PROGEN'S FIRST U.S. CLINICAL TRIAL WITH PI-88 BEGINS.The first two patients have been enrolled in Progen Industries Limited (Nasdaq:PGLAF PGLAF Project Gutenberg Literary Archive Foundation ) (ASX ASX See: Australian Stock Exchange :PGL Persistent generalized lymphadenopathy (PGL) A condition in which HIV continues to produce chronic painless swellings in the lymph nodes during the latency period. Mentioned in: AIDS ), Brisbane, Australia, Phase I/II trial of anti-cancer drug PI-88. The trial, which has received ethics committee ethics committee A multidisciplinary hospital body composed of a broad spectrum of personnel–eg, physicians, nurses, social workers, priests, and others, which addresses the moral and ethical issues within the hospital. See DNR, Institutional review board. approval is being conducted in two phases at the University of Colorado Health Sciences Center The University of Colorado Health Sciences Center (UCHSC) is part of the University of Colorado System. It has recently been merged with the University of Colorado at Denver (UCD) to form the University of Colorado at Denver and Health Sciences Center. (CUHSC) in the United States. The first phase (Phase I) will determine the appropriate dose and safety of the drug when administered subcutaneously (injected under the skin) to patients with advanced malignancies. The second phase (Phase II) will evaluate the drug's effect on tumour progression in patients with advanced melanoma, and gather information about PI-88's ability to inhibit the formation of blood vessels Blood vessels Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names. (angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization. an·gi·o·gen·e·sis n. ) feeding the tumours. This phase will involve patients who have received therapies that have failed or do not have any other treatment options available. Progen's vice president of Research and Development, Dr. Robert Don said the trial is a significant milestone in Progen's ongoing research and development program with PI-88. "This trial represents an exciting opportunity for us to learn more about the drug's ability to control cancer," Don said. "Existing research shows that PI-88 has multiple modes of action that enable it to target both the growth and spread of cancers, giving it a unique advantage over many other cancer treatments." Don said PI-88 inhibited the action of heparanase, an enzyme involved in the spread of tumours to secondary sites (metastasis metastasis /me·tas·ta·sis/ (me-tas´tah-sis) pl. metas´tases 1. transfer of disease from one organ or part of the body to another not directly connected with it, due either to transfer of pathogenic microorganisms or to ), and also inhibited the growth of new blood vessels (angiogenesis) that supply tumours and allow them to grow and spread. Don said Progen had chosen melanoma as the disease target for the first Phase II study with PI-88 because it allowed for samples of skin lesions Skin Lesions Definition A skin lesion is a superficial growth or patch of the skin that does not resemble the area surrounding it. Description Skin lesions can be grouped into two categories: primary and secondary. (biopsies) to be taken and also enabled direct observation of changes in blood vessels. The principal investigator conducting the trial is Dr. S. Gail Eckhardt, an associate professor at the CUHSC and a clinician with a long-standing interest in angiogenesis inhibitors as therapies for cancer. "Tumour angiogenesis continues to be a very important target for anti-cancer therapy. PI-88 is a compound that is unique among other angiogenesis inhibitors, and we are looking forward to investigating its potential in treating cancer patients," Dr. Eckhardt said. The PI-88 trial at the CUHSC follows the completion of a Phase Ib trial of the drug in cancer patients in February this year at the Centre for Developmental Cancer Therapeutics involving the Peter McCallum Cancer Institute and the Royal Melbourne Hospital The Royal Melbourne Hospital (RMH) in Parkville is one of Australia’s leading public hospitals. It is a major teaching hospital for tertiary health care with a reputation in clinical research. . A Phase I trial examining subcutaneous administration of PI-88 in healthy volunteers is nearing completion at the specialist clinical research organization, Medeval, in the United Kingdom. Progen's strategic alliance partner, Medigen Biotechnology Corporation, is currently conducting an independent Phase Ib trial of PI-88 in Taiwanese patients suffering advanced forms of cancer. Progen plans to form a strategic alliance with a reputable pharmaceutical or biotechnology company at the completion of Phase II trials to take PI-88's development through Phase III trials and eventually onto the market. About the research leaders Dr. Gail Eckhardt has been the principal investigator on over 40 Phase I/II trials and co-investigator on a further 50 experimental drug trials. She is widely recognized as a leading researcher in cancer and the role of angiogenesis (blood vessel formation) in cancer. Dr. Rene Gonzalez, associate professor at the CUHSC and a well-established melanoma specialist involved in multiple melanoma clinical trials, will assist Dr. Eckhardt with the Phase II trial. About Progen Progen Industries is a biotechnology company committed to the discovery, development and commercialisation of small molecule pharmaceuticals for the treatment of a variety of diseases for which there is a significant demand for new therapies. The company's lead drug candidate, PI-88, is under development as a potential treatment for cancer and cardiovascular disease. The company's drug discovery efforts are focused on the development of potent, selective inhibitors of carbohydrate-protein interactions, which are implicated im·pli·cate tr.v. im·pli·cat·ed, im·pli·cat·ing, im·pli·cates 1. To involve or connect intimately or incriminatingly: evidence that implicates others in the plot. 2. in a range of different diseases. The company has a world-class facility that manufactures drug candidates under Good Manufacturing Practices (GMP GMP (guanosine monophosphate): see guanine. ) for clinical trials. Progen Industries is collaborating with internationally respected researchers. A collaboration with Professor Mark von Itzstein from Australia's Griffith University has been established to develop inhibitors of the enzyme heparanase. For more information, visit http://www.progen.com.au or call 415/776-6499. |
|
||||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion