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Huntington's Disease

Prana’s PBT2 presented at the Huntington’s Disease Society of America National Convention: Prana’s ‘Reach2HD’ Phase II trial on track

Melbourne – June 13, 2012: Prana Biotechnology (NASDAQ:PRAN; ASX:PBT) today announced that an update on Prana’s Phase 2 clinical trial in Huntington disease (HD) was presented at the HDSA annual National Convention held in Las Vegas, Nevada over the weekend. Professor Ira Shoulson, Professor of Neurology, Pharmacology and Human Science and Director, Program for Regulatory Science & Medicine at Georgetown University spoke to the ‘Reach2HD’ trial objectives and potential future of PBT2 as a novel therapeutic strategy for the treatment of HD.

“We are hopeful that PBT2 can bring the same cognitive benefits to HD patients that it did to Alzheimer’s disease (AD) patients in a Phase IIa trial.” commented Geoffrey Kempler, Prana’s Executive Chairman. Mr Kempler also commented that “the Reach2HD study has been initiated and enrollment commenced on time and it is pleasing that the trial has been so enthusiastically embraced by the HD community”.

Phase II Reach2HD clinical trial.
Prana has commenced a FDA approved Phase II placebo controlled double blind study in 100 early to mid-stage HD patients, in Australia and the US The study, named ‘Reach2HD’, is a 6 month clinical trial testing PBT2, the Company’s drug in development for HD. The Principal Investigator on the study is Dr. Ray Dorsey of The Johns Hopkins University in Baltimore. For further information visit the Huntington Study Group website www.huntington-study-group.org

What benefits has PBT2 already shown
In a Phase IIa trial* of PBT2 in mild AD, cognitive executive function was significantly improved in patients. Recently the company published that PBT2 was able to directly restore neurons critical to cognition in mouse models. In particular it was demonstrated that PBT2 increased the number of spines on the branches (or dendrites) of neurons, an important means of permitting many more neurons to interconnect with any particular neuron thereby increasing the brain’s capacity to carry out learning and memory functions.

These findings pointing to the ability of PBT2 to restore cognition in degenerative conditions, together with positive data achieved with PBT2 in mouse models of HD** provide confidence that PBT2 will be able to confer cognitive benefit to patients with HD.

Mr Kempler also commented, “With only one drug for Huntington disease on the market, with utility limited to the symptomatic treatment of chorea and no other drugs in development that have established clinical evidence for treating the cognitive decline associated with HD, this is a significant debilitating unmet medical need that we hope to address”.

* Lannfelt et al. Lancet Neurology (2008) vol. 7, pp. 779-86; Lannfelt et al. Lancet Neurology (2009) vol. 8, pp. 981. Faux et al. J. Alzheimer’s Disease 20 (2010) pp. 509-516
**Presented at the International Conference on Alzheimer’s Disease, Honolulu Hawaii, 2010.