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March 31, 2014
07:39 EDTPRANPrana reports PBT2 did not meet primary endpoint in Alzheimer's study
Prana Biotechnology released the top line results of the 12-month Phase II Imaging trial in Alzheimer's Disease "IMAGINE" Trial, based on draft results. Prana's PBT2 did not meet its primary endpoint of a statistically significant reduction in the levels of beta-amyloid plaques in the brains of prodromal/mild Alzheimer's disease patients, as measured using PiB-PET Standardized Uptake Value Ratio. Whilst there was a reduction in the overall levels of the PiB PET signal in patients treated with PBT2, the results were confounded by an atypical reduction of levels of the PiB PET signal in the placebo group as well. No improvement was observed on the secondary endpoints of brain metabolic activity, cognition and function; however there was a trend towards preserving hippocampal brain volume in the PBT2 group. PBT2 was shown to be safe and very well tolerated over the 52 weeks. The adverse event profile was equivalent between placebo and treated groups. Commenting on the result, Geoffrey Kempler, CEO of Prana Biotechnology said: "It is possible the result may point to PBT2 targeting soluble species of Abeta including toxic oligomers rather than plaques. Abeta oligomers are not visible in the PiB-PET scans which can only detect amyloid plaques. Alternatively, what we are seeing is simply the result of an inconclusive imaging readout in a small sample size with 42 participants."
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September 5, 2014
16:25 EDTPRANOn The Fly: Closing Wrap
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10:28 EDTPRANHigh option volume stocks
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September 4, 2014
18:50 EDTPRANPrana up 9.8% in after hours trading after receiving FDA orphan designation
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18:06 EDTPRANPrana granted orphan status for treatment of Huntington disease
The FDA posted on its website that Prana Biotechnology has been granted orphan status for its treatment of Huntington's disease. Reference Link

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