Yaky Yanay to deliver two presentations regarding accelerated clinical development pathways in Europe and Japan
HAIFA, ISRAEL, December 17, 2015 — Pluristem Therapeutics Inc. (NasdaqCM / TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that the Company’s President and COO Yaky Yanay will deliver two presentations at the 12th Annual Phacilitate Cell & Gene Therapy World Conference which takes place January 25-27, 2016 in Washington D.C.
On Monday, January 25 at 3:00pm Mr. Yanay will present “Pursuing clinical development as an in house manufacturer under the new regulations in Japan” during the session titled “Sharing Experiences to Date of Western Industry Trailblazers Seeking to Access the Japanese Regenerative Medicine Marketplace.”
On Tuesday, January 26 at 3:15pm Mr. Yanay’s presentation titled “Industry perspective on the EMA Adaptive Pathway” will be part of Focus Session 2 “Accelerated clinical development pathways across the globe – what evidence of benefits to date for cell & gene therapy?”
This year’s conference, titled “From Promise to Products,” features a one-day Japan Executive Summit which will focus on the novel regulatory pathways that have opened up in the Japanese regenerative medicine arena.
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has cleared Pluristem’s PLX-PAD cells for use in clinical trials in Japan. Pluristem is pursuing approval to conduct a pivotal Phase II clinical trial for conditional marketing approval of PLX-PAD in critical limb ischemia (CLI) through Japan’s accelerated regulatory pathway for regenerative medicine.
Pluristem’s PLX cell program in critical limb ischemia (CLI) was one of a handful of programs that were selected for the European Medicines Agency’s (EMA) Adaptive Pathways pilot project whose goal is to improve timely access for patients to innovative new medicines. Pending a single successful Phase II trial, PLX-PAD could enter the European market in 2018 with conditional approval to treat CLI with PLX-PAD.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
