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Pharmos: Phase III Dexanabinol not effective against TBI, Shares fell 50+ percent before the bell
Globes correspondent, "Pharmos Phase III: Dexanabinol not effective against TBI" (20 December 2004, Globes Online)
Leading text: "Pharmos (Nasdaq:PARS) announced today top line results of its pivotal Phase III trial of dexanabinol to treat severe traumatic brain injury (TBI). As reported earlier today by "Globes", dexanabinol did not demonstrate efficacy as measured by the Extended Glasgow Outcome Scale (GOSE).
In pre-market trading, Pharmos shares have so far dropped to $0.85, meaning that they have lost nearly 76% of their value.
The double-blind, randomized, placebo-controlled trial was conducted in 86 trauma centers in 15 countries. In the 861 patient trial, 846 patients were available for analysis, 428 treated with dexanabinol and 418 treated with placebo. The randomization provided well-balanced groups for this study.
The company noted that the trial demonstrated an excellent safety profile with no evidence of excess side effects in the dexanabinol-treated patients. The company also noted that not all secondary endpoints have been analyzed; however, no differences were observed in mortality or in analysis of subgroups in the trial.
Pharmos chairman and CEO Dr. Haim Aviv said, "We are very disappointed and frankly somewhat perplexed that we did not observe any neuroprotective effect of dexanabinol in TBI..." [FullText]
Leading text: "Pharmos (Nasdaq:PARS) announced today top line results of its pivotal Phase III trial of dexanabinol to treat severe traumatic brain injury (TBI). As reported earlier today by "Globes", dexanabinol did not demonstrate efficacy as measured by the Extended Glasgow Outcome Scale (GOSE).
In pre-market trading, Pharmos shares have so far dropped to $0.85, meaning that they have lost nearly 76% of their value.
The double-blind, randomized, placebo-controlled trial was conducted in 86 trauma centers in 15 countries. In the 861 patient trial, 846 patients were available for analysis, 428 treated with dexanabinol and 418 treated with placebo. The randomization provided well-balanced groups for this study.
The company noted that the trial demonstrated an excellent safety profile with no evidence of excess side effects in the dexanabinol-treated patients. The company also noted that not all secondary endpoints have been analyzed; however, no differences were observed in mortality or in analysis of subgroups in the trial.
Pharmos chairman and CEO Dr. Haim Aviv said, "We are very disappointed and frankly somewhat perplexed that we did not observe any neuroprotective effect of dexanabinol in TBI..." [FullText]
posted by Dr.Koudinov @ 24.12.04
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