MELBOURNE, Australia--(BUSINESS WIRE)--Prana Biotechnology (ASX:PBT) (NASDAQ:PRAN) has today announced the safety outcomes of the IMAGINE Extension study in patients with Alzheimer's disease.
A 250mg dose of PBT2 was safe and well tolerated over a 2 year period. The independent Data Safety Monitoring Board did not identify any safety concerns related to PBT2.
The IMAGINE Extension Study allowed all 40 participants who completed the original 12 month IMAGINE trial to receive PBT2 for a further 12 months. In all, 33 out of the 40 eligible IMAGINE patients elected to continue onto the Extension study. It was an Open Label study, with all participants taking PBT2. A total of 27 patients completed the Extension Study.
Clinical and scientific experts are reviewing the effects of PBT2 taken for 2 years. Whilst there is no placebo group to compare to within the Extension Study, the experts are very interested in better understanding how treatment with PBT2 would differ from the anticipated outcome without treatment.
The safety data will form part of the package presented to the FDA as part of our goal to remove the Partial Clinical Hold on PBT2 in the US.
Prana will continue to work with the US Food and Drug Administration and other agencies to initiate a Phase 3 trial for PBT2 to treat Huntington disease. PBT2 for the treatment of Huntington disease was recently granted Orphan designation in Europe and was granted Orphan designation in the US in 2014.
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.