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


To: BRAVEHEART who wrote (395)1/4/1999 1:51:00 PM
From: yosi s  Respond to of 1386
 
1. The P-3 study for HU 211 is anticipated for what specific indication?

Phase 3 study will take place with a partner. A major pharmaceutical with intrest in neurology.
Indication are expected for Traumatic brain injury, as a neuroprotector.

There is no need to repeat phase 1 study for stroke indication.
If Pharmos so choses they may combine phase 2 and 3 for stroke indication.
There is a possibility that stroke indication study will take place
parrallel to TBI it depends on the intrest of a partner.
Other wise epect stroke indication to start going as soon as phase 3 results are out or before if Pharmos choses to go with different partner for that indication.
I am sure it will be part of their negotiation.

3. You mention European Markets. Are there trials in Europe for any
specific indication?

phase 3 is planed to be a multicenter trial which will take place in US and Europe...that is for HU 211

for Alrex and Lotemax BOL is suppose to get NDA in Europe with trial data from USA study

Le tobra is going to be a modified phase 3 study. should not take long time to take place..

4. What specific trial is this ?

HU 211 phase 2 study was in 3 stages 3 different dosages, Pharmos unblinded the study after the second dosage results were done,
it is now on going with the third dosage 200 mg. the other were 48mg and 150 mg.

Hope this answers your questions.

Have a Happy New Year