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Two conventional prostate cancer hormone therapies, buserelin and flutamide, were given alongside OGX-011. Post surgery analysis of the patients' prostate cancers showed that the higher the dose of OGX-011 given, the lower clusterin levels were within the cancer cells. At the highest dose given of 640mg the clusterin messenger RNA (mRNA) was down to a mean 8% level as compared to historical controls. The drug was well tolerated by patients.

Said Dr. Chi: "We designed the Phase I trial in such a way that we could identify the biologically active dose in the tumour tissue. Being able to identify the active dose in this way gives us confidence that the Phase II dose of the drug that we have selected is the appropriate one. The Phase II studies are of a more conventional design, looking at response rates from OGX-011 plus standard chemotherapy in patients with metastatic hormone refractory prostate, breast and lung cancer. Phase II breast and prostate studies will begin near the end of the year, and a Phase I lung cancer trial started this month. The trials will recruit around 40 to 50 patients each and accrual should be complete in around six to 12 months, with results soon after that.

"Of course, it is still early days, but we are optimistic. The drug worked well in animal models and we hope that we will be able to see benefits akin to some of the other targeted therapies now in use."

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Contact: Margaret Willson
m.willson@mwcommunications.org.uk
41-227-612-205
European Organisation for Research and Treatment of Cancer
29-Sep-2004