Progen Pharmaceuticals Limited, a biotechnology company, engages in the discovery, development, and commercialization of small molecule therapeutics primarily for the treatment of cancer. Products PI-88 PI-88 is a carbohydrate-based small-molecule, which works through two mechanisms. Firstly, it inhibits the enzyme heparanase, which plays a major role in tumor spread and invasion through surrounding tissues. Secondly, PI-88 exerts an anti-angiogenic effect by inhibiting the interaction between growth factors, heparan sulfate and cellular receptors. The company has a binding license and collaboration agreement with Medigen Biotechnology Corporation (Medigen) for the development and commercialization of muparfostat worldwide. The agreement grants Medigen the exclusive worldwide and sub-license rights for the commercialization of muparfostat for the therapeutic and prophylactic treatment of cancer. The intellectual property owned or licensed by the company to Medigen includes the rights to PI-88 covered in the global patent family entitled ‘Preparation and Use of Sulfated Oligosaccharides’. All clinical trials of PI-88 have been conducted under an active Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA). PI-88 is in a fully recruited, randomized, placebo controlled Phase III clinical trials (ClinicalTrials.gov Identifier: NCT01402908) to confirm the safety and efficacy of PI-88 in the adjuvant treatment of hepatocellular carcinoma after surgical resection. Worldwide oncology rights to PI-88 have been licensed to Medigen, who would further develop and commercialize the compound and thus the company would not undertake any further development in melanoma at this stage. PG545 PG545 is a proprietary synthetic small molecule created to modulate the tumour microenvironment through multiple mechanisms of action. PG545 binds to angiogenic growth factors vascular endothelial growth factor and various members of the fibroblast growth factor family, which leads to a reduction in angiogenesis and the function of the blood vessels. PG545 is also active in lymphoma models and is reliant upon the activation of natural killer cells to kill lymphomas in this model. PG545 entered a Phase 1 clinical trial in late 2013 to test the safety and tolerability by intravenous administration in advanced cancer patients. This trial is ongoing and expected to be completed by early 2016. In 2014, the company completed treatment of the first three patient cohorts (25, 50, and 100 mg). The utility of PG545 at 150 mg is continuing to be explored. It is anticipated that this trial would be completed in February-March 2016. Manufacturing PharmaSynth Pty Ltd (PharmaSynth), a subsidiary of the company, operates a current good manufacturing practice certified pilot manufacturing facility that provides contract manufacturing services to the biotechnology industry. PharmaSynth’s business is the provision of contract pharmaceutical manufacturing development services and manufacture of material for phase 1 to phase 3 clinical trials, as well as the manufacture of veterinary and animal health products. Government Regulation The manufacturing facility, run by PharmaSynth, is licensed by the Australian Therapeutic Goods Administration for the manufacture of biological-based starting materials for human therapeutics to current good manufacturing practice and by the Australian Office of Gene Technology Regulator for the manufacture of large scale genetically modified organisms. The company’s manufacturing facilities are also subject to regular inspections by the Australian Therapeutic Goods Administration. FDA approval to market the company’s drug products in the U.S. is expected to be undertaken by the company or in conjunction with a commercial partner. Patents The company’s policy is to protect and defend the intellectual property associated with its technology and products, principally through patent protection. The company achieves this by filing patent applications. The most material of these patents and patent applications being: PI-88: Composition of matter and method of use patent families have been granted in countries, including the U.S., Canada, Australia, Korea, Taiwan, Japan, Europe, China, South Africa, and New Zealand. The PI-88 composition of matter patent expires in 2016. PG545: Composition of matter compounds and method of use patents have been granted in Australia, Japan, Israel, Singapore, Russia, and South Africa, while patents are pending in various other key jurisdictions. The PG545 composition of matter patents and applications expire in 2028. Licenses PI-88: The company has a worldwide license from the Australian National University in Canberra, Australia, to five families of patents and patent applications relating to PI-88, the company’s sulfated oligosaccharide heparanase inhibitor. The company’s license rights terminate in 2026. Trademark Progen is a registered trademark of the company. History The company was founded in 1989. It was incorporated in 1989 as Almagest Pty. Ltd. in the state of Queensland, Australia. The company changed its name to Progen Industries Pty. Ltd. in 1990 and then to Progen Industries Limited in 1991. Further, the company changed its name to Progen Pharmaceuticals Limited in 2007.
progen pharmaceuticals ltd
(PGL:Australian Stock Exchange Ltd)
2806 Ipswich Road
Darra, QLD 4076
Phone: 61 7 3273 9133
Fax: 61 7 3375 1168www.progen-pharma.com
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