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Prana Biotechnology Limited Message Board

kadaicher1 50 posts  |  Last Activity: 2 hours 22 minutes ago Member since: Jan 23, 2004
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  • kadaicher1 kadaicher1 2 hours 22 minutes ago Flag

    WOW, depending on the FDA reaction to this advisory committee vote, you could be right. Prana probably have a stronger claim with stat sig gains seen in the pre specified subgroup of early stage patients AND a two year safety profile for PBT2. HD is one of the most terrible neurodegenerative diseases for sure. To have the HSG founder Ira Shoulson presenting the case to the FDA would be a plus, considering any advisory panel would probably have docs committed to the RNA drug efforts who may try to shoot it down.

    Sentiment: Strong Buy

  • kadaicher1 kadaicher1 2 hours 36 minutes ago Flag

    Now we need to see what the FDA do with that recommendation. If the FDA do give a conditional approval of Kalydeco based on post approval trials, that could be a big green flag for Prana in HD. There is a strong argument to bring PBT2 to patients if there is a possibility of delaying onset of symptoms.

    Sentiment: Strong Buy

  • kadaicher1 kadaicher1 2 hours 47 minutes ago Flag

    Not sure you could use the petri dish for Schizophrenia, but the Florey are running human trials on different NAC combinations.
    A lot is riding on the ability of Prana, and probably more Ira Shoulson to design a HD trial that can demonstrate the most effective stage to showcase PBT2 strengths against HD, or to convince the FDA to bring it to HD patients with a post approval trial based on the strong results in the early stage sub group of Reach2HD. I think the latter is unlikely.
    Once to market for HD, PBT2 could be considered for many forms of mental health problems where zinc or other metal imbalances are suspected, such as Schizophrenia.

    Sentiment: Strong Buy

  • kadaicher1 kadaicher1 9 hours ago Flag

    ITM, exactly. If PBT2 synergies are found with NAC in Schizophrenia,, then PBT2 could be made available very quickly for schizophrenia, which is a huge market. That would be after approval for HD.

    Sentiment: Strong Buy

  • kadaicher1 kadaicher1 14 hours ago Flag

    Copper, if the Florey is going after an NAC/PBT2 cocktail, forget about how many staff Prana have. The Florey is home to more than 500 neuro scientists and support staff and conduct their own trials with NAC combinations over multiple combinations and conditions.
    If you look at the page of Ashley Bush's Oxidation lab at that institute you you will see he focuses on;
    • Oxidative stress in neurological disorders;
    • The molecular and cellular basis of neurotoxicity
    associated with the deposition of aggregating proteins
    in neurodegenerative disorders;
    • Understanding the interactions between cellular
    proteins and biologically important metals.

    It is not surprising his work overlaps some of Prana's.

    Sentiment: Strong Buy

  • kadaicher1 kadaicher1 22 hours ago Flag

    Copper those remedies have been around a long time and we still have schizophrenia.
    The Florey and others have been looking at adjunctive treatments for a wide range of conditions. If they want to test with PBT2 I think it is a good thing. This is not new. They have been talking about NAC(an antioxidant) for a few years now and it was probably inevitable they would get around to zinc levels and PBT2.
    PBT2 is almost through Prana's pipeline. Once approved for HD PBT2 can be used at a doctors discretion, for any indication, if he thinks it will benefit his patient.
    It would be nice to see some positive news on PBT2 in schizophrenia treatment emerge as PBT2 is approved for HD.
    From the MHRI 2011 report.
    "The Unit continues to be involved in a range of trials to test
    the benefits of the antioxidant N-acetyl cysteine (NAC) on
    the symptoms of disorders including bipolar disorder,
    depression and autism. In conjunction with these trials,
    magnetic resonance spectroscopy is being used to
    investigate changes in biomarkers following NAC treatment."
    Maybe they can find synergies with MPACs.

    Sentiment: Strong Buy

  • Reply to

    Genervon - ALS, HD, Parkinson Trials

    by vinewooddev Oct 21, 2014 10:56 AM
    kadaicher1 kadaicher1 23 hours ago Flag

    I guess if PBT2 is compared to historical placebo for the IMAGINE trial it was a complete success, reducing plaque against historical trends of increasing plaque.
    Not sure how the FDA will look at historical placebo.
    Maybe Prana will also be asking how to make PBT2 available to HD patients also considering the strong result in the early stage patients sub group compared to a real time placebo. Just a little more time till the full PBT2 safety profile is available for the FDA. That will be 2 year safety data from one trial, 6 month from the Reach2HD , 3 months from the Euro trial and the safety Ph1 trials.
    Great news if they have something effective against ALS. Trouble is with those numbers we just don't know yet. My opinion is the FDA will want more data on ALS. For sure the need is desperate.

    Sentiment: Strong Buy

  • kadaicher1 kadaicher1 Oct 20, 2014 12:44 PM Flag

    Pivalde here is one. Look who brokered it. Pete Smith, the same guy Prana brought on board for the end of the IMAGINE trial. This one was a generic. I think Alchemia already had Dr Reddys making the drug, as Prana has with PBT2. I guess Prana could cut deals like that for single MPAC's.
    "Alchemia and Dr Reddy’s Expand Fondaparinux Marketing Collaboration
    July 14, 2010 09:10 PM Eastern Daylight Time
    BRISBANE, Australia--(BUSINESS WIRE)--Alchemia (ASX:ACL) today announced the agreement of terms with Dr Reddy’s Limited for marketing fondaparinux sodium for injection (the generic version of GlaxoSmithKline’s Arixtra®) in all territories outside of North America. This agreement does not in any way alter the existing arrangements between the companies for the manufacture and North American marketing of fondaparinux.

    “This agreement makes a great deal of sense for Alchemia”

    Dr Reddy’s will pay to Alchemia a royalty on sales at an agreed proportion. Dr Reddy’s will have the option to market the drug itself or enter into agreements with third parties.

    “This agreement makes a great deal of sense for Alchemia,” said Pete Smith, CEO of Alchemia. “Dr Reddy’s has the experience of directly marketing generic drugs in a large number of countries and supplying API to numerous other pharmaceutical and generic companies across the globe. Whilst Alchemia has been approached by a number of companies interested in marketing fondaparinux, it would be inefficient for us to identify and enter into multiple agreements in the markets where we have no experience.”

    And it was just a generic.

    Sentiment: Strong Buy

  • kadaicher1 kadaicher1 Oct 16, 2014 8:25 PM Flag

    I recall early Prana research in the petri dish demonstrated the need for metals where neurons grew new dendrite, spines and synapses only in the presence of zinc and copper. I don't know for sure but imagine that some sort of trophic factor would need to be present in the gel for all that energy expenditure.
    With Tanzi being involved in the Prana research demonstrating the need for metal for the growth to take place I don't think he would have to think twice about making metals available in the gel or whatever growth medium. I am sure Pivalde or ITM, being more organized than me, could give you the link to that research. I am not saying Prana beat them to that research, the miracle from Tanzi's lab was doing it with human cells.
    I guess the amyloid is caused by introduced genetic mutations causing inefficiencies in metal homeostasis during metal driven signalling across synapses, with neuron's APP then reacting by producing amyloid to soak up the excess metals building around the synapses. If he can produce the AD trigger point, imagine, they will be able to watch neurons dying, iron building, GSK3 modulators like zinc and insulin losing as supplies are lost at the synapses, as GSK3 goes into hyper destruction of tau, secretase enzyme increase causing the APP amyloid production to go into overdrive with the final signal to the death receptor(DR6). At the end trophic factor is shut down to the neuron and I am not sure if asrtocytes are required for that process. Then there is the nutrients spilling from ruptured cells being taken up by healthy or strassed cells leading to the risk of excitotoxicity and inflammation. All in real time, in human neurons. Very exciting.
    Did Rudy mention if there were astrocytes in the stew. That would be interesting because as well as delivering trophic factor from the BBB they are said to double as stem cells.
    My bet is that all those final processes are irrelevant and control of GSK3 is required before it goes berserk.

    Sentiment: Strong Buy

  • Reply to

    What Prana knew and when

    by pierreluke77 Oct 15, 2014 10:43 AM
    kadaicher1 kadaicher1 Oct 15, 2014 4:05 PM Flag

    I imagine there are many labs capable of replicating that test, including the Florey right next to Prana.
    PBT2 will not directly directly #$%$ GSK3, but the zinc it introduces to the neuron will. So will insulin for that matter. Changing stem cells into neurons is a neat tick. I have read metformin can promote the change in a model.

    Sentiment: Strong Buy

  • Reply to

    What Prana knew and when

    by pierreluke77 Oct 15, 2014 10:43 AM
    kadaicher1 kadaicher1 Oct 15, 2014 1:19 PM Flag

    Sorry Linda, just I did not recall the exact figure. Of the experimental drugs, I think MPACs should and would be first in line.
    Another question would be is this test restricted by patent or can labs across the globe begin to use this method?

    Sentiment: Strong Buy

  • Reply to

    What Prana knew and when

    by pierreluke77 Oct 15, 2014 10:43 AM
    kadaicher1 kadaicher1 Oct 15, 2014 12:24 PM Flag

    Tanzi seems to have good relations with Susan Lindquist, and it was probably Tanzi who got the MPACs included in the Whithead mass screening. Likewise, I think he would be using the Whitehead results to help pick candidates. As MPACs emerged at the top after the unbiased screening was finished, I think it is natural that MPACs and combinations of MPACs would be some of the first tests.
    It would be very interesting to see PBT434 in combo with PBT2 against HD.

    Sentiment: Strong Buy

  • Reply to

    What Prana knew and when

    by pierreluke77 Oct 15, 2014 10:43 AM
    kadaicher1 kadaicher1 Oct 15, 2014 11:49 AM Flag

    Didn't Tanzi say he had about 1500 drugs to test:-)

    Sentiment: Strong Buy

  • Reply to

    Also from the report, very good news

    by kadaicher1 Oct 15, 2014 10:00 AM
    kadaicher1 kadaicher1 Oct 15, 2014 11:46 AM Flag

    I think a lot of traders were working hard to create the myth that IMAGINE was everything.

    Sentiment: Strong Buy

  • Reply to

    Also from the report, very good news

    by kadaicher1 Oct 15, 2014 10:00 AM
    kadaicher1 kadaicher1 Oct 15, 2014 11:35 AM Flag

    Hi RKF, I can't see the reason why this is so cheap. Prana are now still on track to take PBT2 to market for HD, and the value of Prana's huge drug library has potentially just become a lot more valuable with the latest developments.
    Of course if anyone has been hoodwinked into thinking the IMAGINE trial was everything Prana had, then I see a belief in this value, but that is not the case, and things could move very quickly from here.
    The IMAGINE trial didn't prove or disprove anything much except prove the safety profile which also applies to HD being that they are using the same drug for both indications.

    Sentiment: Strong Buy

  • "The highlight of the year was the release of clinical data for the Phase 2 trial investigating PBT2 in Huntington
    Disease, the Reach2HD trial. The trial passed its primary endpoint of safety and tolerability and, most
    pleasingly, reported data supporting improved executive function. Huntington Disease represents the most
    exciting short term pathway to commercialise PBT2.
    In patients on the highest dosage of PBT2, the trial found a statistically significant improvement in executive
    function via the results of the Trail Making Test Part B. There was also a trend towards improvement on the
    executive function composite z-score, accompanied by a trend toward improvement on functional capacity. A
    small exploratory neuroimaging study also suggested decreased brain atrophy in patients taking PBT2 that we can explore further in future trials."
    It was nice to see the trend in reduction of brain atrophy across the Reach2HD and IMAGINE trials.
    Now HD was always said by Prana to be the fastest way to market. The timeline has not changed. Reach2HD has given them enough to design a pivotal HD trial for approval.
    Possibly the worlds foremost expert in HD and PD has come on board to guide the trial design and development in those indications. The same doc who ran the trial for the only approved HD drug, Dr Shoulson.
    The IMAGINE trial was never powered to demonstrate much in AD but plaque reduction, and even there a few placebo outliers were enough to wreck the result there. For the immediate present I expect AD to take second place to HD, and Prana have been saying for a few years that would be the case.

    Sentiment: Strong Buy

  • Reply to

    Confirmation of the Metals Theory

    by interestingtome Oct 13, 2014 2:28 PM
    kadaicher1 kadaicher1 Oct 15, 2014 8:59 AM Flag

    Nice observation ITM, this could be a chance to get PBT519 into tests to prove synergies with other cancer drugs, or to replicate the synergy already seen in the mouse model.
    From Edgar Online;
    "In September 2009, we received a report on a study conducted on PBT519, our lead brain cancer MPAC, by the Royal Melbourne Hospital. The report showed that PBT519 was able to significantly prevent the growth of the tumors of the deadly glioblastoma multiforme form of brain cancer in mouse models of the disease. Moreover, PBT519 appeared to be very well tolerated and was at least as efficacious as the current leading form of chemotherapy, temozolomide. The data indicates that PBT519 may work synergistically with temozolomide in reducing the growth of such brain tumors."

    Sentiment: Strong Buy

  • Reply to

    I don't get it

    by brewman228 Oct 13, 2014 5:19 PM
    kadaicher1 kadaicher1 Oct 15, 2014 7:17 AM Flag

    Makes you wonder if Prana didn't know something like this was in the works. With so many compounds ready to go I think they probably have the jump on most.
    Now they can be tested on human neurons under attack with little cost, including combinations with Prana's library and other companies approved and experimental drugs. Example, now they could test with Aricept or Bapi. Now it is easy to understand why getting a biomarker package for PBT2 was so important.

    Sentiment: Strong Buy

  • kadaicher1 kadaicher1 Oct 14, 2014 1:20 PM Flag

    Very true with Prana positioned to do very well.

    Sentiment: Strong Buy

  • Reply to

    I don't get it

    by brewman228 Oct 13, 2014 5:19 PM
    kadaicher1 kadaicher1 Oct 14, 2014 1:09 PM Flag

    I am a little confused. How would Tanzi's product be expected to explain a freak placebo result in an under powered trial. Tanzi's product gives Prana the chance to demonstrate the potential efficacy of hundreds of MPACs and combinations against a range of neurodegeneration conditions. This discovery is a big deal for Prana with so many compounds in reserve.

    Sentiment: Strong Buy

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