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Pluristem Therapeutics Inc. is a clinical-stage biotherapy company using placental cells and a unique, proprietary, three-dimensional (3D) technology platform to develop cell therapies for conditions such as inflammation, ischemia, muscle injuries, hematological disorders and exposure to radiation. 

https://www.pluristem.com/the-company/

 

Company Presentation (Feb 2020) 

https://www.pluristem.com/wp-content/uploads/2016/04/Pluristem-Presentation-February-2020.pdf

 

Pipeline




 

PLX PRODUCTS

https://www.pluristem.com/placental-expanded-plx-products/

Home > PLX Products

PLacental eXpanded (PLX) cells are placenta-derived, mesenchymal-like adherent stromal cells that are designed to be administered to patients without the need for tissue or genetic matching. These cells release soluble biomolecules, such as cytokines, chemokines and growth factors, which act in a paracrine or endocrine manner to facilitate healing of damaged tissue by stimulating the body’s own regenerative mechanisms.

For illustration of the cell’s mechanism of action please press here.

More about the mechanism of action of the cells is available under Science and Technology in this website.

For further information regarding the Placenta press here.

PLX-PAD

PLX-PAD cells respond to chemical distress signals from tissues that have been damaged by ischemia (inadequate blood flow), muscle trauma, or inflammation, by secreting a range of therapeutic proteins that trigger the body’s own repair mechanisms. These secreted proteins drive the body to grow collateral blood vessels to bring oxygenated blood to ischemic tissue, heal damaged muscle, and dampen inflammation. PLX-PAD cells also modulate the immune system, which plays a central role in the body’s response to injuries.

PLX-PAD is being developed in clinical trials for Critical Limb Ischemia via accelerated regulatory pathways. Pluristem has been granted FDA Fast Track Approval and was accepted to the FDA Expanded Access Program, EMA Adaptive Regulatory Pathway and PMDA Accelerated Regulatory Pathway.

Two completed Phase I trials of PLX-PAD in Critical Limb Ischemia produced positive results, and a randomized, double-blind Phase II study has demonstrated the safety and potential efficacy of PLX-PAD in treating muscle injury in the context of hip replacement surgery. Positive results were also seen in a completed Phase II trial in Intermittent Claudication.

Reed more about PLX-PAD in the Treatment of- CLIICOrthopedic indicationsPulmonary Arterial HypertensionWomen’s Health. (Press each indication)

PLX-R18

PLX-R18 cells release a combination of therapeutic proteins in response to a damaged or poorly functioning hematopoietic system; this system creates the blood cells that protect us from infection, uncontrolled bleeding and anemia. The product is currently in development to treat incomplete recovery of transplanted hematopoietic cells and Acute Radiation Syndrome (ARS).

PLX-R18 cell therapy was granted an orphan drug designation by the FDA for the treatment of ARS. The Orphan Drug Act provides for granting special status to a drug or biological product, to treat a rare disease or condition. The benefits of achieving Orphan Drug Designation include close guidance by the FDA, which may accelerate the path to potential marketing approval, orphan drug grants, tax credits, and 7-year market exclusivity upon marketing approval.

The FDA has also cleared Pluristem’s Investigational New Drug (IND) application for PLX-R18 in the treatment of ARS. The IND allows Pluristem to treat victims who may have been acutely exposed to high dose radiation due to nuclear attack or accident.

PLX-R18 is also being evaluated in preclinical studies to explore its therapeutic potential to treat a variety of other hematologic indications.

Read more about PLX-R18 in the treatment for recovery of the Hematological System and ARS- Acute Radiation Syndrome.

PLX-Immune

PLX-Immune are cells that had been induced with tumor necrosis factor alpha (TNF-a) and interferon-gamma (IFN-g), to transiently alter their secretion profile.

The product has been evaluated in pre-clinical studies, published in a peer-reviewed article in the journal Scientific Reports, from the publisher of Nature, which examined the effect of the cells in over 50 lines of human cancerous cells. The results showed that PLX-immune cells exhibited an anti-proliferative effect on 45% of the tested cancer cell lines, with a strong inhibitory effect on various lines of breast, colorectal, kidney, liver, lung, muscle and skin cancers. Comprehensive bioinformatics analysis identified common characteristics of the cancer cell lines inhibited by PLX cells. This knowledge could potentially be used in the future for screening patients’ tumors to identify those patients most likely to show a positive response to treatment with PLX cells.

An additional pre-clinical study of female mice harboring human triple negative breast cancer (TNBC) showed that weekly intramuscular (IM) injections of the cells produced a statistically significant reduction (p= 0.025) in mean tumor size in the treated group compared with the untreated group, with 30% of the treated mice exhibiting complete tumor remission. In addition, a statistically significant reduction (p=0.003) was seen in the percentage of proliferating tumor cells as well as in the level of blood vessels within the tumors.

In order to provide treatments using PLX cells all over the world, we are working according to a clinical development strategy. For more information press here.

 

PARTNERS AND COLLABORATION

Home > Partners and collaboration

NASA

Pluristem has a collaboration with NASA’s Ames Research Center to evaluate the potential of Pluristem’s PLX cell therapies in preventing and treating medical conditions caused during space missions. Dr. Ruth Globus of NASA’s Ames Research Center, in California’s Silicon Valley, has been awarded a 2019 NASA Ames Research Innovation Award (ARIA) for the collaboration with Pluristem. The project, titled, “Therapeutic Stromal Cells for Health in Space,” has been selected to preclinically evaluate the potential of Pluristem’s PLX cell therapies in preventing and treating medical conditions caused during space missions, including indications relating to blood, bone, muscle, brain and heart.

U.S. National Institutes of Health (NIAID)

The U.S. National Institute of Allergy and Infectious Diseases (NIAID), a part of the U.S. National Institutes of Health (NIH), conducted studies in large animals to evaluate dosing for PLX-R18 as a medical counter measure in the treatment of the hematologic component of Acute Radiation Syndrome (ARS). After determining optimal dose in large animals, the next step is to conduct a study, strategically designed to demonstrate the superiority of PLX-R18 versus current standards of care, with the goal of executing a full contract once the study is completed.

The results used to support a Biologics License Application (BLA) submission of PLX-R18 for this indication under the Animal Rule regulatory pathway. The NIAID is supporting and collaborating on the dosing studies, and previously supported and completed two preclinical studies of PLX-R18 as a potential treatment for the hematologic syndrome of ARS, with those studies showing a substantial and statistically significant increase in the survival of irradiated rodents treated with PLX-R18 versus placebo, and revealing the underlying mechanism of action of our cells in this indication.

U.S. Department of Defense (DOD)

Pilot study of the Pluristem’s PLX-R18 cell therapy was initiated by the U.S. Department of Defense’s (DOD) Armed Forces Radiobiology Research Institute (AFRRI), part of the Uniformed Services University of Health Sciences (USU). The study is examining the effectiveness of PLX-R18 as a treatment for Acute Radiation Syndrome (ARS) prior to exposure to radiation.

Chart Industries

A license agreement with a subsidiary of Chart Industries, Inc. is regarding Pluristem’s thawing device  for cell-based therapies. Per the terms of the agreement, Chart obtains the exclusive rights to manufacture and market the thawing device in all territories worldwide, excluding China, with Pluristem receiving royalties from sales of the product and supply of an agreed number of devices. Pluristem’s point-of-care thawing device technology is designed to allow for the precise and automated thawing of cells in a controlled and monitored environment, and is expected to result in the highest levels of cell viability and quality. The technology includes many advanced unique proprietary features which were designed to result in the leading thawing devices on the market.

Thermo Fisher Scientific

A strategic collaboration with Thermo Fisher Scientific was signed to advance fundamental knowledge of cell therapy industrialization and to improve quality control of the end-to-end supply chain. The collaboration combines Thermo Fisher’s experience in cell therapy development and bioproduction scaleup with Pluristem’s expertise in cell therapy manufacturing, clinical development and quality control. Together, the companies hope to transform cell therapy manufacturing into a large-scale, high capacity industry that will enable the production of millions of therapeutic doses of regenerative medicines. Currently, over 850 companies worldwide are developing regenerative medicine and advanced therapies. There are more than 900 clinical trials underway, with several approved and marketed products worldwide. This sector holds the promise of addressing many unmet medical needs, but requires a change in the supply chain of equipment, consumables, reagents and storage systems to enable the treatment of millions of patients.

Cha Biotech

Pluristem has an exclusive out-license and strategic partnership agreement with Cha Biotech (Kosdaq:CHA) for the development and use of PLX-PAD in Critical Limb Ischemia (CLI), and Intermediate Claudication (IC), with rights exclusively in South Korea. Cha Biotech will perform and fund clinical trials in South Korea under the supervision of the Korea Food & Drug Administration (KFDA). Upon a regulatory approval for a PLX product in South Korea, Pluristem and Cha have agreed to establish a joint venture (JV) co-owned by the parties to commercialize PLX cell products in South Korea.

Academic Partners

Pluristem have been privileged to conduct studies of PLX cells in collaboration with renowned researchers at internationally recognized institutions. For further information click here.




 
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PSTI News: Pluristem Therapeutics CEO Issues Shareholder Update 02/10/2020 07:00:10 AM
PSTI News: Quarterly Report (10-q) 02/06/2020 04:11:50 PM
PSTI News: In Its Path Towards Marketing, Pluristem Provides Highly Favorable Market Access Data Regarding the Critical Limb Ischemia Ma... 02/03/2020 07:00:10 AM
PSTI News: Pluristem Completes 75% Enrollment in its Pivotal Phase III CLI Clinical Study 12/17/2019 07:00:10 AM
PSTI News: Pluristem Reaches Milestone in its Phase III Muscle Injury Study, Completes 50% Enrollment 12/03/2019 07:00:10 AM
PostSubject
#28824  Sticky Note Near-term Milestones/Catalysts lorbas95 02/23/20 03:59:01 PM
#17172  Sticky Note BOARD WARNING - ALL: This board is to IH Admin [Meghan] 10/19/18 04:19:14 PM
#30967   I rest my case... Scott999 04/03/20 12:20:10 AM
#30966   Sometimes I stand in front of the mirror SrdghJack 04/02/20 11:32:46 PM
#30965   Oh wow did they. That’s your argument? Really? Scott999 04/02/20 11:28:49 PM
#30964   I'm sorry, but I cannot listen to all skitahoe 04/02/20 11:18:36 PM
#30963   If you’re so confident we are going to Scott999 04/02/20 10:25:06 PM
#30962   Food For Thought ! The Fact That Pluristem FDApproved 04/02/20 09:38:11 PM
#30961   Might be a good time to play out hopester 04/02/20 09:28:07 PM
#30960   Then explain why the Democratic party led by hopester 04/02/20 09:15:24 PM
#30959   You Got That Right !!! FDApproved 04/02/20 09:03:06 PM
#30958   Trump thought it irrelevant. Trying to pass the zzaatt 04/02/20 08:35:24 PM
#30956   Obamma never restocked our PPE stock pile after Docstemcell2020 04/02/20 07:58:30 PM
#30955   Another Chinese Boon doggle Docstemcell2020 04/02/20 07:48:59 PM
#30954   When you think you have it bad look Docstemcell2020 04/02/20 07:47:08 PM
#30953   Turn out the lights.....the party's over......wait...are the lights EichKing 04/02/20 07:45:29 PM
#30952   April Company Presentation Just Came Out !! They FDApproved 04/02/20 06:59:35 PM
#30951   quote: should make drugs like ours available to Karlchen 04/02/20 06:05:27 PM
#30950   this woould happen to poor cv-play-stocks at the Karlchen 04/02/20 05:54:32 PM
#30949   For clinical trials, MHRA says it is FDApproved 04/02/20 05:48:15 PM
#30948   This New Patent That Was Published On Tuesday FDApproved 04/02/20 05:33:32 PM
#30946   Giddy-Up...I Just Found A New Pluristem Patent That FDApproved 04/02/20 05:09:57 PM
#30945   The worldwide count of people infected with coronavirus skitahoe 04/02/20 04:52:47 PM
#30943   Blowout announcement waiting in the wings.I'm poised to Buy. hopester 04/02/20 04:25:08 PM
#30942   Is that what it’s come down to, us Scott999 04/02/20 04:05:41 PM
#30941   Pluristem To The Rescue Real Soon ! FDApproved 04/02/20 04:03:14 PM
#30940   They Have 2 Manufacturing Facilities In Haifa ! FDApproved 04/02/20 04:02:24 PM
#30939   watching fox their reporting huge upick in NY. thesaud 04/02/20 04:02:16 PM
#30938   Bioinformant should email the FDA with that article, thesaud 04/02/20 03:59:50 PM
#30937   No break necessary. Tons of “new” people here Scott999 04/02/20 03:59:03 PM
#30936   ... Been saying it forever. True! Aren't you zzaatt 04/02/20 03:44:12 PM
#30935   Fda (relating to good news soon) Stem one 04/02/20 03:25:12 PM
#30934   I agree 120% its the only way they thesaud 04/02/20 03:22:16 PM
#30933   You in that one too Hopester? Scott999 04/02/20 03:20:43 PM
#30932   Unfortunately Pluristem has an accountant as a CEO Scott999 04/02/20 03:19:06 PM
#30931   This BioInformant Article Just Came Out !!! FDApproved 04/02/20 03:02:23 PM
#30930   While I'd certainly like to hear what's happened skitahoe 04/02/20 03:01:40 PM
#30929   great video you should watch it peterus 04/02/20 02:47:35 PM
#30928   agree we need mr hope peterus 04/02/20 02:45:54 PM
#30927   Unfortunately, no lol. But of course there is always midastouch017 04/02/20 02:44:31 PM
#30926   lol peterus 04/02/20 02:41:02 PM
#30925   One can always blame: 1. The controller. 2.ATM 3.Shorts/Naked shorts 4.Big Pharm midastouch017 04/02/20 02:40:35 PM
#30924   ok thanks peterus 04/02/20 02:32:26 PM
#30923   I sure hope so, but i do not think so. midastouch017 04/02/20 02:31:56 PM
#30922   wow glad thats not us, oh wait, we Terrik9000 04/02/20 02:30:27 PM
#30921   down 40% peterus 04/02/20 02:28:58 PM
#30920   ATHX is getting clipped today in a big way. thesaud 04/02/20 02:27:00 PM
#30919   did you guys see the video on YouTube peterus 04/02/20 02:26:35 PM
#30918   IMO...Big News Coming Soon !!! VERY EXCITING TO FDApproved 04/02/20 02:08:55 PM
#30916   Someone here must demand from the authorities that Stem one 04/02/20 02:03:03 PM
#30915   What do people think will happen to the Scott999 04/02/20 01:57:10 PM
#30914   Thanks. Seriously though all he’s referencing is Allo’s Scott999 04/02/20 01:51:08 PM
PostSubject