HAIFA, ISRAEL, December 21, 2015 — Pluristem Therapeutics Inc. (NasdaqCM / TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that it has reached an agreement with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on the design of the final trial needed to apply for conditional approval of PLX-PAD cells in the treatment of critical limb ischemia (CLI). The approval of the protocol for the 75-patient trial was part of a larger agreement on the development of PLX-PAD via Japan’s new accelerated regulatory pathway for regenerative medicine.
“With this achievement we have advanced our strategy to expedite commercialization of our cell products. Pluristem is now positioned favorably to accelerate negotiations with those Japanese pharma companies interested in becoming dominant players in the expanding regenerative medicine market in Japan,” stated Pluristem Chairman and CEO Zami Aberman.
The trial will collect data on 75 patients suffering from CLI. These patients will be randomized into three groups of 25. Group one will receive an initial 150 million PLX- PAD cell dose followed eight weeks later by a second 150 million cell dose; group two will be treated with an initial 300 million PLX-PAD cells followed eight weeks later by a second dose of 300 million cells; group three will receive two doses of placebo. The cells will be injected into a leg muscle using a standard syringe. Efficacy and safety will be determined from outcomes measured nine months after administration of the first dose. The primary efficacy endpoint will be diagnosis of a patient as CLI-free for 60 days. Pluristem expects to submit the formal Clinical Trial Notification (CTN) to the PDMA, based on the agreement reached with the regulatory body, in early 2016. The PMDA is expected to respond officially within 30 days. Earlier in 2015, the PMDA cleared PLX- PAD cells for use in clinical studies in Japan, a prerequisite to conducting this clinical trial.
Japan’s Act on the Safety of Regenerative Medicines went into effect in November 2014. Its purpose is to facilitate faster approval of cellular therapies and other regenerative medicine treatments for marketing. According to the law, these therapies can receive conditional, time-limited approval for marketing, and be eligible for reimbursement, upon proof of safety and a signal of effectiveness but prior to verification of efficacy. Safety and efficacy need to be confirmed via collection of observational data after the conditional approval.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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 our expectation that the agreement with the PDMA will accelerate discussions with potential Japanese partners, when we discuss our plan to conduct clinical trial of PLX- PAD cells in the treatment of CLI and the trial’s design, and when we discuss our expectation to submit the formal CTN to the PDMA by the end of Q1, 2016 and the expected timing of response by the PDMA. 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 clinical 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. 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.
Yaky Yanay to deliver two presentations regarding accelerated clinical development pathways in Europe and Japan
HAIFA, ISRAEL, December 17, 2015 — Pluristem Therapeutics Inc. (NasdaqCM / TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that the Company’s President and COO Yaky Yanay will deliver two presentations at the 12th Annual Phacilitate Cell & Gene Therapy World Conference which takes place January 25-27, 2016 in Washington D.C.
On Monday, January 25 at 3:00pm Mr. Yanay will present “Pursuing clinical development as an in house manufacturer under the new regulations in Japan” during the session titled “Sharing Experiences to Date of Western Industry Trailblazers Seeking to Access the Japanese Regenerative Medicine Marketplace.”
On Tuesday, January 26 at 3:15pm Mr. Yanay’s presentation titled “Industry perspective on the EMA Adaptive Pathway” will be part of Focus Session 2 “Accelerated clinical development pathways across the globe – what evidence of benefits to date for cell & gene therapy?”
This year’s conference, titled “From Promise to Products,” features a one-day Japan Executive Summit which will focus on the novel regulatory pathways that have opened up in the Japanese regenerative medicine arena.
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has cleared Pluristem’s PLX-PAD cells for use in clinical trials in Japan. Pluristem is pursuing approval to conduct a pivotal Phase II clinical trial for conditional marketing approval of PLX-PAD in critical limb ischemia (CLI) through Japan’s accelerated regulatory pathway for regenerative medicine.
Pluristem’s PLX cell program in critical limb ischemia (CLI) was one of a handful of programs that were selected for the European Medicines Agency’s (EMA) Adaptive Pathways pilot project whose goal is to improve timely access for patients to innovative new medicines. Pending a single successful Phase II trial, PLX-PAD could enter the European market in 2018 with conditional approval to treat CLI with PLX-PAD.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
PLX cells were demonstrated to be safe for both the mother and fetus and improved several parameters of preeclampsia in several animal studies
HAIFA, ISRAEL, December 31, 2015 — Pluristem Therapeutics Inc. (NasdaqCM, TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that the U.S. Food and Drug Administration has granted the Company’s PLX- PAD cells Orphan Drug Designation in the treatment of severe preeclampsia. Preeclampsia is among the most common medical complications of pregnancy and a leading cause of premature births, stillbirths and neonatal and maternal deaths. There is no cure except delivery. Due to high risks to the mother, women diagnosed with severe preeclampsia are usually delivered promptly, even if the baby will be born prematurely and may suffer permanent disabilities as a result. Severe preeclampsia occurs in approximately 1% of pregnancies in Western countries.
Benefits of Orphan Drug Designation for PLX-PAD cells include close guidance that may accelerate time to marketing approval, orphan drug grants, tax credits, and a 7-year market exclusivity upon marketing approval. It is estimated by different sources that preeclampsia costs the global health care system about $3 billion annually.
“Attainment of Orphan Drug Designation for our cells in severe preeclampsia exemplifies our global strategy of bringing cell therapies to patients through accelerated approval pathways,” stated Pluristem Chairman and CEO Zami Aberman. “We are encouraged by the US FDA designation that demonstrates Pluristem’s commitment to the program and the potential promise it holds to address a serious, unmet medical need faced by pregnant women every year”
PLX-PAD cells improved several parameters of preeclampsia in animal models in a study conducted in collaboration with Brett Mitchel PhD, Associate Professor of Internal Medicine at the Cardiovascular Research Institute (CVRI) of the Texas A&M College of Medicine. In a different animal study conducted a Charles River Laboratories, PLX-PAD cells were demonstrated to be safe for both the mother and fetus. As previously requested by the FDA, study in additional animal model (over expression of sFLT-1) to confirm the efficacy of PLX-PAD is on-going to test the efficacy of PLX-PAD in an additional therapeutic pathway. Data is expected in H1 of 2016.
Preeclampsia is one of the most common medical complications of pregnancy, and one of the leading known causes of premature births, stillbirths and early neonatal and maternal deaths. The disease occurs after the 20th week of pregnancy, and is characterized by high blood pressure and significant amounts of protein in the urine or end-organ dysfunction. The disease may lead to liver and renal failure, central nervous system (CNS) abnormalities including seizures, and disseminated intravascular coagulopathy. The only definitive treatment for preeclampsia is delivery. Severe preeclampsia, which occurs in 1% of pregnancies in the U.S., is defined by the presence of at least one additional symptom in a patient meeting the criteria for preeclampsia; these additional symptoms include severe high blood pressure, signs of severe kidney malfunction, low platelets, persistent headaches, and pulmonary edema.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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 benefits of Orphan Drug Designation for PLX cells, or when we discuss our global strategy of bringing cell therapies to patients through accelerated approval pathways, or when we discuss our commitment to the severe preeclampsia program and the potential promise it holds to address a serious, unmet medical need faced by pregnant women every year. 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 clinical 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. 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.
HAIFA, ISRAEL, December 8, 2015 — Pluristem Therapeutics Inc. (NasdaqCM / TASE: PSTI), a leading developer of placenta-based cell therapy products, announced that it received a notice today from United Therapeutics Corporation (“United”) ending its licensing agreement for the development of PLX-PAD for the treatment of pulmonary arterial hypertension (PAH). According to the licensing agreement Pluristem will regain full rights to PLX-PAD in this indication, as well as all clinical data and regulatory submissions, allowing Pluristem to move forward with the clinical development of the program and seek other licensing partners.
Data from the first cohort of three patients given PLX-PAD in the single-arm Phase I trial conducted by United in September 2014 which has now become available for publication, demonstrated a good safety profile and encouraging, albeit limited, efficacy trend. In addition, initial findings from cohort 1 suggest an average improvement of 21 meters from base line in the six-minute walk distance (6MWD) at 3-month follow up. The two patients with Grade 2 (moderate) PAH had an average improvement of 40 meters in 6MWD. The first cohort of patients received a single IV injection of 0.5 million cells/kg patient weight. Enrollment of the second cohort of patients is complete and follow up is ongoing. Those patients received 1 million cells/kg patient weight.
“We thank United for the work they have completed on this project and believe PLX- PAD can make a significant contribution to the health of patients suffering from PAH. The data generated by United provides a good foundation to suggest that our cells can be safely administered intravenously, with potential broad application, and can improve the quality of life for PAH patients. We have previously announced results from several studies that demonstrate the safety of intramuscular administration, and with the new intravenous data we can now expand the potential indications for which PLX cells can be used,” stated Pluristem Chairman and CEO Zami Aberman.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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 our plans to move forward with the clinical development of the PLX-PAD for treatment of PAH program and seek other licensing partners, when we discuss PLX-PAD’s potential to make a significant contribution to the health of patients suffering from PAH, when we discuss the potential for intravenous use of PLX cells across a broad range of 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 clinical 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
Effects of PLX-R18 will be studied in the lungs, gastrointestinal tract, skin, and bone marrow following exposure to catastrophic levels of radiation
HAIFA, ISRAEL, December 3, 2015 — Pluristem Therapeutics Inc. (NasdaqCM/ TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that it has signed a Memorandum of Understanding (MOU) for a collaboration with Fukushima Medical University, Fukushima Global Medical Science Center. The purpose of the collaboration is to develop Pluristem’s PLX-R18 cells for the treatment of Acute Radiation Syndrome (ARS), and for morbidities following radiotherapy in cancer patients.
ARS is caused by exposure to dangerously high levels of radiation, such as could occur in a nuclear catastrophe, and incorporates potentially lethal damage to the gastrointestinal tract, lung, skin and bone marrow, as well as other systems. In this new collaboration PLX-R18 cells will be studied primarily as a potential treatment for radiation-induced damage to the skin, lungs and gastrointestinal tract. The parties intend to develop preclinical models of radiation damage in these tissues, and then use them in trials. Pluristem will contribute PLX-R18 cells and scientific knowledge, while Fukushima Medical University will conduct the studies, and provide the required resources.
The collaboration will proceed alongside research supported by the U.S. National Institutes of Health (NIH), which is studying PLX-R18 as a potential treatment for the hematologic component of ARS. Insufficient blood cell production by the bone marrow, which may be caused by various reasons including ARS and cancer treatments, can be life threatening because it may lead to hemorrhage, the inability to fight infection, and anemia.
Data from a preclinical study, published in the peer-reviewed scientific journal PLOS One, suggest that PLX-R18 cells, administered intramuscularly, may be a highly effective off-the-shelf therapy for bone marrow failure following total body exposure to high doses of radiation. The work with Fukushima Medical University, Fukushima Global Medical Science Center will further evaluate the efficacy of intramuscular administration for systemic treatment of ARS.
“The researchers at Fukushima have a strong interest in cell therapies that may offer a treatment for conditions caused by exposure to ionizing radiation. We are honored to work with the thought leaders in the field at Fukushima Medical University, Fukushima Global Medical Science Center to further develop PLX-R18 for ARS-related indications,” stated Pluristem CEO Zami Aberman.
“We anticipate that our work with Fukushima Medical University, Fukushima Global Medical Science Center will help to maintain the health of those involved in decommissioning the Fukushima reactors; the decommissioning process is estimated to take about 40 years. We hope that this collaboration can advance efforts to safeguard populations around the world from illness related to radiation exposure,” concluded Mr. Aberman.
PLX-R18 is Pluristem’s second cell therapy product in development. It is already being studied as a treatment for bone marrow that is unable to produce blood cells because of a variety of causes including: ARS; unsuccessful hematopoietic cell transplants; certain cancers; radiotherapy and certain chemotherapies used to treat some cancers; and immune-mediated bone marrow failure. Pluristem is applying for FDA approval of a Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation. Pluristem will also be submitting a protocol for late-stage trials of PLX-R18 in the treatment of the hematological component of ARS, targeting the FDA’s Animal Rule regulatory pathway. With its capabilities, PLX-R18 could potentially treat a broad range of indications related to bone marrow function, which together constitute a substantial global market.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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 our expected collaboration with Fukushima Medical University Hospital, when we discuss our expectation to initiate an animal model to study the potential of PLX-R18 cells to treat high-dose radiation therapy, when we discuss our hope that the collaboration with Fukushima Medical University Hospital will advance efforts to safeguard populations around the world from illness related to radiation exposure, when we discuss our plan to submit a protocol for late-stage trials of PLX-R18 in ARS, targeting the FDA’s Animal Rule regulatory pathway, and when we discuss PLX-R18’s potential to treat a broad range of indications related to bone marrow function, which together constitute a substantial global market. 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.
HAIFA, ISRAEL, November 24, 2015 — Pluristem Therapeutics Inc. (NasdaqCM/ TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that members of its executive and scientific teams will present at the following conferences during the month of December:
Florida Wealth Management & Family Office Conference 2015 Date: December 1, 2015
Location: Miami Beach, Florida
Yaky Yanay, Pluristem’s President, CFO and COO will deliver a corporate presentation.
8th International Conference on Cachexia, Sarcopenia and Muscle Wasting Date: December 5, 2015
Location: Paris
Dr. Tobias Winkler of the Center for Musculoskeletal Surgery & Julius Wolff Institute Berlin, Charité, who served as Senior Scientist on Pluristem’s completed Phase I/II orthopedic study, will present data from the trial. His presentation titled, “First in human allogeneic cell therapy after muscle trauma improves functional regeneration,” will be delivered as part of the ‘Late Breaking Clinical Trials & Trial Updates’ session.
Oppenheimer 26th Annual Healthcare Conference Date: December 8, 2015
Location: New York City
Karine Kleinhaus, MD, MPH, Pluristem’s Divisional VP, North Americas, will deliver a corporate presentation.
Israel Society for Biotechnology Engineering Date: December 13, 2015
Location: Tel Aviv
The following three poster presentations will be delivered:
Pluristem previously announced that on December 6, 2015, the Company’s Vice President of Research & Intellectual Property, Dr. Racheli Ofir, will present new data on PLX-R18 at the American Society of Hematology’s Annual Meeting in Orlando, Florida.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
Data show the mechanism of action by which PLX-R18 treats radiation-induced bone marrow damage
HAIFA, ISRAEL, November 17, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI , TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that Dr. Racheli Ofir, Vice President Research & Intellectual Property, will present new data on PLX-R18 cells at the American Society of Hematology’s (ASH) 57th Annual Meeting to be held in Orlando, Florida, from December 5-8, 2015.
The poster presentation titled “Mechanism of Action of PLX-R18, a Placental-Derived Cellular Therapy for the Treatment of Radiation-Induced Bone Marrow Failure”, will be delivered during Program Session 508: Bone Marrow Failure, on December 6, 2015, at 8:00 PM. The poster will describe data from preclinical studies on irradiated mice showing the mechanism of action by which PLX-R18 cells mitigate the damage to bone marrow caused by exposure to high levels of radiation, such as could occur in a nuclear catastrophe. The poster abstract will be published online in the December 3, 2015 supplemental volume of Blood, a peer-reviewed medical journal published by ASH.
The mechanism of action was revealed through a series of trials conducted in conjunction with Charité Universitätsmedizin Berlin Institute of Medical Immunology, the Brandenburg Center of Regenerative Therapy in Berlin, the Sharett Institute of Oncology, Hadassah Hebrew University Medical Center in Jerusalem, and Indiana University; the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), provided support for the research conducted at Indiana University. A previously published article has already described the improved survival overall as well as restoration of bone marrow function in irradiated animals treated with PLX-R18 cells.
“We have a growing body of preclinical evidence demonstrating PLX-R18’s profound capacity to generate and regulate an adaptive cell response to in vivo chemical signals from damaged tissue; this response, a tailored, time-dependent secretion of a broad array of cytokines that contribute to the healing of the hematopoietic and immune systems, was shown to protect and restore bone marrow function,” stated Pluristem CEO Zami
Aberman. “We are pleased to present this latest data on the mechanism of action of our cells to the world’s thought leaders in hematology and bone marrow failure at this year’s ASH conference.”
PLX-R18 is Pluristem’s second off-the-shelf cell therapy in development. It is designed to treat bone marrow that is unable to produce blood cells due to a variety of causes including ARS, certain cancers or cancer treatments, and immune-mediated bone marrow failure. Pluristem is preparing to initiate a Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation, and, in collaboration with the NIH, a late-stage trial in ARS. With its capabilities, PLX-R18 could potentially treat a broad range of indications related to bone marrow function, which together constitute a substantial global market.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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 our plan to initiate a Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation and, in collaboration with the NIH, a late- stage trial in ARS, and when we discuss PLX-R18’s potential to treat a broad range of indications related to bone marrow function, which together constitute a substantial global market. 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 clinical 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.
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, November 9, 2015 —Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, reported financial results for its fiscal first quarter ended September 30, 2015, and provided financial and corporate highlights for the quarter.
“We made significate progress in the last quarter with U.S FDA, EMA and PMDA regulatory agencies, implementing our strategy of early access to markets. We are well capitalized to continue executing our strategy and achieving multiple meaningful milestones in the coming months, and look forward to sharing the accomplishments with our shareholders”, said Zami Aberman, Pluristem’s Chairman and CEO.
As of September 30, 2015, Pluristem had $47.2 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities. The Company’s net cash used for operating activities was $3.8 million for this first quarter. As a result, Pluristem anticipates being well capitalized to conduct the clinical trials that are planned for initiation in 2016, as well as ongoing R&D efforts to support future products approval.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off- the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP- certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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 our capitalization allowing us to continue executing our strategy and achieving our milestones, when we discuss our anticipation to achieve multiple meaningful milestones in the coming months, when we discuss our anticipation to be well capitalized to conduct two clinical trials that are planned for initiation in 2016, as well as ongoing R&D efforts towards development of a third distinct product, when we discuss our development plan for initiation of late-stage trials of PLX-R18 in the treatment of ARS, when we discuss our intention, together with Charité, to advance the development of PLX- PAD cells in those orthopedic indications that could be eligible for Europe’s Adaptive Pathways Project, and when we discuss our plan to submit a Phase II trial protocol via a European rapid regulatory pathway. 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 clinical 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
BioEurope 2015, EU Advanced Therapies Investor Day, & Berlin Dialogue
HAIFA, ISRAEL, October 27, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that Company executives will be participating in three upcoming conferences in Europe.
Pluristem recently reported its PLX-PAD cells have been selected for the European Medicines Agency’s Adaptive Pathways Project, which is designed to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment option. The Company also recently expanded its Collaboration Research Agreement with the Berlin-Brandenburg Center for Regenerative Therapy at Charité – University Medicine Berlin.
BioEurope 2015
Date: November 2-5, 2015 Location: Munich, Germany
Hillit Mannor Shachar MD, MBA, Vice President Business Development, will participate in meetings with potential partners at BioEurope, which is Europe’s largest partnering conference serving pharma, biotech, and medical device companies.
Date: November 12, 2015 Location: London, England
Zami Aberman, Chairman and CEO, will be a speaker on the panel “Cell Therapy Commercialization”. The conference is hosted by the Alliance for Regenerative Medicine.
Date: November 17, 2015 Location: Berlin, Germany
Zami Aberman, Chairman and CEO, will participate in a dialogue session between the Berlin Senator of Economics, Technology and Research, representatives of academia and companies from the field of life sciences on the topic of “Furthering the Innovative Co-
Operation Models between Industry and Academia on the Way to a Strategically Laid Out Long-Term Partnership in the Field of Life Sciences and Medicine”.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration. Pluristem has a strong intellectual property position; Company-owned, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, October 12, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced it has expanded its five-year Collaborative Research Agreement with the Berlin-Brandenburg Center for Regenerative Therapy at Charité – University Medicine Berlin. The expanded agreement, which was executed on October 11th at the Berlin-Tel Aviv Business Forum in Tel Aviv, broadens the parties’ cooperation to include identification of orthopedic indications that may be eligible for development under Europe’s Adaptive Pathways and conditional marketing approval in the European Union. Pluristem’s program to develop PLX cells in critical limb ischemia is already under discussion with the EMA and other European Stakeholders under the Adaptive Pathways.
Under the five-year Collaborative Research Agreement, Pluristem and Charité have jointly completed a successful orthopedic Phase I/II study using PLacental eXpanded (PLX) cells in muscle injury. The parties have also collaborated on a variety of other indications, including kidney diseases such as acute kidney injury, cardiovascular indications such as inflammatory cardiomyopathy, and comprehensive immunological research for Pluristem’s Peripheral Artery Disease clinical programs.
Dr. Tobias Winkler of the Center for Musculoskeletal Surgery & Julius Wolff Institute Berlin, Charité, who served as Senior Scientist on the completed Phase I/II orthopedic study, commented, “In our studies PLX cells demonstrated the potential to improve overall muscle functionality, with an impressive magnitude of effect. An additional orthopedic PLX indication has a promising potential.”
“Pluristem has enjoyed a very productive relationship with European regulators and our PLX cells have already been selected for the Adaptive Pathways in critical limb ischemia. Working with the prestigious Charité, we look forward to advancing an orthopedic indication through Adaptive Pathways as well,” stated Pluristem Chairman and CEO, Zami Aberman.
The Berlin-Brandenburg Center for Regenerative Therapies was founded as a cooperative research institution of the Charité University Hospital in Berlin and Germany’s largest research association, the Helmholtz Association. The mission of the BCRT is to develop a translational platform for Regenerative Therapies from bench-to-bedside. The five clinical platforms–Immune, musculoskeletal, hepatic, neuronal, and cardiovascular system–are cross-linked by technology platforms (basic science, bio-engineering, translational technologies).
The purpose of Europe’s Adaptive Pathways is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options. The pathway is open to clinical programs in early stages of development only.
After a therapy is selected for the program, the Adaptive Pathways Discussion Group provides detailed guidance to the applicant previous to the formal regulatory processes that precede a trial targeting early or conditional approval and further expansion of the indications.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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 PLX cells’ potential to improve overall muscle functionality with an impressive magnitude of effect, when we discuss the potential of the orthopedic PLX indication to be a promising clinical program and when we discuss our plans to continue to work with Charité to advance an orthopedic indication through Adaptive Pathways as well. For example. we are using forward-looking statements when we discuss the findings of the scientific study and the evidence they provide, that the research may lead to a new understanding of how PLX cells influence and potentially heal the immune system through paracrine and endocrine effects, and opens the window for the use of PLX cells for new indications, or that the data from the study suggest the potential for PLX cells to treat a range of severe conditions related to immune function, or that PLX cells could potentially help treat diseases of the immune system such as aplastic anemia, and autoimmune diseases such as multiple sclerosis, lupus and graft versus host disease (GVHD). 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 clinical settings; 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
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