D-Pharm Ltd Appoints CRO for Clinical Development of DP-b99 in China
By D-pharm Ltd, PRNETuesday, November 2, 2010
REHOVOT, Israel, November 3, 2010 - D-Pharm (TASE: DPRM) announced today the appointment of Hangzhou
Tigermed Consulting Co., Ltd as the contract research organization to manage
the regulatory filings and conduct the clinical trials of DP-b99, in China.
The agreement was signed together with Wanbang Biopharmaceuticals, as part of
the D-Pharm - Wanbang co-development program for DP-b99 in China.
(Logo: www.newscom.com/cgi-bin/prnh/20100415/386828 )
DP-b99 was discovered and developed by D-Pharm. DP-b99 is
currently being tested in a pivotal Phase III multinational clinical study in
ischemic stroke patients (study acronym MACSI). The MACSI protocol was
approved as part of the FDA's Special Protocol Assessment program and the
study is being conducted under IND.
In China, the clinical program includes a Phase III trial
based on, but independent of, MACSI. The forthcoming Phase III trial will be
performed according to GCP and ICH guidelines in parallel with the MACSI
trial. The majority of patients will be recruited in China, but the trial
will include clinical sites in Taiwan and Hong Kong. D-Pharm will be entitled
to use the results of the trial towards the receipt of approvals outside
China. Wanbang will finance the first 450 patients recruited into the Phase
III study (except for up to 30 patients outside China) and D-Pharm may elect
to fund recruitment of additional patients.
Dr. Alex Kozak, D-Pharm's CEO commented: "Considerable effort
has gone into the selection of a reputable CRO, with the appropriate
experience in regulatory filings and stroke trial management, to conduct and
manage the studies in China according to the highest possible standards.
Given the huge stroke burden in China, I view this agreement as a significant
step that will enable us to broaden our DP-b99 clinical data package and
hopefully bring our drug to the Chinese market as quickly as possible."
D-Pharm's collaboration with Wanbang is supported by the
bi-national Jiangsu (China) - Israel Industrial R&D Cooperation Program.
About DP-b99
DP-b99 is a unique broad-spectrum neuroprotective drug that
addresses an array of brain damaging processes occurring in stroke patients.
Both preclinical and clinical Phase I and II studies indicate a favorable
efficacy and safety profile for DP-b99. In the Phase IIb trial in 150
ischemic stroke patients, DP-b99 increased by two-fold the percentage of
patients that recovered from ischemic stroke. DP-b99 may be administered
within a nine hour therapeutic window. D-Pharm's Phase III trial, MACSI, will
enroll 770 moderate to severely affected ischemic stroke patients worldwide.
About D-Pharm
D-Pharm (www.dpharm.com) is a 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 for treatment of ischemic stroke patients and DP-VPA, a
novel drug for treatment of epilepsy, bipolar disorder and prophylaxis of
migraine. DP-VPA, a prodrug of valproic acid, is in Phase II clinical
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.
Disclaimer
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: thorovitz@dpharm.com
For further information please contact: Tami Horovitz, Tel: +972-8-9385100, Fax: +972-8-9300795, Email: thorovitz at dpharm.com
Tags: D-Pharm Ltd, Israel, November 3, Rehovot