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HAIFA, ISRAEL, Feb 2, 2015 – Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PSTI), a leading developer of placenta-based cell therapies, announced an important new finding from its Phase I/II clinical trial of PLacental eXpanded (PLX-PAD) cells in the treatment of muscle injury after total hip arthroplasty (THA). Data showed that six months after surgery the magnitude of improvement in muscle force of the contralateral (non-operated) gluteal muscle was approximately 40 times larger in patients treated with 150 million PLX-PAD cells than in those who received placebo, and the difference was statistically significant (19.4 vs 0.5 Nm, p=0.0114). Patients treated with 300 million PLX-PAD cells also showed a larger increase in muscle force than patients injected with placebo (9.48 vs 0.46 Nm, p=0.227). Pluristem further announced positive twelve-month safety data from the trial. These findings follow the January 21, 2014 announcement that the study had met its primary efficacy and safety endpoints. The primary efficacy finding was the change in maximal voluntary isometric contraction force of the gluteal muscle in the operated leg at six months after total hip replacement. There was a large and statistically significant improvement in patients who were injected with 150 million cells versus those who received placebo (31.1 vs 5.4 Nm, p=0.0067).
The study’s Senior Scientist, Dr. Tobias Winkler of the Center for Musculoskeletal Surgery & Julius Wolff Institute Berlin, Charité – Universitaetsmedizin Berlin, Germany, commented “I am impressed with the magnitude of the effect seen in the treated and contralateral legs. PLX cells demonstrated good safety and these newest findings suggest that intramuscular injection of PLX cells might potentially improve overall muscle functionality.”
Zami Aberman, Chairman and CEO, stated “It is very encouraging to have a large and statistically significant effect of PLX-PAD cells on our primary efficacy endpoint and also the unexpected finding of increased muscle strength in the non-operated leg. Although additional confirmatory studies are needed, these findings support our previous studies in which we showed that injection of PLX-PAD cells into muscle generates a systemic effect. The findings also open up new possibilities for the potential use of PLX- PAD cells. Based on these results, we intend to continue to develop PLX-PAD in orthopedic indications including sports injuries and muscle trauma, as well as muscle wasting and rehabilitation.”
The Phase I/II trial was a randomized, double blind, placebo controlled study conducted at the Orthopedic Clinic of the Charité Universitätsmedizin Berlin jointly with the Berlin- Brandenburg Center for Regenerative Therapies under the auspices of the Paul-Ehrlich- Institute (PEI), Germany’s health authority. The injured muscle studied was the gluteus medius muscle, which is intentionally cut during total hip arthroplasty using the transgluteal approach. Post-operative healing is crucial for joint stability and function. The 20 patients in the study were randomized into three treatment groups. Each patient received injections in the gluteal muscle that had been traumatized during surgery. One group was treated with 150 million PLX-PAD cells (n=7), the second was administered 300 million PLX-PAD cells (n=6), and the third received placebo (n=7). The primary efficacy endpoint was clearly met and the safety profile at 12 months was excellent.
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.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws.
For example, forward-looking statements are used in this press release when we discuss the follow up results of our muscle injury clinical trial and the potential of PLX cells to improve overall muscle functionality, when we discuss how the new findings open new possibilities for the potential use of PLX-PAD cells and our intention to continue to develop PLX-PAD in orthopedic indications.
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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; 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:
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Presentations focus on delivery of cell therapy from manufacturing facility to patient bedside aided by Company’s proprietary point-of-care cell thawing device
HAIFA, ISRAEL, January 13, 2015 —Pluristem Therapeutics Inc. (NasdaqCM, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today it will be presenting at two cell therapy conferences during the month of January. Both presentations describe the use of Pluristem’s proprietary cell thawing device to provide rapid, uniform thawing of its PLacental eXpanded (PLX) cells at the point-of-care prior to patient administration.
On January 20, 2015, Lior Raviv, Team Leader of Product Development at Pluristem, will present at ECI’s Fourth Annual Scale-Up and Manufacturing of Cell-Based Therapies Conference in San Diego. His presentation is titled “Bringing cell therapy up to patient bed side- The development of an automated and controlled point-of-care cell thawing device”. Nadav Eshkol, Process Engineering Team Leader, will present a poster titled “From pilot scale to mass production- Bioreactors scale up in cell therapy industry”.
On January 27 and 28, 2015, Dr. Ohad Karnielli, VP Technology and Manufacturing at Pluristem, will present and participate in a panel discussion at the Cell & Gene Therapy Forum 2015 in Washington DC. Dr. Karnielli will be a panel member in the conference’s session titled ‘Clinical/commercial strategy updates: Preparing MSCs and other stem cell therapeutics for market’, on January 27. On January 28, Dr. Karnielli will deliver a presentation titled “Controlling cell delivery, from manufacturing to the patient via shipment, storage, thawing and routes of administration”, during the conference’s session titled “Can next-generation storage technologies unlock regenerative medicine markets?”
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.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss the use of our cell thawing device.
For example, forward-looking statements are used in this press release when we discuss the use of our cell thawing device.
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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; 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:
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, June 5th, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today issued a Letter to Shareholders from its CEO, Zami Aberman.
Dear Pluristem Shareholders,
We have started 2014 with strong momentum on many fronts, including advancements in our clinical pipeline and regulatory approvals surrounding our cell therapy production methods and new manufacturing facility.
The outstanding safety and efficacy results of our Phase I/II muscle injury study announced in January suggest that PLX-PAD cells may be effective in the treatment of muscle and tendon injuries. We analyzed the potential for a variety of orthopedic indications. Based on our findings and in keeping with our strategy, we have decided to move forward with at least two clinical indications, which will be announced in the next few weeks.
May was National Preeclampsia Awareness Month and we have been raising awareness for this potentially lethal disease of pregnancy for which there is no treatment. This tremendous unmet medical need makes preeclampsia one of our top priorities at Pluristem, and we are excited to advance our novel PLX-PAD cell therapy into clinical trials for this indication.
Enrollment of the Phase II intermittent claudication (IC) study is moving forward in the U.S., Germany and Israel and we expect to initiate enrollment in South Korea shortly.
Internally, we have enhanced our executive team by promoting Yaky Yanay to the position of President and Chief Operating Officer and appointing Boaz Gur-Lavie as Chief Financial Officer and Secretary. We are taking a leading role in industry-wide efforts to set standards and garner government support for cell therapy and regenerative medicine, and we will continue this work in the coming months. Pluristem supports the advancement of cell therapy through active participation in industry organizations, like the Alliance for Regenerative Medicine (ARM) and the International Society for Cellular Therapy (ISCT), that play a key role in shaping the future of the industry. Dr. Ohad Karnieli, Vice President of Development and Manufacturing, was recently confirmed as Chair of ISCT’s Process and Product Committee for a two-year post.
$4.2 million) grant from the Office of the Chief Scientist (OCS) within the Israeli Ministry of Economy. The grant will be used to cover R&D expenses for calendar year 2014.
We submitted an application to the FDA requesting the Company’s PLX-PAD cells be granted Orphan Drug Designation in the treatment of severe preeclampsia.
The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), has commenced a mechanism-of- action study of our second product, PLX-RAD cells, for the treatment of acute radiation syndrome (ARS). The study aims to investigate the effects of PLX-RAD cells on body weight, blood count parameters, cytokine concentrations and bone marrow or spleen cellularity at various time points following the administration of PLX-RAD cells to animals receiving total body irradiation.
The FDA has reviewed comparability studies of our PLX cell products and granted Pluristem approval to use cells manufactured at our new state-of-the-art facility in Haifa, Israel for clinical trials in the U.S.
The South Korean Ministry of Food and Drug Safety (MFDS) has approved our proprietary method for 3D commercial-scale cell expansion. With this approval, we may now commence our Phase II Intermittent Claudication trial in Korea using cells manufactured at our Haifa facility. This study was approved by the MFDS in November 2013; the trial is ongoing in the U.S., Germany and Israel.
Our new manufacturing facility has also received the European Union’s Qualified Person Declaration. With this declaration, we are now approved to use cell therapies manufactured at our Haifa facility in all phases of our clinical trials conducted in the European Union.
Our performance over these past months clearly reflects Pluristem’s strengths across our clinical pipeline, our commitment to our intellectual property, our proprietary in-house manufacturing capabilities and the dedication of our staff. We will continue to build on these achievements to successfully execute our long-term strategy to become the leader in the development and manufacture of a variety of “off-the-shelf” cell therapies.
Thank you for your support. Zami Aberman
Chairman & CEO
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the Company’s proprietary 3D micro-environmental 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.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements, when we discuss proposed legislation that may accelerate brining cell therapies to the market, its adoption, if adopted at all and effect on the Company. 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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; 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.
Pluristem Therapeutics Karine Kleinhaus, MD, MPH
Divisional VP, North America 1-914-512-4109
Patent covers methods for using vibration to harvest large yields of viable cells grown with three-dimensional technology
HAIFA, ISRAEL, January 6, 2015 — Pluristem Therapeutics Inc. (NasdaqCM, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that it has been issued Patent No. 2013/07160, titled “Methods and Systems for Harvesting Adherent Stromal Cells”, in South Africa. This patent addresses Pluristem’s methods for using vibration to harvest cells grown on three-dimensional scaffolds, the harvested cells themselves, and devices developed for this process. The lack of an effective technology for harvesting live cells from these carriers was a longstanding roadblock to three- dimensional growth of cell therapy products.
Pluristem’s invention for harvesting manufactured cells from three-dimensional scaffolds is a central element of its technology platform. The scaffolds, contained within proprietary bioreactors, use a high surface-to-volume ratio to make possible an extraordinarily efficient cell growth system. This degree of efficiency is necessary for cost-effective production of commercial quantities of therapeutic products, and could potentially provide Pluristem with a significant advantage.
“Our vibrational harvesting technology works with our patented technology platform to create a high-yield of cells that have high viability and vitality. From cell growth to cell harvesting, Pluristem’s patented and patent-pending methods may enable cell therapy to become a marketable technology on a scale that we believe is unmatched in the cell therapy industry,” stated Pluristem CEO Zami Aberman.
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.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws.
For example, forward-looking statements are used in this press release when we say that our patented and patent-pending methods may enable cell therapy to become a marketable technology on a scale that we believe is unmatched in the cell therapy industry.
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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; 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:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Second collaboration agreement for new PLX-RAD cell therapy product
HAIFA, ISRAEL, December 4, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapy products, announced today that it has entered into a long-term collaboration agreement with Hadassah Medical Center in Jerusalem. The medical center’s Department of Bone Marrow Transplantation and Cancer Immunotherapy, headed by Professor Reuven Or, will use preclinical models to assess the potential efficacy of PLX-RAD cells for treatment and prevention of hematological deficiencies and complications of bone marrow and umbilical cord blood transplantation. PLX-RAD cells are Pluristem’s second cell therapy product candidate.
“Hadassah is one of the leading medical centers in the world and we are honored to work with Dr. Or and his team. The preclinical studies to be conducted at Hadassah are expected to yield important data about the use of PLX-RAD cells in the treatment of hematological diseases. These data may help Pluristem to direct future clinical trials,” stated Pluristem CEO Zami Aberman. “This is our second collaboration with an academic institution to study PLX-RAD cells since announcing in October that we have the capability to manufacture this product candidate on a large scale.”
The Company’s development plan for PLX-RAD cells includes potential indications such as:
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, hematological disorders, radiation damage, and ischemia. 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.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss the PLX- RAD preclinical studies to be conducted at Hadassah, the data they are expected to yield about PLX-RAD cells, that such data may help us to direct future clinical trials, or when we discuss the potential indications for PLX-RAD.
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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; 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:
Pluristem Therapeutics Inc.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, December 1, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today it has been granted a patent in Singapore titled “Methods for Cell Expansion and Uses of Cells and Conditioned Media Produced Thereby for Therapy.”
Patent No. 170761 is Pluristem’s second granted patent in Singapore, and relates to methods of expanding adherent stromal cells from human placental or adipose tissue using Pluristem’s three-dimensional technology. Patents from the same family have previously been granted in Australia, India, Russia, and South Africa. Pluristem’s intellectual property portfolio now includes 33 patents issued and approximately 120 more pending worldwide.
“Singapore is a significant healthcare market and is a manufacturing center in the cell therapy space. We are happy to continue to build our relationship with its governmental agencies while strengthening our 3D technology-based competitive advantage in this important territory. We believe the regulatory environment for cell therapy to be advantageous and supportive of accelerated commercialization pathways in a number of Asian countries. For this reason we are actively seeking partners in Japan, and have already established a partnership with CHA Bio, a major biotechnology company in South Korea,” stated Pluristem CEO Zami Aberman.
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, hematological disorders, radiation damage, and ischemia. 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.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss our belief that regulatory environment for cell therapy is advantageous and supportive of accelerated commercialization pathways in a number of Asian countries.
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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; 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:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Presentations to focus on Pluristem’s industry-leading expertise in 3D cell culturing and cell expansion technologies
HAIFA, ISRAEL, November 25th, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that Dr. Ohad Karnieli, the Company’s vice president of development and manufacturing, will present at two scientific conferences on the latest advancements in large-scale cell therapy manufacturing.
On November 25, 2014 at the 11th Annual bioProcessUK Conference Dr. Karnieli will give a presentation titled, “The Road Not Taken-Challenges and Possible Solutions in Moving Cell Therapy from Bench Top to Industry.” The bioProcessUK conference will take place in Liverpool, England on November 25-26, 2014 and is organized by the UK BioIndustry Association.
At the Cell Therapy Manufacturing conference on December 4, 2014 Dr. Karnieli will give a presentation titled, “Challenges and Possible Solutions for Optimizing Cell Therapy Manufacturing and its Influence on Quality and Cost of the Product.” He will also be a presenter and panelist for the panel titled, “Top Tips When Moving a Process from Phase I to Phase II to Phase III.” The conference will take place from December 3- 4, 2014 in Brussels, Belgium, in association with the International Society for Cellular Therapy.
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, hematological disorders, radiation damage, and ischemia. 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.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. 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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; 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:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Indications include orthopedic, nerve injury and neurodegenerative diseases
HAIFA, ISRAEL, November 12, 2014 — Pluristem Therapeutics Inc. (Nasdaq: PSTI; TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that it has been granted a patent in both Australia and New Zealand for the use of a specified population of placental cells for treating several medical indications. The patent, titled “Adherent cells from placenta and use of same in disease treatment” has been issued in Australia, Patent No. 2010322808, and in New Zealand, Patent No. 600651.
The patents’ claims include the use of the population of placental cells in the treatment of muscle trauma, muscle defect, neuropathic pain, peripheral nerve injury, and neurodegenerative diseases.
“These patents, which cover multiple indications and bring the Company’s total to 32 granted patents, are timely, as we’ve demonstrated Pluristem’s ability to use its technology platform to develop distinct cell therapy product lines for the potential treatment of different conditions. We continue to evaluate additional indications for PLX- PAD and PLX-RAD, our first two cell therapy products,” stated Pluristem CEO Zami Aberman.
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, hematological disorders, radiation damage, and ischemia. 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.
In addition to its strong intellectual property position, Pluristem has 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.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws.
For example, we are using forward-looking statements in this press release when we discuss the potential of our product candidates to treat different conditions or that we continue to evaluate additional indications for PLX-PAD and PLX-RAD. 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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; 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:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
London Regenerative Medicine Network Meeting
Alliance for Regenerative Medicine’s 2nd Annual European Advanced Therapies Investor Day
HAIFA, ISRAEL, November 10th, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapy products, announced today that the Company’s CEO, Zami Aberman, has been invited to present at two regenerative medicine conferences in London regarding Pluristem’s cell therapy platform, large-scale manufacturing methods, and intellectual property strategy.
At the London Regenerative Medicine Network’s (LRMN) November 12 meeting, Mr. Aberman will deliver a presentation titled, “Maturing adherent-cell therapies for commercialization: strategies, technology barriers and possible solutions.” Mr. Aberman is one of three international speakers invited to present on the topic of scalable manufacturing therapies, which will be the focus of LRMN’s November 2014 meeting sponsored by Thermo Fisher Scientific.
Mr. Aberman will also present at the Alliance for Regenerative Medicine’s (ARM) 2nd Annual European Advanced Therapies Investor Day on November 13. His presentation, entitled “The Placenta as a superior source for cell therapy products – strategy and implementation”, will focus on Pluristem’s proprietary three-dimensional cell expansion technology platform, and the Company’s unique methods for developing and manufacturing distinct cell therapy products to treat specific diseases. Mr. Aberman will also discuss Pluristem’s successful intellectual property strategy, which serves as a model for IP protection in the regenerative medicine industry.
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, hematological disorders, radiation damage, and ischemia. 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.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws.
For example, forward-looking statements are used in this press release when we discuss our potential to develop cell therapy products to treat specific diseases, and that Pluristem’s IP assets will in fact protect its position in the regenerative medicine industry.
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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; 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:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
The study will determine whether Pluristem’s second major product line may help cord blood cells to successfully replace damaged bone marrow
HAIFA, ISRAEL, October 27, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-derived cell therapy products, announced today that researchers at Case Western Reserve University will conduct a preclinical study of the Company’s PLacental eXpanded (PLX)-RAD cells. The study will evaluate whether PLX-RAD cells increase the success rate of human umbilical cord blood transplantation.
Umbilical cord blood cells are transplanted to replace a patient’s unhealthy bone marrow cells. When successful, a transplant can treat bone marrow failure, which can result from immune system disorders, genetic diseases, and leukemia treatment. When cord blood cells are administered to a patient, they travel to the bone marrow and produce healthy white and red blood cells and platelets after the patient’s own abnormal cells have been eliminated. Sometimes, however, the cord blood cells fail to take hold and the transplant fails. The study at Case Western Reserve will research the feasibility of using PLX-RAD cells to help the cord blood to engraft more effectively, resulting in higher rates of successful transplantation and treatment.
“Case Western Reserve is one of the top research institutes in the U.S. and we are delighted to work with them. Pluristem will provide the PLX-RAD cells and the university’s researchers will conduct the study,” stated Pluristem’s Chairman and CEO Zami Aberman.
“If animal data show that PLX-RAD cells increase the success rate of umbilical cord blood transplants, this would motivate us to apply to conduct human clinical trials for bone marrow reconstitution following radiation in a number of life-threatening diseases including leukemia, where development of new, healthy bone marrow is the only available cure,” Aberman concluded.
PLX-RAD cells are also being studied by the U.S. National Institutes of Health (NIH) for the treatment of acute radiation syndrome (ARS), which involves bone marrow failure after exposure to high levels of radiation, as can happen after a nuclear catastrophe.
The primary objective of the study at Case Western Reserve is to determine the benefits of administering PLX-RAD cells at the time of transplantation of human hematopoietic CD34+ cells collected from umbilical cord blood. Scientists will compare the success rates of transplant engraftment in the control arm versus those treated with PLX-RAD cells. The secondary objective is to determine if there are any histologic changes in the liver, lung, spleen and intestine in the control versus treated groups. The preclinical study will be conducted in an immunodeficient mouse model that has undergone non-lethal radiation to destroy its own bone marrow cells. There will be three arms in the study: 1) IV (intravenous) injection of human Hematopoietic Cells (hHC) alone for the control; 2) IV injection of hHC plus IV injection of 1 million PLX-RAD cells; 3) IV injection of hHC plus intramuscular (IM) injection of 1 million PLX RAD cells. At 8 weeks bone marrow of the mice will be analyzed.
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 or ischemia. PLX cells are grown using the Company’s proprietary 3D micro-environmental 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.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward looking statements are used in this press release when we discuss the feasibility of PLX-RAD cells to help cord blood cells to successfully replace damaged bone marrow, or when we discuss the PLX-RAD study we are going to conduct at Case Western Reserve University, or when we discuss the possibility of applying to conduct human clinical trials in a number of life-threatening diseases. 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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may be more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; 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:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
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