Replies to post #1940 on Biotech Values

[swampboots]

<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.>

Dew: correct me if I am wrong, but I thought the Visudyne only control group included Visudyne to motivate the trial participants to endure some procedure which has, uh to be generous, suspected possible benefits. Question, has Visudyne ever been linked or indicated for having an ability to neutralize the up-regulation of VEGF by adding any substance?

[EZ2]

THANKS Dew !!

[DewDiligence]

The Squalamine dosing schedule and expectations for the ”209” trial:

[This message is a repost of #46833 on Yahoo. Also see #msg-2922504 for discussion of the “208” trial which includes Visudyne.]

I think matching the monthly retreatment schedule of Lucentis played at least some role in GENR’s design of the phase-2 Squalamine trials, but GENR would not have opted for monthly retreatments for competitive reasons only.

A monthly retreatment schedule for Squalamine may be close to optimal for visual stabilization. A retreatment schedule even more frequent than monthly might be able to produce marginally better results than a monthly schedule, but the tradeoff of marginally better results vs the added inconvenience and expense to patients would be unfavorable.

(To be clear, I am referring to the retreatment schedule following the initial “loading doses” which will probably be done weekly as in the Mexican trial.)

Despite the above, I don’t think investors should expect a 100% rate of improved/stable vision in the “209” phase-2 trial (the main phase-2 trial with 100 patients). There will almost certainly be a few patient dropouts in a study lasting as long as 48 weeks. In an “intent to treat” calculation (which is the kind of calculation normally used by the FDA), dropouts are counted as non-responders.

Moreover, in the larger sample size and longer duration of the “209” trial, as compared to the Mexican trial, there might be a few patients whose response does not last or who don’t respond at all.

It would be great to achieve a 100% rate of improved/stable vision in the “209” trial, but I think a rate in the high 80s or low 90s is more realistic.

Comments?