Prana Biotechnology (PRAN)

[interestingtome]

Rudy Tanzi is also speaking in Boston next week at the CureAlz annual meeting and like last year he may make mention of PBT2.

RESEARCH PRESENTATION:
From Genes to Therapies: Converging on a Cure
Rudy Tanzi, Ph.D., Harvard Medical School/Massachusetts General Hospital;
chair, Cure Alzheimer’s Fund Research Consortium

Wednesday, Oct. 14, 2015 • 3:30 p.m.
- See more at: http://www.curealz.org/symposium#sthash.0c09ukbM.dpuf

[bobmenji]

I've noticed AVXL SP has been rising. I believe it has something to do with their most recent P2A trial results which will be showcased at CTAD in Barcelona. Can anyone shed light on how PBT2s AD results compare to that of Anavex 2-73? Thanks

[Learning53]

Sent a brief email to Marssa Mayer summarizing disruption of PRAN message board and potentially (since I cannot personally attest) other message boards at Yahoo Finance. I felt it was only fair since I have used Yahoo resources freely for well over a decade.

Perhaps it was a waste of time, but on the other hand it might be delegated. The round-the-clock nature of the disruptions, as previously stated, are indeed suspicious. It would take more than a "really annoyed person" to keep up the observable level of activity for this amount of time.

It would be lovely if an orchestrated "assault" on PRAN was
brought to light - especially by an organization with the clout to deal with it appropriately.

Or...(as previously stated) it could have been a minor waste of time

[bobmenji]

A breath of fresh air! Am ready for PRAN to soar.

[interestingtome]

Well....I've just discovered that the problem is not limited to the PRAN board. Same deletion hack happens on MNKD, INO, AVXL, ONCS to name a few. At least it isn't just PRAN. I posted on uservoice about it.

[interestingtome]

Psychiatry and Neuroscience Update

pp 157-179
The Role of Iron and Other Trace Elements on Mental Development and Cognitive Function
Silvia Izquierdo-Álvarez et al

Abstract

In this chapter we review the effect of some trace elements. Consequences of exposure or modification of the levels of iron, lead, methylmercury, mercury, cadmium, manganese, arsenic, and copper on the central nervous system (CNS) and learning and cognition will be discussed. We review the effects of iron deficiency (ID) and anemia on cognitive function and the relationship between its statuses on developmental outcome and the state of the adult brain. The iron needs of the brain vary depending on the stage of the life cycle and the cell types. ID has been reported to have a role in brain development and some trace elements are routinely involved in metabolic processes and oxidation-reactions in the CNS which could have a possible effect on cognitive functions. Behavioral and cognitive adverse effects caused by exposure to lead by the fetus and infant are discussed, as well as fetal and infant exposure to high concentrations of methylmercury and cadmium on CNS development and their cognitive consequences. A significant correlation between elevated levels of cadmium and lead and decreased verbal development and lower IQ has been shown in children. The potential effects associated with the accumulation of manganese in the CNS decreasing levels of neurotransmitter. Arsenic exposure can produce neurocognitive deficits in children. Dysregulation of iron homeostasis is also a critical feature in Alzheimer disease (AD), Parkinson disease (PD), Friedreich ataxia (FA), and neurodegeneration with brain iron accumulation. Copper toxicity and zinc deficiency are associated with cognition loss and AD. Consequently, we consider an update on these issues necessary.

[tbtbtb]

Well if that kid got prosecuted (as a warning to others) for that, I should certainly think that this type of obstruction and manipulation could potentially be much more interesting to the regulators.

[interestingtome]

TB-From the looks of it I think they have figured out how to re route the abuse reporting feature but they also have a few algorithms to block certain keywords in posts. Many times the second I hit the button to post it is deleted right before my eyes. That could only happen with an algorithm IMO. I started out as a computer science major but I didn't like spending all my time behind a computer! haha ironic. I think what you said are good ideas.

[interestingtome]

Hmm good ideas. I just found this-

On Sept. 20, 2000, the Securities and Exchange Commission settled its case against a 15-year-old high-school student named Jonathan Lebed. The S.E.C.'s news release explained that Jonathan -- the first minor ever to face proceedings for stock-market fraud -- had used the Internet to promote stocks from his bedroom in the northern New Jersey suburb of Cedar Grove. Armed only with accounts at A.O.L. and E*Trade, the kid had bought stock and then, "using multiple fictitious names," posted hundreds of messages on Yahoo Finance message boards recommending that stock to others. He had done this 11 times between September 1999 and February 2000, the S.E.C. said, each time triggering chaos in the stock market. The average daily trading volume of the small companies he dealt in was about 60,000 shares; on the days he posted his messages, volume soared to more than a million shares. More to the point, he had made money. Between September 1999 and February 2000, his smallest one-day gain was $12,000. His biggest was $74,000. Now the kid had agreed to hand over his illicit gains, plus interest, which came to $285,000.

[Renee]

Welcome, Interestingtome. This site is committed to the Terms Of Use (T.O.U.). All members are required to abide the T.O.U. so that everyone can enjoy I-Hub.

For all readers, here is the Terms Of Use / Service:

http://investorshub.advfn.com/boards/terms.aspx

[interestingtome]

Nice of you to introduce yourself Renee. Many of us and hopefully more are coming over from the yahoo finance message board since a few bashers have somehow hacked into the algorithm for the board and figured out a way to delete all posts they don't like which mostly include scientific posts, factual information and well thought analysis. The Prana board over there has been a healthy exchange of information until lately. Hopefully none of them will try to sneak over here to play their games but I wouldn't put it past a few to try. Hopefully they won't be able to.

[interestingtome]

I believe the last quarterly showed somewhere around 29M AUS but someone else might have a better number. I seriously am not worried about the money. Prana has shown the ability to raise cash from private investors time and again. The go ahead either in the form of an approval with post approval trial or the go ahead with the trial from either EU or FDA will make money a non-issue.

I think the next significant news will be the lifting of the partial hold or the movement toward one of the above listed. There is also the IMAGINE data and the results of Tanzi's 3D model due. But I think the hold will be lifted prior.

[interestingtome]

Not yet. And you can bet Copper won't because then Kad would know his alias.

[Grebo]

Hi ITM, did Kad come over from the YMB?

[Learning53]

Does anybody know how much money PRANA has left in its kitty?

Is there any "intelligence" concerning when Prana will be making any announcements and what those announcements might concern?

Note: Back on the Yahoo message board (PRAN) - with many serious board members gone (to InvestorsHub) the miscreants don't seem as active. I suspect our absence has inhibited their ability to misinform, confuse, confound and delete. Fortunately, some of you have left "breadcrumbs" to lead other serious investors to this board.

PS - A big thank you to our moderator for the welcoming message! I look forward to the active exchange of relevant information.

[interestingtome]

Editorial about metals in cognitive decline

Worth reading this 2 months old free paper again and look at the other papers the authors recommend.

Front Aging Neurosci. 2015; 7: 116.

Published online 2015 Jun 17. doi: 10.3389/fnagi.2015.00116

Editorial: The molecular pathology of cognitive decline: focus on metals

[interestingtome]

Preserving this Pivalde post

Takeda A, Tamano H: Really many Zn- papers helping to understan the role of Zn in brain

Here some of them :

Modification of hippocampal excitability in brain slices pretreated with a low nanomolar concentration of Zn2.

Takeda A, Shakushi Y, Tamano H.

J Neurosci Res. 2015 Aug 13. doi: 10.1002/jnr.23629. [Epub ahead of print]

PMID: 26268632

Similar articles

Select item 26204819
2.

Influx of extracellular Zn(2+) into the hippocampal CA1 neurons is required for cognitive performance via long-term potentiation.

Takeda A, Suzuki M, Tempaku M, Ohashi K, Tamano H.

Neuroscience. 2015 Sep 24;304:209-16. doi: 10.1016/j.neuroscience.2015.07.042. Epub 2015 Jul 21.

PMID: 26204819

Similar articles

Select item 26044210
3.

Excess influx of Zn(2+) into dentate granule cells affects object recognition memory via attenuated LTP.

Suzuki M, Fujise Y, Tsuchiya Y, Tamano H, Takeda A.

Neurochem Int. 2015 Aug;87:60-5. doi: 10.1016/j.neuint.2015.05.006. Epub 2015 Jun 1.

PMID: 26044210

Similar articles

Select item 25959547
4.

Is interaction of amyloid ß-peptides with metals involved in cognitive activity?

Tamano H, Takeda A.

Metallomics. 2015 Aug 5;7(8):1205-12. doi: 10.1039/c5mt00076a.

PMID: 25959547

Similar articles

Select item 25818846
5.

Regulation of extracellular Zn(2+) homeostasis in the hippocampus as a therapeutic target for Alzheimer's disease.

Takeda A, Tamano H.

Expert Opin Ther Targets. 2015 Aug;19(8):1051-8. doi: 10.1517/14728222.2015.1029454. Epub 2015 Mar 27.

PMID: 25818846

Similar articles

Select item 25603776
6.

Blockade of intracellular Zn(2+) signaling in the dentate gyrus erases recognition memory via impairment of maintained LTP.

Tamano H, Minamino T, Fujii H, Takada S, Nakamura M, Ando M, Takeda A.

Hippocampus. 2015 Aug;25(8):952-62. doi: 10.1002/hipo.22418. Epub 2015 Feb 11.

[imtom9930]

Hello everyone... Thank you ITM (Kad,Pivalde,Pierreluke,Rkf) for spearheading the exodus out of chaos and into a much needed positive and productive new space ! LETS GET BUSY !!

[da_mining]

Hope this works better than the Yahoo board.

[tbtbtb]

On to InvestorsHub.

[interestingtome]

I agree Learning and I appreciate your support. The fact that ymb doesn't moderate their boards is very frustrating. It has been a great source of well thought scientific dialogue over the years. Another place is hot copper. Also moderated well.

[Renee]

Welcome to I-Hub, Learning53. If you have any questions about this site just ask.

http://investorshub.advfn.com/The-iHub-Alias-Board-ALIAS-8465/

http://investorshub.advfn.com/The-Question-and-Answer-Board-IHUB-504/

[Learning53]

To InterestingTome, I appreciate the lead to the IH message board. Getting tired of swimming through the foolishness back at Yahoo. Hopefully, it will be salvaged but nothing is certain.

I hold (for me) a substantial investment in PRAN but am concerned about their ability to last and perform. Information is crucial and I hope that some of the more credible posters will migrate as well.

Thank you

[interestingtome]

Not a chance by chance
EF improvement was seen in the 2A trial for AD as well as the REACH2HD trial is not by chance. In fact statistically it is nearly impossible to achieve this type of error by chance.

Rudy Tanzi talked about this in the post trial conference call and a reference is made to this in the post-trial press- "Given the evidence from an earlier trial that showed that PBT2 improved executive function in Alzheimer’s disease patients, the Reach2HD trial included a plan to assess the effects of PBT2 on an Executive Function composite z-score that included the Trail Making Test Part B. There was a statistically significant improvement in this z-score (p=0.038) in a pre-specified analysis of Reach2HD participants with early stage Huntington disease, as measured by their Total Functioning Capacity. Across all participants, which comprised both early and mid-stage patients, there was a trend to improvement (p=0.069). "

We don't know the results of the IMAGINE trial cognition yet - if any signal was seen at all - but with a placebo group of 12 the chance of random error was very high. That trial was designed as a biomarker trial to test whether amyloid plaques could be reduced with PBT2 at 250 mg. And plaques were removed and Rudy Tanzi repeated this in his 3D model at a rate of 5-fold reduction.

PBT2 is disease modifying in AD and HD.

[interestingtome]

PBT2 effects blood levels of soluble mHtt in early HD subjects.
Repost of an earlier thread started by Kad--

When discussing the PHAROS study in Vol 9 of HD insights, Dr Rosas made this comment.
"The study demonstrates that soluble mHTT can be usefully detected in blood, and that HD may influence its levels. Since then, we have used the same assay in blood from early HD subjects participating in HSG's Reach2HD trial of PBT2 (PRANA Biotechnology), and found that the treatment can affect soluble mHTT levels. Currently we are developing an assay that can measure mHTT aggregates in clinical samples, which we believe will also prove useful for developing treatments that target Huntingtin."

That is a nice little biomarker clearly showing PBT target engagement with the disease. It is nice to see considering it was in the early stage patients PBT2 was stat sig over all Z scores.

[interestingtome]

Lon Schneider comments on REACH2HD trial

I think the insight into the Trail Making Part B tests is valuable.

Lon Schneider
University of Southern California Keck School of Medicine
Posted: 21 Feb 2014

In this small Phase 2 trial of only 109 patients the sponsor's safety objectives were met, and there appears to be no regulatory barrier to going forward to Phase 3 and assessing PBT2 for efficacy. The trial wasn't intended as an efficacy trial and shouldn't be interpreted as one; indeed, none was found, nor should efficacy have been expected.

Of eight neuropsychological tests, only Trails B was reported as significant. Of three composites of some of these eight tests, only the executive-function composite, which included category fluency and Trails B, was statistically significant. There was no effect on motor function, behavior, two functional-ability scales, two global assessments, biomarkers, or imaging that favored PBT2—again, as would be expected.

So only the time for the Trails B test of about 20 possible outcomes and biomarkers was significant. The effect here was that for people on the 250 mg dose, time to complete the test didn't change, while for those on the lower dose and placebo, the time worsened by 15 seconds. That’s quite a big mean change. It would be most interesting to see the mean baseline times and standard deviations for the Trails B for each treatment group and the distribution of the change scores, as these data would help with interpreting any meaning to the p value reported.

[interestingtome]

Post on HD REACH2HD trial
Post from another -

The quicker they can get the ban lifted the better. Desperately need Phase 3 to go ahead. Both my mum and uncle now appear symptomatic. Mum reportedly had positive results with the strongest dose when she participated in Phase 2.

Now that my uncle appears symptomatic, he can hopefully participate in Phase 3 with her.

Are we still looking at around 3 years to market if they can lift the ban and carry out Phase 3 with positive results?

Time is of the essence with this #$%$ disease

[interestingtome]

Prana fundamentals

As posted by kadaicher on ymb

Remember a development biotech has no earnings, so the fundamentals are different from a company with a product on the market.
1. Potential growth - If PBT2 makes it to market in HD then potential growth is 8000%
2. Time to market - 3 years
4. Cash on hand $30m +/-
5. Proven ability to raise more development funds from last trials.
6. Scientific talent on board. The planets most successful movement disorder trials doctor has joined the board to direct the movement disorder programs HD, PD. There are significant readings and trends from Reach2HD to design the trial around.
7. Depth in pipeline. Good with the HD,PD drug ready for final phase3 trials in HD and AD. PD drug PBT434 ready for the clinic, the cancer MPAC 519 into toxicology studies and a library of 2000 more MPACs.
8. Progress. Currently upgrading PBT2 toxicology data prior to Phase3 for FDA approval.
9. Have non clinical study results been independently replicated, Yes for AD by the Max Planck Institute in Germany and for the PD drug, by Leeds University in the UK in three different models.
10.Patent protection secure.
11.Orphan drug status for lead program.
12. Neuroprotection properties of the platform emerged on top of an unbiased 200,000 compound screening for neuroprotection against AD, HD & PD.

[GoGoLi]

Yup, so it seems!

[Belek]

looks like a little bump upward coming........

maybe to $$2.00

[bullrider2]

I won't fool with PRAN. The company;s financial backing won't let this stock grow legs so that it can run.

RUN!! RUN!! AS FAST AS YOU CAN.

[LexTrader]

Prana Announces Safety Outcomes of Alzheimer’s IMAGINE Extension Trial



MELBOURNE, June 30, 2015: Prana Biotechnology (ASX:PBT/NASDAQ:PRAN) has today announced the safety outcomes of the IMAGINE Extension study in patients with Alzheimer’s disease.



A 250mg dose of PBT2 was safe and well tolerated over a 2 year period. The independent Data Safety Monitoring Board did not identify any safety concerns related to PBT2.



The IMAGINE Extension Study allowed all 40 participants who completed the original 12 month IMAGINE trial to receive PBT2 for a further 12 months. In all, 33 out of the 40 eligible IMAGINE patients elected to continue onto the Extension study. It was an Open Label study, with all participants taking PBT2. A total of 27 patients completed the Extension Study.



Clinical and scientific experts are reviewing the effects of PBT2 taken for 2 years. Whilst there is no placebo group to compare to within the Extension Study, the experts are very interested in better understanding how treatment with PBT2 would differ from the anticipated outcome without treatment.



The safety data will form part of the package presented to the FDA as part of our goal to remove the Partial Clinical Hold on PBT2 in the US.



Prana will continue to work with the US Food and Drug Administration and other agencies to initiate a Phase 3 trial for PBT2 to treat Huntington disease. PBT2 for the treatment of Huntington disease was recently granted Orphan designation in Europe and was granted Orphan designation in the US in 2014.

[Belek]

trade the stock on yesterday's doji.................

[GoGoLi]

The company is diluting the stock. I don't think it will come any time soon.

[bullrider2]

NEWS OUT!

[interestingtome]

Well - we are waiting on the extension data any day now and AAIC is around the corner. I don't think it will be that long.

The partial clinical hold who knows when but I am sure that is in the works. The company has said that there are no issues with safety in humans. Take advantage of the lows and maybe some day you will tell your grand kids about it.

[GoGoLi]

Let's hope we will fly, even though I believe it will take a while.

[interestingtome]

$6.8M tax rebate ---Yes now they have more cash...

Prana receives $6.8 million R&D Tax Incentive Refund
MELBOURNE, June 19th, 2015: Prana Biotechnology Limited (ASX:PBT/NASDAQ:PRAN) has today announced that it has received a $6.8 million cash refund under the Australian Government’s R&D Tax Incentive Scheme. The refund relates to the cost of eligible research
and development activities conducted during the 2014 financial year. These funds will be used to further Prana’s development of PBT2 for the treatment of Huntington’s Disease.

[Belek]

Could be some interesting times ahead for PRAN..............

worth the risk,,,,picking up a small position for now will increase

as it trends up.....best

jeff
,,,,$$$$$

[Nkore]

Wow .. Last minute trades

[interestingtome]

CEO bought $50K and officially notified of EMA orphan designation. We are moving premarket today! and last night on ASX.

[Nkore]

Awesome info - thanks for postin link!! go PRAN!~!

[interestingtome]

PBT2 gets orphan designation from EMA!

EU/3/15/1497 5,7-dichloro-2-dimethylaminomethyl-8-hydroxyquinoline hydrochloride Treatment of Huntington’s disease Prana Biotechnology UK Limited 21/05/2015


http://ec.europa.eu/health/documents/community-register/html/orphreg.htm

[Nkore]

Just read the 6k, good info! thanks

Wednesday, 27th May 2015

This notice is given under paragraph (5)(e) of section 708A of the Corporations Act.

Type: Shares
Class/Description: Ordinary Fully Paid
ASX Code: PBT
Date of Issue: Wednesday, 27th May 2015
Number Issued: 6,784,000
Issue Price: AUD $1,419,890

The Company intends to apply to Australian Stock Exchange Limited for quotation of the above shares.

Accordingly the Company gives notice under section 708A(5)(e) of the Corporations Act 2001 (Cth) (the “Corporations Act”) that:

1. the abovementioned ordinary shares were issued without disclosure to investors under Part 6D.2 of the Corporations Act;

2. as at the date of this notice the Company has complied with:

(i) the provisions of Chapter 2M Corporations Act as they apply to the Company; and

(ii) section 674 Corporations Act; and

3. as at the date of this notice there is no "excluded information" (as defined in subsection 708A(7) of the Corporations Act) which is required to be disclosed by the Company.

For and on behalf of the Company,


Phillip Hains
Company Secretary
Prana Biotechnology Limited

[Nkore]

Reload!!go PRAN!$$$$$

[interestingtome]

Someone just paid a premium for PBT shares
Someone just pulled 6,784,000 shares at 0.2093Au and raised A$1.419,890. That compares to the current price of 16.5-17 cents a share. That's a premium of over 23% to the current share price. Someone obviously wanted to get on board and were happy to pay a health premium to do so.

[Nkore]

: ) Happy Friday and Memorial DAY weekend!!

For love of country they accepted death... ~James A. Garfield

[harry crumb]

This could run!

[lil green bull]

Please keep accumulating i appreciate it and so do all longs.

[GoGoLi]

Good Morning! :)

$$$ PRAN $$$