OnQuality Pharmaceuticals Expands Part 2 of the NOVA-II Phase 2 Clinical Trial to China and India
OnQuality Pharmaceuticals, a targeted oncology supportive therapy company developing innovative medications to address the quality of life for patients receiving anticancer medications, has announced that regulatory authorities in China and India have approved Part 2 of the NOVA-II Phase 2 clinical trial, evaluating OQL011, a topical ointment for the management of Hand-Foot Skin Reaction (HFSR) in cancer patients receiving vascular endothelial growth factor receptor (VEGFR) inhibitor(s) (VEGFRi) as part of their anti-cancer treatment.
VEGFRi-associated HFSR is a common treatment-related side effect that can cause treatment interruption or discontinuation and contribute to a declining quality of life for patients. There are no treatments with FDA-approved labeling for VEGFRi-associated HFSR. In September 2022, the first patient in Part 2 of the NOVA-II Phase 2 clinical trial was enrolled in the United States. With a multi-regional clinical trial (MRCT), currently with US, India, and China, OnQuality is leveraging its resources to harmonize a robust trial design and global operations across these regions to accelerate recruitment and improve demographic exposure for the target population.
“The expansion of the Part 2 of the NOVA-II clinical trial to China and India allows patients to access OQL011 in the world’s most populated countries,” commented Chief Medical Officer and Co-Founder of OnQuality Pharmaceuticals, Hong Tang, M.D. “Data generated in Part 2 will further validate OQL011 and determine the optimal OQL011 dosage for a Phase 3 clinical trial.”
“Adding sites in China and India will increase the scale of NOVA-II Part 2 to a total of 31 clinical sites and help to accelerate the development of OQL011,” said Michael McCullar, Chief Executive Officer of OnQuality. “We are excited to expand NOVA-II to a global scale and look forward to including additional countries in the Phase 3 study.”
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 VEGFRi-associated HFSR. Patients eligible for the NOVA-II study must be receiving VEGFRi-based anticancer therapy (monotherapy or combination therapy) and have HFSR severity (per IGA-HFSR) of grade 3 or higher (i.e., moderate to severe HFSR). Initial findings from Part 1 of the Phase 2 trial showed OQL011 to be safe and well tolerated with no significant adverse events.
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