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April 28, 2014
05:48 EDTPSTIPluristem's manufacturing facility approved by EU auditors for Phase III trials
Pluristem Therapeutics announced that its new manufacturing facility has received the European Union's Qualified Person Declaration. With this declaration, Pluristem is now approved to use cell therapies manufactured at its state-of-the-art facility located in Haifa, Israel, in all phases of its clinical trials conducted in the European Union, including Phase I, Phase II and Phase III. The Qualified Person inspection was conducted in line with the European Union's Good Manufacturing Practice, or GMP, legislation, directives and guidelines. The audit focused on the design, construction and validation of Pluristem's new facility, equipment, utilities, and quality management systems. Pluristem's manufacturing and cell expansion operations were deemed compliant with EU GMP requirements.
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September 15, 2014
07:27 EDTPSTIIBC Life Sciences to hold a conference
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September 8, 2014
05:43 EDTPSTIPluristem Therapeutics advances to second cohort in PLX-PAD cells Phase I trial
Pluristem Therapeutics announced that its licensee, United Therapeutics Corporation, has completed the dosing of the first cohort of patients in its Phase I study using Pluristem's PLacental eXpanded, or PLX-PAD, cells in patients diagnosed with pulmonary arterial hypertension, or PAH. PAH, with a global market estimated at approximately $3B, is characterized by abnormally high blood pressure in the arteries of the lungs; it can disrupt lung and heart function, leading to debilitating conditions such as heart failure. The Phase I study, being conducted in Australia, is an open-label, dose-escalation study designed to enroll 9 patients diagnosed with PAH. The first cohort of 3 patients has received 0.5M PLX cells per kilogram body weight. An independent Data Safety Monitoring Board recommended advancement to the second cohort. The second cohort will receive 1M cells per kilogram, while the third cohort is planned to be administered 2M cells per kilogram. The primary endpoint of the study is the safety of PLX-PAD cells, which will be evaluated at 12 weeks and one year after dosing. Secondary efficacy endpoints are to be measured at six weeks post-treatment in order to assess changes in the ability to exercise, disease severity and cardio-respiratory function; measures include six-minute walk distance and cardio-pulmonary hemodynamic parameters evaluated via right heart catheterization and echocardiogram.

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