MELBOURNE, AUSTRALIA--(Marketwired - Jun 19, 2013) - Melbourne-based Prana Biotechnology (
The Poster entitled: "The Huntington's Disease patient-reported outcome of problems: feasibility and applicability in clinical research (HD-PROP)" details a new benchmarking system to assess the problems experienced by people with HD. The HD-PROP test aims to overcome some of the challenges associated with assessing clinically relevant outcomes in HD where progressive motor, cognitive and psychiatric symptoms can interfere with comprehension of lengthy patient self-report questionnaires and communication of responses. The HD-PROP test may be a useful tool to evaluate Prana's clinical trial results.
The HD-PROP test asks trial participants three questions in relation to their HD at the commencement of the trial. What problem is most bothersome? In what way is this problem bothersome? How severe is this problem?
The HD-PROP test was created by clinical investigators involved in Prana's Phase 2 clinical trial of PBT2 known as the REACH2HD Study. This 109 patient trial is fully recruited and nearing completion.
Professor Ira Shoulson, one of four authors of the Poster and an internationally renowned clinical investigator, said: "This is the first time this type of patient response testing has been applied to HD, and we expect it will form an important part of future trials in HD."
"Patient-reported outcomes are an important area of focus for the US Food and Drug Administration (FDA) and along with clinical measures provide a more complete understanding of the relevance as well as safety and effectiveness of potential treatments."
At the commencement of Prana's Phase 2 trial, 97% of participants reported at least one bothersome problem, 87% reported at least two problems, and 67% reported at least three problems. Motor symptoms, cognitive symptoms, functional decline, and behavioral symptoms were the most commonly reported first, second and third problems.
Geoffrey Kempler, Chief Executive Officer of Prana Biotechnology, added: "This new assessment gives us great insight into the issues and concerns of people with HD and has established an important benchmark that we can consider when assessing the final clinical results of our REACH2HD trial."
The full Poster is attached.
About Prana Biotechnology Limited
Prana Biotechnology was established to commercialise research into Alzheimer's Disease and other major age-related neurodegenerative disorders. The Company was incorporated in 1997 and listed on the Australian Stock 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.