In our view, PI-88 is near-destined for registration as a treatment for post-resection liver cancer. The efficacy and safety profiles delivered by Progen for PI-88 bear the hallmark of a drug poised well for registration
Registration is expected by 2011; but could occur in 2010
Importantly, the time to progression analysis drawn from the phase-II study is underpinned by a highly supportive p-value. This is very encouraging given the small number of data points that were included in the analysis: Investors should take note that the power of the study was limited by two factors; 1) the number of patients enrolled in each arm; and 2) the fact that only 50% of the controls and 70% of the PI-88 (160 mg) dose arms yielded an event (recurrence) respectively. Our analysis of several blockbuster oncology biologics (e.g. Avastin, Herceptin etc) indicates that p-values can shrink dramatically when studies switch from phase-II to statistically powered phase-III registration studies. In general we have observed a decrease in p-values by two to three orders of magnitude across phase-II to –III studies. Progen is now in a position to use summary statistics from the phase-II study to appropriately design and power a phase-III trial for the 160 mg dose. If previous studies are indicative then it is near certain that a p-value less than 0.05 will be generated in the upcoming phase-III trial
Our risk-adjusted DCF model has been adjusted to reflect increased confidence in PI-88 successfully reaching the market as a therapy for post resection liver cancer. In our previous note concerning PGL’s interim data release we re-rated the chance of success for PI-88 (liver cancer) from 30% to 65%. Based on the data released today, we have further upwardly revised the chance of PI-88 reaching the market to 85%.
As a result, we continue to rate PGL as STRONG SPECULTAIVE BUY with a target price of *A$20.15*
PGL Price at posting:
0.0¢ Sentiment: LT Buy Disclosure: Held