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 [http://www.dpharm.com ] 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
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
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.
For further information please contact: Tami Horovitz Tel: +972-8-9385100 Fax: +972-8-9300795 Email: firstname.lastname@example.org
SOURCE D-Pharm Ltd