Category Archives: Pluristem Therapeutics Inc. PSTI

Pluristem Therapeutics, Inc. (PSTI) Reports Latest Developments at Industry Conference

January 22, 2013

Pluristem Therapeutics, a leading developer of placenta-based cell therapies, announced that its senior scientists will present updated developments relating to the company’s proprietary 3D cell expansion technology at the Scale-Up and Manufacturing of Cell-Based Therapies II Conference in San Diego, California, which is being held January 21-23, 2013. These innovations will be implemented in Pluristem’s new state-of-the-art manufacturing facility for expansion of placental-derived mesenchymal-like Adherent Stromal Cells (ASCs).

The following presentations will be made by Pluristem’s team:

• “Bioreactors in Cell Therapy, the Advantages of High-Throughput Culturing Technologies and the Downstream Challenges” – Ohad Karnieli PhD, MBA and VP of Development at Pluristem, will present Pluristem’s new production line and demonstrate how the company has utilized high-throughput culturing to solve many of the problems related to the mass production of ASCs. Dr. Karnieli’s presentation will be made available at the company’s website .

• “From Gene Expression to In Vivo Models – Characterization and Potential Therapeutic Properties of Placenta Derived Mesenchymal-Like Adherent Stromal Cells” – Eytan Abraham, PhD and Product Innovation Research Manager, will address the specific changes that occur in gene regulation and protein secretion when ASCs are grown in a 3D culturing phase and the biological changes and therapeutic advantages of implementing this technology in the mass expansion of ASCs use.

Pluristem Therapeutics, a leading developer of placenta-based cell therapies, has a robust patent and patent applications portfolio, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions, and a seasoned management team. Pluristem is focusing on the development of PLX (PLacental eXpanded) cells administered locally to potentially treat systemic diseases and potentially obviating the need to use the intravenous route.

For more information, visit www.pluristem.com

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Pluristem Therapeutics, Inc. (PSTI) and NYU Medical Center Partner in Study of Diabetic Foot Ulcers

March 16, 2011

Today, Pluristem Therapeutics, Inc. and New York University Medical Center jointly announced that they have formed a partnership to study the use of Pluristem’s proprietary placenta-derived PLX cells for the treatment of Diabetic Foot Ulcers (DFU). The pre-clinical studies are the first step towards a potential Phase II clinical study for treatment of DFU.

An in vitro and a series of animal models will be used to evaluate the role PLX cells have in healing DFU. Through a novel academic-industrial collaborative research paradigm, these trials, with proposed support from the National Institutes of Health (NIH), will be used as a bridge towards the potential treatment of patients with diabetic foot ulcers.

The principal investigator will be Weiliam Chen, R.Ph. Ph.D., Director of the Tissue Engineering Research Laboratory, Department of Surgery at NYU’s Helen L. and Martin S. Kimmel Wound Healing Center. Dr. Chen commented, “Diabetes affects over 170 million people worldwide and more than 20 million Americans with the prevalence expected to double by 2030. Chronic diabetic foot ulcers are the leading cause of lower extremity amputations,” said Dr. Chen. “No new therapy for diabetic chronic wounds has been introduced into clinical use since 1998 and there is a critical unmet need for innovative therapies able to accelerate DFU healing, prevent amputation and reduce associated morbidity and mortality.”

“This partnership with Pluristem is important to developing an innovative advanced cellular therapy,” added Dr. Chen. “Many diabetic patients have advanced atherosclerosis and have lower extremity vascular insufficiencies. Pluristem’s PLX cells can stimulate angiogenesis, which is highly advantageous in treating diabetic chronic wounds. Besides, the PLX cells can directly address cellular impairment in diabetic wounds leading to tissue regeneration in the wound beds.”

“We are very proud to be working with a world-renowned expert such as Dr. Chen and partnering with the NYU Medical Center in using PLX cells for the potential treatment of Diabetic Foot Ulcers,” said Zami Aberman, Chairman and Chief Executive Officer of Pluristem. “Our PLX-PAD cells have been shown to be safe and potentially effective and to improve the quality of life in patients with Peripheral Artery Disease (PAD), some of whom had suffered from ulcers. We are, therefore, excited about testing the PLX cells’ effectiveness in treating DFU.”

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Pluristem Therapeutics Inc. (PSTI) Granted FDA Clearance to Begin “First-In-Human” Placenta-Derived Stem Cell Clinical Trial

March 2, 2009

Pluristem Therapeutics Inc. announced that the US Food & Drug Administration (FDA) has given the company clearance to begin a Phase I clinical trial for the treatment of Critical Limb Ischemia (CLI), the end stage of peripheral artery disease (PAD), using Pluristem’s PLX-PAD. This will be the first clinical trial using PLX-PAD, Pluristem’s placenta-derived stem cells that are expanded using the company’s proprietary 3D PluriX™ technology.

PLX-PAD is a unique one-size-fits-all product that doesn’t require tissue matching before being administered to patients. According to the press release, PLX-PAD will be administered to patients considered “late stage” and defined as patients afflicted with CLI that have not responded to traditional medical or surgical interventions.

Zami Aberman, Chairman, President and CEO of Pluriste, commented, “We are excited the FDA has cleared our IND application for our PLX-PAD product so quickly. PLX-PAD is our first product candidate in our PLX pipeline and this clinical trial will be the first time a placenta-derived stem cell product, grown using our 3D expansion technology, will be used in humans.”

He added, “Our PLX cells are an off-the-shelf, one-size-fits-all product that needs no tissue matching prior to being administered to patients. We believe this unique approach can provide patients with an affordable, immediate source of cell therapy and will position Pluristem as a leader in the cell therapy field.”

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Pluristem Therapeutics, Inc. (PSTI) Prepares Presentation for Italian CREM Workshop Focused on Placental-Derived Cells

February 17, 2009

Pluristem Therapeutics Inc., a bio-therapeutics company focused on the commercialization of unrelated donor-patient cell therapy products for a variety of disorders, announced that its Senior Scientist, Racheli Ofir, Ph.D., has been invited by the Centro di Ricerca E. Menni (CREM), Fondazione Poliambulanza, Brescia, Italy, to present at a workshop titled “Placenta-Derived Cells for Treatment of Inflammatory Diseases: Moving Toward Clinical Applications” on March 13, 2009.

Zami Aberman, Chairman, President and CEO of Pluristem, commented, “The research and medical communities are very interested in the placenta as a superior source for cell therapy. This entire workshop is devoted to studies performed on placental cells and their potential for becoming therapeutic products. At Pluristem, we believe the placenta will play a major role in the developing cell therapy market. Based on substantial pre-clinical data, we have developed a pipeline of placental-derived mesenchymal-like stromal cell products, the first one being PLX-PAD for the treatment of critical limb ischemia.”

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Pluristem Therapeutics, Inc. (NASDAQ: PSTI)

November 3, 2008

Pluristem Therapeutics, Inc. (NASDAQ: PSTI), a bio-therapeutics company, has their focus on commercializing allogeneic (non-personalized) cell therapy products designed to treat a range of severe degenerative, ischemic and autoimmune disorders. Each of Pluristem’s products begin as mesenchymal stromal cells (MSCs). These cells are derived from the human placenta, an organ that has been considered medical waste after childbirth, but recognized by the company as a source of embryonic, non-controversial source of cells. For further information, visit the Company’s web site at www.pluristem.com.

Pluristem Therapeutics Inc. (PSTI) Shares Trade at New 52-Week Low

July 16, 2008

Pluristem Therapeutics Inc. (NASDAQ: PSTI; DAX: PJT) is a bio-therapeutics company working to commercialize non-personalized cell therapy products for the treatment of a variety of severe degenerative, autoimmune disorders for situations where current therapies are impractical. The company was founded in 2001 as A.I. Software, Inc. and changed its name to Pluristem Therapeutics, Inc. in November 2007. The company is based in Haifa, Israel.

Pluristem’s pipeline of products is derived from mesenchymal stromal cells (MSCs) that are obtained from the human placenta, an organ that has traditionally been considered medical waste after childbirth. Because of this, it is a non-embryonic, non-controversial source of cells. The company then expands the MSCs using its proprietary PluriX™ 3D bioreactor. Pluristem’s products are then stored and are “ready to use” with no matching needed.

Current products in development include:

PLX-PAD is intended to treat patients suffering from the critical stage of peripheral artery disease (PAD). PAD affects millions of patients whose symptoms stem from a decrease in blood supply primarily to the lower extremities. PAD is aggravated by conditions such as atherosclerosis, diabetes and smoking. Animal studies have shown that PLX-PAD significantly increases the number of new blood vessels and blood flow to the extremities. Pluristem plans for human studies to begin later in 2008.

PLX-BMT is intended to address the global shortfall of matched stem cells (HSCs) required for bone marrow transplants (BMT), because approximately 60% of patients diagnosed with leukemia each year are unable to find a suitable bone marrow donor match. Tests in animals have shown promising results, and Pluristem expects to begin human trials in early 2009.

PLX-STROKE shows potential to become a new treatment for functional recovery from a stroke.

PLX-MS shows potential for the treatment of Multiple Sclerosis, an autoimmune disorder in which the immune system attacks the central nervous system (CNS). PLX-IBD shows potential for the treatment of ulcerative colitis and Crohn’s disease, known collectively as Inflammatory Bowel Disease (IBD).

Pluristem also believes its PLX cells are potentially useful for other health issues such as organ transplantation, orthopedic injuries and radiation sickness.

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Dutton Associates Featured Company: Pluristem Therapeutics, Inc. (PSTI)

July 10, 2008

Pluristem Therapeutics, Inc. (NASDAQ: PSTI) is a regenerative biotherapeutics corporation focused on commercializing non-personalized (allogeneic) stem cell therapy products for the treatment of severe degenerative, malignant, and autoimmune disorders. The company is dedicated to developing a platform designed to create stem cell-based therapeutic products that can treat severe blood, cardiovascular, autoimmune, and other disorders.

The company is currently developing the PluriX™ 3D Bioreactor System, which is designed to create an artificial physiological environment where mesenchymal stem cells can expand in three dimensions and reproduce without the use of exogenous biologics or pharmacological products. This new method is superior to the traditional method of MSC expansion that uses standard, two-dimensional cell culture techniques in conjunction with fetal bovine serum, growth factors, and leukemia inhibitory factor.

Pluristem’s products are obtained from mesenchymal stromal cells found in the placenta—not from controversial embryonic stem cells—and are stored in a readily available state for patient use. The company anticipates that this new technology has the potential to partake of the approximately $30-billion therapeutic and regenerative cellular industries.

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Pluristem Therapeutics Inc. (PSTI) Conducts Trials Showing Product Advancement

June 2, 2008

Pluristem Therapeutics works to commercialize cellular biotherapies for the treatment of several degenerative, ischemic and autoimmune conditions. In a release that was largely overlooked last week, Pluristem conveyed the success of recent clinical trials, showing the pronounced effectiveness of its PLacental eXpanded (PLX) cells in treating inflammatory bowel disease (IBD).

Pluristem defines its PLX product as mesenchymal stromal cells (MSCs) that have been expanded using the company’s proprietary PluriX™ 3-D bioreactor. Basically, MSCs are undifferentiated, protoplasmic placental cells.

In the study, mice which were afflicted with IBD were administered PLX cells intrarectally, while a control group was treated with a saline solution. Pluristem’s treatment was shown to greatly reduce colon lesions associated with IBD in both macroscopic and microscopic evaluations, as compared to the control subjects.

Pluristem President and CEO, Zami Aberman stated: “This trial’s favorable results, which demonstrate our PLX cells’ ability to treat Inflammatory Bowel Disease, as well as our previous studies indicating their potential use to help Multiple Sclerosis patients, show the potential for our PLX cells to treat global autoimmune diseases. We believe that the unique capabilities of our PLX cells will lead to cooperative efforts between Pluristem and other significant players in the field of autoimmune diseases to benefit millions of patients.”

He continued, “As a cellular therapy, our PLX cells, that are derived from human placenta, a non-controversial, non-embryonic, adult stem cell source and are stored ready-to-use, could prove to be a readily available therapeutic alternative or addition for these disorders.”

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Lebed.biz Featured Company: Pluristem Therapeutics Inc. (PSTI)

April 29, 2008

In less than a month’s time, Jonathan Lebed’s recommendation to buy PSTI on April 5th at $2.05 has translated into a 148% profit. That is an incredible value, and one of the reasons for this increase – and potential future increases – lies in the cutting edge technology that Pluristem possesses. Pluristem Therapeutics engages in the research and development of mesenchymal and stem cell production technology, and the commercialization of cell therapy products. Their cell therapy products are used for the treatment of a variety of severe degenerative, ischemic and autoimmune disorders where current therapies are unavailable or inadequate.

This field is still somewhat controversial, but is creating some of the best cures for diseases that were previously thought to be untreatable. Pluristem has three products currently on the market, PLX-PAD, PLX-I and PLX-STROKE, which have proven benefits in the medical community. PLX-PAD is intended to treat patients suffering from the critical stage of peripheral artery disease (PAD), manifesting as limb ischemia. It has been proven to increase blood flow to lower extremities that surgery and traditional medicine cannot match. PLX-I is intended to resolve the global shortfall of matched hematopoietic stem cells (HSCs) for bone marrow transplantation. Over 60% of leukemia patients in need of transplant are unable to find a suitable match, but – if successfully combined with umbilical cord blood – this technology will create an alternative to the transplant with no matching required.

Pluristem Therapeutics announced on April 23 that it was chosen to present at the First Annual Israeli Presidential Conference termed “Facing Tomorrow”, to be held on May 13-15, 2008 in Jerusalem. The conference will focus on Jewish and Israeli contributions to humanity, and will showcase 60 inventions and innovations developed by Israeli scientists, researchers and inventors that have the potential to revolutionize the future for Israel as well as the world. In addition to hundreds of leading scientists, researchers and inventors, the most notable guests attending the conference will be President George W. Bush, Former British Prime Minister Tony Blair, Former President of the USSR Mikhail Gorbachev, Former U.S. Secretary of State Dr. Henry Kissinger, New York Times columnist Thomas L. Friedman, and Chairman and CEO of News Corporation, Rupert Murdoch.

Pluristem’s President and CEO, Zami Aberman, stated, “Pluristem is pleased to be invited to this high level international conference to present its business and products in development to world-renowned business leaders, technology thought leaders and entrepreneurs.” “It will be the first opportunity for the company to show their technology to outsiders of the medical community. Lebed and others believe that this stock could take off in the weeks following this world famous conference.

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Lebed.biz Featured Company: Pluristem Therapeutics Inc. (PSTI)

April 8, 2008

Pluristem Therapeutics Inc. (PSTI) is a leading bio-therapeutics company with research and manufacturing facilities located in Israel. The company derives its products from stem cells which are obtained from the placenta, a non-controversial source unlike embryonic stem cells. The company is seeking to commercialize these non-personalized stem-cell therapy products for the treatment of certain, severe autoimmune disorders.

After obtaining these stem cells, Pluristem literally grows its product in a proprietary PLURI-X bio-reactor and the product is stored “ready-to-use”. The bio-reactor mimics the natural microstructure of bone marrow so supplemental growth materials are not required.

The company’s initial product, called PLX-I, is designed to target the $3 billion market for matching tissue needed for bone marrow transplantation. Pluristem also believes that its PLX cells will be useful in treating a variety of other diseases, and is currently conducting pre-clinical trials for Peripheral Artery Disease (PAD), Critical Limb Ischemia (CLI), and blood cancer.

Pluristem is also currently conducting in vitro trials with its product with regard to Parkinson Disease, and the preliminary results have been promising. The company is also conducting trials for treating ischemic stroke, and seems poised to take advantage of the fast-growing $30 billion therapeutic and regenerative cellular market.

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