PRANA UP 54% ON ALZHEIMER'S DISEASE COGNITIVE SUCCESS
March 2nd 2008 10:09
Biotech Daily
Tuesday February 26, 2008
Daily news on ASX-listed biotechnology companies
Tuesday February 26, 2008
Daily news on ASX-listed biotechnology companies
* ASX UP, BIOTECHS DOWN: PRANA UP 54%; NEUREN DOWN 8.33%
* PRANA UP 54% ON ALZHEIMER'S DISEASE COGNITIVE SUCCESS
* 35 TRIAL META-ANALYSIS QUESTIONS ANTIDEPRESSANT EFFICACY
* BIONOMICS TREATS FIRST CANCER PATIENT WITH BNC105
* SIRTEX H1 PROFIT UP 22% TO $1.1m
* ANADIS SELLS NON-CORE BUSINESS
* FRAMEWORK FOR VICTORIAN NANOTECHNOLOGY
* NOMINATIONS OPEN FOR 2008 VICTORIA PRIZE
* EUROPEAN PATENT FOR INCITIVE’S ICV0019
* PORTLAND APPOINTS AUSTRALIAN DISTRIBUTOR
THE MARKET
Thirteen of the Biotech Daily Top 40 stocks were up, 18 fell, four traded unchanged and five were untraded.
Prana was best, up 24.5 cents or 54.44 percent at 69.5 cents with 4.9 million shares traded, followed by Proteome up two cents or 13.33 percent to 17 cents and Portland up 0.6 cents or 7.59 percent to 8.5 cents.
Neuren led the falls, down one cent or 8.33 percent to 11 cents on modest volumes followed by Polartechnics down two cents or 7.84 percent to 23.5 cents and Cytopia down three cents or 7.69 percent to 36 cents.
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PRANA
In a phase IIa study of early Alzheimer’s disease Prana’s PBT2 has demonstrated improved cognition as well as safety, tolerability and reducing Abeta 42 protein levels.
Prana said that PBT2 improved ‘executive function’ performance in two of four cognitive tests.
Prana’s share price jumped 52 percent to 68.5 cents on the news.
Prana chairman and chief executive officer Geoffrey Kempler said the results were “very exciting” and an important milestone for the company.
He said PBT2 was known to inhibit the toxic oligomers of Abeta that cause the functional damage in Alzheimer’s disease and importantly the study “was able to show such a clear effect in a short trial”.
The randomized, double-blind, multi-centre trial of 78 patients in Sweden and Australia compared placebo with PBT2 50mg and PBT2 250mg capsules once a day for 12 weeks.
Analysis of the trial data demonstrated that the safety and tolerability profile of PBT2 at both doses was indistinguishable from that of placebo.
There were no study withdrawals related to adverse events.
There was no serious adverse event (SAE) in any PBT2 treated patient.
The study demonstrated the impact of PBT2 on reducing Abeta 42 in the cerebrospinal fluid (CSF) that surrounds the brain and spinal cord, considered a key biomarker for Alzheimer’s disease.
PBT2 at the 250mg dose showed a highly significant reduction in CSF Abeta 42 compared to placebo (p=0.006).
The effect of PBT2 was dose related (p=0.02).
The director of the Easton Centre for Alzheimer’s Disease at UCLA and head of Prana’s research and development advisory board, Prof Jeffrey Cummings, said: “PBT2 has hit what we consider to be the critical target for Alzheimer’s disease, as evidenced by the significant reduction in Abeta 42.”
Cognitive improvement measured by the Neuropsychological Test Battery (NTB), was also observed.
Statistically significant improvement was evident in two of the four executive function NTB tests: the category fluency test (p=0.028) and the trail making test part B (p=0.005), both after 12 weeks of treatment at the 250mg dose compared to placebo.
PBT2 had no effect on ADAS-cog, a test of cognition not designed to measure executive function changes.
Mr Kempler told Biotech Daily that executive function was the ability to plan and execute a strategy, without necessarily testing memory. He gave as examples daily activities such as dressing in the correct order or ability to bake a cake.
Prana said NTB was a test of cognition that was more sensitive to the changes in executive function that are seen in the early stage of Alzheimer’s disease.
Prana said the impact of PBT2 on executive function was “very encouraging as this is likely to predict an improvement in the day to day functioning in the lives of people with Alzheimer’s disease”.
“The ability to plan and execute everyday activities, even more so than memory, offers great practical and clinical benefit to patients,” Prof Cummings said.
The results build on earlier observations using PBT2 in transgenic mouse models of Alzheimer’s disease, where PBT2 reduced toxic oligomers of Abeta, reversed the Abeta-induced loss of neurotransmission and improved cognition.
Prana plans to take PBT2 into larger clinical trials to investigate its potential as a disease modifying drug.
Prana closed up 24.5 cents or 54.44 percent at 69.5 cents with 4.9 million shares traded.
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