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Progen to meet with FDA to discuss trials for PI-88
New York, March 27 - Progen Industries said it will meet with the Food and Drug Administration on April 5 to discuss the design of current clinical trials for its PI-88 compound and the strategy for future trials.
The company said the designs are important as part of planning a route to market for PI-88.
"We are committed to moving PI-88 forward rapidly in clinical development," said Justus Homburg, chief executive officer of Progen, in a news release.
"At the FDA meeting we will be discussing the design of our current trials as well as protocol designs of future trials. This is an important step forward, as it will assist us in moving PI-88 towards eventual registration."
Progen, a Brisbane, Australia, biotechnology company, has PI-88 in a phase 2 trial treating patients with hepatocellular carcinoma (primary liver cancer) following resection.
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