In today’s CC, the names of the three phase-2 trials were given as 209, 208, and 207.
The 209 trial is the main phase-2 trial with 100 patients. The 208 trial is the 30-patient trial which includes Visudyne. The 207 trial is the 18-patient safety and pharmacokinetics study (#msg-2914787).
Of the two phase-3 Squalamine trials (if indeed two will be needed), one of them will almost certainly include Visudyne. So it’s logical to get Visudyne into the mix now in one of the phase-2 trials.
One of the details I was hoping for in today’s CC was the nature of the control arm in the “208” study which includes Visudyne. It’s notable that the “208” study is “masked” but is not “double masked” as the “209” study is.
What this may mean is that patients in a Visudyne-only control arm will be allowed to receive Visudyne re-treatments if ordered by the attending clinician following disease progression. Patients in the Visudyne+Squalamine arm, who will be retreated monthly with Squalamine, will presumably not be permitted to obtain Visudyne retreatments. This is speculation, of course, but it explains the “masked” but not “double masked” characterization of the “208” trial.
P.S. EZ2: VEGF Burst refers to the fact that Visudyne has the nasty side effect of up-regulating VEGF, which can lead to a sudden worsening of a patient’s condition. Currently, VEGF Burst is often dealt with by giving Visudyne in conjunction with the steroid drug Triamcinilone (a.k.a. Kenalog), which has been described as a “poor man’s VEGF inhibitor.”
By adding Squalamine to Visudyne, the VEGF-inhibiting action of Squalamine may be able to neutralize the up-regulation of VEGF by Visudyne, obviating the need to use a steroid drug such as Triamcinilone.
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