Significant Progress for Pluristem: PLX Cells Were Selected for European Medicines Agency's Adaptive Pathways Pilot Project
(Thomson Reuters ONE) -
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of
placenta-based cell therapy products, today announced a significant advancement
to its clinical development plan: the PLX cell program in critical limb ischemia
has been selected for the European Medicines Agency's Adaptive Pathways pilot
project. The goal of the project is to improve timely access for patients to new
medicines. It allows for early marketing authorization of a therapy in a
restricted patient population, followed by additional assessments and the
possibility of later approval for use in broader patient populations. Critical
limb ischemia (CLI), a severe blockage in the arteries of the legs which
markedly reduces blood-flow, is associated with a significantly increased risk
of leg amputation and death. It currently affects approximately one million
people in the U.S., and the prevalence is expected to increase significantly in
the coming decades. CLI therefore represents a major commercial opportunity.
Acceptance of Pluristem's cells for the treatment of CLI into the Adaptive
Pathways could significantly curtail the time and investment needed to bring
this product to market.
"Acceptance into Europe's Adaptive Pathways pilot project is a tremendous
milestone for Pluristem. It allows us to potentially commercialize our product
earlier than expected," stated Pluristem CEO Zami Aberman. "We are extremely
pleased with this outcome, which was one of the key elements we defined in our
long term strategy to lead the cell therapy industry. Reducing time to market is
a critical element of our strategy. The Adaptive Pathways has the potential to
assist us in accomplishing this goal." Mr. Aberman added, "last week we
announced a milestone in Japan, which is also an important territory for us. We
are pursuing our strategy for expedited approval of PLX cells in Japan. We have
applied to Japan's Accelerated Pathway for Regenerative Medicine for our PLX
cells in critical limb ischemia, and Japan's Pharmaceuticals and Medical Devices
Agency just validated the proposed quality and large-scale manufacturing methods
for PLX-PAD cells for use in clinical trials."
Pluristem has already amassed experience in working with the European Medicines
Agency and conducting trials in the EU. The Company completed both a Phase I
trial in CLI and a Phase II trial in muscle injury in Europe. Pluristem is
currently conducting a multinational Phase II trial in intermittent
claudication, the less advanced stage of peripheral artery disease that can
precede CLI, and several of the trial sites are located in Europe. Pluristem has
also effectively protected its IP in Europe. In October 2014 Pluristem
successfully defended a European Patent whose claims cover treatment of ischemia
with adherent placental cells which are propagated using a 3D culture. CLI is a
type of ischemic disease, so the potential future treatment of CLI with PLX
cells is protected by this robust European patent.
About Critical Limb Ischemia and Its Market Potential
CLI is a chronic condition caused by a severe compromise of blood flow to the
leg that is usually due to narrowing of the arteries as a result of the buildup
of fatty deposits called plaque. Complications of this poor circulation can
include gangrene and amputation of the affected limb. Estimates of the economic
burden of CLI patients exceeds 10 billion dollars annually in the U.S. alone
because of the high incidence of limb loss and need for major amputation.
Current therapies have many limitations, especially in patients who cannot
undergo angioplasty or surgery for revascularization. Anticipated increases in
the incidence of CLI will likely generate an expanding market for innovative
therapies such as PLX cells.
About the Adaptive Pathways
The purpose of Europe's Adaptive Pathways is to shorten the time it takes for
innovative medicines to reach patients with serious conditions that lack
adequate treatment options. The pathway is open to clinical programs in early
stages of development only. After a therapy is selected for the program, the
Adaptive Pathways group conducts high level discussions and provides guidance to
the applicant regarding the formal regulatory processes that precede a trial
targeting early approval and further expansion of the indications.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell
therapy products. The Company's patented PLX (PLacental eXpanded) cells release
a cocktail of therapeutic proteins in response to inflammation, ischemia,
hematological disorders, and radiation damage. PLX cells are grown using the
Company's proprietary three-dimensional expansion technology and are an "off-
the-shelf" product that requires 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. For more
information visit www.pluristem.com, the content of which is not part of this
press release.
For Safe Harbor Statement and more information please visit-
http://www.pluristem.com/index.php/press-room/111-press-releases/press-room-
2015/522
CONTACT: Pluristem Therapeutics Inc.
Karine Kleinhaus, MD, MPH
Divisional VP, North America
1-914-512-4109
karinek(at)pluristem.com
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Source: Pluristem Therapeutics Inc. via GlobeNewswire
[HUG#1922057]
Datum: 18.05.2015 - 10:47 Uhr
Sprache: Deutsch
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