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.
About Prana Biotechnology Limited
Prana Biotechnology was established to commercialise research into Alzheimer’s Disease, Huntington’s Disease and other major age-related neurodegenerative disorders. The Company was incorporated in 1997 and listed on the Australian Securities Exchange in March 2000 and listed on NASDAQ in September 2002. Researchers at prominent international institutions including The University of Melbourne, The Mental Health Research Institute (Melbourne) and Massachusetts General Hospital, a teaching hospital of Harvard Medical School, contributed to the discovery of Prana’s technology.
For further information please visit the Company’s web site at www.pranabio.com.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as “expects,” “intends,” “hopes,” “anticipates,” “believes,” “could,” “may,” “evidences” and “estimates,” and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to any statements relating to the Company’s drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company’s drug development program, including, but not limited to, PBT2, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company’s drug components, including, but not limited to, PBT2, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company’s drug compounds, including, but not limited to, PBT2, that could slow or prevent products coming to market, the uncertainty of patent protection for the Company’s intellectual property or trade secrets, including, but not limited to, the intellectual property relating to PBT2, and other risks detailed from time to time in the filings the Company makes with Securities and Exchange Commission including its annual reports on Form 20-F and its reports on Form 6-K. Such statements are based on management’s current expectations, but actual results may differ materially due to various factions including those risks and uncertainties mentioned or referred to in this press release. Accordingly, you should not rely on those forward-looking statements as a prediction of actual future results.
Prana Biotechnology Limited
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Source: Prana Biotechnology Limited