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| Pluristem Therapeutics, Inc. (PSTI) | |||
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Business Summary excerpt from SEC filing dated: Septemer 5, 2007
Our Current Business We are dedicated to the commercialization of cell therapy (technology that replaces or help to replace (regenerate) diseased or dysfunctional cells with healthy, functioning ones) to treat severe blood, cardiovascular, autoimmune, and other disorders. We use stem cells for its cell therapy products, as these stem cells have the potential to treat a range of complicated diseases, such as leukemia, lymphoma, myeloma, and other diseases. Stem cells are unspecialized cells that can renew themselves for long periods through cell division and have the ability to differentiate into specialized cells (e.g. nerve cells, blood cells, lung cells, etc.). Our first product, PLX-I, seeks to address the global shortage of matched tissue for bone marrow transplant (BMT) patients, with the intent of eliminating the currently deficient BMT search-and-match process. Unlike BMTs, where a perfect tissue match between donor and patient is required to perform a transplant, we employ umbilical cord blood (UCB) as a source of hematopoietic stem cells that are needed for the transplant. Because these cells are younger and less likely to be rejected by the immune system, they can be used successfully even when there is only a half-match. This means that ~95% of patients seeking stem cell transplants may find a compatible donor versus traditional methods, where only approximately 30% of patients find a match. The key to using UCB lies in finding ways to enlarge the quantity of hematopoietic stem cells to improve engraftment. Our technology is intended to improve the engraftment process of the hematopoietic stem cells found in UCB. Engraftment is the process by which newly transplanted stem cells begin to produce normal quantities of mature cells in the body. This is accomplished by using our most advanced cell therapy product, PLX-I. PLX-I is based on expanding mesenchymal stem cells from a placenta obtained after birth (known as Placenta expanded or PLX cells) and cultivating these cells with the Company’s proprietary PluriX™ Bioreactor System. By co-transplanting both mesenchymal stem cells and hematopoietic stem cells, Pluristem aims to improve the engraftment rate of the hematopoietic stem cells. |
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This System mimics the natural environment of human bone marrow and permits stem cells to expand (grow and replicate) outside of the body devoid of differentiation—a difficulty encountered by current stem cell-expansion technologies.
A mesenchymal stem cell is a type of adult stem cell found in both the bone marrow and placenta that can differentiate into a variety of non-hematopoietic cells, such as bone, cartilage, muscle, and neural cells. A hematopoietic stem cell can be isolated from peripheral blood, UCB, or bone marrow, can self-renew, differentiate into a variety of specialized blood-producing cells (e.g. red blood cells, white blood cells, or platelets), move out of the bone marrow into circulating blood, and undergo apoptosis (programmed cell death)—a process by which cells that are detrimental or unneeded self-destruct. The Company’s potential therapeutic products are intended to be used as an alternative or improvement to the cells currently harvested and used in BMTs. Scientists have found that taking hematopoietic stem cells from tissues at earlier development stages (such as UCB) have a greater ability to self-replicate and are less likely to be rejected by the immune system—possibly making them more useful for therapeutic transplantation. Furthermore, to our knowledge, there is no such technology that can increase the number of mesenchymal stem cells taken from a placenta without causing differentiation. Stem Cells Unspecialized cells that can renew themselves for long periods through cell division and have the ability to differentiate into specialized cells are called stem cells. Stem cells are separated from other cells within the body by three general properties: (1) they are capable of self-division and self-renewal over long time periods; (2) they are unspecialized; and (3) they can give rise to specialized cells. Stem cells offer the possibility of renewable sources of replacement cells and new tissues to treat many kinds of diseases, conditions, and disabilities. All stem cells originate from three places: (1) certain adult tissues (adult); (2) UCB (umbilical); and (3) the human embryo (embryonic). Stem cells obtained from a person after birth are adult stem cells and are found within various tissues that make up the body. These stem cells act as a repair and maintenance systems, dividing regularly to provide the body with specialized cells to take the place of those that perish. Pluristem’s technology employs only adult mesenchymal stem cells from the placenta. Bone Marrow Transplants (BMTs) Each year, hundreds of thousands of patients are diagnosed with diseases that can be treated by a hematopoietic or blood stem cell transplant, such as a BMT procedure. This procedure replaces diseased or treatment-damaged bone marrow with healthy marrow. The hematopoietic stem cells used come from one of three types of bone marrow donation: (1) from a human leukocyte antigen (HLA) tissue type matched relative or unrelated donor (an allogeneic transplant); (2) from patients who have previously donated their own marrow (autologous transplant); or (3) from a patient’s genetically identical twin (syngeneic transplant). Approximately 150,000 people require a BMT annually, while only 45,000 to 60,000 receive them. Of these, an estimated 100,000 patients each year face difficulties obtaining a BMT due to either a lack of a suitable donor or failed transplants due to complications, such as Graft-versus-Host disease (GVHD), a potentially fatal condition in which donor cells can attack the recipient’s tissues. Umbilical Cord Blood (UCB) Transplants UCB is retrieved from the umbilical cord and placenta after the birth of a baby. While normally the cord and placenta are discarded after birth, the cord blood can be saved, frozen, and stored. UCB contains hematopoietic stem cells, which are a component of bone marrow and are capable of maturing into red blood cells, white blood cells, or platelets. Therefore, when transplanted into a cancer patient whose own bone marrow has been depleted after chemotherapy or radiation treatments, these UCB stem cells can provide the basis for a new, healthy, blood-forming immune system. The use of UCB as a source of cells may make hematopoietic stem cell transplants more readily available in the general population. Unlike the stem cells found in bone marrow, UCB immune cells are younger, more tolerant, and less likely to be rejected by the immune system. This could be due to the muted immune system of certain cells contained in UCB, as these cells are not yet educated to attack the recipient. Unfortunately, UCB is currently incapable of solving the unmet demand for implantable hematopoietic stem cells, as UCB alone yields a low volume of hematopoietic stem cells. UCB is also associated with a delayed time to engraftment, possibly leading to complications from the procedure. Our technology, outlined below, is targeted to address both of these current UCB technology deficiencies. |
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