The SGO abstract stated 29% CR+PR, 29% SD and 48% PD, which gives a total of 106%. When I bought this to the attention of Novogen, they said the data had been released without reference to them and the correct figures were 29% CR+PR, 33% SD and 38% PD.
This gives a 'response' (CR+PR+SD) of 62% but the company announcement used a figure of 74% and I've been surprised that no one has picked up the discrepancy before now. You were the first, so take a bow!
There is a reason for the discrepancy. RECIST criteria require that patients are not “evaluable” unless they have received 2 radiographic scans. Some patients who had not had 2 scans at the time data were reported may have had tumor regression, but by RECIST criteria cannot be recorded as responders. In other words, the data continues to move about until all patients have completed treatment.
These discrepancies highlight the dangers of reporting interim findings from unvalidated data. Investors demand the release of data, of course, but we do not always understand what has been said.
For instance, the SGO abstract prepared by Yale included some platinum and taxane-free intervals but did not say if the patients had been treated with other drugs in the meantime, as one might expect. It is simply impossible to accurately evaluate announced results without access to all the data, yet it is simply impossible to release all the data at interim analysis.
My advice is to use your common sense to judge progress. In a nutshell: if IV PXD achieved (at minimum) a 29% Complete and Partial response and the company decided to switch to Oral PXD, surely we can expect better results than 29% given that Oral PXD achieves much higher steady-state levels in the body.
If OVATURE patients are truly refractory, the comparator arm should have near enough to zero response.
NRT Price at posting:
0.0¢ Sentiment: Buy Disclosure: Not Held
