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December 20, 2016

Pluristem, Sosei Set Up in Japan to Commercialize Cell Therapy for CLI

  • Sosei Corporate Venture Capital (Sosei CVC) and Pluristem are establishing a Japanese company that will carry out clinical development and commercialization of Pluristem’s placental-derived adherent stromal cell (PLX-PAD) therapy in Japan. Sosei CVC’s investment fund, Sosei RMF1, together with other Japanese investors, aim to raise and invest $11 million in the new company, which has yet to be named, in return for a 65% stake. Pluristem will own the remaining 35% of the new firm.

    Pluristem’s placental expanded (PLX) cells are placenta-derived, mesenchymal-like adherent stromal cells that can be administered to patients without tissue or genetic matching. The cells release soluble cytokines, chemokines, and growth factors, which stimulate the body’s own regenerative mechanisms to speed healing. The PLX-PAD cells are in development for ischemic indications, including critical limb ischemia (CLI), for which the product is negotiating accelerated regulatory pathways in both Europe and Japan.

    CLI is the initial indication that Pluristem and Sosei CVC’s new Japanese company will focus on in Japan. A 75-patient study with PLX-PAD has already been agreed with Japan's Pharmaceuticals and Medical Devices Agency, under the accelerated regulatory pathway for regenerative medicine. Pluristem says the single study may be enough to achieve conditional marketing approval and early reimbursement for the product in Japan. The new company will also undertake future PLX-PAD marketing activities, for which a definitive agreement is anticipated the end of Q1 2017.

    “The development of our CLI program through the accelerated regulatory pathway could allow a more rapid entrance into the sizeable Japanese market, as has been our strategy,” stated Zami Aberman, Pluristem’s chairman and CEO. “Our cooperation with Sosei CVC also creates the potential to develop additional indications in this market, by drawing on our robust portfolio of cell therapy product candidates in development.”

    Japan’s Safety of Regenerative Medicine Act is designed to facilitate the commercialization of cell-based and regenerative therapies. Relevant products can receive conditional, time-limited marketing approval, and be eligible for reimbursement, once proof of safety and an indication of effectiveness have been demonstrated. Observational data from patients treated following the conditional approval then form the basis for confirmation of safety and efficacy.

    In November 2016, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) approved the start of a 250-patient U.S.- and U.K.-based pivotal Phase III study with PLX-PAD in the treatment of CLI. The single trial may also be sufficient for conditional marketing approval of PLX-PAD in Europe, under the European Medicines Agency's (EMA’s) Adaptive Pathways pilot project.

    Pluristem manufactures its PLX products using a proprietary 3D bioreactor system that can manufacture cell products on a mass scale. The firm’s second PLX cell therapy product, PLX-R18, is in development for treating hematologic disorders, including incomplete engraftment of transplanted hematopoietic cells, and acute radiation syndrome (ARS). At the start of December, Pluristem reported that the U.S. NIH’s National Insitute of Allegy and Infectious Diseases (NIAID) had started the final phase of animal dosing in a large animal study, which is designed to determine the treatment dose for a subsequent pivotal large animal study that would meet the requirements for submitting a Biologics License Application (BLA) under FDA’s Animal Rule regulatory pathway. NIAID previously completed two small animal studies of PLX-R18 to evaluate the efficacy and mode of action of PLX-R18 as a potential treatment for the hematologic disorders associated with ARS.

     

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