- Planning for Phase 3 Trial Initiation on Track -
BRISBANE, Australia, Aug. 16 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited (ASX: PGL; Nasdaq: PGLA) today announced it has executed an agreement with Quintiles, the world's largest Contract Research Organisation, to utilise their services for a number of clinical development- related projects. This agreement includes the execution of the Phase 3 clinical trial of anti-cancer drug PI-88 for the treatment of primary liver cancer (hepatocellular carcinoma).
Progen remains on track to initiate recruitment for the Phase 3 clinical trial in the fourth quarter of 2007. Quintiles operates directly in each of the 14 North American, European and Asian countries where Progen will be conducting the Phase 3 PI-88 trial.
"Quintiles has over 18,000 employees world-wide and has managed over 520 separate oncology studies. A number of these employees have been working with us as we prepare to initiate our Phase 3 trial in post-resection liver cancer. We have been consistently impressed with Quintiles's infrastructure in the regions where the trial will be conducted. They have already demonstrated to us that they have the communication and project management systems in place to successfully integrate key clinical operational procedures on the international level that this important trial requires," said Justus Homburg, Progen's CEO.
"Since the middle of last year, we have been working with external advisors, including Quintiles and the U.S. Food and Drug Administration (FDA), to develop our Phase 3 trial. We are aggressively pursuing the launch of this clinical trial on schedule and in parallel continue our discussions with the FDA on the SPA process," concluded Mr. Homburg.
The primary endpoint of the Phase 3 trial is the length of time
patients remain disease-free (disease free survival or DFS) following
surgery to remove tumour-affected parts of the liver. "Recent feedback f
|SOURCE Progen Pharmaceuticals Limited|
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