Celcuity (CELC) Shoots Up 26% – First Patient Dosed in Phase 3 Breast Cancer Trial
Celcuity (CELC), a clinical stage biotech company, shot up 26% for the day, shortly following their latest press release, announcing the first dosing of their Phase 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.”
“Patients with HR+/HER2- advanced breast cancer whose disease progressed while on treatment with a CDK4/6 inhibitor need better therapeutic options. VIKTORIA-1 is an important and innovative study that has the potential to provide two different treatment regimens for these patients,” said Sara Hurvitz, M.D., Professor at the David Geffen School of Medicine at UCLA and a co-principal investigator for the clinical trial.
Celcuity is a clinical-stage biotechnology company focused on development of targeted therapies for treatment of multiple solid tumor indications. The company’s lead therapeutic candidate is gedatolisib, a potent, reversible dual inhibitor that selectively targets all Class 1 PI3K isoforms and mTOR. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer, is currently enrolling patients. The company’s CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and Twitter.