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Neurology

Prana Biotechnology Announces Phase II/III Study to Examine PBT-1's Effect on Alzheimer Disease

Strategic Insights

— 2 min read

Prana Biotechnology, a company focused on developing treatments for Alzheimer disease and other age-related degenerative disorders, has announced plans to initiate a phase II/III study in the late first quarter or second quarter of 2005 to examine the effect of PBT-1 on moderate to severe Alzheimer disease patients. The study, known as the Progression Limiting in Alzheimer: ClioQUinol's Efficacy study (PLACQUE), will be conducted under the direction of Dr. Craig Ritchie of the Royal Free Campus, University College London.

The study aims to enroll 435 patients in the United Kingdom, Australia, and the Republic of South Africa, who will be treated for 52 weeks and randomized into placebo and two treatment arms (125 mg and 250 mg BID). Prana anticipates that the results will be available by late 2006. The company's decision to advance PBT-1 into advanced clinical trials was influenced by the promising proof-of-principle phase II results published in the Archives of Neurology, which demonstrated a disease-modifying treatment effect, not simply a cognition-enhancing effect.

Key Takeaways:

  • Prana Biotechnology plans to initiate a phase II/III study to examine the effect of PBT-1 on moderate to severe Alzheimer disease patients in the late first quarter or second quarter of 2005.
  • The study, known as the PLACQUE study, will be conducted under the direction of Dr. Craig Ritchie of the Royal Free Campus, University College London.
  • The study aims to enroll 435 patients in the United Kingdom, Australia, and the Republic of South Africa, who will be treated for 52 weeks and randomized into placebo and two treatment arms (125 mg and 250 mg BID).
  • Prana anticipates that the results will be available by late 2006.
  • The company's decision to advance PBT-1 into advanced clinical trials was influenced by the promising proof-of-principle phase II results published in the Archives of Neurology.
  • The study's primary goal is to assess the efficacy of PBT-1 in slowing down the progression of Alzheimer disease.
  • Dr. Jon Alsenas, CEO of Prana Biotechnology, stated that the initiation of the study allows the company to make a substantial leap forward in the time it will take to achieve potentially pivotal results with their core MPAC platform.

Statistics:

  • 435 patients will be enrolled in the PLACQUE study.
  • The study will be conducted in the United Kingdom, Australia, and the Republic of South Africa.
  • Patients will be treated for 52 weeks.
  • 2 treatment arms will be used (125 mg and 250 mg BID).
  • The results are expected to be available by late 2006.

Sources:

  • NewsRx.com & NewsRx.net
  • Prana Biotechnology Limited (NASDAQ:PRAN)(NASDAQ:ASX:)(NASDAQ:PBT)
  • Archives of Neurology
  • Royal Free Campus, University College London
  • Pharma Business Week via NewsRx.com & NewsRx.net

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