By Huntington Study Group appointed to coordinate the trial and start recruitment
Melbourne - 4 January, 2012: Prana Biotechnology (NASDAQ:PRAN; ASX:PBT) today announced that it has received approval from the United States Food and Drug Administration (FDA) to start recruiting patients for the company's first clinical trial using PBT2 in patients with Huntington's Disease (HD).
Prana's Investigational New Drug Application (IND) is now
open. "The opening of this IND for a Phase 2 study follows an
extensive review of PBT2 data by the FDA and reflects a
favourable analysis from the FDA to support the study of PBT2
in Huntington's Disease patients", commented Geoffrey
Kempler, Prana's Executive Chairman.
Huntington's Disease is a complex and severely debilitating
genetic, neurodegenerative disease, for which there is no
cure. The disease often affects young adults and, whilst
associated with severe physical movement symptoms,
progressively impacts the mind and emotions as well. The
disease causes incapacitation and death about 15-25 years
after onset.
The Company has appointed the Huntington Study Group (HSG) to
coordinate the trial. HSG will commence recruitment of
patients for the trial, named "Reach2HD, at clinical sites
across USA and in Australia. The randomised, double-blind,
placebo-controlled trial will enrol 100 patients with early
to mid-stage Huntington's Disease. The Principal Investigator
on the study is Dr. Raymond Dorsey of Johns Hopkins
University Medical Center. The protocol synopsis appears
below in Appendix 1.
Professor Ira Shoulson, Professor of Neurology, Pharmacology
and Human Science at Georgetown University (Washington DC)
and the Chair of the Executive Committee of the Huntington
Study Group said "PBT2 attracted our attention as an
experimental drug with the potential to bring real benefit to
Huntington's Disease patients who suffer from a range of
motor, behavioural and cognitive symptoms. The favourable
signals from the PBT2 trial in Alzheimer's Disease are
particularly promising".
The disease affects 30,000 people in the US and about 70,000
worldwide. There are no drugs in development that have
established clinical evidence for treating cognitive decline.
Prana aims, in this trial, to demonstrate safety, motor
benefits and the same cognitive benefits for Huntington's
patients that it has already demonstrated in Alzheimer's
patients treated with PBT2.
Title | A randomised, double-blind, placebo-controlled study to assess the safety and tolerability, and efficacy of PBT2 in patients with early to mid-stage Huntington's disease (HD) |
Study Number | PBT2-204 |
Study Name/Acronym | Reach2HD |
Study Design | Randomised, double-blind, placebo-controlled, parallel group, multi-centre, Phase 2a study. |
Objectives | Primary objective: To evaluate the safety and tolerability of two dose levels of PBT2 when administered orally once daily over 26 weeks in patients with HD. Secondary objectives: Determine the effect of PBT2 after 26 weeks in patients with HD on: 1. Cognition 2. Motor function 3. Behaviour 4. Functional abilities 5. Global function 6. Plasma and urine biomarkers 7. Brain volumes and function (imaging), and 8. To evaluate the Pharmacokinetics of PBT2 in patients with HD. |
Number of Patients | It is planned that 100 patients will be randomised in to the study. |
Key Patient Criteria | Share
© Publicnow - 2012
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