Biotech Values

[gym gravity]

So how does an open label extension of a double blind placebo controlled trial work without unblinding? Only way is for all patients to cross over to drug.

From today's Prana response:

Prana was not aware of the segment and did not participate in the segment. The IMAGINE trial is a randomised, double-blind trial. Prana, the clinical investigators and the patients involved are unaware of the treatment assignment (PBT2 or a placebo).

The clinical benefit, if any, of PBT2 compared to a placebo will not be known until treatment assignment is un-blinded and the trial data analysed.

From open label extension press release mid-summer:

The approval follows a full review by Austin Health HREC of the potential benefit to patients and safety data collected during the ongoing IMAGINE trial, a 12-month double-blind Phase II clinical trial of PBT2 in Alzheimer's patients. Fifteen percent of participants in IMAGINE have now finished the full 12 months of treatment and one hundred percent have completed at least 6 months of treatment.

Patients who have completed the full 12-month term of the IMAGINE trial are eligible for participation in the open-label extension study. All participants in the extension study will receive a 250mg once daily oral dose of PBT2 for an additional 12 months, with the first patient expected to start next month.

It leaves enough wiggle room for speculation that technically the patient could have been on the extension and not from the original IMAGINE trial. I don't know of any antibodies that come in little red pills.