SOURCE: Prana Biotechnology

November 29, 2007 08:30 ET

Prana Receives Positive Report From Independent Data Safety Monitoring Board

Report Included 75% of Patients and Confirmed the Clinical Trial Is Safe to Continue

MELBOURNE, AUSTRALIA--(Marketwire - November 29, 2007) - Prana Biotechnology Limited (NASDAQ: PRAN) (ASX: PBT), a biopharmaceutical company focused on the research and development of treatments for neurodegenerative disorders, today announced an update on its Phase IIa clinical trial of PBT2 in patients with Alzheimer's disease.

Steven D. Targum, M.D., Chief Medical Advisor to Prana, commented: "The Data Safety Monitoring Board has completed its pre-determined cycle of safety monitoring meetings and identified no emergent pattern of unwanted adverse events or treatment-related study withdrawals. Accordingly, we remain very optimistic about the safety and tolerability profile of PBT2 that this trial will report."

Data Safety Monitoring Board (DSMB)

The independent DSMB has submitted its 3rd and final report to the Company. A total of 59 patients were included in the review, being over 75% of the randomized patients. The DSMB noted that there have been no treatment-related serious adverse events or withdrawals. The DSMB confirmed that the trial is safe to continue.

Trial Progress

Enrollment and randomization were completed in September and about 60 patients have completed dosing as of today. Final dosing of the last patient is expected to be completed within the next few weeks. Results will be reported in the first quarter of 2008.

This Phase IIa trial is a double-blind, placebo-controlled study of PBT2 in patients with mild Alzheimer's disease. PBT2 is Prana's proprietary lead compound. The primary outcome measure of this trial is safety and tolerability. In addition to safety, the trial is also investigating the effect of PBT2 on cerebrospinal fluid (CSF) and blood biomarkers that have been directly associated with the etiology of Alzheimer's Disease. Outcomes include measures of CSF A-beta and tau protein levels, as well as neurocognitive and behavioural changes. There is a growing acknowledgement in the literature and the pharmaceutical industry that the biomarkers measured in this trial, specifically the A-beta and tau proteins, might be the indicator of therapeutic benefit of drugs such as PBT2.

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 From 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.

Contact Information

  • Contacts:
    Prana Biotechnology Limited
    T: +61 3 9349 4906