Biotech creating a new therapy for hot flashes in breast cancer patients launches clinical trials across United States
Atlanta, USA, April 2, 2019 – Clinical stage biotechnology company QUE Oncology today announces the launch of its Phase II trials which will see its novel non-hormonal therapy, for women with breast cancer suffering hot flashes and night sweats, tested at key sites in the United States.
QUE Oncology 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.
QUE Oncology is now set to commence a placebo-controlled, double-blind study to examine the efficacy of Q-122 at leading clinical sites across the United States, including Brigham and Women’s Hospital, Boston, Johns Hopkin’s, Baltimore, and Indiana University, Indiana. Additional clinical sites in other US states will follow, subject to relevant ethics and regulatory approvals.
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 flashes and night sweats. These symptoms can severely impact a women’s general wellbeing and often cause women to stop taking their breast cancer treatment. 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 flashes.
QUE Oncology Chief Executive Officer Dr Rob Crombie says, “Evidence shows that up to 75% of women undergoing long-term preventative breast cancer treatment suffer hot flashes and night sweats, with some facing more than 20 events in one day. Through our Phase II trials we hope 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.”
Dr Hadine Joffe, Director of the Connors Center for Women’s Health and Gender Biology at Brigham and Women’s Hospital, and the Paula A. Johnson Associate Professor of Psychiatry in the Field of Women’s Health at Harvard Medical School, a key investigator on the trial in the United States says, “For women undergoing breast cancer treatment, hot flashes can be debilitating, not only during the day but also at night, impacting sleep quality. In extreme cases, these symptoms can make women consider stopping their anti-cancer therapy. Trials in this area are urgently needed to identify effective treatments to combat these side effects.”
QUE Oncology’s products also have the potential to expand into related conditions, such as hot flashes associated with menopause, and hot flushes experienced by men undergoing prostate cancer treatment.
Women interested in further details about QUE Oncology’s clinical trials should visit www.queoncology.com
Notes to Editors:
For further information or to arrange an interview, please contact:
QUE Oncology: Andrew Hamilton, email@example.com, +61 420 447 669
About QUE Oncology, Inc.
QUE Oncology, Inc. is a global clinical stage biotechnology company developing drugs for large unmet medical needs. The company’s lead drug program, Q-122 is initially focused on the treatment of hot flashes in breast cancer survivors undergoing hormone therapy. Several clinical studies with Q-122 have shown the drug to be safely administered to over 60 patients and healthy volunteers.
QUE Oncology was jointly established by Emory University (Atlanta, GA) and the University of Queensland’s main commercialisation company, UniQuest Pty Ltd. The Series A investment round was led by the Medical Research Commercialisation Fund (MRCF), alongside Uniseed.
Que Oncology has now commenced a placebo-controlled Phase 2 study in breast cancer patients, with multiple sites across Australia and the USA. Backed by a A$21.5M capital raise (June 2017) led by Australia’s Medical Research Commercialisation Fund (MRCF) and Uniseed, QUE is well funded to execute on its clinical development programs.
Q-122 is being developed for the treatment of hot flashes in women diagnosed with breast cancer who are receiving hormonal therapy. Q-122 is an orally available small molecule that has been investigated in several in vitro and in vivo pharmacology studies. The clinical results have shown that Q-122 has an excellent safety profile and warrants the needs for further clinical studies to assess the efficacy of the drug in the treatment of hot flashes.
Clinical trials to date
To date Q-122 has been safely administered to a total of 62 participants in 4 separate clinical trials as described briefly below.
• Phase 1 – first-in-human (FIH) study: Examined the safety of Q-122 in cancer patients with solid or haematological malignancies. In this study, seven cancer patients received either 50 or 75 mg of Q-
122 daily for up to 110 days. No maximum tolerated dose was identified, and no trends in adverse events (AEs) noted.
• Phase 1 Single Ascending Dose (SAD): In this study, 22 healthy participants received single doses of 50 mg, 100 mg, 200 mg or 400 mg Q-122. Q-122 was well tolerated with no serious adverse events
• Phase 1b Initial Proof-of-Concept (Q-1001): This open-label study enrolled breast cancer survivors taking endocrine therapy (tamoxifen or an aromatase inhibitor) who were experiencing 49 or more moderate to severe hot flashes per week. In this study, 21 participants received daily doses of 100 mg (10 participants) or 200 mg (11 participants) Q-122 for up to 28 days. In this study, both the frequency and severity of hot flashes were significantly reduced following treatment with Q-122 as were menopausal symptoms assessed using the Greene Climacteric Scale.
• Phase 1 Pharmacokinetic (PK) Study (Q122-1002): A Phase 1 study was conducted to determine the effect of food and dosing regimen on Q-122 pharmacokinetics. In Part 1, healthy volunteers were administered Q-122 (200 mg) in either fed or fasted conditions. The results demonstrated an increase in bioavailability of Q-122 under fed dosing conditions. In Part 2, the same 12 participants were randomized to a once daily (200 mg) versus twice daily (2 doses of 100 mg) to examine the effect of the dosing regimen of Q-122.
Given these very encouraging study outcomes, QUE has accelerated development of Q-122 as a treatment for vasomotor symptoms in breast cancer survivors taking tamoxifen or an aromatase inhibitor.