Gedatolisib is under clinical development by Celcuity and currently in Phase I for Pancreatic Cancer. According to GlobalData, Phase I drugs for Pancreatic Cancer have a 74% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Gedatolisib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Gedatolisib overview
Gedatolisib (PF-05212384, PKI-587) is under development for ER+/HER2-negative metastatic breast cancer, HER-2 positive breast cancer and triple-negative breast cancer, head and neck cancer squamous cell carcinoma, small-cell lung cancer, pancreatic cancer, metastatic hormone refractory (castration resistant, androgen-independent) prostate cancer, solid tumor endometrial cancer, ovarian cancer, cervical cancer and unspecified. It is administered as intravenous infusion. The drug candidate acts by targeting dual PI3K/mTOR. It was also under development for endometrial cancer as second and third line therapy, metastatic colorectal cancer, glioblastoma, renal cancer and pancreatic ductal adenocarcinoma.
It was under development for the treatment of relapsed refractory acute myeloid leukemia and myelodysplastic syndrome, non-small cell lung cancer, squamous small cell lung carcinoma, endometrial cancer, ovarian cancer, cervical cancer, metastatic breast cancer, metastaic ovarian cancer, esophagal-gastric cancer, head and neck cancer squamous cell carcinoma and hormone refractory (castration resistant, androgen-independent) prostate cancer, transitional cell cancer (urothelial cell cancer), oropharyngeal cancer, ovarian cancer and pancreatic cancer.
Celcuity overview
Celcuity is a clinical-stage biotechnology company specializing in developing targeted therapies for the treatment of multiple solid tumor indications. The company’s lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTOR inhibitor for the treatment of breast cancer, prostate cancer and gynecological cancer. Celcuity is also developing VIKTORIA-1, VIKTORIA-2 and CELC-G-201 therapeutics. The company utilizes the CELsignia platform, to identify abnormal oncogenic signaling pathways in cancer patients. It partners with pharmaceutical companies to evaluate targeted therapies’ efficacy in cancer patients. Celcuity is headquartered in Minneapolis, Minnesota, the US.
For a complete picture of Gedatolisib’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
