ネクセラファーマ(株)【4565】の掲示板 2017/09/22〜2017/09/26

※Pluristem Receives Positive Feedback from FDA and EMA as Company Prepares for Phase III Trial of PLX-PAD to Support Recovery from Hip Fracture.(9/26)
• 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, September 26, 2017-- Pluristem Therapeutics Inc., 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 theEuropean 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.

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.

“Now that this Phase III trial has been awarded $8.7 million from the Horizon program,
we are eager to move forward and are extremely pleased by the positive outlook of these key regulatory bodies regarding our proposed study design and endpoints,
which we believe may allow for early recognition of performance improvement in patients,”
noted Zami Aberman, Chairman and Co-CEO of Pluristem.
“With this positive feedback from the FDA and EMA, we believe that this trial will again yield significant results,
offering new hope for the thousands of patients around the world who have difficulty healing from hip surgeries due to poor muscle recovery.”

Pluristem plans to submit the Investigational New Drug (IND) and Clinical Trial Application (CTA) for the trial in the coming months.
The company plans to use the results of this Phase III trial to achieve regulatory approval in both the U.S and Europe.
Pluristem’s PLX-PAD program is one of only a handful to be accepted
into Europe’s Adaptive Pathway program, which may also allow for early marketing approval in Europe.

About Hip Fracture
Femoral neck fracture is the most common form of hip fracture, with mortality rates of up to 36%,
and annual treatment costs estimated to be between $10-$15 billion in the U.S. alone.
Following surgery, many patients do not fully recover due to poor muscle regeneration, leading to significant morbidity,
loss of the ability to live independently, and an overall decline in quality of life.
The incidence of hip fracture is expected to increase as populations age.