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January 30, 2013
05:36 EDTPSTIPluristem takes possession of, moves into new manufacturing facility
Pluristem Therapeutics announced that the company has taken possession of and is moving into its new state-of-the-art GMP facility. The facility allows for the production of mass quantities of PLacental eXpanded cells that possess the advantages of being grown utilizing Pluristem's patented 3D bioreactor technology. The new manufacturing facility will have the capability to produce different PLX product candidates with the potential capacity of over 150,000 doses annually. Additionally, if more indications are approved by regulators for clinical trials, this new facility will enable us to supply PLX cells to conduct these additional trials in parallel.
News For PSTI From The Last 14 Days
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September 16, 2014
05:49 EDTPSTIPluristem Therapeutics pursues development strategy in Japan
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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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