BIOGUIDE BRIEF: NOVOGEN JOINS THE FAILED PHASE III CLUB
July 10th 2010 07:21
Wednesday June 2, 2010
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MARC SINATRA’S BIOGUIDE BRIEF: NOVOGEN
Novogen joined a club today that includes Neuren, Progen and Avexa - the club for companies that have taken un-partnered projects into pivotal trials only to see them fail.
Novogen’s phenoxodiol didn’t just fail, though; it bombed miserably with only one responder out of 142 ovarian cancer patients given the drug. This was despite a 30% response rate in a phase II trial.
It is hard to tell exactly what went wrong in the trial, but suffice to say that all of those companies who looked at licensing Phenoxodiol and chose not to, were right.
The vibe coming from Novogen when they closed the phase III trial in April of last year was not good. The company said the trial was closed for two reasons: one was that the global economic downturn made raising the funds to complete the trial difficult and the second was that a change in the standard-of-care for ovarian cancer patients during the trial period had slowed recruitment rates.
Nonetheless, the spectacular failure of the trial does raise ones eyebrows as to whether Novogen had an idea the trial would fail when they decided to close it early.
When I reviewed Novogen in 2007, I noted that a compound very similar to phenoxodiol, Sanofi Aventis’s flavopiridol, had been extensively studied for numerous indications and produced disappointing results, albeit with some success in ovarian cancer patients.
The combined results of phenoxodiol and flavopiridol do not auger well for Novogen’s other isoflavonoid-derived compounds and the company should probably review these compounds to see if it is really worth taking them forward.
On the positive side, there is interest in flavopiridol as a treatment for chronic lymphocytic leukaemia and results so far have been encouraging. So, all hope may not be lost for isoflavonoids.
The fortunes of Neuren, Progen, Avexa and, now, Novogen, suggest that investors be wary of companies taking un-partnered compounds into phase III trials.
However, Chemgenex’s Omapro, Pharmaxis’s Aridol and Peplin’s ingenol mebutate should ultimately gain marketing approval after the companies took their respective compounds into phase III trials on their own. It should be noted that some have hit a few fairly nasty speed bumps along the way.
All of this suggests that investors need to pick and choose which companies with un-partnered compounds they follow into phase III.
A few of the questions that should be asked are: has the company previously tried and failed to licence the compound; how solid are the phase II results; what will the phase III program cost and can the company access this level of funding; and has the company appropriately killed under-performing projects in the past?
Marc Sinatra
Analyst
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