The company said that the trial is unlikely to meet the forecast patient recruitment timetable and further significant delays were expected due to – slower than expected regulatory processes in China, Korea and Vietnam; slower than expected initiation of clinical sites; slower than expected recruitment of patients into active sites; and the recent launch of a competitive Phase III trial, assessing Bayer/Onyx Nexavar in the same indication.
As part of the strategic review, Progen has determined that the current Phase IIb melanoma trial, will be completed but no further development in melanoma by Progen is anticipated at this stage. This trial is expected be finalized at an estimated additional cost of $300,000.
In addition, and as part of the strategic review, the company has also decided to terminate further development of its Phase I compound PI-166, based on a recent commercial assessment of the market and the approval of Nexavar in this indication.
Progen will focus its resources on aggressively pursuing its other compounds in development PG11047 (Phase I), the 500 series (late preclinical) and the epigenetics platform (early preclinical).