolide for the treatment of prostate cancer and endometriosis.
Shown two before randomized, double-blind, placebo-controlled Phase 2 and 3 clinical trials, centers in the USAlinically meaningful results when compared with the current standard of care, including a lowered exposure to systemic corticosteroids following allogeneic transplantation. Currently there are no approved products to treat GI GVHD. The Phase 3 trial was a 129 – patient Phase 3 multi – center study with orBec at 16 leading bone marrow / stem cell transplant centers in the U.S., and France. Although orBec do not reach statistical significance in the primary endpoint of of the pivotal trial, namely median time to treatment failure through Day 50 , no statistical significance in other key secondary endpoints such, the proportion of patients free of GVHD at Day 50 and Day 80 were randomized and the median time to treatment failure through Day 80 at 200 days post-transplant with only 5 patients. deaths in the orBec group to 16 patients deaths in the placebo group compared tract, and randomization in the pivotal Phase 3 trial, 18 patients in the orBec group and 28 patients in the placebo group died within one year after randomization . (more…)