QUE Oncology launches Phase II trials
Clinical stage biotechnology company QUE Oncology has launched Phase II trials which will see its novel non-hormonal therapy, for women with breast cancer suffering hot flushes and night sweats, tested at six sites across Australia.
The company is developing drugs for large unmet medical needs and has already advanced clinical development of its lead drug program Q-122, through four Phase 1 trials. It is now set to move Q-122 into a pivotal proof-of-concept trial to examine the efficacy of the drug at leading clinical sites across Melbourne, Sydney Perth and Adelaide. The placebo-controlled, double-blind study will see a total of 130 women take part, with the trial expected to take up to eight months to complete. Leading hospitals in the USA will also participate in the study.
After a diagnosis of breast cancer, women are routinely prescribed drugs such as tamoxifen or aromatase inhibitors (known as endocrine therapy) which reduce or block the action of estrogen, a hormone known to stimulate the growth of breast cancer. However, the side effect of reducing estrogen is an increased likelihood of moderate to severe hot flushes and night sweats. QUE Oncology is looking to develop a therapy to address these debilitating symptoms.
Previous trials with Q-122 have shown an excellent safety profile in over 60 patients and healthy volunteers. In a previous Phase 1b trial in women undergoing estrogen reduction therapy for breast cancer, 85% of women showed a reduction in both the frequency and severity of their hot flushes.
QUE Oncology Chief Executive Officer Dr Rob Crombie said, “Evidence shows that up to 75% of women undergoing long-term preventative breast cancer treatment suffer hot flushes and night sweats, with some facing more than 20 events in one day. We expect through our Phase II trials to replicate the data that we have already seen in this patient group as we develop a treatment to substantially improve the quality of life for women on long-term endocrine therapy.”
Specialist endocrinologist Professor Susan Davis, President of the International Menopause Society and Chair of Women’s Health at Monash University, will head the trials as lead clinical investigator.
Professor Davis said, “Many people don’t understand the full impact of hot flushes and night sweats. They can be debilitating and negatively affect overall quality of life. There is a desperate need for clinical trials of treatments for hot flushes experienced by women undergoing breast cancer therapy.”
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