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Pluristem Therapeutics, Inc. Message Board

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  • Reply to

    FDA Animal Rule

    by mdplanet Jan 16, 2015 11:58 AM

    King, I don't directly respond to Allo in threads due to his propensity to delete threads that he does not like the messages of. As far as my google search, I was doing DD as Allo suggested and using the most basic search terms having to do with compassionate use data, found it brought me to that unfortunate sequence of events of the recent past. It is just an unfortunate reminder of the past missteps of current management.

  • Reply to

    FDA Animal Rule

    by mdplanet Jan 16, 2015 11:58 AM

    I hope you don't think I am allo....I am not....however since I was the last to respond to the same thread as you, on the compassionate....this is old news, known by most on the MB and it's negative effect has already been baked into the share price. Future dilution is a possible fact of life with this type of company as they have no commercial means of generating revenue outside of new products, partnerships, grants, bank loans and stock holders that are willing to take the risk. this company will likely have it's first commercial income through licensing of its 3-D replication technology to others that commercialize stem cell therapies. By definition compassionate use is done as a last resort for terminally ill patients, in cases where there are no other options. In the two cases which resulted in death in 2012, I applaud the company for allowing use of their product, when they had absolutely no idea of the outcome. Regarding them pumping the stock just prior to dilution while knowing of the deaths and not reporting it.. while the timing was unfortunate....I for one do not believe this was orchestrated prior in an unethical and repugnant manner. The simple fact is there are those who "pump" the stock (this is not me as you see I am in a hold position), there are those that bash the stock (either because they are short, are day traders or are just bitter from losses).....This stock has no valid technicals to trade on as it remains unprofitable...for now. PSTI may leap higher just prior to announcing any paradigm shift...or conversely may drop in the event of another dilution or worse, bankruptcy. The only people that know which way this will go are those within the organization, those that may be in a partnership (currently or pending) or those in regulatory positions that know where this stands. IMO, stem cell efficacy across the globe is gaining momentum, and PSTI is no riskier than oil refineries today from a paradigm point of view.

    Sentiment: Hold

  • Reply to

    FDA Animal Rule

    by mdplanet Jan 16, 2015 11:58 AM

    Good Stuff ! Can You Say PLX-Magic Cells ?

    Sentiment: Strong Buy

  • Reply to

    FDA Animal Rule

    by mdplanet Jan 16, 2015 11:58 AM

    Hey Allo, google....Pluristem, compassionate use data. It's a real eye opener.

  • Reply to

    Positive info on PSTI

    by hangons Jan 19, 2015 7:07 PM

    Pluristem is evaluating strategic opportunities in Japan, which is one of the largest healthcare markets, to co-develop and commercialize its PLacental eXpanded (PLX) cell therapies in the near term.

    Conclusion:

    Considering its high potential in the regenerative therapies, which can bring benefits in less time than expected, we remain long in this stock. Looking to its wide pipeline and the potential of this new emerging market, we think its value should be more than a billion. For us it is a long term investment.

    Sentiment: Strong Buy

  • Reply to

    FDA Animal Rule

    by mdplanet Jan 16, 2015 11:58 AM

    I watch this message board for perspectives other than mine....and for the humor it provides most days. I do have a question, since cancer patients regularly are treated with radiation for various indications, and in many cases have negative consequences to healthy tissue, what is to stop stem cell trials for these patients directly related to their purported regenerative efficacy? i personally have experience with radiation treatment (a close loved one ) I can assure you we would have welcomed any option to help with the suffering. If stem cell therapy had been available in 1999 we would have participated to see the effects in conjunction with radiation therapy.

    Sentiment: Hold

  • Google "PSTI, PLURISTEM: THE FUTURE OF STEM CELLS THERAPIES"

    We are witnessing a new biotechnological revolution, stem cells therapies.

    In December 19th, European regulators have recommended approval of the first medicine containing stem cells to treat a rare condition caused by eye burns.

    The japanese equivalent of the FDA (MHLV) has changed the process for commercialization of cellular therapy products with “conditional approval”. This means that the products could be in the market before the end of all the trial phases, and results in a significant time reduction of the clinical process for these new cell therapies.

    (Go to website for more info and charts)

    Sentiment: Strong Buy

  • Reply to

    FDA Animal Rule

    by mdplanet Jan 16, 2015 11:58 AM

    Your Ignorance Is Awesome ! Lots of Human Data From Compassionate Use Patients From Around The World ! Do Some DD For Once In Your Life ! It Is Better To Remain Silent And Thought A Fool, Then To Speak And Remove All Doubt !

    Sentiment: Strong Buy

  • Reply to

    FDA Animal Rule

    by mdplanet Jan 16, 2015 11:58 AM
    mdplanet@ymail.com mdplanet Jan 19, 2015 3:51 PM Flag

    No matter what, PLX-R18 will need to be tested for safety on 1) healthy subjects, 2) subjects being treated for another indication using this therapy. Since PLX-R18 has ZERO known human data, the timeline isn't as short as some believe. A dosing scale for humans will also need to be determined. Right now we are in the early stages as the NIH is evaluating the mechanisms of the cells in a preclinical model.

  • Big Push Into Asia ! :)

    Sentiment: Strong Buy

  • Excellent !

    Sentiment: Strong Buy

  • Reply to

    Pluristem At: Medical Japan 2015 !

    by allo_g Jan 14, 2015 11:56 AM

    In comes Japan, long supportive of regenerative medicine and about to play a major role in its future: the country passed a revision of its Pharmaceutical Affairs Law that allows marketing approval as soon as safety and efficacy in cell therapy clinical trials are proven, as soon as Phase II. This way, products will reach patients faster while industry players get an early chance at profitability. The new law could shorten approval time by as much as two years. Japan's move was prompted by demographics; as the 2nd largest healthcare market in the world, its over-65 population is expected to double in the next 10-20 years. Resources will be strained, so regenerative medicine is attractive as an alternative to traditional medicine that has less impact on diseases common to aging and unable to address unmet medical needs that puts economic pressure on Japanese society.

    Sentiment: Strong Buy

  • Summary
    •Pluristem's novel cell therapy shown to stimulate the sought-after immune response, a new chapter in medicine pursued by Big Pharma.
    •All eyes are on Japan, whose revised regenerative medicine law offers quick approval upon safety and efficacy in Phase II.
    •Pluristem to pursue Japanese studies in GvHd with help of top consultants to find partners.
    •Risks include positive results for GvHD in larger studies and Japan’s current economic woes that could dampen healthcare initiatives.
    •Close competitor Mesoblast also reaches for Japan’s brass ring with GvHD trials.

    With data in hand that shows evidence its PLX cell therapy produces an immune response, Pluristem Therapeutics (NASDAQ:PSTI) enters the exploding area of immunotherapy, or treating disease via manipulation of the human immune system, and joins the ranks of its larger pharmaceutical counterparts in an industry estimated at $35 billion with fast growth expected in the next seven to eight years. Immunotherapy has become the focus of multinational giants like Bristol-Myers Squibb (NYSE:BMY), Merck & Co. (NYSE:MRK) and Roche Holding AG (OTCQX:RHHBY) who all vigorously seek this new panacea for disease.

    A look at the science - in May 2013, Pluristem discovered PLX cells improved grafts of hematopoietic stem cells in failed bone marrow transplant (BMT)due in theory to modulation of the immune system through secretion of cytokines and other proteins to stimulate the production of all blood cell types, a necessary function for recovery after BMT. Of the 25,000 allogenic (from donor) BMT's done worldwide, roughly 15% fail to the great physical detriment of patients already suffering with sickness.

    June of that year, Gaberman, E. et.al published data using PLX cells on irradiated mice; results were positive with nearly all of animals rescued and healthy. Microscopic study after sacrifice revealed a startling discovery responsible for the therapy's success - the stimulation and secretion of Interleukin-10 (IL-10) whose job is to stop cytokines from causing harmful inflammation via T cell proliferation, just the way immunosuppressant drugs like cyclosporine work but without leading to infections stemming from compromised immune systems. When PLX cells were treated with lipopolysaccharide (NYSE:LPS), an organic compound composed of fatty acid and sugars, efficacy was further increased at a statistically significant P-value of less than 0.01, meaning the results are not due to chance. Independent research has determined that LPS does indeed facilitate production of IL-10.

    Four months later, mice treated with PLX cell therapy after BMT showed a statistically significant drop in symptoms associated with graft-versus-host disease ((GvHD)), a dangerous condition common after BMT where the body rejects implanted tissue from a donor and mediated by T-cell/cytokine response that may lead to liver failure; blistering skin; intestinal hemorrhage; and scarring of the lungs. Mice did not exhibit these symptoms, and overall improvement in survival 42 days after treatment was observed. Efficacy was achieved regardless of whether cells were given intravenously or intramuscularly, lending the therapy freedom of choice for future patients. More recently, Pluristem presented good preclinical results using PLX cells for complications from GvHD at the 2nd UK-Israel Regenerative Medicine Conference (BIRAX) at Technion, Israel's heart of cell therapy research.

    These results came on the heels of compassionate use of PLX cells several years ago for three patients who failed BMT, restoring health with no local or systemic side effects and a significant increase in red blood, white blood, and platelet cell count as therapy stimulated hematopoietic stem cell recovery.

    To uphold and expand the role PLX cells play in immunotherapy, international journal Biochimica et Biophysica Acta (BBA) - Molecular Cell Research recently published a study using Pluristem's cells in stroke that showed secretion of another immunogenic agent - IL-6, in addition to vascular endothelial growth factor (VEGF), a protein that promotes angiogenesis or the production of blood cells to restore oxygen supply to damaged tissue.

    Sentiment: Strong Buy

  • Times of Israel January 13, 2015

    Israeli biotech company Pluristem says its PLX technology could potentially treat and repair damaged nerves.

    The ability to reverse stroke damage is just another of the unique properties of human placental cells, which research indicates is much more effective in dealing with many conditions than the regular stem cells that therapies currently rely on.

    The findings indicate that PLacental eXpanded (PLX) cells, produced by Israeli biotech start-up Pluristem, protect PC12 cells – rat-derived cells that behave similarly to and are used as stand-ins to study human nerve cells.

    The study also shows PLX cells protecting the PC12 cells from death after oxygen and glucose deprivation. Such deprivation is an important factor in stroke, thus indicating, according to Pluristem CEO Zami Aberman, that there is a good chance that PLX cells could prevent, or even reverse, the damage caused by stroke or other neuronal disease.

    The PC12 cell study reveals yet another property of placental cells – the ability to repair and restore nerve cells. The protective effects of PLX cells were strongly correlated with the secretion of interleukin 6 (IL-6) and vascular endothelial growth factor (VEGF), which scientists know protect nerves in humans who have sustained injuries to the nervous system that can occur after a stroke or similar events. A correlation, of course, is not necessarily a cause, but it’s an indication that there is a connection, scientists believe.

    Sentiment: Strong Buy

  • Reply to

    FDA Animal Rule

    by mdplanet Jan 16, 2015 11:58 AM

    Bingo ! That's Why The Deal & Approval Are Coming Real Soon ! Giddy-Up ! Big News Coming !

    Sentiment: Strong Buy

  • Reply to

    FDA Animal Rule

    by mdplanet Jan 16, 2015 11:58 AM

    Yes! Great find and should be noted! Here is what I consider a summarizing quotation of the FDA Animal Rule. Makes perfect sense for PLX-R18. Obviously you can't irradiate humans to be test subjects for ARS. I wonder what kind of timeline this creates for approval? Obviously shouldn't take as long as multiple stage human trials..

    "The Animal Rule states that for drugs developed to ameliorate or prevent serious or life­ threatening conditions caused by exposure to lethal or permanently disabling toxic substances, 6when human challenge studies would not be ethical to perform and field trials to study effectiveness after accidental or intentional human exposure have not been feasible, FDA may grant marketing approval based on adequate and well-controlled animal efficacy studies when the results of those studies establish that the drug is reasonably likely to produce clinical benefit"

  • Presenters: Ohad Karnieli, Ph.D., MBA, VP Development & Manufacturing
    Lior Raviv, Product Development Team Leader

    The fourth annual conference on Scale-Up and Manufacturing of Cell-Based Therapies is scheduled for January 18-22, 2015 and will take place at the Hyatt Regency in San Diego.

    This conference will focus on process development, scale-up, and manufacturing of cell-based therapies and will bring academicians, clinicians, industry leaders, and regulators from all over the world together to discuss the most critical scientific and engineering challenges in this field. It is our aim that this conference will continue to play a central role in defining and refining the engineering sciences of cell-based therapies

    Sentiment: Strong Buy

  • Google this : Multipotent stromal stem cells from normally discarded human placental

    Sentiment: Strong Buy

  • The recently signed R&D cooperation agreements include a Memorandum of Cooperation (MOC) – between the Israeli Ministry of Economy (MOE) and the METI of Japan, as well as a Memorandum of Understanding (MOU) between MATIMOP and NEDO .

    Together these agreements aim to encourage bilateral industrial R&D activities and projects between private sector firms from Japan and from Israel, serving as a basis for an R&D cooperation program between the two countries, which will provide access to funding for collaborative R&D projects between Israeli and Japanese companies, and will also assist companies to locate eligible partners in both countries. The program will be implemented by MATIMOP in Israel and NEDO in Japan.

    “We expect that Japanese companies can collaborate with Israeli companies to create a ‘win-win’ relationship,” said Muto. “Additionally, METI/NEDO also believe that MATIMOP's function of providing partner matching will play a key role in facilitating the industrial R&D cooperation between Israeli and Japanese companies.”

    Muto explained that METI and NEDO believe that Japanese companies could greatly benefit from Israel’s strong innovation ecosystem and its support system for start-up companies. While Japan has many large global corporations, it does not have many start-ups. The strengths of the two countries complement each other, and cooperation can led to innovation as well as serve as a “gateway to the Asian market for Israel.”

    What's Next ?

    A new Japan-Israel R&D Cooperation program is set to launch in early 2015, following ratification of the MOC in the Israeli parliament. The program will provide Israeli and Japanese companies an opportunity to apply for funding for joint R&D projects and get assistance in finding partners. Although the funding program will only open next year, companies can already get MATIMOP and NEDO’s help now to search for R&D partners in Israel and Japan.

    Sentiment: Strong Buy

  • Israel-Japan ties have been going through a renaissance since last year, including Netanyahu’s May visit to Japan, the signing of an Industrial RD Agreement in July 2014

    Sentiment: Strong Buy

PSTI
2.673-0.007(-0.26%)12:05 PMEST

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