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Osiris Therapeutics, Inc. Message Board

pivalde 176 posts  |  Last Activity: 1 hour 51 minutes ago Member since: Feb 15, 2001
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  • Reply to

    Open investigational new drug program with FDA

    by pivalde 2 hours 58 minutes ago
    pivalde pivalde 1 hour 51 minutes ago Flag

    That is my prediction but let us see. So the case would be " Accelerated review- approval with post approval conditional studies" . It could well be something else but I think we will hear soon about it more.

  • To me it looks like discussions are ongoing and that also ph3 study will be done for HD. I assume that PBT2 could get to the market as an investigational drug.

  • pivalde by pivalde Sep 29, 2014 4:36 AM Flag

    J Alzheimers Dis. 2014 Sep 26. [Epub ahead of print]

    Towards a Unified Vision of Copper Involvement in Alzheimer's Disease: A Review Connecting Basic, Experimental, and Clinical Research.

    Pal A1, Siotto M2, Prasad R1, Squitti R3.

    Copper is an essential micronutrient for physiological cell functioning and central nervous system (CNS) development. Indeed, it is a cofactor of many proteins and enzymes in a number of molecular pathways, including energy generation, oxygen transportation, hematopoiesis, cellular growth and metabolism, and signal transduction. This is because it serves as a catalyst of reduction-oxidation (redox) reactions in these processes. When copper is kept under control, bound to special proteins, it yields key properties. However, when it spirals out of control, it is exchanged among small compounds (it is loosely bound to them), and its redox activity makes it dangerous for cell viability, promoting oxidative stress. Copper homeostasis in the CNS is securely synchronized, and perturbations in brain copper levels are known to underlie the pathoetiology of wide a spectrum of common neurodegenerative disorders, including Alzheimer's disease. The main objective of this review is to provide some of the most relevant evidence gleaned from recent studies conducted on animal models and humans, and to discuss the evidence as it pertains to a new concept: Aberrant copper metabolism, which appears to have a genetic basis, is a modifiable risk factor accelerating Alzheimer's disease and initiation/progression of cognitive deficits in a percentage of susceptible persons.

  • pivalde pivalde Sep 29, 2014 4:28 AM Flag

    Yes, this is just the way how the hedge fund managers do, they do it in both ways ! They can use a few millions to get the pps up and down, what ever they want. Cremer told it all few years ago in a video interview ( it was posted again on the HC board) They give misinformation to some who distribute it further etc.

  • Reply to

    Prana preparing Post Phase 2 Trial dossier for FDA

    by pivalde Sep 17, 2014 9:19 AM
    pivalde pivalde Sep 27, 2014 10:23 AM Flag

    So I think that they only took the info from the safety monitoring board (perhaps a bit old report) and what they had used when filling the forms for PBT2 to be an Orphan drug. In that application safety is a big thing, they had to inform exactly how long the patients had been on the drug. If anyone reports something only about the progress of extension study he will not tell in this quite a complex way as was in this July announcement. Only my opinion once again.

  • Reply to

    Prana preparing Post Phase 2 Trial dossier for FDA

    by pivalde Sep 17, 2014 9:19 AM
    pivalde pivalde Sep 27, 2014 10:07 AM Flag

    Linda, in the preliminary annual report they say " study is on going and will be compleated at the end of 2014/early 2015".
    I think they reported in July safety info, how many people had been checked by the safety monitoring board and how long each of them had been on PBT2. But this has been informed very poorly.
    It would not be according to the protocol if one single person had been not taken the drug for several months and then started on it again. At this point I believe the preliminary annual report "the end of 2014/early 2014".

  • This is a free paper but unfortunately in Japanese language. There are however also nice pictures about plaque formation and about the role of metals in synapses. In any case this is a good demonstration that metal theory is widely accepted in the world and in fact it is not anymore a theory.

    Nihon Eiseigaku Zasshi. 2014;69(3):155-65.

    Crosstalk between Metals and Neurodegenerative Diseases.

    Kawahara M1, Mizuno D.

    Trace elements including iron, zinc, copper, and manganese play essential roles in the maintenance of brain functions. Accumulating evidence suggests that dyshomeostasis of trace elements is implicated in the pathogenesis of neurodegenerative diseases including Alzheimer's disease, vascular type of dementia, prion diseases, and dementia with Lewy bodies. These diseases share similarity in the formation of β-sheets containing amyloid fibrils from disease-associated proteins, including the β-amyloid protein (AβP), the prion protein, α-synuclein, and polyglutamine, and the introduction of apoptotic degeneration. Trace elements can bind to these proteins and cause their conformational changes. Furthermore, these proteins reportedly play crucial roles in the regulation of trace elements. Considering that these proteins colocalize in synapses, it is possible that the interactions between the disease-associated proteins and trace elements are based on the physiological roles of these proteins. We review here the current understanding of the pathology of neurodegenerative diseases based on metal binding to disease-associated proteins and on the disruption of metal homeostasis.

  • Reply to

    short trading increased yesterday

    by pivalde Sep 26, 2014 3:51 AM
    pivalde pivalde Sep 26, 2014 9:30 AM Flag

    I think that the daily numbers are better than the ones reported twice a month because they inform the daily shorts bought and it is easy to remember what happened on that day. What we should still need to know how much shorts have sold each day and so we would know the daily balance of shorts. Big picture is more valuable and so small accuracy problems do not matter. One day we will have it and so more clear picture can be seen about the short activity. With Prana the short activity is not so important at all because all that really matters is the progress of PBT2 to the market.

  • Yesterday it was 27% ( 303277) of the total vol of 1129080. This could indicate again some pressure on the PPS but it could be that the total vol of shorts has gone down during the past few weeks.

  • Reply to

    Osiris announces...

    by ozark580 Sep 25, 2014 3:19 PM
    pivalde pivalde Sep 26, 2014 2:49 AM Flag

    What is he presenting ? Title? Announcement? A new product? Scientific report ?

  • This is a crossectional study, but looks like it would be beneficial to do exercises and control your wight.

    Neurobiol Aging. 2014 Aug 27. pii: S0197-4580(14)00541-7. doi: 10.1016/j.neurobiolaging.2014.05.036. [Epub ahead of print]

    Physical activity, body mass index, and brain atrophy in Alzheimer's disease.

    Boyle CP1, Raji CA2, Erickson KI3, Lopez OL4, Becker JT5, Gach HM6, Longstreth WT Jr7, Teverovskiy L8, Kuller LH9, Carmichael OT10, Thompson PM11.

    The purpose of this study was to use a novel imaging biomarker to assess associations between physical activity (PA), body mass index (BMI), and brain structure in normal aging, mild cognitive impairment, and Alzheimer's dementia. We studied 963 participants (mean age: 74.1 ± 4.4 years) from the multisite Cardiovascular Health Study including healthy controls (n = 724), Alzheimer's dementia patients (n = 104), and people with mild cognitive impairment (n = 135). Volumetric brain images were processed using tensor-based morphometry to analyze regional brain volumes. We regressed the local brain tissue volume on reported PA and computed BMI, and performed conjunction analyses using both variables. Covariates included age, sex, and study site. PA was independently associated with greater whole brain and regional brain volumes and reduced ventricular dilation. People with higher BMI had lower whole brain and regional brain volumes. A PA-BMI conjunction analysis showed brain preservation with PA and volume loss with increased BMI in overlapping brain regions. In one of the largest voxel-based cross-sectional studies to date, PA and lower BMI may be beneficial to the brain across the spectrum of aging and neurodegeneration.

  • Short vol was yesterady 55420, only 8% of the total 762411. Could be that it is a sign that we do not get much lower at this time (??) In Australia PBT closed up 2% to 0.245, corresponding 2.16 in NY, so there is a cap between Australia and NY as it has been the case for a while.

  • The vol of PBT was only 45.200 corresponding 4520 Pran shares in NY. PPS was at the same level as it was in NY yesterday. Short vol yesterday in NY was only 10% and was 17025. On Tuesday the % was 11 but the volume was almost 58000.

  • Reply to

    PBT up over 6% in Australia

    by pivalde Sep 23, 2014 2:51 AM
    pivalde pivalde Sep 24, 2014 1:14 AM Flag


  • Reply to

    PBT up over 6% in Australia

    by pivalde Sep 23, 2014 2:51 AM
    pivalde pivalde Sep 23, 2014 12:56 PM Flag

    The % of shorts of the volume has gone down during the 5 last previous traiding days: 21%, 17%, 16%, 14% and yeasterday 11%. To me it indicates loss of short interest and one factor taking the volume down. Now just under 100K after 3.5 h .

  • Reply to

    PBT up over 6% in Australia

    by pivalde Sep 23, 2014 2:51 AM
    pivalde pivalde Sep 23, 2014 10:56 AM Flag

    Vol in NY seems also to be low, only some 50.000 in the first 1.5 hours. Let us see if the pps starts getting some lift !

  • Vol was very low, just under 40.000. pps was 0.250 and that corresponds 2.23 level in NY.

  • pivalde pivalde Sep 22, 2014 2:50 PM Flag

    Thanks, but there is no need.

  • pivalde pivalde Sep 22, 2014 2:47 PM Flag

    No, I think there is no need for it. It is just a in vitro study, but interesting when it includes PBT2 and is done by not Prana scientists.

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