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March 6, 2014
06:05 EDTPSTIPluristem's commercial scale cell manufacturing process approved by FDA
Pluristem Therapeutics announced that the FDA has reviewed Pluristem's comparability studies of its PLacental eXpanded, or PLX, cell products and granted approval for the company to manufacture these products in its new commercial-scale cell manufacturing facility. Pluristem has implemented its proprietary, fully automated 3D cell expansion manufacturing platform that uses its patented high-throughput culturing technologies, 3D bioreactors, and downstream equipment. Pluristem's facility has the ability to efficiently produce approximately 150,000 doses of PLX cells annually, with batch-to-batch consistency, which potentially translates into significant economic value.
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October 21, 2014
05:09 EDTPSTIPluristem moves to large-scale manufacturing after second product line completed
Pluristem Therapeutics announced that it has completed development of its second major product line, and can now begin manufacturing the cells on a large-scale at its state-of-the art facility in order to meet demand for anticipated studies in a range of hematologic conditions. This second cell product candidate, called PLX-RAD, was created using Pluristem's proprietary three dimensional cell expansion technology platform. The company's first product, PLX-PAD, is already in clinical trials for the treatment of peripheral artery disease, muscle injury and pulmonary arterial hypertension. Pluristem's development plan for the PLX-RAD cells considers numerous potential clinical indications such as: enhancement of engraftment of transplanted hematopoietic stem cells for the treatment of bone marrow deficiency, which can result from immune system disorders, genetic diseases, and treatment of leukemia and other blood cancers; treatment of bone marrow deficiency in patients who have undergone chemotherapy; treatment of acute radiation syndrome, or ARS in conjunction with the U.S. National Institutes of Health's National Institute of Allergy and Infectious Diseases.
October 20, 2014
07:19 EDTPSTIIBC Life Sciences to hold a conference
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October 14, 2014
16:42 EDTPSTIPluristem Therapeutics files $200M mixed securities shelf

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