ApoCell is under clinical development by Enlivex Therapeutics and currently in Phase II for Osteoarthritis. According to GlobalData, Phase II drugs for Osteoarthritis have a 45% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how ApoCell’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
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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.
ApoCell overview
ApoCell is under development for the prevention of peritoneal tumor and lower mortality post hematopoietic stem cell transplantation, for treatment of sepsis, cytokine release syndrome associated with CAR T-cell therapies, solid tumors, psoriatic arthritis, knee and thumb joint osteoarthritis, mesothelioma and Non-Covid-19 acute respiratory distress syndrome and ovarian cancer. ApoCell is administered through intravenous and intraperitoneal route. ApoCell is composed of HLA-matched donor mononuclear enriched leukocytes. It is a derivative of placental protein 14 (PP14) with potential immunomodulating activity.
It was also under development for the treatment of Crohn's disease, peritoneal tumor, rheumatoid arthritis, gout, multiple sclerosis and for prevention of solid organ transplant rejection, acute lymphocytic leukemia, acute graft vs host disease (GvHD), chronic lymphocytic leukemia and coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and COVID-19 associated ARDS.
Enlivex Therapeutics overview
Enlivex Therapeutics (Enlivex) is a clinical-stage biopharmaceutical company focused on developing innovative therapies for inflammatory diseases. The company’s pipeline products include ENX-CL-02-002 for organ failure associated with sepsis; ENX-CL-05-001 which treats moderate knee osteoarthritis; 0189-22-KMC for end-stage knee osteoarthritis; 0006-24-KMC treats basal thumb osteoarthritis; ENX-CL-06-001 which treats psoriatic arthritis. It develops Allocetra, a universal, off-the-shelf cell therapy designed to reprogram macrophages into a homeostatic state. The company serves for patients suffering from acute and chronic inflammatory diseases. It collaborates with various clinical trial sites to evaluate the efficacy and safety of its therapies. Enlivex is headquartered in Ness-Ziona, Israel.
For a complete picture of ApoCell’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.
