Biotech Values

[genisi]

AMGN's OncoVex

Phase II single-arm study of 50 patients has shown reasonable response rate with impressive durability and good safety. The encouraging part for me was the fact that response was seen with durability also in uninjected lesions including visceral sites. However, I'm only a bit optimistic on this as no details on the visceral metastases were given.
Phase III study has a good chance of success (ie repeat the data seen in phase II) for several reasons: it's quite similar to the phase II, has an SPA and the trial design is appropriate (the nature of the control arm, primary endpoint being durable response rate and not OS, good selection of patients (eg exclusion of certain metastases etc). Commercial success if approved is something else.