First Patient Dosed in Ph 3 VIKTORIA-1 Clinical Trial of Gedatolisib for the Treatment of HR+/HER2- Advanced Breast Cancer
“We are excited to begin enrolling patients in the VIKTORIA-1 trial and advancing towards our ultimate goal of providing a transformative therapeutic option for patients with breast cancer,” said Igor Gorbatchevsky, M.D. Chief Medical Officer of Celcuity. “We look forward to generating robust data with the goal of supporting a future regulatory submission.”
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“The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer,” said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. “We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers.”
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Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.