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Pluristem Receives Positive Feedback from FDA and EMA as Company Prepares for Phase III Trial of PLX-PAD to Support Recovery from Hip Fracture

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• Trial was recently awarded $8.7 million grant from the European Horizon 2020 program
• Pluristem plans to use results of trial to achieve marketing approval in both the U.S and
Europe

HAIFA, Israel, Sept. 26, 2017 — Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, has today reported the status of its planned Phase III hip fracture study. In previous discussions held with the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA), the company received positive feedback on the proposed study design and endpoints of its Phase III trial in PLX-PAD cells as a treatment for muscle recovery following arthroplasty for hip fracture. This trial was recently awarded an $8.7 million grant by the Horizon 2020 program, the European Union’s largest research and innovation program.

Pluristem Prepares for Phase III Trial of PLX-PAD The proposed Phase III trial is intended to support marketing authorization and will be a double-blind, randomized, placebo-controlled trial with approximately 180 patients enrolled in clinical sites across the U.S. and Europe. Patients will be injected intramuscularly with 150 million PLX-PAD cells during arthroplasty for hip fracture. The primary endpoint for the trial will be the change of Short Physical Performance Battery (SPPB) from baseline to six months after surgery. Additional endpoints may include objective measurements of muscle strength and muscle volume.

This Phase III trial follows positive results from a Phase I/II trial which demonstrated significant muscle regeneration when PLX-PAD cells were injected following arthroplasty, including a 300% improvement in muscle volume (p=0.004) and a 500% (p=0.0067) boost in muscle force when observed six months after surgery compared to the control group. [Read more…]

U.S. FDA Grants Fast Track Designation to Pluristem’s PLX-PAD for the Treatment of CLI

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  • Pluristem’s Ongoing Phase III CLI trial has been selected for accelerated approval pathways in both the U.S. and Europe

  • Fast Track Designation allows for expedited review of drugs to treat serious conditions with unmet medical need

HAIFA, Israel, Sept. 18, 2017 (GLOBE NEWSWIRE) — Pluristem Therapeutics, Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the company’s ongoing Phase III study of PLX-PAD cells for the treatment of Critical Limb Ischemia (CLI) in patients ineligible for revascularization. The FDA’s Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and unmet medical needs. With Fast Track Designation, there is an increased possibility for a priority review by the FDA of PLX-PAD cells for the treatment of CLI.

Zami Aberman, Pluristem Therapeutics - FDA Fast Track Designation“We are extremely pleased with the FDA’s decision to grant Fast Track Designation to PLX-PAD in the treatment of CLI. Up to 40% of patients with CLI are ineligible for revascularization and are at high risk of amputation and death within the first year of diagnosis. This disease takes a heavy toll on patients and their families, while the cost of treating CLI in the U.S. alone is estimated at over $25 billion per year. We are working tirelessly to provide a cell therapy that will address this severe unmet medical need,” said Zami Aberman, Chairman and Co-CEO of Pluristem.

“Regulators in some of the largest healthcare markets in the world are now in alignment regarding the need for accelerated approval pathways for our cell therapy product in the treatment of CLI. Programs like the Fast Track Designation offer real hope for patients battling this disease and we look forward to accelerating the path to market for PLX-PAD,” stated Pluristem President and Co-CEO, Yaky Yanay. [Read more…]

Pluristem Strengthens Its Position in Asia, Awarded Two New Patents in Hong Kong for CLI and Muscle Regeneration

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Pluristem TherapeuticsHAIFA, Israel, Sept. 13, 2017 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that the company has been issued two new patents by Hong Kong Patents Registry for its cell therapy products relating to two of the company’s leading  indications, Critical Limb Ischemia (CLI) and muscle regeneration.

The first patent addresses the use of mesenchymal stem cells for the treatment of skeletal muscle damage or injury. The second is for the use of adherent cells to treat ischemia and for connective tissue regeneration and repair. [Read more…]

U.S. DOD to Conduct Studies of Pluristem’s PLX-R18 in a New ARS Project for Use Before Radiation Exposure

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• The DOD studies seek to test the effectiveness of PLX-R18 as a novel medical countermeasure for Acute Radiation Syndrome (ARS) prior to and within 24 hours of exposure to high levels of radiation
• The DOD studies will be conducted in parallel with the ongoing ARS project with the NIH

Pluristem TherapeuticsHAIFA, ISRAEL, August 16, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI) (TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that a pilot study of the company’s PLX-R18 cell therapy will be initiated by the U.S. Department of Defense’s (DOD) Armed Forces Radiobiology Research Institute (AFRRI), part of the Uniformed Services University of Health Sciences (USU). The study will examine the effectiveness of PLX-R18 as a treatment for Acute Radiation Syndrome (ARS) prior to, and within the first 24 hours of exposure to radiation.  [Read more…]

PLX-R18 Supports Hematological Recovery After Low Radiation Exposure

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  • Findings pave the way to potentially use PLX-R18 to support hematological recovery following radiotherapy or chemotherapy

  • Data focuses on 12 additional NHPs that were exposed to lower radiation levels

Pluristem TherapeuticsHAIFA, ISRAEL, JULY 26, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI) (TASE: PSTI), a leading developer of placenta-based cell therapy products, today presented new data at the RITN (Radiation Injury Treatment Network) conference from a recent study evaluating PLX-R18 as a treatment for Acute Radiation Syndrome (ARS). [Read more…]

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