The IMAGINE Trial is a randomised, double-blind and placebo-controlled study which is assessing the safety and tolerability of PBT2, and its effect on amyloid deposition in the brains of patients with prodromal or mild Alzheimer’s disease.
The trial has successfully recruited 42 patients via hospital test sites across the state of Victoria, in Australia. Patients have commenced one year (52 weeks) of treatment with either a daily placebo tablet or 250mg of PBT2.
Participants are undergoing brain scans to measure PBT2’s effect on amyloid deposits in the brain and effects on increasing brain activity. Cognition effects are being measured using a scientifically validated test that measures the type of cognitive problems experienced by prodromal and early Alzheimer’s patients.
It is thought PBT2 would benefit Alzheimer’s disease patients by selectively binding to, and redistributing, brain metals (copper, zinc) that have become imbalanced due to disease or the ageing process. This would prevent build-up of a toxic by-product of this imbalance – Abeta – which is implicated in neurodegenerative disease.
In an earlier 12-week, Phase 2a Alzheimer’s Disease trial, PBT2 significantly reduced the level of Abeta protein in the spinal fluid of treated patients and significantly improved their cognitive Executive Function.1,2,3
The trial has received funding from the Alzheimer’s Drug Discovery Foundation (ADDF), the only non-profit organization whose sole mission is to accelerate the discovery and development of drugs to prevent, treat and cure Alzheimer’s disease.
There is strong data in support of PBT2 delivering a meaningful clinical benefit to Alzheimer’s disease patients.
IMAGINE EXTENSION TRIAL
In July 2013, Prana announced that the Austin Health Human Research Ethics Committee (HREC) approved a 12-month open label extension study for patients completing the double- blind placebo-controlled IMAGINE trial. There is no placebo group in the Extension trial. All participants receive a once daily dose of 250mg of PBT2. PBT2 is Prana’s drug in Phase 2 development for Alzheimer’s and Huntington’s diseases.
The approval followed a full review by the Austin Health HREC of the potential benefit to patients and safety data collected during the IMAGINE trial.
All patients in the IMAGINE trial were given the opportunity to participate in the Extension trial. Participation in the Extension study required patients to consent to receive PBT2 for 12 months following the end of the IMAGINE trial, as well as undergoing further brain scans, blood tests and cognitive testing.
A total of 33 patients have elected to go into the Extension trial, representing 83% of the 40 patients who completed 12 months of treatment in the IMAGINE trial.
and PRAN will be in 20s or 30s and then higher and higher IMO
80-100 per share
so if the HD trial is successful, then the AD trial must be a success too, if not better
then ALZ trial comes next
if PRAN reports positive trials.... do we expect bidding war...
◾ To expand Prana’s MPAC platform to build new pipeline assets.
◾ Identification of new MPACs for the treatment of AD.
◾ Identification of new MPACs for the treatment of other neurodegenerative diseases.
◾ Identification of MPACs for the treatment of selected cancers, including Brain Cancer.
◾ Identification of non-MPACs for the treatment of AD. Since the initiation of Prana chemistry in 2001, more than 1000 compounds now exist in the company's chemical library. Those compounds are tested in a panoply of disease-specific screens, providing structure-activity relationship (SAR) information. The information from these data sets is then critically analysed to rationally design the next set of compounds.
Outcomes of Discovery
◾ Up to 2002: Screening of hundreds of potential leads through AD screens to identify the 8-hydroxyquinolines as an active scaffold.
◾ 2002-2003: Approximately 200 8-hydroxyquinolines were synthesized, resulting in the discovery of PBT2 (nomination as a candidate in 2003)
◾ 2003-present: Over 200 non-8-hydroxyquinoline Follow-Up compounds were synthesized. From this, a number of candidates for AD (PBT3 series) and other indications (PBT4 series) are being pursued.
◾ 2002-present: Non-MPACs projects are being pursued as therapeutic and imaging agents.
all these biotechs lately are jumping out of this world LOL
in new website, I cant help but notice that they use the word significantly more than once in Imagine Alzheimer early results, but in HD result, although they said significantly one time, they also use maybe able...
WPCS drops after independent accounting firm resigns
WPCS International disclosed late Friday that it received a notice of resignation from CohnReznick LLP, the company’s independent registered public accounting firm. WPCS stated, "The Former Accountant’s reports on the company’s financial statements for the past two years do not contain an adverse opinion or a disclaimer of opinion, and are not qualified or modified as to uncertainty, audit scope, or accounting principles, except as that the reports of the Former Accountant for the past two fiscal years ended April 30, 2013 and 2012 indicated conditions which raised substantial doubt about the Company’s ability to continue as a going concern." The resignation of CohnReznick was not recommended or approved by the audit committee or board of directors of the company, it added. WPCS said it has not engaged a replacement independent public accounting firm as of Friday.