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PRANA Biotechnology (PRAN) Receives Recommendation to Proceed With Alzheimer's Clinical Trial From Data Safety Monitoring Board (DSMB)


9/12/2012 10:16:15 AM

MELBOURNE, AUSTRALIA--(Marketwire - September 12, 2012) - Prana Biotechnology (NASDAQ: PRAN) (ASX: PBT) today reported that it had received a recommendation from the Data Safety Monitoring Board (DSMB) that the IMAGINE trial for Alzheimer's disease should continue as planned based on the initial review of clinical data. The DSMB is an independent group of experts who review the accumulated safety data in ongoing clinical trials, in order to safeguard the interests and safety of participating and future patients. The DSMB considers study-specific data as well as relevant background knowledge about the disease, test agent, or patient population under study.

The IMAGINE trial is a double-blind placebo controlled trial enrolling 40 patients with prodromal or mild Alzheimer's disease at five sites in Melbourne, Australia. Brain Imaging is being used to measure PBT2's effect on amyloid deposits in the brain (using PiB-PET scanning) and effects on increasing brain activity (FDG PET). Cognition effects are being measured by the Neuropsychological Test Battery (NTB).

In the current IMAGINE trial:

  • 100% of sites approved and open for recruitment;
  • 45% of patients in dosing;
  • Recruitment On Track to report 2H13;
  • 3 patients have reached 28 weeks of dosing -- over double the previous longest exposure to PBT2;
  • No serious adverse events reported

In an earlier 12 week trial PBT2 both significantly changed amyloid levels in spinal fluid and improved the cognition of patients with Alzheimer's disease. The IMAGINE trial, with 12 months of treatment, aims to establish PBT2 as a safe and effective treatment for Alzheimer's disease. PBT2 has a unique therapeutic action that can benefit people suffering neurodegenerative disease because of its specialized ability to prevent the toxic relationship between disease proteins and the metals, zinc and copper, in the brain.

Prana is also conducting a 6 month trial in 100 patients with early to mid-stage Huntington disease and the company believes that PBT2 has the potential to bring real benefit to Huntington Disease patients who suffer from a range of motor, behavioural and cognitive symptoms. The trial objective is to demonstrate safety, motor and behavioural benefits and the same cognitive benefits for Huntington's patients that it has already demonstrated in Alzheimer's patients treated with PBT2.

About Prana Biotechnology Limited
Prana Biotechnology was established to commercialize research into 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.


Contacts:
Australia
Prana Biotechnology
+61 3 9349 4906

US
Leslie Wolf-Creutzfeldt
T: 646-284-9472
E: leslie.wolf-creutzfeldt@grayling.com

US - Media
Ivette Almeida
T: 646-284-9455
E: ivette.almeida@grayling.com



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