|Prana Biotechnology Limited (ADR) (NASDAQ:PRAN) Tumbled To New Low As FDA Puts Hold on Phase 2 clinical trial evaluating PBT2|
|By Josh Gee|
|Friday, 13 February 2015 16:20|
Shares of Prana Biotechnology Limited (ADR) (NASDAQ:PRAN) tumbled on Friday and were recently down 53 cents or 32.32% to $1.11 after hitting new low of $1.07 earlier in the session. Volume is very high as more than 4.21 million shares have been traded, compared to its 30-day average volume of 201K shares.
Investors were rushed to offload their holdings after Prana Biotechnology reported that the FDA has placed its Phase 2 clinical trial evaluating PBT2 in Huntington's disease (HD) on partial clinical hold based on findings from animal tests. This significantly limits the dose of PBT2 that can be given to HD patients, although the agency has not raised any concerns about the PBT2 safety data in human trials so far.
The company's options are to proceed with the Phase 2 trial at a dosage level that is not considered clinically relevant (unlikely) or to conduct additional animal neurotoxicity studies or identify a strategy for safely using a clinically relevant dose of PBT2 in humans in its planned Phase 3 HD study.PBT2 is a Metal Protein Attenuating Compound (MPAC) which is designed to interrupt interactions between metals and target proteins in the brain and thereby prevent deterioration of brain cells.
Normally occurring metals in the brain play a major role in neurodegenerative diseases like Alzheimer's and Huntington's.In a previous Phase 2a study, PBT2 significantly decreased beta-amyloid in the cerebrospinal fluid and improved executive function in mild Alzheimer's patients within three months of treatment.