Date: 2014-01-14
Type of information:
phase: 2
Announcement: recruitment of the first patient
Company: D-Pharm (Israel)
Product: DP-b99
Action
mechanism: DP-b99 modulates the activity of a range of metal dependent enzymes involved in the cell death cascade and inflammation. It is a first-in-class drug addressing multiple mechanisms damaging to insulted cells in a variety of human diseases. Results from studies in in vitro and in vivo models of pancreatitis suggest that DP-b99 can suppress some severe detrimental processes associated with the disease.
Disease: pancreatitis
Therapeutic area: Inflammatory diseases
Country:
Trial details:
Latest
news: * On January 14, 2014, D-Pharm has announced that the first patient has been recruited into its Phase 2 clinical trial of DP-b99 in patients with acute high-risk inflammation of the pancreas (pancreatitis). This double-blind, placebo-controlled, multicenter study is examining for the first time DP-b99’s efficacy in patients with acute pancreatitis. The study is enrolling thirty patients to be treated, twice daily for 2 days, with either DP-b99 or placebo. The follow-up involves clinical assessment scales, monitoring of inflammatory biomarkers and abdominal imaging.* On October 14, 2013, D-Pharm has announced that an Investigators Meeting has been scheduled later this month, in Prague, to discuss the clinical protocol for a first feasibility study to test DP-b99 in patients with pancreatitis. Results from studies in in vitro and in vivo models of pancreatitis suggest that DP-b99 can suppress some severe detrimental processes associated with the disease. At present, D-Pharm is planning to explore DP-b99’s utility in patients with acute pancreatitis in a Phase 2 clinical study.DP-b99 was originally developed for protection of brain tissue in ischemic stroke. Development for pancreatitis will be based on the extensive clinical safety database, pre-clinical research, as well as the CMC package of DP-b99 validated in the past both by the FDA and EMA. DP-b99 has, so far, been safely administered to 456 patients and healthy volunteers. Both preclinical and clinical studies indicate a favorable safety profile for DP-b99.Initiation of a clinical program for DP-b99 in acute severe pancreatitis will be the second Phase II clinical program to start in 2013; the first being a Phase 2 study with THR-18 in acute stroke patients treated with tissue plasminogen activator (tPA).
