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d-pharm ltd (DPRM) Snapshot

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11/4/14 - $16.07
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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 pipeline of products comprise 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, 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

d-pharm ltd (DPRM) Top Compensated Officers

Co-Founder, Chief Executive Officer and Presi...
Total Annual Compensation: 777.0K
Vice President of Finance & Human Resources
Total Annual Compensation: 458.0K
Vice President of Clinical Development
Total Annual Compensation: 561.0K
Manager of Chemistry Department
Total Annual Compensation: 291.0K
Compensation as of Fiscal Year 2014.

d-pharm ltd (DPRM) Key Developments

D-Pharm Ltd Receives Final Report for Phase 2 Clinical Study of DP-B99 in Acute High-Risk Pancreatitis Patients

D-Pharm Ltd. announced final positive results from a pilot Phase 2 study of DP-b99 in acute pancreatitis. This was the first clinical study exploring DP-b99 in patients with acute high-risk inflammation of the pancreas ('Pancreatitis'). A total of 10 pancreatitis patients were enrolled into the study (five in each treatment arm, Placebo and DP-b99). The results demonstrate that DP-b99 administered i.v., twice a day, to this population is safe and well tolerated. The efficacy analyses were not performed due to the small number of enrolled patients. However, a non-pre-specified analysis of inflammation markers, C-reactive protein (CRP) and Matrix metallopeptidase 9 (MMP-9), were found to be, on average, lower in the DP-b99 treatment group compared to the placebo group. In this double-blind, placebo-controlled, multicenter trial, patients were treated twice daily for 2 days, with either DP-b99 or placebo and followed up using clinical assessment scales, inflammatory biomarkers and abdominal imaging. Patients were enrolled in clinical sites in the Czech Republic, Ukraine and Slovakia. Due to the slow enrollment rate the study was stopped early after the enrolment of ten of the intended thirty patients. Preclinical and clinical data indicate a favorable safety profile for DP-b99. To date, the drug has been safely administered to 466 patients and healthy volunteers. DP-b99 interferes with several fundamental pathological processes relevant for pancreatitis such as inappropriate calcium-initiated intracellular activation of proteolytic enzymes in acinar cells and activation of trypsinogen to trypsin, which cause pancreatic tissue damage. Another aspect of DP-b99 action is the drugs ability to modulate generation of pro-inflammatory cytokines which apparently play a pivotal role both in the pathogenesis of acute pancreatitis and its systemic complications.

D-Pharm Receives Final Report for its Phase 2 Clinical Study of THR-18 in Acute Stroke Patients Treated With tPA

D-Pharm Ltd. reported that it has received the final report for its Phase 2 clinical study of THR-18. THR-18 demonstrated statistically significant reductions in the incidence of intracranial hemorrhage (ICH), brain swelling (edema) and a satisfactory safety profile in stroke patients treated with tPA. Moreover, stroke recovery was improved 2-fold in patients receiving THR-18, as judged by clinical outcome measures, 30 days following stroke. THR-18 is a novel drug-candidate designed to neutralize or reduce the life-threatening adverse effects of thrombolytic therapy with tPA. This double-blind, placebo-controlled, escalating single-dose, Phase 2 study was the first to assess the safety, pharmacodynamics and pharmacokinetics of THR-18 and tPA in AIS patients. The study results were presented last month at the European Stroke Organization conference in Glasgow. The study successfully defined the maximal tolerated and safe dose of THR-18 in AIS patients. The imaging data as assessed by CT (computed tomography) on day 2 following stroke and tPA treatment indicate that, in contrast to the placebo group, no patients treated with THR-18 had an intracranial hemorrhage, (p=0.02). Similarly, 0.54 mg/kg of THR-18 reduced by more than twice the occurrence of brain edema (p<0.05). The clinical outcome following stroke was assessed using the modified Rankin Scale (mRS) and the NIH stroke scale (NIHSS); the former reflecting disability in terms of daily living and the latter neurological deficit. The efficacy data analysis indicates that 0.54 mg/kg of THR-18 was associated with doubling of the recovery rate assessed both with mRS and NIHSS scales.

D-Pharm Ltd. and Jiangsu Nhwa Pharmaceutical Co., Ltd. Receives Approval from the Chinese Food and Drug Administration That Allows Clinical Development of DP-VPA

D-Pharm Ltd. announced that it has been notified by its co-development partner, Jiangsu Nhwa Pharmaceutical Co., Ltd. or NHWA, that they received an approval letter from the Chinese Food and Drug Administration or C-FDA that allows clinical development of DP-VPA, through Phase 3, for epilepsy. The specific clinical protocols will be communicated to the C-FDA before the start of each new study. NHWA will begin with a bridging safety study and then proceed with a large dose-ranging Phase 2b clinical study in epilepsy patients. Prior to the IND approval, DP-VPA was granted Fast Track status, a designation designed to bring important new drugs which treat a serious or life-threatening condition and fill an unmet medical need to patients earlier. DP-VPA is a novel drug discovered and developed by D-Pharm, a derivative of the valproic acid (VPA). VPA is the active ingredient in one of the best antiepileptic drugs, with combined peak sales over $1 billion in epilepsy, migraine and bipolar disorder. In Phase 1 and 2 clinical studies DP-VPA showed superb safety and efficacy in epilepsy patients. D-Pharm and Nhwa are developing DP-VPA following a strategic agreement signed in 2011. Nhwa has responsibility for development, manufacturing, registration and marketing of DP-VPA for epilepsy in China, Hong Kong and Macau. D-Pharm has the rights for DP-VPA in the rest of the world. D-Pharm also has the right to use data produced in China to support its global development program, primarily in North American and European markets. The financial terms of the collaboration agreement include milestone payments upon achieving the development and commercial goals, as well as royalty payments from sales of DP-VPA.


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