REHOVOT, Israel, March 4 - D-Pharm announced today that
it has held its Pre-IND (Investigational New Drug) meeting with the FDA to
discuss the forthcoming IND submission for DP-b99, a novel drug to aid
recovery following acute stroke. The Pre-IND meeting focused on the
proposed plans for the Phase III clinical program and the discussion
included clinical trials to date, preclinical pharmacology, toxicology data
and the FDA requirements and suggestions for the IND submission. DP-b99 is
a unique drug protecting brain cells in stroke patients, discovered and
developed by D-Pharm.
Alex Kozak, PhD, President and CEO of D-Pharm, said “The positive and
constructive feed-back we’ve received from the FDA is most encouraging.
With a number of uncertainties in the developmental program removed we may
now follow a clear path towards an IND application for a pivotal Phase III
study towards the end of this year. This is good news for D-Pharm and for
stroke patients.”
Most recently, D-Pharm successfully completed a Phase IIb trial for
DP-b99 in 150 ischemic stroke patients. Results from this study will be
published shortly in the peer reviewed journal, Stroke. DP-b99
statistically significantly increased by two-fold the percentage of
patients that completely recovered from ischemic stroke. In addition,
DP-b99 has at least a 9hr therapeutic window and may be safely administered
in this patient population.
D-Pharm has commenced preparations for the pivotal Phase III trial,
including manufacturing of the drug, certain customary studies and IND
submission. The Phase III trial is expected to commence in 2009 and to
recruit about 750 moderately severe acute stroke patients in North America,
Europe and Asia. D-Pharm will be seeking a suitable CRO for the next study
with DP-b99. Interested CROs can find more details by following this link:
http://www.dpharm.com/docs/reports/Call_for_proposals_for_DP-b99_Ph_III_study.pdf
(Due to the length of this URL, it may be necessary to copy and paste
this hyperlink into your Internet browser’s URL address field. Remove the
space if one exists.)
About Stroke
Every year approximately 750,000 Americans have a new or recurrent
stroke. The second most common cause of death worldwide, stroke is also the
leading cause of serious long-term disability; 15% to 30% of stroke
survivors experience permanent disability. According to the American Heart
Association, the mean lifetime cost resulting from an ischemic stroke is
estimated at $140,000 per patient. Other than tissue plasminogen activator
(tPA), which must be administered 3 hours after stroke, there are no FDA
approved medicines for this indication.
About D-Pharm Ltd.
D-Pharm (http://www.dpharm.com) is clinical stage biopharmaceutical
company pioneering the development of lipid-like therapeutics and has
generated a rich pipeline of patent protected proprietary products.
D-Pharm’s pipeline includes advanced clinical stage products, DP-b99 and
DP-VPA, a novel drug for treatment of epilepsy, bipolar disorder and
migraine prophylaxis, currently in Phase II development. DP-460 is in
preclinical development intended as an oral, disease-modifying therapy for
Alzheimer’s disease. Other mimics of bioactive lipids, LipidoMimetix, are
at an earlier developmental stage, for cancer.
For further information please contact:
Tami Horovitz, PhD.
Tel: +972-8-9385100
Fax: +972-8-9300795
Email: thorovitz@dpharm.com
SOURCE D-Pharm Ltd