the Safety and Efficacy of OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients
Seattle, WA—August 14, 2020. OnQuality Pharmaceuticals (USA) LLC, dedicated to the discovery and development of therapies to improve quality-of-life and outcomes in cancer patients, today announced the first patient has been enrolled in a Phase II study of QOL011 for treatment of hand-foot skin reaction (HFSR). OQL011 is a topical ointment for the management of HFSR in cancer patients receiving a vascular endothelial growth factor receptor inhibitor (VEGFRi) as part of their treatment.
“Today’s announcement marks the start of our clinical program which uses a mechanistic medicine approach to potentially alleviate the severity of HFSR and allow patients to remain on their VEGFRi therapy. Dose interruption or permanent discontinuation due to moderate or severe HFSR is one of the most common reasons patients reduce or discontinue VEGFRi therapy.” said Hong Tang, M.D., chief medical officer of OnQuality Pharmaceuticals. “We expect that this study will generate important insights about the dose, safety, and efficacy of OQL011 among patients who have moderate to severe HFSR. There is currently no FDA approved treatment option for these patients.”
About the Study
The Phase II, multicenter, double-blinded, dose ranging clinical trial of OQL011 is designed to assess the safety and efficacy of OQL011 as a topical ointment in treating HFSR for subjects currently receiving VEGFRi-based anticancer therapy (monotherapy or VEGFRi-based combination therapy), and whose HFSR severity (per NCI CTCAE v5.0 grading of palmar-plantar erythrodysesthesia) is grade 2 or higher.
Key objectives in the study include determining the pharmacokinetics of OQL011, improvement in patient reported pain using a Visual Analog Scale (VAS), and the optimal dose – determined by the proportion of patients who achieve NCI CTCAE v5.0 - PPE grade 0 or 1 after three weeks of treatment. Please refer to www.clinicaltrials.gov (NCT04088318) for additional clinical trial details.
About OnQuality Pharmaceuticals
OnQuality Pharmaceuticals is dedicated to pioneering the discovery and development of mechanism-based therapies that have the potential to improve both quality-of-life and outcomes for cancer patients by managing the dose-limiting toxicities of cancer therapeutics. For more information, please visit our website at https://www.onqualityrx.com/
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements. Although forward-looking statements contained herein are based upon what OnQuality Pharmaceuticals believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. OnQuality undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
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