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d-pharm ltd (DPRM) Details

D-Pharm LTD., a drug-development company, focuses on the development of drugs for the treatment of central nervous system conditions. Its products pipeline includes DP-VPA, a generic anti-epileptic drug, which has completed the phase II clinical-stage trial for the treatment of various seizures, as well as for the treatment of manic depression and prophylaxis of migraine; and THR-18, a thrombolytic drug, which is in the Phase II clinical development for treatment of patients with acute ischemic stroke. The company is also developing DP-b99, which is in the phase II clinical stage of development for the treatment of acute high-risk pancreatitis; and DP-NDD, a novel platform technology for disease-modifying drugs for the treatment of protein-misfolding neurodegenerative disorders (NDDs), such as Alzheimer’s disease and other types of dementia, Parkinson’s disease, amyotrophic lateral sclerosis, and Huntington's disease. D-Pharm LTD. was founded in 1993 and is based in Rehovot, Israel.

Founded in 1993

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d-pharm ltd (DPRM) Key Developments

D-Pharm LTD., Annual General Meeting, Jul 10, 2014

D-Pharm LTD., Annual General Meeting, Jul 10, 2014., at 15:00 Israel Standard Time.

D-Pharm Ltd. Obtains Fast Track Status from China's Food and Drug Administration for Its Epilepsy Treatment

D-Pharm Ltd. has obtained fast track status from the China's Food and Drug Administration (CFDA) for its epilepsy treatment, DP-VPA. D-Pharm is jointly developing the drug in China with its local partner, Jiangsu NHWA Pharmaceutical Co. Ltd., under a strategic agreement signed in 2011. D-Pharm has the right to use the Chinese data to support its development program for DP-VPA in North America and Europe. The Fast Track notification follows a pre-IND meeting between NHWA and D-Pharm and the CFDA earlier this year. Fast track designation is intended to get important new drugs which treat a serious or life-threatening condition and fill an unmet medical need to the patient earlier. NHWA now is set to proceed with a Phase 1 bridging study and a large dose-ranging Phase IIb clinical trial in epilepsy patients. D-Pharm discovered and is developing DP-VPA, a novel drug derived from the generic drug valproic acid, sales of which peaked at $1 billion for the treatment of epilepsy, migraine, and bipolar disorder. DP-VPA has already completed a first Phase II clinical trial. NHWA is developing and will manufacture, register and sell DP-VPA for epilepsy in China, Hong Kong and Macau, in compliance with US Food and Drug Administration (FDA) standards. D-Pharm will receive milestone payments upon achievements of the development and commercial goals, as well as royalty payments from sales of DP-VPA.

D-Pharm Ltd. Reports Announces Completion of the Second Dose Tier in its Phase 2 Clinical Study of THR-18 in Acute Stroke Patients

D-Pharm Ltd. announced the interim results for the second dose tier of stroke patients that completed follow-up in its Phase 2 clinical study of THR-18 and confirms the tolerability of THR-18 at a dose of 0.54 mg/kg, administered together with tissue plasminogen activator (tPA) in acute ischemic stroke (AIS) patients. The primary goal of the current study is to identify the maximal tolerated and safe dose of the drug suitable for further clinical development. The current interim report indicates that the study may already have achieved this goal. To confirm this finding, the company has elected to recruit more patients at the same dose level and collect more data related to the effect of a high dose of THR-18 in AIS. THR-18 is novel drug-candidate designed to reduce or neutralize the life-threatening adverse effects of tPA, such as intracranial hemorrhage (ICH) and brain edema. In this study, so far, patients treated with THR-18 have had fewer cases of ICH and edema compared to the placebo treated group. The groups are, however, too small to demonstrate statistical significance. The Phase 2 clinical study of THR-18 is the first double-blind, placebo-controlled, escalating single-dose, study to assess the safety, pharmacokinetics, and pharmacodynamics of THR-18 in acute ischemic stroke patients treated with tPA. THR-18 corresponds to a fragment of plasminogen activator inhibitor-1 (PAI-1), a natural inhibitor of tPA activity. THR-18 binds at one of the PAI-1 docking sites on tPA that leaves tPA's catalytic activity intact. THR-18 binding uncouples the clot-dissolving properties of tPA from its deleterious non-fibrinolytic effects on the blood vessel wall, including intracranial hemorrhage and brain edema.


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