parimifasor (LYC-30937 EC) / Lycera, BMS - LARVOL DELTA

Parimifasor elicits broad-spectrum antitumor effects by suppressing the expression of oncogenic genes. (PubMed, Transl Cancer Res) - "Integration with TCGA data identified 10 oncogenic genes (PARP10, OAS1, OAS3, PRR4, ZNFX1, HELZ2, SP110, CSRNP1, DDX3L, and PARP14) dysregulated across 20+ cancer types; qPCR confirmed their consistent downregulation posttreatment in both cell lines (P<0.05). This study establishes parimifasor's antitumor efficacy via the suppression of immune pathway-associated oncogenes, supporting its repurposing as a cancer therapeutic agent and providing biomarker candidates for clinical development."

IO biomarker • Journal • Brain Cancer • Esophageal Cancer • Glioblastoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • NLRC5 • PARP10

An Efficacy and Safety Study of LYC-30937-EC in Subjects With Moderate Chronic Plaque-type Psoriasis (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: Lycera Corp.; Trial primary completion date: Feb 2017 ➔ Jun 2017

Trial primary completion date • Biosimilar • Immunology • Psoriasis

Lycera announces presentations of positive preclinical results for lead candidate LYC-30937 and for selective Rho kinase inhibitor program at the 11th Congress of the European Crohn's and Colitis Organization (ECCO) (PRNewswire) - "Lycera Corp...announced today positive preclinical findings for...LYC-30937-Enteric Coated, were presented at the 11th ECCO Congress...Administration of LYC-30937 to animals with established inflammatory bowel disease (IBD) reduced pro-inflammatory cytokine production and improved histopathology scores, weight loss and other measures of disease severity. LYC-30937 demonstrated equivalent or superior activity in these endpoints compared to prednisolone or 5-aminosalicylic acid...completed Phase 1 testing of LYC-30937-EC in healthy volunteers and expects to commence a Phase 2 program in patients with ulcerative colitis later this year."

Anticipated new P2 trial • Conference • Trial completion • Inflammatory Bowel Disease

Feasibility and performance of a fully automated endoscopic disease severity grading tool for ulcerative colitis using unaltered multisite videos (ECCO-IBD 2020) - "The automated whole video MES workflow was tested in a separate endoscopic video set from an international multicenter UC clinical trial (LYC-30937-EC)...Ordinal characteristics are shown for the automated process, predicting progressively increasing disease severity. TPR, true positive rate; FPR, false-positive rate.Conclusion Though premature for immediate deployment, these early results support the feasibility for artificial intelligence to approach expert-level endoscopic disease grading in UC."

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Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis (clinicaltrials.gov) - P2; N=112; Terminated; Sponsor: Lycera Corp.; Trial completion date: Nov 2018 ➔ Jul 2018; Active, not recruiting ➔ Terminated; Trial primary completion date: Nov 2018 ➔ Jul 2018; Lack of efficacy of test drug

Clinical • Trial completion date • Trial primary completion date • Trial termination