"Our team is delighted to start Part 2 of the NOVA-II clinical trial to address the unmet need of cancer-therapy-induced skin toxicities," commented Chief Medical Officer and Co-Founder of OnQuality Pharmaceuticals, Hong Tang, M.D. "OQL011 generated positive initial findings in Part 1 of the Phase 2 study and we look forward to advancing the Part 2 study to determine the optimal dosage of OQL011 for Phase 3." NOVA-II is a global multicenter, randomized, double-blinded, vehicle-controlled, dose-ranging Phase 2 clinical trial designed to assess the safety and efficacy of OQL011 as a topical ointment in treating VEGFR inhibitorVEGFR inhibitor-associated HFSR. Patients eligible for the NOVA-II study must be receiving VEGFR inhibitorVEGFR inhibitor-based anticancer therapy (monotherapy or combination therapy) and have HFSR severity (per IGA-HFSR) of grade 3 or higher. Initial findings from Part 1 of the Phase 2 trial showed OQL011 to be safe and well tolerated with no significant adverse events. Key objectives in the study include evaluating the safety and efficacy of OQL011, identifying an optimal dosage for Phase 3, and exploring the pharmacokinetics profile of OQL011 in HSFR patients. Please refer to www.clinicaltrials.gov (NCT04088318) for additional details. VEGFR inhibitorVEGFR inhibitor associated HFSR is characterized by redness, swelling, discomfort or pain, and blistering in the palms of the hands or the soles of the feet. Incident rates can exceed 50% of patients treated depending on the inhibitor used. In cases of severe HFSR, dose reduction or discontinuation is required. There is currently no FDA-approved therapy for the treatment of HFSR and the effectiveness of current symptom relief strategies remains limited. OQL011 is a proprietary ointment that targets the key pathway of VEGFR inhibitorVEGFR inhibitor-associated HFSR and may improve or restore VEGF signaling and potentially alleviate HFSR symptoms. By addressing side effects, OnQuality aims to keep patients in cancer treatment and improve their quality of life. IGA-HFSR: It is an investigator global assessment scale developed by OnQuality in collaboration with key oncodematologists and oncologists for the evaluation of treatment efficacy for VEGFRi-associated HFSR.
OnQuality Pharmaceuticals is dedicated to pioneering the discovery and development of targeted supportive oncology therapies that address treatment-related toxicities at their molecular source. By treating on-target toxicities of the anticancer treatments, OnQuality's targeted supportive therapy candidates have the potential to reduce the severity and incidence of adverse events while sustaining the efficacy of the cancer treatments. OnQuality's targeted therapies, therefore, can potentially improve both the quality of life and outcomes for cancer patients.