Jul. 10, 2014 9:58 AM ET By: Sharon di Stefano
See 2 Page Article Just Released !
•Pluristem’s role in the newly-formed Human Placenta Project underscores PLX cells’ important connection with angiogenesis and inflammation.
•A prominent preeclampsia researcher speaks out for Pluristem with a special recommendation.
•Pluristem’s clinical efforts in problem pregnancies are still early, but favorable, and point to other cures.
•The Human Placenta Project may ultimately benefit from Pluristem’s scientific knowledge.
For the first time in medical history, the placenta, an overlooked and undervalued organ critical to the creation of new life, is targeted as vital to human disease by a government funded initiative called the Human Placenta Project. Pluristem Therapeutics, Inc. (PSTI), whose research and clinical work revolves around regenerative medicine based on special placental cells, could become a central figure in the Project.
Sentiment: Strong Buy
Zami Aberman - Pluristem CEO said in biomedical conference in MIBI - FXG College.
Aberman added : it all begins and ends with the strategy and the moment you want to be an Israeli company which is a world leader, you must produce your product. You cannot sell knowledge.
Pluristem want to be an a world leader in development and cell therapy manufacturing and today is the largest company in terms of manpower with 160 employees and only company in the field, which has its manufacturing plant who can produce in terms of sales up to a billion dollars a year, and those two things very rare and unique .
Pluristem is also traded on the NASDAQ and Tel Aviv,. Aberman noted at the conference that Pluristem is the first and to date the only one who developed technology for producing three-dimensional cells. The technology was acquired from the Weizmann Institute and the Technion in 2007 - to enable commercialization and transactions to date two of them. As it has 27 patents and intellectual property much. The company has a cash equivalent of $ 59 million, when the last report was 49 but after a deal with Korean CEA she added another $ 10 million, so it has quite a lot of money to manage clinical programs.
Zami explained that Pluristem has proved to be injected muscle stem cells anywhere in the body and get a positive systemic effect on the patient and it changes some things are done. "Our process begins at birth, the placenta. We take the remainder stays, medical waste, and proved to be realized from stem cells of various types.
I feel our time is fast approaching, as a long time PSTI investor, I believe we are on the precipice of a major leap forward in cellular therapy science. It has been tough sledding for Pluristem longs for the past few years however, I feel the scientific community has just now begun to understand the immense importance of the power of PLX Cells in relation to the powerful cells that they are able to extract and expand from the maternal side of a newborn caesarean sectioned placenta and how those cells are so incredibly viable and potent as their long telomeres are exactly what a 35-90 year old patient needs in order to repair and or quell inflammation from a myriad of inflammatory diseases and or any intra-cellular disruptions. As PLX Cells are able to detect and secret the necessary cytokines via a paracrine effect from a single Inter-muscular injection of PLX Cells that currently appear to provide a total body wide effect ! ( An effect that is just now beginning to be understood by the previously uneducated scientific community). " As they have been rather late in understanding the true power of PLX Cells)."
With that said, I believe this is the reason why the NIH has just initiated the Human Placenta Project in order to discover the true basis for the mechanism of action for PLX Cells. They currently have a phase 1 study completed in 2013 that demonstrated very positive results. Which has led to their phase 2 studies initiated in February of 2014. Their early results appear to have prompted them to launch a major full-scale multi-million dollar project to determine the exact mechanism of action of PLX Cells. This is a feather in the cap of Pluristem as we now have the US Government (FDA) doing full-scale clinical studies with PLX Cells on behalf of Pluristem Therapeutics. A scenario that to me is unprecedented as they must feel that all of their current data to date has encouraged them to pursue the Human Placenta Project ! Pluristem is a Sleeping Giant !
Sentiment: Strong Buy
Pluristem's application for Orphan Status for preeclampsia was filed in February of this year. I expect them to receive orphan status approval in August. If the first phase of clinical trials go as well as the pre-clinincal results indicate they could - I believe Pluristem will then file for and receive Fast Track Designation from the FDA as it addresses an unmet medical need.
Interview conducted by April Cashin-Garbutt,
Insights from Industry
Chairman & CEO of Pluristem Therapeutics Inc.
June 16, 2014
Please can you outline how you convert human placental cells into PLacental eXpanded (PLX) cells?
We start with birth and we collect the cells after C-section. The reason for that is we have to have the mother sign a consent letter that she is donating the placenta and, on top of that, we have to have a blood sample from the mother to test for any viral contamination.
Following this we start the processing. At our manufacturing facility we take the region from the placenta that we are interested in and then we extract the cells that we are using to develop our PLX cells.
Once we have selected the cells we then grow them in our 3D bioreactors to make our cell therapy products. About eight weeks after birth we have the product, the PLX cells, prepped that are ready to use, and they can be shipped from our facility across the world without any further manipulation being necessary.
Why does the processing take eight weeks?
We expand the cells we harvested from the placenta with up to twenty-five doublings, so that we can treat approximately ten thousand patients from one placenta. This process of cell expansion is a major determinant of the processing time. They multiply within twenty-four hours. There is a doubling over this period, so there are around twenty-five doublings in twenty-five days.
Then we need more time for processing to deliver them from one state to another, and that’s the reason that we end up with about eight weeks, or about forty days from birth to the product ready to go.
Why do you use a 3D bioreactor and what advantages does this have?
The rationale behind the 3D bioreactor is to try to imitate the natural body structure. Cells in the body are grown in 3D space, not in 2D space such as in a petri dish.
We grow them in a way that we imitate the environment in the patient’s body. The cells are grown at 37 degrees Celsius and at a pH level similar to the pH level in the human body.
Growing cells in a 3D bioreactor allows us to precisely control other aspects of the environment so that we can precondition our cells to secrete certain therapeutic proteins. The 3D bioreactor, in part because it creates a more “natural” environment, also makes it possible to grow cells much more efficiently and reliably.
What signals do damaged tissues produce and how do the PLX cells recognise these signals?
The PLX cells react in response to many signals originating from throughout a patient’s body. The body releases chemical signals called chemokines into the bloodstream. When the chemokines reach PLX cells, the chemicals interact with specific receptors on the cells.
That interaction generates internal responses that instruct the cell nucleus to produce specific proteins. At the end of the process the cells produce proteins that are required based on the signal they received.
In what ways do the PLX cells respond to the signals produced by damaged tissues?
We develop our product by designing the cells for different indications. Today we have one cell product in Phase I and Phase II clinical trials. We are testing our cells for treatment of critical limb ischemia, intermittent claudication, muscle injuries, pulmonary hypertension and shortly we expect to enter into trials for pre-eclampsia.
We have three additional products. One is in preclinical trials to treat bone marrow failure after acute radiation. Another is targeting autoimmune diseases and one is targeting metabolic conditions. The latter two will enter into trials next year.
Do various tissue types respond differently to damage? Do they send out different signals?
Exactly. We are educating the cells. Our therapeutic cells all originate from the placenta, but by changing the culture conditions we can educate the cells to produce the types of growth factors that are needed for specific indications.
For example, when we draw the cell from the bioreactor we can apply a hypoxic condition, less oxygen. When there is less oxygen in the clinical condition, the cells become challenged, in return they start to produce high levels of EDF, ATF and other intergenic factors.
The outcome is that, due to the fact that the cells are challenged by the situation, they produce higher levels of entertaining factors, which converts them into suitable cells for that indication.
If you want to go to the autoimmunity, we do different processing. Similar to axial stem cells, but we need them to produce anti-inflammatory cytokines, like IL-10 and others. They do it in return with the challenging when they are grown with the inflammatory cytokines.
What types of tissue damage do you hope PLX cells will treat?
The first one is the lack of blood flow in the lower extremities. What the cells do when they feel the lack of blood flow is secrete a hypergenic factor that induces the body to generate new blood vessels.
The second example is in muscle injuries associated with trauma or an operation. By generating growth factors that are associated with the generation of blood vessels, what the cells actually do is promote endogenesis.
By promoting endogenesis in the traumatic tissue, due to the fact that there is better blood flow, the recovery process is better, the muscles are recovered, the fibrosis, the scar, is diminished because of good blood flow in the scar area.
So they improve the generation and the outcome is improvement in the force and the volume of the muscle following the PLX treatment.
How are the PLX cells administered?
It depends on the indication. When we are dealing with muscle trauma, critical ischemia, intermittent claudication, we inject them into the muscle. Not necessarily into the damaged muscle, but we inject them into the muscle because we want them to stay longer.
They actually use the muscles as some kind of human incubator so the cells can last from the injection for about four to six weeks. During that time they interact with body and secrete the growth factors needed for the therapeutic effect.
Other indications, like pulmonary hypertension, we inject them intravenous because we want them to be stuck in the lungs for a while. When they are stuck in the lung they receive a signal from the hypertension situation and they secrete higher levels of intergenic and other factors to improve the hypertension.
What stage of development are you at?
We have a product in phase 2 and we are shortly initiating a phase 2/3 study in Korea associated with critical limb ischemia. So we are a phase 2/3 company.
What are Pluristem Therapeutics’ plans for the future?
I strongly believe that cell therapy is the next generation of biological product. If you look back into history and you look into the development of the antibody market, which today is representing about 1.7 billion dollars in sales, I believe that cell therapy will be in the same development curve.
We are only at the beginning. You can compare our situation to the antibody business fifty years ago. From the beginning some clinical trials will fail, some will be successful, but step-by-step the companies will be developed.
I believe that we can become one of the leaders of this phase, mainly because of the fact that we take control from A to Z. The manufacturing, the developing and all of the stuff that’s going around and we have a variety of product, a variety of clinical indications going around.
We believe the probability of success is high. We have two clinical studies that have demonstrated significant efficacy in clinical ischemia and muscle trauma. We have ongoing clinical studies. We are building a lot of evidence to support our claims that we can become the next generation of biological product.
How has our understanding of cell therapy changed?
The world has shifted in its understanding of cell therapy since it started about twenty years ago. In the beginning, the cell therapy drivers, the people that were involved in cell therapy claimed that the mechanism of action would be the replacement of damaged tissue.
A lot of hope has been built-in there because a lot of people were thinking that we can replace hearts and heart muscles that had been damaged due to a heart attack, and so on.
I think that today we can understand that in the coming years the cell therapy product will be more a secreted therapeutic proteins, and not replace the heart.
I think that the fact that this is an understanding, and luckily we are one of the drivers of this understanding.
I’m not saying that in the future no one can take embryonic stem cells and replace a heart, but not now. It takes time. As of today I believe that the center of the way the cells secrete a variety of proteins that are of a therapeutic effect, that is the existing generation of cell therapy.
The next generation some time will be replaced. By understanding the change in the understanding of the whole collection, it will help people to understand the mechanism of the dynamics in that field and we are moving forward in that dynamic.
Sentiment: Strong Buy
Sentiment: Strong Buy
: ( Google translate) Stem Cell Research: Human placenta project is underway: which Israeli company will benefit Big?
National Institute of Health of the United States decided to launch the "human placenta Project" . What analyst Sharon di Stefano think about that? :
National Institute of Health of the United States decided to establish the "Project of Human placenta". Perspective of the company Pluristem stem cells, this is good news and positive recognition of the Company's activities on the basis of a technology-based company and manufacture stem cells (PLX).
Reference to the subject given last weekend analyst biomed assessed Sharon di Stefano who reviews the sympathetic PLURISTEM notes that "for the first time in medical history, the placenta, which usually is an organ underestimated or ignored, will be the centerpiece of a project funded by the government, organ may be necessary to combat diseases humanity ".
Human placenta project is expected to encompass dozens of experts in the fields of gynecology, children, geneticists and researchers placenta. The experts are expected to discuss the healing potential of the various parts of the placenta.
PLURISTEM: "a key element in the project" Di Stefano reviewing marks the PLURISTEM candidate has the potential to displace the initiative: "PLURISTEM, its clinical research revolves around restorative medicine derived cells in the placenta, may become a central pillar in the project."
She says, "The very construction of the project is supporting and strengthening the research direction of Pluristem and even notes that the initiative could draw important information research carried out PLURISTEM so far."
Yaki Yanai, President of Pluristem responded the article saying that: "it is a further recognition capability of the human placenta, which until recently was considered primarily medical waste."
He said, "We are so pleased that the NIH established this important project devoted entirely to the Study of
Sentiment: Strong Buy
By DENISE GRADY JULY 14, 2014
Google Above Title:
Everybody is Now Rushing to Learn What Pluristem Already Knows ! That's A Good Thing !
Sentiment: Strong Buy
Pumpetee do day, pumpatee yay, I am gonna do a bunch of pumping today! Hey, it is a miracle we are doing as well as we are given what is going on in the skies above Israel.
HAIFA, ISRAEL, May 07, 2014 -- Pluristem Therapeutics Inc. (NasdaqCM:PSTI; TASE: PLTR) today announced that its shares of common stock will be added to a newly created TA Tech-Elite index on the Tel Aviv Stock Exchange. Scheduled for launch on May 11, 2014, the TA Tech-Elite index will comprise shares of Israel’s leading technology and biomed companies. Initially, the index will include 34 eligible companies with Pluristem comprising approximately 2.05% of the index. The cumulative float-adjusted market cap of these companies exceeds approximately NIS 45 billion ($13 billion). Pluristem’s shares of common stock are also currently traded on additional indices such as the Tel Aviv Stock Exchange’s TA-100 and TA-75.
According to the Tel Aviv Stock Exchange, the TA Tech-Elite index will also be part of a new “Israeli High-tech” index, which will be calculated by an international index vendor and is expected to serve as the underlying asset for various index-tracking products, enabling greater exposure of Israel’s high tech industry among foreign investors.
On May 11th, the date of the TA Tech-Elite index’s launch, Pluristem Chairman and CEO Zami Aberman will ring the opening bell at the Tel Aviv Stock Exchange. Also on May 11th, Mr. Aberman will deliver a corporate presentation at the Oppenheimer 15th Annual Israeli Conference in Tel Aviv at 10:50 am.
“Inclusion in the new TA Tech-Elite index will broaden our company’s exposure and we expect our stock will be more widely held by both Israeli and global investors,” commented Mr. Aberman.
Sentiment: Strong Buy
Over the last few days after the PPS bottomed out on very low volume. Looks like someone knows something/ or the technicals are supporting this move. Either way- it is starting to look like this thing has legs for support...
Since the month of May has been declared National Preeclampsia Awareness Month and Pluristem's sincere acknowledgement of it on their website home page, It tells me that they are very confident that PLX Cells may provide a future cure for this unmet medical need. As their PLX Cells have clearly demonstrated their effectiveness in numerous animal clinical trials and I see no reason why they will not succeed in human clinical trials as it appears they have done all the necessary preclinical trials to welcome an FDA human clinical trial approval any day now.
PLX Cells are ground-breaking cellular technology/science and if successful will become the future of cellular therapy that will come rather quickly in a seminal moment announcement of a Pluristem successful outcome for the treatment of preeclampsia with PLX Cells. It is my understanding that a future clinical trial of PLX Cells for preeclampsia will involve just a few patients that may occur later this year. The results of which will tell the tale of the future of these incredible potent cells ? I have studied PLX Cells for the past 8 years and I believe they will become the most prolific/used " non-stem cell therapy cells" in the coming years that will be used around the globe.
With that said, I believe that Pluristem has realized that " Big Pharma" wants to own a piece of the action ?
Which leads me to believe why Pluristem wants to double their shares on May 22nd, 2014. It is my belief that big Pharma wants the same deal that CHA obtained in that big Pharma will be able to buy 50 % of the market for the country they wish to secure ? The beauty is, Pluristem can pick and choose their markets or say no and walk away as they know the power of their PLX Cells. I believe it is in Pluristem's best interest to say No to big Pharma and walk away and develop their PLX Cell therapy's on their own as they will become a much more robust company if they choose to ignore the many low-ball deals from Big Pharma !
Sentiment: Strong Buy
2016 here we come!!! Now I know when the first indication will hit the market. I have time to load up.
Sentiment: Strong Buy
The facts remains this company isn't everything some here boast about. They would like you to believe PSTI is on the brink of a break out. In reality, we are still years away from any major move.
These posters refuse to view both sides of the picture.
Let's dissect some points here:
Cash: With less than a 12 month supply, dilution and financing are inevitable in the very near future.
Clinical Trials: As of today, there is basically only 1 trial in progress, the IC PH2, which has not yet fulfilled the 150 patient enrollment goal. Data from this trial won't be released until 2015. The UT trial in Australia has, in essence, been sidelined while UT & PSTI can't agree on the method of administration, IV vs. IM. This trial requires only 9 patients and has yet to complete enrollment. Also, UT has extended the agreement an additional 5 years as they are taking their time with this.
Partnerships: PLX cells have not been tested enough on human patients. Very few people have been injected and results are available for only about 40 patients in various indications. The major players will wait until more data is released which will be next year, not next month as some here would like you to believe. Upfront payments on deals have fallen in recent years and any deal will fund the company for just a few months until milestone payments are made down the road, years from now. They will still have a need to dilute.
Pluristem’s Ohad Karnieli to Deliver a Plenary Presentation on Cell Therapy Manufacturing at ISUS 2014 Conference
Pluristem to share insights on emerging markets and its industry-leading cell manufacturing methods with audience of bio-manufacturing experts
HAIFA, ISRAEL, June 30, 2014 -- Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapies, today announced its VP of Development & Manufacturing, Ohad Karnieli, Ph.D., will give a plenary talk at the Bio-Process Systems Alliance’s (BPSA) 4th Annual International Single-Use Summit (ISUS 2014), which will be held on July 9-11, 2014 in Washington, D.C.
Speakers at this year's ISUS 2014 event will offer insight on building bio-manufacturing venues tailored to single-use technologies, new markets for single-use (disposable) biopharmaceutical manufacturing equipment, and a host of other technical topics facing this fast-evolving industry.
On Thursday, July 10th from 11:45 a.m. to 12:30 p.m., during his presentation on behalf of the ISCT titled, “Emerging Markets for Single-Use: Cell Therapy and Regenerative Medicine,” Dr. Karnieli will speak about process and product development and innovation in single-use manufacturing of cell therapy and regenerative medicine products.
Pluristem is currently the only company manufacturing large quantities of homogeneous, clinical-grade, placenta-based cell products using a 3D bioreactor. Driving this achievement are research, development and manufacturing teams dedicated to shaping the future of placenta-based cell therapies.
The Bio-Process Systems Alliance (BPSA) was formed in 2005 as an industry-led trade association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies for the production of biopharmaceuticals and vaccines. BPSA facilitates education, sharing of best practices, development of consensus guides a
Sentiment: Strong Buy
Acute Radiation Sickness
The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), has commenced a mechanism-of-action study of our second product, PLX-RAD cells, for the treatment of acute radiation syndrome (ARS). The study aims to investigate the effects of PLX-RAD cells on body weight, blood count parameters, cytokine concentrations and bone marrow or spleen cellularity at various time points following the administration of PLX-RAD cells to animals receiving total body irradiation
Sentiment: Strong Buy
Pluristem Presentation Title - Systemic Therapeutic Effect of Placental Expanded (PLX) Cells Following Local Administration
Presenter: Lena Pinzur, Basic and Preclinical Research Manager
Sentiment: Strong Buy