Key Developments: Pluristem Therapeutics Inc (PSTI.PH)

PSTI.PH on Philadelphia Stock Exchange

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11 Jul 2014
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Latest Key Developments (Source: Significant Developments)

Pluristem Therapeutics Inc initiates South Korean Arm of Multinational Phase II Intermittent Claudication Trial
Tuesday, 8 Jul 2014 03:00am EDT 

Pluristem Therapeutics Inc:Says initiation of South Korean sites in Phase II study assessing PLacental eXpanded (PLX) cells in treatment of intermittent claudication (IC).Patient screening is underway at three clinical centers, making South Korea the fourth country to participate in this randomized, double-blind, placebo-controlled Phase II trial.Says trial has been ongoing at clinical sites in the U.S., Israel and Germany with an enrollment target of 150 patients.Says In May, Pluristem received clearance from the South Korean Ministry of Food and Drug Safety (MFDS) to use PLX cells in South Korean trials.  Full Article

Pluristem Therapeutics receives patent in russia for treatment of inflammatory bowel disease using placenta-derived cells
Thursday, 19 Jun 2014 03:00am EDT 

Pluristem Therapeutics Inc:Says Russia's Federal Service for Intellectual Property has granted to Pluristem Patent No. 2515156 titled, "Methods of Treating Inflammatory Colon Diseases".Patent covers methods for treating ulcerative colitis or Crohn's disease using placenta-derived cells.Patent has already been issued to Pluristem in South Africa and is currently pending in several other jurisdictions.  Full Article

Pluristem Therapeutics Inc receives patent in india for cell therapy production methods and compositions
Monday, 16 Jun 2014 03:00am EDT 

Pluristem Therapeutics Inc:It has been granted Patent No. 261087 from India's Office of the Controller General of Patents.Patent, which has also been granted to Pluristem in Australia, Russia and South Africa, covers the Company's key technology platform, its method for 3-dimensional expansion of placental and adipose (fat) derived cells.Says it also covers the composition of cells derived using this methodesigns & Trade Marks for a patent titled.  Full Article

Pluristem Therapeutics Inc updates on phase I/II clinical trial
Thursday, 29 May 2014 03:00am EDT 

Pluristem Therapeutics Inc:Says it it has enhanced its activity in the orthopedic indications for its PLacental eXpanded (PLX) cell therapies.In Jan. Pluristem announced positive results from its phase I/II clinical trial for the treatment of injured gluteal muscle after total hip arthroplasty (THA).  Full Article

Pluristem Therapeutics Inc to be added to new TA Tech-Elite Stock Index in Israel
Wednesday, 7 May 2014 03:00am EDT 

Pluristem Therapeutics Inc:Its shares of common stock will be added to a newly created TA Tech-Elite index on the Tel Aviv Stock Exchange.Scheduled for launch on May 11.TA Tech-Elite index will comprise shares of Israel's leading technology and biomed companies.  Full Article

Pluristem Therapeutics Inc's manufacturing facility approved by European auditors for phase III trials
Monday, 28 Apr 2014 03:00am EDT 

Pluristem Therapeutics Inc:Says its new manufacturing facility has received European Union's Qualified Person Declaration.With this declaration, Pluristem is approved to use cell therapies manufactured at 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.Qualified Person inspection was conducted in line with the European Union's Good Manufacturing Practice (GMP) legislation, directives and guidelines.Audit focused on 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.  Full Article

Pluristem Therapeutics Inc approves Pluristem's commercial scale cell manufacturing process
Thursday, 6 Mar 2014 03:00am EST 

Pluristem Therapeutics Inc:United States Food and Drug Administration (FDA) has reviewed Pluristem's comparability studies of PLacental eXpanded (PLX) cell products.Granted approval for to manufacture these products in new commercial-scale cell manufacturing facility.  Full Article

Pluristem Therapeutics Inc submits FDA orphan drug application for Preeclampsia
Thursday, 20 Feb 2014 03:00am EST 

Pluristem Therapeutics Inc:Says submitting its application to the United Stated Food and Drug Administration.Says requesting the company to be granted Orphan Drug Designation for its PLacental eXpanded (PLX-PAD) cells in the treatment of severe preeclampsia.Says Orphan Drug Designation may qualify a company for several benefits under the Orphan Drug Act of 1983 (ODA), as amended.  Full Article

Pluristem Therapeutics Inc receives key 3d cell expansion patent in Australia
Tuesday, 18 Feb 2014 03:00am EST 

Pluristem Therapeutics Inc:Says it has been granted a new patent by the Australian Patent Office.Says the Patent #2007228341 covers the method and composition of matter for three-dimensional (3D) expansion of placental or adipose (fat) stromal cells, Pluristem's key technology platform.Says Patent claims also include methods of treatment using placental cells for numerous diseases including graft vs. host disease (GvHD), heart disease, stroke, burns, loss of tissue, loss of blood, anemia, and autoimmune disorders.  Full Article

Pluristem Therapeutics Inc appoints President and Chief Financial Officer
Wednesday, 5 Feb 2014 05:00am EST 

Pluristem Therapeutics Inc:Says Yaky Yanay has been promoted to President and Chief Operating Officer.Says Boaz Gur-Lavie has been appointed to the position of Chief Financial Officer and Secretary.  Full Article

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