pSivida issued a press release on March 13 2009 with a 12 month read-out on the Phase II Human PK & efficacy trial for Iluvien. The press release made clear the next read-out was due at 18 months.
All things being equal, this indicates the 18 month read-out is due around September 13 2009. This is of course a mere 4 days after pSivida will present at Rodman & Renshaw. Therefore, it’s quite possible pSivida will announce the read-out on the 9th & discuss it in detail at the conference. A complicating fact is their partner Alimera is funding the trial & may not be pushed to fit in with pSivida’s IR calendar. However, Rodman & Renshaw is a big event and good PR would reflect well on them as well.
Linked to this, I think this is an unusually significant Phase II trial :
* It’s a well known fact drug candidates on average perform less well in Phase III than in prior Phase II trials. * Why is this case? My view is Phase II trials - by design - are underpowered statistically to save time & money. This means 3 outcomes are likely from a Phase II trial : the compound outperforms its true efficacy potential ; it matches its true efficacy potential or it underperforms its true efficacy potential. * Now a Phase II trial that underperforms is much more likely to be (unfairly) dumped by its developer and so not make it to Phase III. * Therefore, Phase III trials contain a disproportionate level of compounds that outperformed their true efficacy potential in Phase II. * This then leads to totally unexpected & devastating failures at the Phase III read-out stage. Examples in recent months could include Acadia, Aeterna Zentaris, BioMS & Array. * However, very unusually, this Phase II trial started recruiting in August 2007 – just 1 month before recruitment started on the Phase III trial. * Therefore, this Phase II trial is just as likely to be underperforming the true efficacy potential as outperforming it. * Put another way, the decision to go to Phase III here was not influenced by an outperforming Phase II trial. * Therefore, the read-outs from this Phase II trial could in a way be regarded as a low-powered Phase III trial that’s very helpfully releasing results before the make-or-break Phase III read-out in December 2009.