HAIFA, ISRAEL, February 18, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today the positive results of a recently completed trial conducted by the U.S. National Institutes of Health (NIH) to evaluate PLX-R18 cells to treat bone marrow damaged by exposure to high levels of radiation, such as can occur after a nuclear disaster. Injection of PLX-R18 cells into muscle, as compared to a placebo, resulted in a statistically significant improvement in the recovery of white blood cell, red blood cell, and platelet levels in animals exposed to high levels of radiation. The data also suggested that the treatment may potentially be able to shorten time to recovery. High levels of radiation can destroy the body’s ability to produce these three blood lineages, and rapidly regaining that capacity is a key factor in surviving the hematologic component of acute radiation syndrome (ARS), a condition caused by high-dose irradiation that can involve severe, sometimes lethal damage to the bone marrow as well as other physiologic systems and organs.
The objective of this latest trial was to investigate the mechanism of action behind the significant improvement in survival in irradiated mice treated with PLX-R18 that was demonstrated in the NIH’s first efficacy study. The results of the current study indicate that intramuscular administration exerts a systemic healing effect on bone marrow, lending further support to the concept that Pluristem’s cells work systemically via secretion of therapeutic proteins, although the cells themselves remain in the muscle into which they were initially injected. While additional animal trials are needed prior to U.S. Food and Drug Administration (FDA) approval of PLX-R18 for use in ARS, no human trials would be required because product development is conducted under the FDA’s Animal Rule.
“Our PLX-R18 cell product was developed and targeted to become a strong candidate for government procurement programs designed to protect the population in the case of exposure to dangerous levels of radiation. PLX-R18 cells are an off-the-shelf cell therapy product with a long shelf life. They do not require matching before use and can be administered through intramuscular injection. These features are important to facilitate rapid initiation of treatment on a large scale. The study results also support Pluristem’s unique approach of injecting cells intramuscularly to enable the cells to remain in the body long enough to respond to signals from damaged tissues and adapt their therapeutic secretion profiles accordingly,” stated Zami Aberman, Chairman and CEO of Pluristem.
“We have had a productive working relationship with the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), which has independently conducted its studies with PLX-R18 cells provided by Pluristem,” Aberman added.
Pluristem is developing PLX-R18 cells for other potential indications including enhancement of engraftment of transplanted hematopoietic stem cells for the treatment of bone marrow deficiency. Trials for this indication are ongoing at Case Western University and Hadassah Medical Center. Data from the NIH studies in ARS are expected to benefit Pluristem’s development of its hematology program.
The objective of this study, performed at the Indiana University School of Medicine and funded by the Product Development Support Services Contract HHSN277201000046C from NIAID, was to investigate the mechanism of action behind the results of the NIH’s first study of the efficacy of PLX-R18 in ARS. That first study showed a significantly increased 30-day survival and overall survival time of mice treated with PLX-R18 compared to controls.
In the current study, 256 mice were randomized to be injected intramuscularly with PLX- R18 or placebo after total body irradiation, or PLX-R18 or placebo after sham irradiation. Mice were dosed intramuscularly with PLX-R18 cells or a placebo on day 1 and day 5 post-irradiation. Complete blood count parameters and body weight were measured at 8 post-irradiation time points (days 2, 4, 6, 9, 13, 15, 17, and 23), and bone marrow and spleen cellularity and hematopoietic progenitor cells (HPC) were measured at 6 time points (days 2, 4, 6, 9, 13, and 23). Treatment with PLX-R18 cells significantly increased recovery of white blood cells (p=.0024), neutrophils (p=.0026), monocytes (p=.0272), red blood cells (p<.0001), platelets (p=.0005), hemoglobin (p<.0001), and hematocrit (p<.0001) at day 23 post-irradiation compared with vehicle-treated control mice. Increases in lymphocytes and percent of neutrophils were also observed, but were not statistically significant. The increase in bone marrow progenitor cells was accelerated in mice treated with PLX-R18 cells as compared to the control group, but this was not statistically significant. The population of bone marrow cells responsible for the earlier stages of new red cell, white cell, and platelet production began to increase before those involved in later stages of production; this is consistent with normal physiology in which the progenitor cells proliferate and replenish the more mature cell populations and eventually the peripheral blood cells.
Previous studies of PLX-R18 cells for ARS were conducted by Prof. Raphael Gorodetsky, head of the Biotechnology and Radiobiology Laboratory at the Sharett Institute of Oncology at the Hadassah Hebrew University Medical Center. Those studies showed an up to four-fold increase in the survival rate of irradiated animals treated with PLX cells versus those treated with a control, as well as improvements in additional parameters. The findings have been published in the peer-reviewed journal PLOS ONE.
Acute radiation syndrome (ARS) is an acute illness caused by irradiation of the whole body (or a significant portion of it). It follows a somewhat predictable course and is characterized by signs and symptoms that reflect cellular deficiencies and the reactions of various cells, tissues, and organ systems to ionizing radiation. The hematologic component of ARS results from damage to the bone marrow and is characterized by acute decreases in red and white blood cell and platelet counts, which can lead to infection, hemorrhage and death. The gastrointestinal component is characterized by loss of cells lining the intestines, resulting in fluid and electrolyte loss, sepsis, and damage to the intestinal microcirculation, all of which can lead to death. Other components of ARS include potentially lethal damage to the central nervous system and the lungs.
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, 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 that our PLX-R18 cell product is a strong candidate for government procurement programs designed to protect the population in the case of exposure to dangerous levels of radiation or when we discuss our unique approach of injecting cells intramuscularly in order to enable the cells to remain in the body long enough to respond to signals from damaged tissues and adapt their therapeutic secretion profiles accordingly.
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 Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
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
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