It took D-Pharm Ltd. (TASE: DPRM) two years to recover from the failure of its lengthy and expensive Phase III clinical trial of its stroke treatment, and the company has restocked its products pipeline and embarked on new clinical trials.
Last week, D-Pharm announced the commencement of a Phase II clinical trial of a product acquired through the merger with Thrombotech, which had been owned by Hadasit Bio Holdings Ltd. (TASE:HDST; Bulletin Board: HADSY) and Clal Biotechnology Industries Ltd. (TASE: CBI) (which also controls D-Pharm).
"This is a great product," D-Pharm CEO Dr. Alex Kozak told "Globes". "On one hand, it has huge potential, because it targets the entire stroke market. On the other hand, its risk compared with other stroke products is low because the product acts on an existing medication and not on the stroke mechanism directly."
D-Pharm's product, THR-18, improves the action of tissue plasminogen activator (tPA), the only stroke drug currently on the market. This will be the first clinical trial to test the product on stroke patients in conjunction with tPA. Until now, THR-18 has only been tested on its own on healthy patients. The Phase II study will test the product's safety profile in combination with tPA and provide a preliminary indication if it improves tPA's action by reducing the risk of hemorrhaging that usually occurs with tPA, jeopardizing patients. (This is what happened to former Prime Minister Ariel Sharon in 2004). The study is due to be completed in 2014.
D-Pharm's previous leading product, DP-b99, failed in a stroke study, but is now being tested for the treatment of acute pancreatic inflammation ((pancreatitis).
"We still believe that this product can protect cells in conditions of external pressure," said Kozak. "We're conducting a small efficacy trial on 30 patients. This study is also due to be completed in 2014."
DP-VPA is another product in D-Pharm's pipeline is still in the early stages, but attracted less attention during the Phase III trial for DP-b99 for the treatment of strokes. DP-VPA is now under development in China with a local partner for the treatment of epilepsy, migraines, and bipolar disorder. D-Pharm's partner, Jiangsu Nhwa Pharmaceutical Corporation Ltd. (Shenzhen: 2262) has applied to the Chinese regulator to conduct a clinical trial of the drug for the treatment of epilepsy. D-Pharm may also conduct a trial of the drug for the treatment of bipolar disorder during 2014, outside China, if it obtains the necessary permits.
Published by Globes [online], Israel business news - www.globes-online.com - on January 5, 2014
© Copyright of Globes Publisher Itonut (1983) Ltd. 2014