Replies to post #434 on Biotech Values

[DewDiligence]

>> If memory serves, the study in Mexico that was reported had a weekly treatment schedule… Eventually, having patients receive a monthly treatment that involves an IV is far better than a weekly IV treatment. <<

z3peru: We need to distinguish between the initial treatment schedule and the retreatment schedule. The initial treatment schedule for Squalamine will likely remain four weekly infusions of 25mg/m2. It is best to think of these four infusions as a single entity or treatment regimen; i.e. the 2nd, 3rd, and 4th infusions in the initial treatment regimen are not considered retreatments but simply components of the initial regimen.

With Squalamine as with other AMD drugs, retreatments are defined as treatments which occur a specified period following the initial treatment regimen, regardless of how many infusions or injections comprise the initial regimen.

In approved commercial use, Visudyne patients are typically retreated every three months, provided there is evidence that the abnormal blood vessels are leaking. In a recent Visudyne trial, there was no benefit found to retreating patients every month rather than every three months.

In the phase 2/3 Macugen trial, patients were retreated every six weeks unconditionally, which implies that some patients may have received more drug (and more exposure to the risks of intravitreal injections) than these individual patients needed.

According to Dr. Levitt’s presentation at the Rodman & Renchaw conference, the impetus for GENR’s interest in a new phase-2 trial to test monthly retreatment is the enhanced efficacy seen with Lucentis when the interval between its retreatments was shortened.

Clearly, Squalamine’s advantage in convenience and safety relative to the intravitreally administered drugs (Macugen and Lucentis) becomes even larger when one considers the amount of retreatment required to reach the point of ultimate success or failure in arresting disease with a given patient. So the retreatment issue is likely to be a key selling point for Squalamine relative to Macugen and Lucentis.

Notwithstanding the importance of fine-tuning the Squalamine retreatment schedule, as stated in message #433 I would rather see GENR and partner test various retreatment schedules within the confines of pivotal trials rather than in a separate phase-2 trial. I think shortening the time to market outweighs the other considerations.