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Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company developing targeted therapies for oncology, today announced that the first patient has been dosed in its Phase 1b/2 study (CELC-G-201) evaluating gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC). Gedatolisib, the company's lead therapeutic candidate, is a potent, reversible dual inhibitor that selectively targets all Class 1 PI3K isoforms and mTORC1/2.
"We are excited to begin enrolling patients in our 201 trial and advancing towards our ultimate goal of providing a transformative therapeutic option for patients with prostate cancer," said Igor Gorbatchevsky, M.D. Chief Medical Officer of Celcuity. "A significant unmet need remains for patients with metastatic castration resistant prostate cancer who have become resistant to a next generation androgen receptor inhibitor."
"Evaluating a PAM inhibitor, such as gedatolisib, in combination with a next generation androgen receptor, has strong scientific rationale and is an important priority for mCRPC research," said Karim Fizazi, M.D., Ph.D., Professor of Medicine at Institute Gustave Roussy and GETUG President, and one of the primary principal investigators in the study. "As it stands, there are limited options for patients with mCRPC whose disease progressed on or after treatment with an androgen receptor inhibitor. Gedatolisib's differentiated mechanism of action, and comprehensive blockade of the PAM pathway, may provide an additional treatment option for these patients."
In August 2023, Celcuity announced that it had entered into a clinical trial collaboration and supply agreement with Bayer AG to provide Nubeqa® (darolutamide) to Celcuity at no cost for the Phase 1b/2 trial.
About CEL-G-201
The CELC-G-201 Phase 1b/2 clinical trial is evaluating gedatolisib plus darolutamide, an androgen receptor (AR) inhibitor, in patients previously treated with a next generation AR inhibitor for metastatic castration resistant prostate cancer (mCRPC). The study is expected to enroll up to 54 participants with mCRPC who progressed after treatment with an androgen receptor inhibitor. In the Phase 1b portion of the study, Celcuity expects that 36 participants will be randomly assigned to receive 600 mg darolutamide combined with either 120 mg gedatolisib in Arm 1 or 180 mg gedatolisib in Arm 2. An additional 12 participants will then be enrolled in the Phase 2 portion of the study at the RP2D level to enable evaluation of 30 participants treated with the RP2D of gedatolisib.
The primary objectives of the Phase 1b portion of the trial include assessment of the safety and tolerability of gedatolisib in combination with darolutamide and determination of the recommended Phase 2 dose of gedatolisib. The primary objective of the Phase 2 portion of the trial is to assess the radiographic progression-free survival (rPFS) at six months of patients who received the RP2D.
Posted In: CELC
