Menu
Safety clearance is another step towards the start of Phase II CLI trial via Japan’s accelerated approval pathway
HAIFA, ISRAEL, August 12, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has cleared the Company’s PLX-PAD cells for use in clinical trials in Japan. This clearance is required in order to apply for approval to conduct a Phase II study of PLX-PAD in critical limb ischemia (CLI) through Japan’s accelerated regulatory pathway for regenerative medicine. This regulatory pathway generally allows for conditional, time- limited marketing approval after a single successful Phase II trial.
“We are very pleased to receive this important safety clearance to administer PLX-PAD to Japanese patients during our anticipated clinical trial in Japan. Our next step is to conclude the discussion of the clinical protocol with the PDMA for our proposed Phase II CLI study. We expect to talk with the PDMA during the last quarter of 2015, and are anticipating that we will receive permission to begin the trial by the end of 2015,” stated Pluristem CEO Zami Aberman. “This approval would enable us to potentially start a trial in early 2016.”
Safety clearance is the second of three authorizations required by the PMDA prior to commencement of a Phase II trial. Pluristem announced that it received the first of these in May 2015, when the Agency accepted PLX-PAD cells’ quality standards and large- scale manufacturing methods. The third and final step, yet to be achieved, is approval of the clinical study design.
Japan’s Act on the Safety of Regenerative Medicines went into effect in November 2014. It effectively fast-tracks the 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. No formal Phase III trial is expected to be required.
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 whether the PDMA will allow us to conduct a Phase II clinical study of PLX-PAD in CLI, the expected timing for the approval of our Phase II protocol for CLI by the PDMA, the expected timing for starting a Phase II trial for CLI and whether a Phase III clinical trial will be required. 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; changes in legislation, 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
Pluristem also presented plans to develop accelerated clinical programs for PLX cells in ischemic stroke, muscle wasting and hip fracture
HAIFA, ISRAEL, August 10, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that it has conducted detailed discussions with the European Adaptive Pathways Discussion Group regarding the clinical development plan for PLX cells in Critical Limb Ischemia (CLI) patients, and received guidance on the planned design of the initial Phase II trial of PLX cells in a subgroup of patients with severe CLI. Positive results from this trial could be sufficient for conditional approval to market PLX cells in this indication. Pluristem is receiving this in-depth guidance from European regulatory officials following the selection of this clinical program for the European Medicine Agency’s Adaptive Pathways project in May 2015.
In the discussions Pluristem also presented other indications for potential development through the Adaptive Pathways project; these were ischemic stroke, muscle wasting, hip fracture and additional subgroups of CLI.
The Adaptive Pathways project is part of the European Medicine Agency’s (EMA) efforts to improve timely access for patients to new therapies. It targets treatments with the potential to heal serious conditions with an unmet medical need, and may reduce the time to a medicine’s approval or to its reimbursement for targeted patient groups.
“We are very pleased with the invaluable guidance we are receiving from EMA regulatory officials as we design our clinical trial protocol in a subgroup of CLI with particularly high unmet medical need,” stated Pluristem CEO Zami Aberman. “As we previously announced, we plan to apply to expand our program in CLI to include additional subgroups of the disease for development via the Adaptive Pathways, and expect to apply for consideration of other important indications with large potential markets. We are also benefiting from high-level guidance on these initiatives. Development of indications via the Pathways project could potentially provide patients earlier access to our therapies, while creating value to our shareholders by shortening time to market. In parallel, we continue to advance our clinical development programs for PLX cells in the U.S.”
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 regarding the formal regulatory processes that precede a trial targeting early 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 that a successful phase II study could potentially be sufficient to receive early regulatory approval for marketing of PLX cells to treat CLI, when we discuss our plans to apply to expand our program in CLI to include additional subgroups of the disease, and in parallel to apply specifically to each of the other indications we presented to the EMA with large potential markets, or that this expansion allow us to optimize our long range planning for our [European?]clinical development side by side with our US clinical development plan and potentially cut time to market significantly or when we discuss that early regulatory approval after a successful Phase II trial could provide patients earlier access to our therapies, while creating value to our shareholders by shortening time to 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 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
Study results published in peer-reviewed scientific journal
HAIFA, ISRAEL, July 27, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI , TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced the publication of a scientific study regarding PLacental eXpanded (PLX) cells in the prominent peer-reviewed journal Stem Cells. The paper, titled “Mesenchymal stromal cells prevent allostimulation in vivo and control checkpoints of Th1 priming: migration of human DC to lymph nodes and NK cell activation”, describes the findings of a recent mechanism of action study conducted by independent scientists at the Berlin-Brandenburg Center for Regenerative Therapy at Charité – University Medicine Berlin. The paper was co-authored by scientists from the Charité and Pluristem.
The study demonstrated mechanisms by which PLX cells and other mesenchymal stromal cells (MSC) influence the immune system in order to modulate immune reactions and to prevent immune reactions against the cells when they are administered as an off-the-shelf product (unmatched). It was demonstrated in vitro that MSC, and in particular PLX cells, control the induction of an immune response at several points. The main target for MSC and PLX cells in this process are dendritic cells, which are the key player in inducing a T-cell immune response. Moreover, in vivo data from patients suffering from critical limb ischemia who were treated with PLX cells in a phase I/II study confirmed that HLA-unmatched PLX cells did not provoke an immune response in immunocompetent patients.
These findings confirm the feasibility of using PLX cells in an off-the-shelf manner, and explain the mechanisms that make this possible.
“Our findings in this study provide novel evidence for the regulation of several checkpoints of T- cell priming by PLX cells and other MSC, via modulation of the crosstalk between myeloid dendritic cells and natural killer cells. While the complete mechanism of immunomodulation by PLX cells requires further investigation, this study demonstrates how PLX cells might inhibit the immune responses of Type 1 T helper cell,” stated the study’s Principal Investigator, Dr. Hans- Dieter Volk, Director of the Berlin-Brandenburg Center for Regenerative Therapy and head of the Institute of Medical Immunology at the Charité.
“The investigation of the interaction between unmatched PLX cells and patient immune systems is central to Pluristem’s clinical research. This research may lead to a new understanding of how PLX cells influence, and potentially heal, the immune system, thereby possibly expanding the use of PLX cells for new indications,” stated Pluristem CEO Zami Aberman. “By modulating a patient’s immune response, PLX cells could potentially help treat severe diseases of the immune system such as aplastic anemia, which has been designated as an orphan indication, autoimmune diseases such as multiple sclerosis and lupus, as well as graft versus host disease (GVHD),” Aberman added.
PLX cells, and other MSC, affected complex pathways in order to prevent the priming of Type 1 T helper cell (Th1) responses towards major histocompatibility complex mismatches. The study utilized both in vitro and ex vivo data from PLX cells and other MSC. In vivo evidence came from patients in a study of PLX cells for critical limb ischemia. Peripheral blood mononuclear cells (PBMC), collected from the patients at different time points after PLX injection, were re- stimulated with the corresponding PLX-PAD cells or unrelated third party donor PBMC. The in vivo induced memory Th1 response was measured by using the IFN-g Elispot test. There was no, or only very marginal, Th1 priming specific for the MHC-mismatch even after application of high-dose allogeneic PLX cells. Collectively, the study data indicated that MSC, and in particular PLX cells, inhibit the priming of Th1-driven immune responses via modulation of myeloid dendritic cell (mDC). The maturation, migration to stimulatory chemokines, and the release of NK and T-cell stimulating cytokines of mDC are inhibited by PLX cells and some other MSC. For example, mDC exposed to PLX/MSC secreted reduced levels of IL-12p70and IL-1b and increased levels of IL-10 and IL-1Ra, representing a cytokine profile typical for tolerogenic dendritic cells (TolDC), which are required for the development and maintenance of immunological tolerance.
The Berlin-Brandenberg Center for Regenerative Therapy was established as an interdisciplinary translational center with the aim of enhancing endogenous regeneration by cells, biomaterials, and factors which can be used to develop and implement innovative therapies and products.
The primary focus of the Center is on diseases of the immune system, the musculoskeletal system and the cardiovascular system for which only insufficient treatment options are available.
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 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). 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, June 25, 2015– Pluristem Therapeutics Inc. (NASDAQCM:PSTI, TASE:PSTI) today announced that it has entered into definitive agreements to sell 6,800,000 shares of common stock and warrants to purchase up to 4,080,000 shares of common stock at a combined price of $2.50 per share and related warrants. The gross proceeds from the offering are expected to be approximately $17.0 million. The warrants have an exercise price of $2.85 per share of common stock, are immediately exercisable and expire 5 years from the closing of this offering.
Maxim Group LLC acted as lead placement agent for the offering.
The offering is expected to close on or around June 30, 2015, subject to customary closing conditions.
The shares and warrants are being offered by Pluristem pursuant to a shelf registration statement on Form S-3 (file number: 333-199303) filed pursuant to the Securities Act of 1933, which was previously filed with, and declared effective by, the Securities and Exchange Commission (SEC). When filed with the SEC, copies of the prospectus supplement and the accompanying base prospectus relating to this offering may be obtained at the SEC’s website at http://www.sec.gov or by request at Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at 212-895-3745
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
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 expected closing of this offering. 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, including closing conditions being met for the offering, that could cause actual results to differ materially from those described in the 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
Phase I trial of PLX-PAD cells underway in Australia for pulmonary arterial hypertension
HAIFA, ISRAEL, June 24, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced that it has been granted an Australian patent titled “Adherent Cells From Placenta Tissue and Use Thereof in Therapy”. Patent #2009288781 covers Pluristem’s proprietary, three-dimensional method of growing cells from placental or adipose tissue, cells produced by the process, and the use of such cells in the potential treatment of a broad range of conditions. These include peripheral artery disease, other ischemic and cardiovascular diseases, graft-versus-host disease, organ transplantation, cancer, and autoimmune diseases. The patent term will extend until 2027.
The newly granted patent is Pluristem’s fifth in Australia, with six more patent applications pending there. Australia has one of the longest life expectancies in the world, and healthcare spending in 2013 totaled $172 billion. It is an important market for therapies that target chronic diseases that occur more commonly in ageing populations, such as critical limb ischemia, intermittent claudication and muscle injury or wasting, all of which figure prominently in Pluristem’s clinical pipeline.
Pluristem’s out-licensing partner, United Therapeutics, is currently conducting a Phase I study in Australia of Pluristem’s cells in the treatment of pulmonary arterial hypertension, and is recruiting patients for the second cohort in the study.
Pluristem has been issued over 40 patents, and has approximately 150 more patents pending worldwide.
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. 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, June 17 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced that its wholly owned subsidiary, Pluristem Ltd., has been awarded 11.1 million New Israeli Shekels (approximately $2.9 million) from the Office of the Chief Scientist (OCS) of the Israeli Ministry of Economy. The grant will support R&D activities for calendar year 2015.
“We are delighted to receive the OCS grant to support clinical trials of PLX cells, and innovations in the use of serum free medium in our cell cultures,” stated Zami Aberman, Chairman and CEO of Pluristem. “This OCS award is designed to promote hi-tech and biotech R&D in Israel. Israel has emerged as a global hub for breakthrough technologies, and the OCS’s funding program contributes to this phenomenon. Pluristem is very proud to be among Israel’s leading life sciences companies.”
The OCS, empowered by the Law for the Encouragement of Industrial Research & Development – 1984, oversees all government sponsored support of R&D in the Israeli hi-tech and bio-tech industries. This broad-spectrum support stimulates the development of innovative, state-of-the-art technologies, enhances the competitive power of the industry in the global hi-tech market, and creates employment opportunities.
According to the OCS grant terms, Pluristem Ltd. is required to pay royalties of 3% – 4% on sales of products and services derived from technology developed using this and other OCS grants until 100% of the dollar-linked grants amount plus interest are repaid. In the absence of such sales, no payment is required.
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 receipt and use of the OCS grant. 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, June 3, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced that it has been awarded a Smart Money grant from Israel’s Ministry of Economy. The program’s aim is to assist companies to extend their activities in international markets. The Israeli government will grant Pluristem budget and resources for the marketing of its advanced cell therapy products in Japan and for regulatory activities there. Pluristem will also receive assistance from Israel’s trade attachés stationed in Japan, and from experts appointed especially by the “Smart Money” program. In this first round of the program seventy-nine requests were submitted, of which thirty-nine were approved.
Pluristem recently announced that Japan’s Pharmaceuticals and Medical Devices Agency agreed to the proposed quality and large-scale manufacturing methods for PLX-PAD cells for use in clinical trials. This is an important prerequisite for initiation of a Phase I/II study in critical limb ischemia via Japan’s Accelerated Pathway for Regenerative Medicine. The new regulatory pathway can significantly reduce time to market for regenerative therapies such as PLX cells.
“We are pleased to receive the support of the Israeli government in our efforts to bring our cell therapy products to Japan. In recent years the governments of Israel and Japan have increased cooperation on many fronts including investment and trade. We are targeting the Japanese market and expect to be one of the first to launch an allogeneic cell therapy there via Japan’s Accelerated Pathway for Regenerative Medicine regulation,” stated Pluristem Chairman and 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, 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 potential of the Japan’s Accelerated Pathway for Regenerative Medicine regulation to significantly reduce time to market our regenerative therapies and when we discuss our expectation to be one of the first to launch an allogeneic cell therapy in Japan via such new 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 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
Company fortifies IP assets in important markets
HAIFA, ISRAEL, June 1, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced it has been granted patents covering cell manufacturing, pharmaceutical compositions and disease treatment in China, South Korea, Mexico, Russia, and Israel.
The State Intellectual Property Office of the People’s Republic of China granted Pluristempatent #ZL201080054298.4. It is titled “Adherent Cells from Placenta and Use of Same in Disease Treatment”, and addresses the use of adherent placental cells for the treatment of muscle trauma, skeletal muscle defects, neuropathic pain, peripheral nerve injury, and neurodegenerative disease.
The Korean Intellectual Property Office issued to Pluristem patent #KR101490449 titled “Methods for Cell Expansion and Uses of Cells and Conditioned Media Produced Thereby for Therapy”. The patent covers important aspects of Pluristem’s platform technology, including: adherent placental or adipose cells that were expanded utilizing Pluristem’s culture methods; Pluristem’s culture methods themselves; and pharmaceutical compositions containing these cells for various therapeutic indications.
Mexico’s Instituto Mexicano de la Propiedad Industrial issued to Pluristem patent #MX 327981 titled, “Method and Apparatus for Maintenance and Expansion of Hemopoietic Stem Cells and/or Progenitor Cells”, addressing the use of stromal cells for supporting the growth of Hematopoietic Stem Cells in the context of bone marrow transplantation. Pluristem has also been issued patent #MX327763 in Mexico, which is titled “Adherent Cells from Placenta Tissue and Use Thereof in Therapy”. This patent addresses methods of growing placental cells under three-dimensional culturing conditions.
The patent titled “Adherent Cells from Placenta Tissue and Use Thereof in Therapy” has also been issued to Pluristem by Rospatent in Russia under patent #RU2539786. This patent addresses adherent placental cells that have been cultured under 3D conditions.
The Israel Patent Office issued the Company patent #IL194232, titled, “Methods for Cell Expansion and Uses of Cells and Conditioned Media Produced Thereby for Therapy.” The patent addresses methods of growing adherent placental or adipose cells under 3D conditions, cells produced by the methods, methods of producing conditioned medium from the cells, and medium produced by the methods.
“Pluristem has been granted key patents in multiple important markets. We believe the continued expansion of our intellectual property assets fortifies our position as a leader in the development, manufacturing, and clinical application of placental-derived cell therapies,” stated Pluristem CEO Zami Aberman. “These newest additions to our IP portfolio are significant as we pursue our strategy to bring PLX cells to markets worldwide.”
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 our pursuit of our strategy. 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, May 27, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced participation at two important conferences:
International Congress of Radiation Research Location: Kyoto, Japan
Date: May 27, 2015
Presentation title: The Mechanism of Action of Placenta Derived Cellular Therapy in Mitigation of Acute Radiation Syndrome
Presented by: Racheli Ofir, Ph.D., Vice President of Research & Intellectual Property
The Japanese government is focused on the development of treatments for Acute Radiation Syndrome (ARS), as is the U.S. National Institutes of Health. ARS is caused by exposure to high levels of radiation, and produces severe, sometimes lethal damage to the bone marrow and other physiologic systems and organs. Pluristem recently announced the results of an NIH study conducted in animals exposed to high levels of radiation: injection of PLX-R18 cells, as compared to injection of a placebo, resulted in a significant improvement in survival, as well as in the recovery of blood cell production after irradiation. These blood cells are necessary to resist infection, prevent hemorrhage, and transport oxygen throughout the body.
International Society for Cellular Therapy, 21st Annual Meeting Location: Las Vegas, Nevada
Date: May 28, 2015
First Session titled: Hot Topics in Process and Product Development; Particulates, Serum Free Media and Bioreactors
Chaired by: Ohad Karnieli, Ph.D., MBA, Vice President of Technology & Manufacturing Date: May 29, 2015
Second session titled: Translational Process Development
Chaired by: Ohad Karnieli, Ph.D., MBA, Vice President of Technology & Manufacturing
Advanced Therapy Medicinal Products Location: Amsterdam, Netherlands Date: June 3, 2015
Presentation title: Case Study: Comparability of MSC’s during Scaling Up – From Design to Approval
Presented by: Ohad Karnieli, Ph.D., MBA, Vice President of Technology & Manufacturing
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.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Dear fellow stockholders,
A common objective drives our efforts at Pluristem: to bring innovative, effective treatments to patients suffering from conditions with few or no adequate treatment options. With exciting progress made on many fronts since the start of 2015, Pluristem has moved closer to reaching this objective. We have accomplished a key element of our strategic plan to significantly shorten the time to commercialization of our PLX-PAD cells in critical limb ischemia (CLI), while also advancing development of PLX-R18, our second product. We have reported additional positive findings from our successful Phase II muscle trial, which already met its primary and secondary endpoints last year. Pluristem has also made meaningful additions to its robust patent portfolio. We anticipate new accomplishments in 2015, and look forward to sharing them with you.
A key element of Pluristem’s strategic plan has been to reduce time to commercialization of our PLX-PAD cells in critical limb ischemia (CLI). To achieve this we applied to the new Adaptive Pathways pilot project in Europe and to the new regulatory pathway for regenerative therapy created under the Regenerative Medicine Law in Japan. In 2014, both Europe and Japan began offering unique opportunities to bring new products to market more quickly. Each country may now allow for limited commercialization of a product after a single successful initial trial, followed by further data collection and analysis after marketing has begun in order to evaluate the product for full marketing authorization. After the two programs were announced, we began working immediately to apply for the chance to commercialize PLX-PAD cells following a Phase II study and to circumvent the need for a long and expensive Phase III study. Building on the positive results of our two completed Phase I trials in CLI, we prepared and submitted applications to both new pathways.
On May 18, 2015, Pluristem announced that its PLX cell program in critical limb ischemia (CLI) was selected for the European Medicines Agency’s Adaptive (EMA) Pathways pilot project, the goal of which is to improve timely access for patients to new medicines. Pluristem’s successful application could significantly curtail the time and financial investment needed to bring the product to market. The acceptance into the Adaptive Pathways will provide Pluristem with detailed guidance and frequent, high-level communications with the Adaptive Pathways discussion group and other relevant stakeholders while preparing a trial protocol for submission to the EMA. A successful phase II study could then be the basis for a limited marketing authorization of the PLX-PAD cells in the subset of CLI tested in the trial, and also the potential for expansion of the indication or even expansion to other indications with PLX-PAD. Pluristem’s manufacturing facility was approved in 2014 by EMA’s Qualified Person after inspection of the
manufacturing facility and the 3D cell expansion technology platform. The Approved factory is capable of producing up to 150,000 doses per year and is ready to supply PLX-PAD as needed. Subject to a successful Phase II trial and with the EMA’s conditional approval, Pluristem anticipates that PLX-PAD cells could enter the market in 2018 to treat patients with the clearly defined subtype of CLI studied in the trial.
On May 13, 2015 the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) recognized the current quality and commercial-scale manufacturing methods of PLX-PAD cells for use in CLI trials in Japanese patients. This was a crucial step towards Pluristem’s acceptance into Japan’s new accelerated pathway for regenerative medicines. This pathway permits a regenerative medicine product to reach patients without having to complete lengthy and expensive Phase III clinical trials. An exploratory study whose results show that a product is safe and likely to be effective can be sufficient for the product to receive conditional, time-limited marketing authorization. Following approval, the product is subject to post-marketing safety monitoring in conjunction with surveillance and study to further confirm its efficacy and safety. The new Regenerative Medicine Law presents an exceptional opportunity for Pluristem, and we eagerly await the PMDA’s decision regarding our application to the pathway.
Pluristem continues working to establish additional business collaborations with pharmaceutical companies. The new opportunities in Europe and Japan have translated into substantial interest from potential partners who would like to work together with us in both geographic regions. We are hopeful that we will achieve additional partnership for our CLI program over the next twelve months, and are also discussing partnerships for our muscle injury program and our emerging clinical program for PLX-R18, our second product. The first planned study of PLX-R18 in humans would be a Phase I trial to be submitted later this year.
More details about the program are provided below.
Since the start of 2015, Pluristem has been granted key patents from Europe, Israel, South Africa, China, South Korea, Mexico and Russia. The European Medicines Agency’s selection of Pluristem’s PLX-PAD program in CLI for the Adaptive Pathways pilot project, together with patent No. EP2200622, granted in 2014 and titled “Adherent Cells From Adipose or Placenta Tissues and Use Thereof in Therapy”, whose claims cover treatment of ischemia with placental- derived cells propagated using a 3D culture, place Pluristem in a unique position to move forward with its CLI program in Europe.
Other activities in the cell therapy arena also contribute to maintain our position as a leader in cell therapy. We continue to study the mechanism of action and capabilities of our cells and to share this knowledge with the scientific community and the cell therapy industry. Pluristem management has presented at 9 major scientific and industry conferences since January 2015. As active members in the Alliance for Regenerative Medicine and the International Society for Cellular Therapy, Pluristem continues to support the development of the regenerative medicine industry as a whole.
Over the next 12 months we are looking forward to continuing our momentum and achieving several additional milestones
We will continue to execute our long-term strategy to bring innovative and effective treatments to market in a timely fashion and to become a leader in the development and manufacture of cell therapies. We recognize and appreciate your continued support, and look forward to sharing upcoming achievements with you.
Sincerely, Zami Aberman
Chairman and Chief Executive Officer
For Pluristem Conference presentation, May 25, 2015- http://www.pluristem.com/images/Pluristem_for_TASE_Combined.pdf
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 moving closer to reaching our objective to bring innovative, effective treatments to patients, when we discuss our anticipation for new accomplishments in 2015, when we discuss potential of approving our cells for the treatment of CLI via the Adaptive Pathway to significantly curtail the time and investment needed to bring this product to market, when we discuss our anticipation that PLX- PAD cells could enter the market in 2018 to treat patients with the clearly defined subtype of CLI studied in the trial, when we discuss achieving additional partnership for our CLI program over the next twelve months, when we discuss our planned study of PLX-R18 in humans, the timing of its submission and related FDA and NIH approvals, when we discuss the timing for completion of recruitment for our phase II IC trial, when we discuss that PLX-PAD cells may potentially treat additional muscle indications, when we discuss the timing for submission of Phase II study protocol to several national authorities for PLX-PAD cells in CLI and submission for Phase I/II study protocol to the PMDA, or when we discuss timing for receipt of preliminary data from the Phase I trial in pulmonary arterial hypertension.
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. In addition, historic results of scientific research do not guarantee that the conclusions of future research would not suggest different conclusions or that historic results referred to in this letter would not be interpreted differently in light of additional research or otherwise. Also, while the company’s program was selected for the European Medicines Agency’s Adaptive Pathways pilot project, as well as recognized by the PMDA, these agencies are not bound by these communications and accordingly may change their position in the future due to reasons within or outside the control of Pluristem.
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.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.