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Progen has commenced development of PG-11047 - the lead clinical compoundin the Company's polyamine program - following its acquisition of Cellgate,Inc earlier this year. The first patient to be recruited into the trialre-initiation has been enrolled at the University of Chicago.
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The trial is exploring the potential of PG-11047 as a single anti-canceragent and is designed to assess the agent's maximum tolerated dose. UnderCellGate, the trial had recruited 31 patients and had shown little evidence oftoxicity, while using significantly higher doses than most previous studies ofpolyamine compounds.
Justus Homburg, Progen's CEO, said, "Since the acquisition of CellGate, wehave been assessing our portfolio of clinical and pre-clinical compounds inorder to determine which to drive forward. Our re-initiation of PG-11047 inphase 1 clinical development is the first step in driving potential value fromour expanded portfolio of first-in-class oncology therapies."
Data from the trial will be used in parallel with a separate PG-11047study assessing the agent in combination with other marketed anti-cancer drugsas the basis for determining potential phase 2 development. Progen expects thestudy to produce data within the next 12 months.
About Progen: Progen Pharmaceuticals is a globally focused biotechnologycompany committed to the discovery, development and commercialization of smallmolecule pharmaceuticals primarily for the treatment of cancer. Progen hasoperations in Australia and the US.
About PG-11047: PG-11047 is a polyamine analogue which modifies theproduction of natural polyamines. Polyamines are a class of chemical which areinvolved in regulation of cell growth. They are overproduced in many cancers,and PG-11047 is believed to restore polyamine reduction to natural levels.Despite being the focus of scientific interest for many years, this mechanismis unique, and if successful, PG-11047 could become a first-in-class oncologyproduct. To date, PG-11047 has been shown to have anti-tumor activity inanimal models, combined with a good safety profile.
This press release contains forward-looking statements that are based oncurrent management expectations. These statements may differ materially fromactual future events or results due to certain risks and uncertainties,including without limitation, risks associated with drug development andmanufacture, risks inherent in the extensive regulatory approval processmandated by the United States Food and Drug Administration and the AustralianTherapeutic Goods Administration, delays in obtaining the necessary approvalsfor clinical testing, patient recruitment, delays in the conduct of clinicaltrials, market acceptance of PI-88, PI-166 and other drugs, future capitalneeds, general economic conditions, and other risks and uncertainties detailedfrom time to time in the Company's filings with the Australian SecuritiesExchange and the United States Securities and Exchange Commission. Moreover,there can be no assurance that others will not independently develop similarproducts or processes or design around patents owned or licensed by theCompany, or that patents owned or licensed by the Company will providemeaningful protection or competitive advantages.Progen Information: Justus Homburg, CEO Progen Pharmaceuticals Limited T: +61 7 3842 3333 E: [email protected] Media and Investor Relations: Cindy Ingram, Investor Relations Manager Progen Pharmaceuticals Limited T: +61 7 3842 3333 E: [email protected]
SOURCE Progen Pharmaceuticals Limited
