Progen Terminates PATHWAY Trial & Confirms Focus on Potential High Value Molecul...( BRISBANE Australia July 22 /- Fol...),Health

BRISBANE, Australia, July 22 /PRNewswire-FirstCall/ -- Following a thorough review that concluded late yesterday, the Board of Progen Pharmaceuticals Limited (ASX: PGL; Nasdaq: PGLA) today announced that it had 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 strategic review was triggered by a recent accumulation of a number of factors that impacted the commercial return for the phase 3 PATHWAY trial.

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 commercialise 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.

These aspects would have delayed market entry significantly and seriously impacted on the commercial return of the phase 3 PATHWAY trial.

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.

The PI-88 trial had been facilitated through external agencies, and had resulted in 23 sites being opened for patient recruitment and 12 patients from 5 recruitment centres having be
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