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.
Google - Pluristem's IP strategy: great expectations
“We assume our first approved product will be for an indication of severe pre-eclampsia or bone marrow transplant failures,” he says.
He says that Pluristem hopes to take advantage of the adaptive licensing provision in Europe, and the breakthrough therapy designation in the US, which allow drug makers to enter the market with their much-needed therapies faster.
“That’s very important to us as a public company,” Aberman says.
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.
Not Sterile, After All: The Placenta’s Microbiome
Posted on May 28, 2014 by Dr. Francis Collins
When thinking about your health, or the health of your children, you’re probably not thinking of the placenta. This often neglected, yet vital, pancake-shaped organ develops during pregnancy. It adheres to the inside surface of the uterus and guides development; partly maternal, partly fetal, it delivers food and oxygen to the growing fetus via the umbilical cord and removes waste products—among other vital functions. Yet, the placenta may be even more important to the health of mother and child than we’ve previously imagined.
Until recently, the uterus and the placenta were thought to be germ-free and sterile—to keep the baby safe from infection. But at just one week old, babies have a complex collection of microbes in their guts. Where do those bacteria come from? It was thought that a baby received its first dose of bacteria as it passed through the #$%$—or from the mother’s skin, if the child was born via C-section. But Kjersti Aagaard, a 2007 recipient of a NIH Director’s New Innovator Award and an obstetrician and associate professor of gynecology at Baylor and the Texas Children’s Hospital, began to suspect there was more to the story.
Aagaard’s suspicions were, in part, fuelled by evidence provided by the NIH-led Human Microbiome Project [HMP]. Launched in 2007, the HMP seeks to identify the microbes living in our nasal passages, oral cavities, skin, gastrointestinal tract, and urogenital tract. It has already taught us a great deal about the microbial populations characteristic of each location. But when Aagaard studied the infant microbiome, she found that microbes in babies’ intestines didn’t resemble the collections seen on the skin or in the #$%$.
Then, Aagaard read an NIH-funded study by a team at Washington University in St. Louis, revealing the presence of microbes in the placenta . Perhaps, thought Aagaard, the placenta had its own microbial population—and babies received their first dose of microbes directly from the placenta, while still in the mother’s womb.
To test the idea, she and her team collected tissue samples from 320 placentas and isolated the bacteria present in each. Rather than using a traditional microscope and petri dishes to identify the bacteria, as the Washington University researchers had done, she and her team focused on the DNA. Her team collected DNA from the placentas and sequenced the genetic material, which revealed the identity of the microbial inhabitants. When they compared the placental microbes with those in the mouth, nose, skin, #$%$ and gut of non-pregnant women, they found they most closely resembled the microbes that lived in the mouth .
The finding was unexpected. How would oral microbes from the mother end up in the placenta? Aagaard turned to earlier animal studies for possible answers. A mouse study suggested that one of the oral microbes, Fusobacterium nucleatum, could alter the structure of blood vessels, enabling the infiltration of other microbes into the blood . Once in the bloodstream, these oral microbes could presumably find their way to the placenta. Aagaard reasoned that in humans, oral microbes would similarly enter the bloodstream from the oral cavity and “seed” the placental microbiome. Her team provided further support for this idea by showing that women who had suffered a bacterial infection (such as a bladder infection) during the first or second trimester had “microbial fingerprints” of this infection in their placenta.
They also found that the microbes from placentas from babies born earlier than 37 weeks (preterm births) had a significantly different collection of microbes compared to those of babies carried for the full term of 40 weeks. That’s an intriguing observation, with possible clinical significance. Every year, 500,000 babies—1 in 8—are born preterm. These early arrivals can be dangerous, because the baby is still developing vital brain and lung functions in the womb until 39 weeks. While most preterm babies do well with the kind of support now available in hospitals, they are at greater risk of breathing and feeding difficulties, cerebral palsy and vision deficits, and neurological problems later in life.
Aagaard and her colleagues are now beginning a NIH-sponsored longitudinal study of 526 women to determine whether microbes may actually play a causative role in preterm births. It may be that specific microbes, or predictable shifts in the bacterial community, may explain why some infants are more likely to be born preterm. If these possibilities are confirmed, early diagnostic testing may help identify women at risk—and ultimately there might even be ways to reset the microbiome to encourage full term pregnancies.
Aagaard’s findings are just the tip of the iceberg. It may surprise you to know that when the placenta malfunctions, the mother’s health also suffers—with problems like insulin resistance, preeclampsia, gestational hypertension, and even heart disease later in life. Yet, because the placenta is difficult to study during pregnancy, most research occurs after delivery; but that doesn’t tell us much about how the organ grew and functioned, or malfunctioned, while fetus was developing. That’s why Alan Guttmacher, director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, has proposed the Human Placenta Project [HPP] . Next week, researchers from NIH will convene with international experts in placental biology to develop a research agenda for the HPP. This is a project with the potential to have a profound impact on the health of current and future generations worldwide. Perhaps the HPP will also bring long overdue attention and respect to the importance of this amazing organ.
We have the early-stage products in Phase I. The one that I think is perhaps most trans-formative is our cell therapy product. As I know you know from being a keen observer of the industry, I think most people would kind of feel that cell therapy is the mAbs of like the last decade. Like 10, 15 years ago, there really were scarcely any approved monoclonal antibodies. Now they are becoming a mature product class. Cell therapy is there today where mAbs were 10 years ago, and we are pouring significant resources into advancing our cell therapies forward for pulmonary hypertension. The one which I think you probably maybe most familiar with is our license of Pluristem's cell therapy product for pulmonary hypertension. And I'm not completely sure if we've previously announced that, that's now dosing patients in Phase I
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
The National Institute of Child Health and Human Development calls the placenta “the least understood human organ and arguably one of the more important, not only for the health of a woman and her foetus during pregnancy but also for the lifelong health of both.”
In May, the institute gathered about 70 scientists at its first conference devoted to the placenta, in hopes of starting a Human Placenta Project.
Pluristem Preeclampsia Steering Committee Member Dr. Baha M. Sibai is a key investigator for the NIH (HPP) Human Placenta Project.
Prof. Baha M. Sibai, M.D.
Prof. Sibai is an internationally recognized researcher and clinician in maternal-fetal medicine at The University of Texas Health Science Center at Houston (UTHealth) Medical School in the Department of Obstetrics, Gynecology and Reproductive Sciences. Dr. Sibai serves as the Director of the Maternal-Fetal Medicine Fellowship Program and the Principle Investigator for Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network.
Dr. Sibai has an extensive history of grant funding from the National Institutes of Health (NIH) and Centers for Disease Control and has led several multi-center clinical trials. In addition he has previously served as the principal investigator of the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU Network) at the University of Tennessee.
Dr. Sibai is a leading authority in the care and treatment of women with preeclampsia, eclampsia, pre-term birth, rare obstetric syndromes, and medical emergencies during pregnancy and childbirth. He has published more than 500 peer-reviewed articles in various scientific journals.
Sentiment: Strong Buy
Nice To See The Director of The NIH Understands The Power of The Placenta ! All Aboard !
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
PLX Cells Currently are Viable after 18 months of Cryopreservation ! They Believe it Will Jump to 3-4 Years !
US Government Will Stock-Pile PLX Cells For Potential Future Radiological Events !
Sentiment: Strong Buy
I believe the FDA-NIH have come to the realization that the placenta may be the fountain of youth. Those newly minted long-telomeres on PLX Cells are what makes those cells so viable and potent and their ability to secrete various cytokines to promote angiogenesis. The NIH is getting very serious now that they have tested Pluristem's PLX Cells and have first hand knowledge of their efficacy and future potential to change medicine as we know it. I believe things could change quite rapidly now and PSTI may see a major move to the upside.
Sentiment: Strong Buy
I do remember meeting you, as I do believe you asked me twice to help pump this board with carrot on a stick tactics to lure dumb money in, Well, it looks like everything is going as you planned. We'll meet again in about few weeks to go over new tactics on how to pump this baby and roll in the dough.
Recent changes in Japan's laws governing regenerative medicine and the approval of stem cell therapies indicate the country may now offer the fastest track to commercialization in the world for regenerative medicine treatments. As part of Pluristem's strategy in Japan, on September 16, 2014, Company executives presented to a group of Japanese pharmaceutical executives in Tokyo, and conducted a series of one-on-one meetings with Japanese companies exploring a potential partnership with Pluristem.
To support its strategy in Japan, Pluristem is working with The Sage Group, a consulting firm specializing in healthcare industry transactions and business strategy, and Sage's partner Waterfield HealthCom, a Japan-based firm managed by Yoshi Mizuta. Mr. Mizuta is a highly experienced pharmaceutical industry executive with more than 40 years in the business of financial healthcare transactions in the Japanese arena.
Japan's government passed a bill in 2013, which goes into effect in November of this year, effectively fast-tracking the approval of stem cell therapies for marketing. According to the law, stem cell regenerative medicine therapies can receive conditional, time-limited approval for marketing, and be eligible for reimbursement, upon proof of safety but prior to verification of efficacy; safety and effectiveness need to be confirmed after the conditional approval.
Waterfield HealthCom's Mr. Mizuta commented, "With its broad portfolio of indications and its commercial scale 3D cell manufacturing capabilities, Pluristem is a very desirable partner for Japanese pharmaceutical companies looking to bring cell therapies to the market in the near term."
Sentiment: Strong Buy