Genelux Corporation, a privately-held, clinical-stage immunotherapy company, today announced the outcome of a Type C meeting with the U.S. Food and Drug Administration (FDA) held on M
| SAN DIEGO, May 7, 2020 /PRNewswire/ -- Genelux Corporation, a privately-held, clinical-stage immunotherapy company, today announced the outcome of a Type C meeting with the U.S. Food and Drug Administration (FDA) held on May 6, 2020. The discussion focused on elements of the Company’s proposed Phase 3 registrational clinical trial design for oncolytic virus Olvi-Vec in the treatment of platinum-refractory/resistant ovarian cancer, a patient population with grave prognosis and a significant unmet medical need.
“We are pleased with the guidance received from the FDA and appreciate their continued collaborative approach in our clinical advancement of Olvi-Vec,” said Thomas Zindrick, President and CEO of Genelux. “Genelux looks forward to incorporating their guidance as we prepare for our End-of-Phase 2 meeting to advance Olvi-Vec into a registrational trial.” This was the Company’s second meeting with the FDA in the past 12 months, with plans for the next FDA meeting later this year following data lock of the Phase 2 VIRO-15 trial in 4Q 2020. The Company plans to initiate its Phase 3 Registrational trial and to extend clinical development of VIRO-15 to other indications, including platinum-resistant cervical cancer, in 2021. About Olvimulogene Nanivacirepvec (Olvi-Vec) About Genelux Corporation
SOURCE Genelux Corporation |
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