July 24, 2008
Knobias Clip Report (07-23-2008) PGLA
By admin
Submitted By Knobias ClipReport
PGLA: Terminates Phase 3 Trial of PI-88 in Liver Cancer
By Fain Hughes, fhughes@knobias.com
Progen Pharmaceuticals Limited (PGLA) has discontinued the PI-88 phase 3 study in liver cancer. Progen confirmed its strategic direction to develop its existing portfolio of compounds and the company will actively seek to acquire additional compounds and opportunities through Merger & Acquisition activity.
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 3 trial, assessing Bayer/Onyx Nexavar(R) in the same indication.
Due to a lack of a global partner willing to meaningfully develop and commercialize PI-88, the commercial opportunity is much less than previously expected. Without a significant global partner contributing, Progen will be less able to expand into additional indications and exploit all potential PI-88 commercial opportunities.
The next step is that Progen will seek expressions of interest in PI-88, at a regional level, initially from amongst those parties that had entered into Non-Disclosure Agreements and Due Diligence on PI-88.
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