OnQuality Pharmaceuticals (“OnQuality”), today announced that Part 1 of the Phase 2 NOVA-II clinical trial evaluating OQL011 met the company’s expectations of safety, efficacy and the patient reported outcome of Hand-Foot Skin Reaction (HFSR)-related pain.
SEATTLE, Wash., Jan. 4, 2022 /PRNewswire/ -- OnQuality Pharmaceuticals ("OnQuality"), an oncology company developing targeted supportive therapies to address unmet needs in oncodermatology and oncogastroenterology (cancer therapy-induced side effects occurring in the skin and gastrointestinal tract, respectively) and to improve quality of life for patients receiving anticancer medications, today announced that Part 1 of the Phase 2 NOVA-II clinical trial evaluating OQL011 met the company's expectations of safety, efficacy and the patient reported outcome of Hand-Foot Skin Reaction (HFSR)-related pain. NOVA-II is a 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 inhibitor-associated HFSR. Patients eligible for the NOVA-II study must be receiving VEGFR inhibitor-based anticancer therapy (monotherapy or combination therapy) and have HFSR severity (per NCI CTCAE v5.0 grading of palmar-plantar erythrodysesthesia, or PPE) of grade 2 or higher. "While the outlook for many types of cancer has improved in recent years, largely due to advancements in anticancer treatments, the new and painful side effects of these treatments have not been addressed accordingly. The first part of our Phase 2 trial demonstrated the potential of OQL011 in helping patients who are suffering from Hand-Foot Skin Reaction," said Hong Tang, M.D., Chief Medical Officer and co-founder of OnQuality Pharmaceuticals. "Completing part one of this proof of concept study is a significant milestone, supporting our approach in cancer supportive drug development and bringing us one step closer to fulfilling our mission of bringing innovative new therapies to patients." "Due to the debilitating side effects of VEGFR inhibitor treatment to combat cancer, up to 30% of patients reduce their therapy dose and up to 17% completely discontinue treatment. We are working to balance the scale in cancer therapy and provide a much-needed solution to side effects that will allow more patients to remain in treatment," added Michael McCullar, Ph.D., Chief Executive Officer of OnQuality Pharmaceuticals. "We are looking forward to advancing QOL011 to Part 2 of the study at a higher dose level." Dr. McCullar will be discussing the novel targeted supportive therapies in OnQuality's pipeline in presentations at two virtual investor conferences this month: Biotech Showcase 2022 (January 10-12 and 17-19) and the H.C. Wainwright Bioconnect Conference (January 10-13). OnQuality is working with the U.S. Food and Drug Administration (FDA) to utilize the data from Part 1 to inform and update its protocols for Part 2 of the NOVA-II study. OnQuality will present its findings from Part 1 at a future conference and Part 2 is set to begin in Q1 2022. For additional details, please refer to www.clinicaltrials.gov (NCT04088318). About OQL011 and Hand-Foot Skin Reaction Hand-Foot Skin Reaction (HFSR) is a common side effect of tyrosine kinase inhibitors, including vascular endothelial growth factor receptor (VEGFR) inhibitors, used for the treatment of cancer. VEGFR inhibitors impair vascular repair mechanisms, which are especially important in areas exposed to high pressure and repetitive force, such as the palms and soles.
SOURCE OnQuality Pharmaceuticals |