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Re: z3peru post# 438

Saturday, 11/22/2003 7:26:00 PM

Saturday, November 22, 2003 7:26:00 PM

Post# of 257295
>> Am I correct in thinking that the retreatment schedule of squalamine is now 3 months, and the Phase II trial in question would test whether there is any advantage to a monthly retreatment schedule?

Squalamine does not yet have a standard retreatment schedule because the phase 1/2 trial (the 40 patient trial done in Mexico) conducted no treatments beyond the initial regimen of four weekly infusions.

My guess is that the planned phase-2 trial will test whether retreating patients every month (for as long as 4-6 months) provides a clinical benefit relative to the initial treatment regimen alone or a benefit relative to a retreatment interval longer than one month.

GENR will presumably release further details on this phase-2 trial if and when enrollment begins. (I say “if and when” because I continue to hope that GENR will decide to proceed directly to phase 3.) Regards, Dew


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