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Pluristem Therapeutics, Inc. (PSTI)

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Last Post: 11/28/2020 9:56:29 AM - Followers: 222 - Board type: Free - Posts Today: 8

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: Current Report Filing (8-k) 11/18/2020 07:53:43 AM
PSTI News: Pluristem to Present Initial Results from Its Phase I HCT Study with PLX-R18 Demonstrating Safety and Efficacy at the ASH Ann... 11/18/2020 07:00:00 AM
PSTI News: Quarterly Report (10-q) 11/05/2020 04:08:19 PM
PSTI News: Statement of Changes in Beneficial Ownership (4) 11/03/2020 04:52:00 PM
PSTI News: Statement of Changes in Beneficial Ownership (4) 10/29/2020 04:28:17 PM
PostSubject
#39551  Sticky Note Check This Out !!! FDApproved 10/20/20 08:10:34 AM
#17172  Sticky Note BOARD WARNING - ALL: This board is to IH Admin [Meghan] 10/19/18 04:19:14 PM
#40272   We got SCIENTISTS!!! PLuristem’s scientists good. Rest of Scott999 11/28/20 09:56:29 AM
#40271   That happens every flu season. Scott999 11/28/20 09:50:59 AM
#40270   It’s Trumps mishandling of the thing from the Scott999 11/28/20 09:47:35 AM
#40269   2 years ya sure. I’m out, don’t care Scott999 11/28/20 09:40:43 AM
#40267   The new numbers are out. 65 patients per hopester 11/28/20 07:36:46 AM
#40266   Bleeb Bleeb. 2yrs. hopester 11/28/20 06:03:20 AM
#40265   Bodies stored in refrigerated trucks as pandemic spreads Mikems 11/28/20 05:43:29 AM
#40264   Little more than a few weeks! Mikems 11/27/20 08:51:22 PM
#40263   Haven’t you been beliebing that for like 3 Scott999 11/27/20 05:52:18 PM
#40262   It does make zero sense how you belieb Scott999 11/27/20 05:48:30 PM
#40261   Very Soon...IMO !!! FDApproved 11/27/20 05:48:14 PM
#40260   I don't "belieb" you and I don't believe hopester 11/27/20 05:39:04 PM
#40259   ...good...belieb them...all others...bad...don’t belieb...Your long vacation from thi zzaatt 11/27/20 05:15:21 PM
#40258   We got scientists. Pluristems...good...belieb them...all others...bad...don’t be Scott999 11/27/20 04:52:49 PM
#40257   I would think that we're near the point skitahoe 11/27/20 02:37:30 PM
#40255   there’s 70 million people who belieb whatever..In zzaatt 11/27/20 02:31:45 PM
#40254   PSTI TASE Closed At $9.32 Yesterday !!! FDApproved 11/27/20 01:07:12 PM
#40253   It looks to me like some news got Docstemcell2020 11/27/20 10:02:24 AM
#40252   IMO...Pluristem Is Going Global With World Courier !!! FDApproved 11/27/20 09:53:20 AM
#40251   Things are what they seem. December will be Mikems 11/27/20 08:09:48 AM
#40250   I’d be willing to bet there’s 70 million Scott999 11/26/20 08:53:25 PM
#40239   Tweet Tweet FDApproved 11/26/20 10:26:40 AM
#40235   Logistics in Cell and Gene Therapy; as Complex FDApproved 11/26/20 09:32:03 AM
#40233   Big mistake. Put covid on the back burner. hopester 11/26/20 07:20:22 AM
#40231   No one id denying it is real but Thunderforce1 11/26/20 06:39:13 AM
#40230   I sold another portion my holdings today; not emit 11/26/20 01:59:12 AM
#40228   Ark Bought 10,000 Shares Today !!! FDApproved 11/25/20 06:48:31 PM
#40227   Plasma from recovered patients shows little benefit in FDApproved 11/25/20 02:40:48 PM
#40226   Germany records daily record of COVID-19 deaths as FDApproved 11/25/20 01:04:15 PM
#40225   Tweet Tweet FDApproved 11/25/20 11:40:30 AM
#40224   Still 1.2 Million Shares Sold Short !!! If FDApproved 11/25/20 10:43:01 AM
#40223   Joe Gantos Tweet !!! FDApproved 11/25/20 10:37:16 AM
#40222   It's Going To Be A December To Remember !!! FDApproved 11/25/20 10:32:08 AM
#40221   The contrary indicator is back. I 'm bullish hopester 11/25/20 09:24:57 AM
#40220   Joe gantos contacted Pluristem today And they told Docstemcell2020 11/25/20 09:16:57 AM
#40219   PLX-CELLS COHERE THE ARK OF THE COVENANT !!! FDApproved 11/24/20 07:31:27 PM
#40218   ARK Bought 25,000 Shares Today !!! FDApproved 11/24/20 07:01:51 PM
#40217   Right on, Jackson. These Zombies like to been Mikems 11/24/20 04:11:33 PM
#40216   WOW !!! We can now implement FDApproved 11/24/20 01:52:34 PM
#40215   Industrializing allogeneic cell therapy bioprocessing: devising streamlined s FDApproved 11/24/20 01:19:56 PM
#40214   Sweet Tweet Tweet FDApproved 11/24/20 01:16:58 PM
#40213   World Courier FDApproved 11/24/20 12:50:12 PM
#40212   and your're down already. Man I never seen hopester 11/24/20 12:11:53 PM
#40211   Jackie..Hang In There Little Buddy...Help Is On The FDApproved 11/24/20 12:08:14 PM
#40210   Can we start a movement to make Pluristem SrdghJack 11/24/20 11:33:02 AM
#40209   .77% to .55% tells the story. They like obryanjfg 11/24/20 11:10:23 AM
#40208   Smart Move..New Drug Launch Imminent !!! FDApproved 11/24/20 09:42:33 AM
#40207   I backed up the truck and bought bigly Docstemcell2020 11/24/20 09:35:46 AM
#40206   Cost of shares factors into it. Did you hopester 11/24/20 09:25:21 AM
#40205   Pluristem Has A Drug... Ready To Launch !!! FDApproved 11/24/20 07:50:32 AM
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