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Biotech / Medical : Pharmos (PARS) -- Ignore unavailable to you. Want to Upgrade?


To: tom r. phillips who wrote (1360)12/20/2004 9:32:36 AM
From: NeuroInvestment  Read Replies (1) | Respond to of 1386
 
$60 million plus in cash after BOL makes its payment.
The CB-2 platform is near PhI, and its value has gone up with the COX-2 snafu.

They aren't going to go bankrupt, and a quick look at some comparable companies in the CNS sector gives me a post-TBI value of 2.00.

But it's going to be a long time before it gets there--especially given the fact that management's recent stock sales are going to raise a lot of questions about 'who knew what when?' It will probably settle in the 1.00-1.50 range.

Another bitterly disappointing day in the neuroprotection world.

Harry
NeuroInvestment



To: tom r. phillips who wrote (1360)12/20/2004 9:56:10 AM
From: rjk01  Respond to of 1386
 
from Globes;
Pharmos Phase III: Dexanabinol not effective against TBI

CEO Dr. Haim Aviv: It's unlikely we'll continue with dexanabinol for
traumatic brain injury. Pharmos shares plunged in pre-market
trading.

Globes correspondent 20 Dec 04 14:13

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. This trial was one
of the largest ever completed in TBI. TBI is a severe injury of the
most complex organ in the body and involves a patient population
with high heterogeneity. It is therefore a very difficult indication
to study, but we believe this study was performed according to the
highest scientific standards and included important innovative
aspects in the design and analysis aimed at improving the quality of
the study.

"In the next few weeks, we will carefully analyze the results of
this trial before making final decisions about our future plans, but
it is unlikely that we will continue to develop dexanabinol for TBI.
We plan, however, to continue developing dexanabinol for cognitive
impairment in cardiac surgery, and we also remain committed to
developing a drug candidate for pain."

Dr. Andrew Maas, chairman of the European Brain Injury Consortium
and chairman of the study's Steering Committee, said that the
committee will work closely with the company to analyze the data
from the trial "in order to garner scientific and medical
information that will be valuable in treating TBI patients."

Pharmos president and COO Dr. Gad Riesenfeld said, "We all share the
disappointment in the results for TBI. However, we will continue to
analyze the results of the Phase II coronary artery bypass graft
(CABG) trial of dexanabinol and are committed to continuing that
program.

"In addition, we expect to initiate clinical studies of our lead CB2-
selective drug candidate, PRS-211,375, during the first half of 2005
for a pain indication. This compound and others in the preclinical
pipeline have demonstrated very positive results in a range of pain
and autoimmune disease animal models. We believe that the pipeline
represents significant potential value for the company."

Published by Globes [online], Israel business news -
www.globes.co.il - on Monday, December 20, 2004