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ATH - ALTERITY THERAPEUTICS LIMITED


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Looks like the right shoulder is forming.

 

Trouble ahead IMHO.

 

Even if those trials are a success, I can imagine a naked short being put on this. Some broker somewhere will say the data was good but not good enough. Therefore the market was disappointed. Thus this run up is the exit opportunity for those in the know.

 

Further down the track I expect them to pursue PIII trials and reverse this better science in to the company for pipeline or be bought out for cheap chips.

 

Whatever the case this is ringing alarm bells everywhere for me.

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Copied n pasted;

 

http://www.thestreet.com/story/12400705/1/...mp;cm_ven=YAHOO

 

But buried deep in Prana's press release Tuesday was the most important -- and negative -- assessment of PB2's efficacy: "No significant changes were seen in motor, functional, behavioural or global assessments in either PBT2 treatment group compared to placebo over the 26 week treatment period."

 

 

 

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Good time to raise some capital. Say its for PIII, keep the boys in their overpaid jobs, then wait for the Tanzi rated better science to gazump PBT with a fast track to market.

 

If they go for PIII instead of obtaining a FDA approval for market access then I still believe this is a pump n dump.

 

Can still make a buck though. Need to look at QRX, PXS, ACR and couple of others to know what to watch out for.

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  • 2 weeks later...

hat-tip "tomsilver39"

 

Geoffrey Kempler, executive chairman and chief executive officer of Prana Biotechnologies, said he is optimistic about the results of the Imagine trial, testing lead candidate PBT2 in Alzheimer's disease due this month. In an interview with Bloomberg's Elizabeth Krutoholow, he said the agent may be useful early stages of the disease when it can combat the prevention of memory formation. He said the company's recent Phase II results in Huntington's disease provide additional support for the drug's mechanism

 

Q: Are you on track to announce top-line results from the. Imagine study this quarter?

 

A: We are on track for a March target.

 

Q: Will you pursue a Phase IIb or registrational Phase II/III adaptive trial?

 

A: We have started to think about it, and it is something we will discuss with the regulators. We are a small ambitious company. The trials we have conducted are small in terms of patient numbers. The question is how many times do we need lightening to strike to prove our drug works? I am optimistic for several reasons. In an earlier trial we have shown a 13 percent reduction in beta-amyloid and we improved executive function scores. These results were published in the Lancet Neurology in 2008 and 2009. The data looked good, so we invested more money in the program. Everyone has been chasing beta amyloid and after several failures, the hypothesis was questioned. Still, the genetics point to beta-amyloid, Oligomers are toxic and their formation is a metal dependent event. If the metal is removed, they won't aggregate. This is where PBT2, our metal-protein attenuating compound comes in. In addition, metals in the brain are part of memory formation, so it is useful to remove them from oligomers and plaques and redistribute to neurons for improved function and increased synaptic transmission. We can best intervene early in the disease. In the Imagine study, our primary endpoint is a decrease in beta-amyloid as measured by PET imaging. We have an enriched population since PET scans were performed as part of our entry criteria. We hope we can catch people early in the disease.

 

Q: What is your sense of the regulatory view of a decrease in brain amyloid beta without an improvement in executive function? Why did you choose the imaging endpoint as your primary endpoint?

 

A: It is not reasonable to expect functional improvements in patients with very early disease because patients may not yet have functional problems to treat. The NEJM article published last year by the FDA says it may be possible to achieve early approval for a drug by demonstrating improvements in cognitive tests, and that companies may be able to look for functional improvements afterwards. More specifically to your question, in the NEJM article the authors said that a lot more work is needed because a decrease in brain amyloid alone, without some cognitive benefits, would be enough for approval.

 

Q: If you obtain a disease modifying claim, what is the market opportunity?

 

A: The disease modifying claim versus the symptomatic treatment has been debated for a long time. It is important to look at the sustainability of the benefit. There is a large number of patients. This is the Holy Grail. With an aging population, there would be massive demand. Safety must be established first. If there is a real and meaningful benefit, there are millions of?people who could be treated.

 

Q: Let's talk about Reach2HD results. You saw improvements in cognitive function at the highest dose after 12 and 26 weeks. Why do you think there wasn't an effect on motor function, behavior or functional capacity?

 

A: This was a small Phase II study, not a Phase III trial. It was conducted to establish safety and tolerability. We met the primary endpoint, and had 95 percent of participants finish the study. We saw a statistically significant improvement in executive function as measured by the Trail Making Test Part B. We don't think this was a fluke since we saw that PBT2 also improved executive function Alzheimer's disease patients in an earlier trial. This is why we are so enthusiastic. This was a go/no-go trial and we think what we have seen in the real. Regarding other measures, it is too soon to say if PBT2 will/won't have an effect as these parameters are probably best addressed in a larger Phase III population.

 

Q: You spoke to the heterogenous patient population in this study. Will you look to better stratify patients in the Phase III trial?

 

A: We might stratify different characteristics in the next trial. In Reach2HD, we saw a very small but positive signal in the TFC scale. We enrolled patients that were TFC (Total Functional Capacity) 6-13, which captures early-stage to midstage disease. The signal was seen in the early stage group, so it might be useful to focus more on this group in the next trial.

 

Q: What is your capital position? When will you look to raise additional capital/pursue partnerships?

 

A: We have about 20 million AUD and we will have a few million additional in tax credit at the end of March. We can raise additional capital any time after we see the Imagine results. There is a possibility of working with a pharmaceutical partner. We hired Dr. Peter Smith as our VP of business development. He will make us reaction ready when it comes to any partnerships. We are open to it.

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