Pluristem Therapeutics
| eröffnet am: | 14.09.08 18:19 von: | 14051948Kibbuzim |
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Mit PLURISTEM THERAPEUTICS findet ein weiteres israelisches Unternehmen Platz auf meiner entsprechenden speziellen Watch - List !
Allgemeine Infos über das Unternehmen.
Pluristem Therapeutics Inc. (NASDAQ: PSTI; DAX: PJT) is a bio-therapeutics company dedicated to the commercialization of allogeneic (non-personalized) cell therapy products for the treatment of a variety of severe degenerative, ischemic and autoimmune disorders where current therapies are unavailable or inadequate.
PLX-PAD, Pluristem’s first product, targets an annual $4 billion market and is intended to treat patients suffering from the critical stage of peripheral artery disease (PAD), manifesting as limb ischemia. 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. PLX-PAD targets those patients where traditional medical and surgical therapies have not helped and are potentially facing continued symptoms or amputation. In animal studies PLX-PAD has shown to significantly increase the number of new blood vessels (angiogenesis) and blood flow in the involved extremity. Pluristem plans for human studies to begin later in 2008.
PLX-BMT, Pluristem’s second product, targets an annual $2 billion market and is intended to resolve the global shortfall of matched hematopoietic stem cells (HSCs) for bone marrow transplantation (BMT). Approximately 60% of the 150,000 patients diagnosed annually with leukemia and other hematological malignancies are unable to find a suitable bone marrow donor match and are left with no reasonable therapeutic alternatives. In animals PLX-BMT, combined with the HSCs found in umbilical cord blood (UCB), has been shown to significantly increase the engraftment of these HSCs in bone marrow. Therefore, Pluristem believes it has potentially found an alternative to bone marrow transplantation by using UCB with PLX-BMT, an off-the-shelf product that requires no matching. Pluristem expects human trials to begin in early 2009.
PLX-STROKE targets an annual $4 billion market and shows potential to become a new treatment for the functional recovery from an ischemic stroke. PLX-MS targets an annual $5.4 billion market and shows potential for the treatment of Multiple Sclerosis, an autoimmune disorder in which the immune system attacks the central nervous system (CNS), leading to demyelination. MS may cause numerous physical and mental symptoms, and often progresses to physical and cognitive disability. The World Health Organization (WHO) estimates that over 2.5 million people globally suffer from MS.
PLX-IBD targets an annual $2 billion market and shows potential for the treatment of Ulcerative colitis and Crohn's disease, known collectively as Inflammatory Bowel Disease (IBD), which currently affects 0.5-1% of the Western world's population. Pluristem believes its PLX cells are also potentially useful for other indications such as organ transplantation, orthopedic injuries and preventing radiation sickness. Pluristem’s pipeline of products begins as mesenchymal stromal cells (MSCs) that are derived from the human placenta, an organ that has traditionally been considered medical waste after childbirth and a non-embryonic, non-controversial source of cells. Pluristem’s placental-derived MSCs are then grown in a unique and proprietary three-dimensional (3D) microenvironment, termed the Pluristem PluriX™ 3D bioreactor, without the addition of growth factors or other adulterants. The MSCs derived from this process are called PLacental eXpanded or PLX cells. Pluristem believes these cells are multi-potent and able to differentiate into a variety of cell types. Recent evidence also suggests their efficacy may be related to the secretion of cytokines or other potent immune modulators. Furthermore, these PLX cells are immune-privileged and possess immunomodulatory properties, thus protecting the recipient from immunological reactions that often accompany transplantations.
The PLX cells are stored “ready to use” with no histocompatibility matching required. Pluristem is an American public company that employs 25 talented, experienced individuals including three PhDs and an MD.
The Company has an office in Colorado with headquarters housing its research and development and FDA good manufacturing practices (GMP)-approved facilities in Haifa, Israel.
For further information, contact: William R. Prather RPh, MD Sr. VP Corporate Development +1-303-883-4954 bill@pluristem.com
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NEW YORK--(BUSINESS WIRE)--Pluristem Therapeutics Inc. (Nasdaq:PSTI) (DAX:PJT), a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for a variety of degenerative, ischemic and autoimmune indications, announced today the successful conclusion of its pre-clinical studies utilizing PLX-PAD prior to the initiation of human clinical trials. PLX-PAD is Pluristem’s cellular product for the treatment of critical limb ischemia (CLI), the end phase of Peripheral Artery Disease (PAD).
The final studies involved 150 animals that received single, repeated intra-muscular (IM) injections of PLX-PAD or a control substance then followed for up to 3 months post-injection. No adverse effects were noted to be caused by the PLX-PAD injections throughout the study period. Moreover, all the histology, hematology and biochemistry panels and biodistribution results support the safe administration of PLX-PAD.
Previously, the Company had reported that in animals whose hind legs were rendered ischemic (reduction in blood flow) using standard industry methodologies, post-treatment evaluation using laser Doppler technology indicated revascularization (return of blood flow) of the limbs treated with PLX-PAD but not in those limbs not treated with PLX-PAD. The affected limbs’ function also improved in those animals receiving PLX-PAD. Additionally, microscopic analyses of those limbs treated with PLX-PAD indicated a statistically significant increase in the number of new capillaries (vessels) supplying the limb, suggesting PLX-PAD has the ability to promote angiogenesis (new vessel formation).
Zami Aberman, Pluristem’s President and CEO commented, “The successful completion of the PLX-PAD pre-clinical phase, in accordance with the regulatory authority's requirements, is a major milestone. This was our final study using our PLX-PAD. We now intend to commence human trials, following receipt of the required regulatory approvals. The impressive results we have obtained in these studies give us confidence that we will be able to prove safety in our planned US and European dose escalation Phase I/II human studies, followed by proof of efficacy in our later trials.”
About Critical Limb Ischemia
In the US alone, it is estimated that 8-12 million people suffer from limb ischemia associated with PAD. The disease is characterized by narrowing and hardening of the arteries in the patient’s limb(s) caused and/or aggravated by diabetes, Buerger's Disease, other diseases and smoking. With decreased blood flow to the affected extremity, patients can suffer a host of complications including nerve and tissue damage. In advanced stages, limb ischemia can lead to gangrene, which often requires treatment with amputation. The disease is associated with a high rate of mortality and the need for frequent hospitalization from surgical complications. Industry experts have estimated that the market for therapeutics used in the treatment of limb ischemia to be over $1 Billion. However, current therapeutic methodologies have proven ineffective for many severe limb ischemic situations and have led the medical community to call for the development of cellular therapies, such as Pluristem’s PLX-PAD, as alternative treatments.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for the treatment of several severe degenerative, ischemic and autoimmune disorders. The Company is developing a pipeline of products, stored ready-to-use, that are derived from human placenta, a non-controversial, non-embryonic, adult stem cell source.
These placental adherent stromal cells (ASCs) are expanded in the Company's proprietary PluriXTM 3D bioreactor, which imitates the natural microstructure of bone marrow and does not require supplemental growth factors or other exogenous materials. Pluristem believes that the resultant PLX (PLacental eXpanded) cells’ efficacy may be related to the secretion of cytokines or other potent immune modulators. Furthermore, PLX cells are immune privileged and possess immunomodulatory properties, thus protecting the recipient from immunological reactions that often accompany transplantations.
Pluristem's first product in development, PLX-PAD, is intended to improve the quality of life of millions of people suffering from peripheral artery disease (PAD). The Company's products in development also include PLX-IBD, targeting Inflammatory Bowel Disease (IBD); PLX-MS, targeting Multiple Sclerosis; PLX-BMT, targeting the global shortfall of matched tissue for bone marrow transplantation (BMT) by improving the engraftment of hematopoietic stem cells (HSCs) contained in umbilical cord blood; and PLX-STROKE, targeting ischemic stroke.
Pluristem has offices in the USA with research and manufacturing facilities in Israel.
See our product animation on YouTube: YouTube Video
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TEL AVIV, Jan 18 (Reuters) -
Israeli stem cell therapy company Pluristem Therapeutics has won U.S. and European approval to conduct an advanced trial for its treatment of peripheral artery disease, a degenerative disorder.
The Israeli biotech company has completed early Phase I trials and said on Tuesday it will be able to conduct an advanced Phase II/III trial in both Europe and the United States to treat the end stage of peripheral artery disease (PAD), known as critical limb ischemia.
PAD is an obstruction of blood vessels, usually in the leg, causing pain, difficulty in walking and leading eventually to amputation.
Chief Executive Zami Aberman said Pluristem will also conduct a Phase II trial to test its treatment on an earlier stage of the disease, placing it on track for a preventative treatment in addition to treating amputation-destined cases.
The treatment for both stages of the disease targets a 20 million patient market....
www.finanznachrichten.de/nachrichten-2011-01/...dvanced-trial-020.htm
Die periphere arterielle Verschlußkrankheit ist in der Tat eine stark zunehmende Erkrankung, die man zu den zivilisatorisch bedingten Erkrankungen zählt,da die Gefäße aufgrund eines multifaktorellen Zusammenspiels Schaden nehmen und insbesondere Diabetes enorme Zuwachsraten aufweist und Bewegungsmangel in Kombination mit falscher ernährung in den Industrieländern ein ernst zunehmendes Problem darstellen.
Dieses Segment ist von Firmen sehr umkämpft,weil hoch profitabel, Pluristemm ist nach wie vor ein sehr interessanter Wert,der hier vielversprechend mitspielt (auch wenn die Aktie tatsächlich schon sehr gut gelaufen ist).
Agencies Agree to Consider Clinical Studies Proposal for Pluristem Pipeline