D-Pharm Schedules Investigators Meeting to Discuss Protocol of Phase 2 Clinical Study of DP-b99 for Acute High-Risk Pancreatitis
REHOVOT, Israel, October 14, 2013 /PRNewswire/ --
D-Pharm Ltd (TASE: DPRM) announced today October 14th 2013, 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 acute high-risk inflammation of the pancreas (pancreatitis).
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. 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.
Dr. Gilad Rosenberg commented: "I am looking forward to discussing our plans with clinical experts in the field. Acute pancreatitis at high-risk of becoming severe is a potentially life threatening condition, representing a huge unmet medical need; success in the planned feasibility study could spur development of the first specific therapeutic option for these critically ill patients."
Acute pancreatitis necessitates hospitalization in an intensive care unit and in severe cases mortality may reach 20%. In the US there are around 20 cases of acute pancreatitis per year per 100,000 of population and survivors frequently suffer long term disability. There is no effective treatment for acute severe pancreatitis.
D-Pharm (http://www.dpharm.com) is a clinical stage, technology-driven biopharmaceutical company developing proprietary products for treatment of CNS disorders. D-Pharm's pipeline includes clinical stage II products, as well as a rich preclinical development pipeline for Alzheimer's disease, and other types of dementia. 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).
Statements in this press release that are not historical facts are forward-looking information, as defined in the Securities Law, based on information available to D-Pharm at the time of this press release. The estimations could, some or all, be unrealized, or could be realized in significantly different ways than expected.
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SOURCE D-Pharm Ltd