D-Pharm Ltd Appoints CRO for Clinical Development of DP-b99 in China
REHOVOT, Israel, November 3, 2010 /PRNewswire-FirstCall/ -- 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.
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.
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.
D-Pharm (http://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.
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