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Two patients are continuing with PI-88 treatment after successfully completing the combination treatment. Specifically, one patient has remained on the study after 74 weeks while the other remains after 40 weeks.
Dr. James Garner, Progen's Vice President of Clinical and Medical Affairs commented, "We are encouraged by the efficacy trends demonstrated in this patient population. Prostate cancer is an indication with continuing high unmet medical need and there is a clear demand for new therapies here. The febrile neutropaenia rates seen in this study are difficult to interpret, given that this small investigator-led study lacks a control group. We have not seen evidence of febrile neutropaenia in our previous clinical experience combining PI-88 with Taxotere(R), and there is no biological reason to suspect that the combination might result in increased toxicity. We will discuss this unexpected finding with our clinical and scientific advisors to determine the appropriate next steps in terms of development."
Justus Homburg, Progen's Chief Executive Officer continued, "Prostate cancer continues to be an indication we are interested to explore more, therefore, we will continue to analyze the results and do additional work to establish how best to combine PI-88 with existing therapies in this indication. In the interim, our phase 3 study in the adjuvant hepatocellular carcinoma setting is expected to begin recruitment shortly. We do not anticipate any concern regarding febrile neutropaenia in this phase 3 study, as it is a monotherapy study in a patient population with which we already have substantial clinical data."
About Progen: Progen Pharmaceuticals Limited is an Australian-based globally focused biotechnology company committed to the discovery, development and commercialization of small molecule therapeutics primarily for the treatment of cancer.
About PI-88: PI-88 is one of a new class of multi-ta
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