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news.Progen Pharmaceuticals has resumed patient enrolment in the Phase I dose-escalation study of the company's polyamine analogue, PG-11047 for patients with advanced cancer.
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Progen has commenced development of PG-11047 (formerly CGC-11047), following the acquisition of Cellgate, in early 2008. The first patient to be recruited into the trial re-initiation has been enrolled at the University of Chicago.
The trial is investigating the potential of PG-11047 as a single anticancer agent and is designed to assess the agent’s maximum tolerated dose. Under CellGate, the trial had recruited 31 patients and had shown little evidence of toxicity, while using significantly higher doses than most previous studies of polyamine compounds.
Data from the trial will be used in parallel with a separate PG-11047 study assessing the agent in combination with other marketed anticancer drugs as the basis for determining potential Phase II development. Progen expects the study to produce data within the next 12 months.