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Off Topic on Adult (=regenerative) cell technology, but very much related i.e. pills and drugs of which we do not know if they work
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TOPIC: PSTI

PSTI 02 Jan 2015 08:33 #3035

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New Published Data Show Pluristem's PLX Cells Protect Neurons

PLX Cells Could Potentially be Used to Treat Stroke or Other Injuries to the Nervous System Attributable to Low Oxygen Levels

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Pluristem Therapeutics Inc.
December 22, 2014 3:00 AM

GlobeNewswire



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HAIFA, Israel, Dec. 22, 2014 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (PSTI) (PSTI.TA), a leading developer of placenta-based cell therapy products, announced today that a study of PLacental eXpanded (PLX) cells was accepted for publication in the February, 2015 issue of Biochimica et Biophysica Acta Molecular Cell Research. The study results show that PLX cells protect PC12 cells -- an established model of various nerve cells including dopaminergic neurons -- from death after oxygen and glucose deprivation. The protective effects of PLX cells were strongly correlated with the secretion of interleukin 6 (IL-6) and vascular endothelial growth factor (VEGF), which are known to have neuroprotective effects in humans with injuries to the nervous system that can occur after events such as a stroke.

"Our findings suggest that PLX cells may potentially treat damaged nerves, and may corroborate and explain the mechanism that leads to one of our findings in our Phase I trial in critical limb ischemia. In that study, patients treated with PLX cells had a statistically significant reduction in pain as compared to their baseline. An earlier preclinical study, published in the journal Brain Research, showed that PLX cells may effectively treat ischemic stroke," stated Pluristem CEO Zami Aberman.

Aberman continued, "These latest findings also call to mind two earlier preclinical studies, which indicated that PLX cells may be an effective treatment for both neuropathic and inflammatory nerve pain, suggesting that PLX cells could be a potential treatment for chronic nerve pain resulting from conditions such as diabetic neuropathy."

The study, titled "Human PLacental eXpanded (PLX) mesenchymal-like adherent stromal cells confer neuroprotection to nerve growth factor (NGF)-differentiated PC12 cells exposed to ischemia by secretion of IL-6 and VEGF", was conducted jointly by researchers at Pluristem and Prof. Philip Lazarovici, Jacob Gitlin Chair in Physiology and Pharmacology at the School of Pharmacy Institute for Drug Research at the Hebrew University and co-authored by Prof. Ephraim Yavin of the Department of Neurobiology at the Weizmann Institute of Science. The study was supported by the Magnet program of Israel's Ministry of Economy

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PSTI 20 Apr 2015 08:40 #4271

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3:37 am Pluristem Therapeutics' Clinical Advisory Board prepares Phase II clinical trials in critical limb ischemia in Europe and Japan (PSTI) : Co announced that its Clinical Advisory Board for Critical Limb Ischemia concluded a key meeting in London, England. During the meeting, Clinical Advisory Board members, including Key Opinion Leaders in the treatment of CLI, outlined the Phase II study design and other critical components of advanced-stage trials for the Company's PLacental eXpanded cells in the treatment of this peripheral artery disease.

•Pluristem has applied to conduct Phase II trials for CLI in regions with recently established rapid regulatory pathways, including the Accelerated Pathway for Regenerative Therapy in Japan and the Adaptive Pathway in the European Union.
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Still more news of a stem cell company moving forward in Japan as we wait and wait for the start of the final phase of a SUI trial and no articulation of any further plans in the country, with what should be the easiest pathway to market.

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PSTI 20 Apr 2015 10:07 #4273

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Yes- but it really isnt only SUI... :bash:

On November 7 2013 Hedrick indicated...

we've got nine or so studies going on, can we take those and convert those into approvals by either taking that data or adding a few more patients and getting formal approval and begin to market it although without reimbursement for that and then set up post-market surveillance studies based on that and then get reimbursement later. And the answer is we absolutely have that as part of our strategy. And if you look at MHLW, the Ministry of Economics and Transport on data, they think that this legislation will cut clinical trial costs in regenerative medicine down by 30%. We probably see more because we hope we're going to be on the lower tier.


That 9 included for instance the 40 patients study on CLI and PAD etc, which should be completed now.

Combine that we the more than excellent news form November 2014- one should think there are plenty of NEAR-TERM opportunities with the right people, money OR partners in Japan.. :bang: :bang: :bang:

Cytori’s Celution System Is in Lowest of Three Risk Categories

The Act on the Safety of Regenerative Medicines and an amendment of the 2013 Pharmaceutical Affairs Act (the PMD Act), collectively termed the “Regenerative Medicine Laws,” replace the Human Stem Cell Guidelines. Under the new laws, the cell types used in cell therapy and regenerative medicine are classified based on risk. Cell therapies using cells derived from embryonic, induced pluripotent, cultured, genetically altered, animal and allogeneic cells are considered higher risk (Tiers 1 and 2) and will undergo an approval pathway with greater and more stringent oversight due to the presumed higher risk to patients. Cytori’s Celution System, which uses the patient’s own cells at the point-of-care, will be considered in the lowest risk category (Tier 3) for most cases, and will be considered in Tier 2 if used as a non-homologous therapy.

Streamlined Regulatory Approval for Certain Medical Devices

In the near future, Cytori intends to pursue disease-specific or therapeutic claims and reimbursement for Cytori’s Celution System and the Company would, at that point, sponsor a clinical trial to obtain Class III device-based approval and reimbursement. The new laws include changes to streamline regulation of Class II and some Class III devices, which will now require the approval of certification bodies rather than the PMDA, similar to the European ‘notified body’ model. To date, certification bodies have only been used for some Class II devices.

Conditional Regulatory Approval and Reimbursement Potential

As a supplementary benefit to Cytori, the Company may also choose to take advantage of the new ‘conditional approval’ opportunities granted under the new laws. Once clinical safety and an indication of efficacy are shown, sponsors may apply for their cell product to receive conditional approval for up to seven years and may be eligible for reimbursement under Japan’s national insurance coverage. Under the conditional approval, the sponsor can then generate post-marketing data to demonstrate further efficacy and cost effectiveness.


A Kingdom for the grabbing as written if certain conditions are met... :really:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

PSTI 20 Apr 2015 10:53 #4275

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***with the right people, money OR partners in Japan***

Yes.....this is the theme for many years. It would just be nice for some communication on studies that get mentioned then seem to disappear into the Cytori black hole of disclosures to investors. Other companies don't have this problem and in voting with my investment here, don't have the same promise. So while I felt the last conference call was promising....frustrations remain. Maybe the good feelings are reignited in a few weeks with some additional disclosures.

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PSTI 20 May 2015 20:05 #4554

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PSTI got their accelerated approval in EU for CLI.

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PSTI 21 May 2015 07:55 #4555

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Yeah, I liked it... and bought it, this is what I am talking about... by the time the company "gets" there the price is affordable enough to get in, no matter how long it takes.

The price is always higher when phase one and two are done, for some strange reason ( look up greed, and herd mentality )

My fear has always been, if a stem cell company has almost-similar results, without that lipo-procedure, then Cytori would be done, fast.

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PSTI 21 May 2015 09:05 #4557

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I agree the lipo procedure may prove more of a liability than originally thought. Think our stopped bone trial in Switzerland. If we ever do get to markets and show what our cells can do we should win on efficacy and price.

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