- Buerger’s disease is a severe vascular inflammatory disease associated with high risk of amputation
- Patient was at a pre-amputation stage and was treated with PLX-PAD cell therapy under compassionate use
treatment
- After a 12 month follow up period, PLX-PAD restored peripheral blood supply to the injured limb and prevented
amputation
- PLX-PAD was granted Orphan Drug Designation by the FDA for the treatment of Buerger’s disease and an expanded
access program for the treatment of critical limb ischemia
HAIFA, Israel, Jan. 09, 2019 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative-medicine company
developing novel placenta-based cell therapy products, today reported a successful one-year follow up of a compassionate use
treatment in a Buerger’s disease patient treated with Pluristem’s PLX-PAD.
The thirty-six years old patient, who was diagnosed with Buerger’s disease approximately four years ago,
displayed painful, non-healing ulcers on his foot. Available medical interventions, including revascularization procedures, were
unsuccessful in restoring sufficient blood flow to the affected limb and the patient progressed to a pre-amputation stage.
Following his physician’s request and regulatory approval, patient was given a compassionate use treatment of PLX-PAD cells,
consisting of two administration to the foot and calf, approximately eight weeks apart.
“The patient was in an advanced stage of Buerger’s disease and was facing amputation,” said Prof Boris Yoffe,
Department of General and Vascular Surgery at the Barzilai Medical Center in Israel. “Following treatment with PLX-PAD cells, we
observed demonstrable restoration of the patient’s peripheral blood supply to the injured limb, which was manifested by a
significant improvement in color, warmth, wound size and reduced pain. One year following treatment, the wound is now fully closed,
the patient was able to resume normal activities and amputation was prevented. This treatment highlights PLX-PAD’s ability to
reduce inflammation, stimulate growth of new blood vessels and support treatment in ischemic conditions such as Buerger’s disease
and Peripheral Arterial Diseases (PAD). Additionally, the other limb, which was in earlier stages of the disease, also showed signs
of improvement demonstrating the cells’ ability to prevent progression of the disease and act as a potential systemic treatment. I
am highly encouraged by these results providing hope for Buerger’s disease patients and am happy to see the significant improvement
in the patient’s medical condition, quality of life and overall wellbeing.”
“The positive outcome experienced by the patient reflects what we believe is the broad potential of PLX-PAD in
treating a wide range of vascular and inflammatory conditions, where improved treatment paradigms are surely needed,” said Zami
Aberman, Chairman & Co-CEO of Pluristem. “While we advance PLX-PAD in our ongoing multinational Phase III clinical study in
critical limb ischemia (CLI), we are pleased to see more supportive evidence of patients benefiting from our PLX regenerative
agents. We are now enabling access to PLX-PAD treatment through our U.S. Expanded Access Program in CLI and will explore to expand
the program to include Buerger’s disease patients.”
Buerger’s disease (thromboangiitis obliterans) is a recurring progressive inflammatory disease resulting in
clotting of small and medium size arteries and veins of the hands and feet. The specific cause of Buerger’s disease remains
unknown. The risk for developing Buerger’s disease increases with heavy smoking. There is no cure available today for Buerger’s
disease. The initial symptoms of Buerger’s disease often begin with claudication, progressing to pain at rest. If the condition is
severe, complications like gangrene may accrue which may lead to limb amputation.
PLX-PAD has been granted Orphan Drug Designation by the FDA for the treatment of Buerger’s disease.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products. The
Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage
trials in several indications. PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia,
muscle trauma, hematological disorders, and radiation damage. The cells are grown using the Company's proprietary three-dimensional
expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong
intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic
relationships with major research institutions; and a seasoned management team.
Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of
1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it states its belief
that the PLX-PAD treatment for a patient’s Buerger’s disease highlights PLX-PAD’s ability to reduce inflammation, stimulate growth
of new blood vessels and support treatment in ischemic conditions such as Buerger’s disease and PAD, its belief that PLX-PAD cells
have the ability to prevent the progression of Buerger’s disease and act as a potential systemic treatment, its belief regarding
the broad potential of PLX-PAD in treating a wide range of vascular conditions and its exploring the possibility of broadening its
ongoing CLI Expanded Access Program to include Buerger’s disease patients. These forward-looking statements and their implications
are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties
that could cause actual results to differ materially from those described in the forward-looking statements. The following factors,
among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in
technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its
clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it
progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract
key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with
Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not
translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of
human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation
may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of
market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem
to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem
undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances
after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and
uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and
Exchange Commission.
Contact:
Efrat Kaduri
Head of Investor and Public Relations
972-74-7108600
efratk@pluristem.com
Karine Kleinhaus, MD, MPH
Divisional VP, North America
1-914-512-4109
karinek@pluristem.com
