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DewDiligence

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DewDiligence

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Re: None

Wednesday, 01/14/2004 10:11:31 PM

Wednesday, January 14, 2004 10:11:31 PM

Post# of 257293
Squalamine may have just gained a year relative to Lucentis:

Here’s an update on the two phase-3 Lucentis trials from this evening’s DNA quarterly conference call: the Lucentis trial in minimally-classic/occult AMD completed enrollment at the end of 2003, but the trial in predominantly-classic AMD is not expected to complete enrollment until mid 2004. What makes this interesting is that these two Lucentis trials started within two months of one another in early 2003; evidently, the predominantly-classic trial is having difficulty recruiting patients.

What is even more interesting than the delay in patient enrollment is what DNA’s CMO Sue Hellmann disclosed at this evening’s CC: in both trials, the FDA wants to see patient data at two years, even though the primary endpoint is visual acuity at one year. I am speculating here, but it seems the FDA may have been spooked by the relatively high incidence of adverse events at one year in the phase-3 Macugen trial.

From a practical standpoint, if DNA/NVS cannot file NDA’s for Lucentis until two years of patient follow-up, Squalamine has effectively gained a full year vis-à-vis Lucentis in the competitive jockeying.


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