Nov 7: "Concurrent pre-clinical findings also firmly indicated that PBT2 passes into the brain with more than 20 times greater efficiency than did its predecessor, PBT1".
The latter because of its size was slow to penetrate the brain membrane; so one can expect less activity.
PBT2 is a "rocket" drug and penetration is much faster giving the drug more quality time to do its work.
So, in Phase I, they had to assess safety and apparently there was't much difference between those who took the drug and the others on placebo.
Also: Nov 7: "Prana has nearly completed a multi-dose escalation safety clinical trial of PBT2 in elderly, healthy, male and female volunteers, having completed three out of four stages of dose escalation.
The company anticipates completing the final dosing stage in December this year. In addition, the chronic toxicology studies and GMP manufacturing development required for Phase II and Phase III clinical studies are underway concurrently" ___________________________________
Nov7: "Prana already has support for PBT2's efficacy via its original ‘proof of concept’ drug, PBT1. (PBT1 demonstrated benefit for Alzheimer’s Disease patients compared to placebo in a Phase II study.)
PBT2 is a related derivative of PBT1, they are both 8-hydroxyquinolines, but was designed specifically for greater safety, efficacy and brain penetration".
COMMENT: That being so, let us have a look at the previous drug PBT1 Pilot Phase II trial results:
16 Dec 2003: Phase II, PBT1: Positive results published for new Alzheimers Disease treatment: http://stocknessmonster.com/news-item?S=PBT&E=ASX&N=213492
Extract: "The more affected patients entering Prana’s PILOT clinical trial (ie those with higher ADAS-cog scores) showed an average deterioration in score at 24 weeks of about 1.5 points on PBT-1 and about 8.9 on placebo, a difference of 7.4 in favour of PBT-1.
Generally, untreated patients with mild to moderate disease could be expected to gain six to 12 points in their ADAS-cog score over 12 months. A panel convened by the Food and Drug Administration in the US deemed that an improvement of four points would be clinically significant".
And here are the results of the open label EXTENSION trial: http://stocknessmonster.com/news-item?S=PBT&E=ASX&N=225749
Extract: “The Extension Study data demonstrates that PBT-1 treatment for Alzheimer’s appears to slow the expected disease progression by about half,” said Jon Alsenas, DVM, chief executive officer of Prana Biotechnology Limited.
Data from the Extension Study data revealed that Alzheimer’s patients with ADAS-cog scores similar to those in the CQAD and the CQADEX would have been expected to decline by an average of 18 points over the treatment period.
The results showed an average decline of approximately eight points for a difference of 10 points from that predicted without treatment in the nine patients on PBT-1 for 84 weeks.
Results from the MMSE (Mini Mental State Examination) were also encouraging, as, when compared to baseline, the patients on 84 weeks of PBT-1 demonstrated no statistically significant decline.
"PBT-1 represents a novel approach to Alzheimer's: namely, a disease-modifier. In other words, PBT-1 targets a key feature of the underlying process that appears to cause the destruction of nerve cells,” said Sam Gandy, MD, PhD, Professor of Neurology and Director of the Farber Institute at Thomas Jefferson University.
“Alzheimer's is believed to begin as long as 10 years or more before clinical memory loss is manifested. Accordingly, disease-modifying drugs may need to be administered for many years. Along this line, it is extremely encouraging to see evidence that PBT-1 is well-tolerated for extended periods.”
COMMENT: As BPT2 is a superior drug, I expect at least the same or better results. It is clear that the FDA is well informed and that is an advantage, should it decide at the end of the Phase II trial that expediency is warranted, ie that the drug ought to be declared commercial asap.
Obviously, no one can guarantee the outcome of the Phase II result, however, the previous drug PBT1 Phase II and Extension trials have given confidence.
Gerry Readers, please do your own research and you decide if and when to buy, hold or sell any stocks.
PBT Price at posting:
0.0¢ Sentiment: None Disclosure: Held
(20min delay)