Date: 2015-07-13
Type of information: Treatment of the first patient
phase: 1-2
Announcement: treatment of the first patient
Company: Five Prime Therapeutics (USA - CA)
Product: FPA008 (cabiralizumab)
Action
mechanism: monoclonal antibody. FPA008 is an antibody that inhibits colony stimulating factor-1 receptor (CSF1R). It blocks the activation and survival of monocytes and macrophages. Inhibition of CSF1R in inflamed RA joints blocks the production of inflammatory cytokines by macrophages and inhibits osteoclasts, monocyte-lineage cells that can cause bone erosions and joint destruction. Inhibition of CSF1R in many cancers reduces the number of immunosuppressive tumor-associated macrophages (TAMs), thereby facilitating an immune response against tumors.
Disease: pigmented villonodular synovitis (PVNS)
Therapeutic area: Rare diseases - Inflammatory diseases
Country: USA
Trial
details: This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of FPA008 in PVNS/dt-TGCT patients. Patients will be enrolled into either Phase 1 (dose escalation) or Phase 2 (dose expansion) of the study, but not both. (NCT02471716)
Latest
news: * On July 13, 2015, Five Prime Therapeutics, a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, announced that the company has initiated patient dosing in its Phase 1/2 clinical trial of FPA008, a CSF1 receptor antibody, in pigmented villonodular synovitis (PVNS). During the Phase 1 dose escalation part of the trial, Five Prime will assess the safety and pharmacodynamics of multiple ascending doses of FPA008 to determine the dose for expansion. During the Phase 2 expansion phase, the company will evaluate response rate and duration, as well as measures of pain and joint function, in approximately 30 patients. Initial data from the Phase 1 dose escalation portion are expected by late 2015 or early 2016. In the immuno-oncology clinical collaboration with BMS, Five Prime is evaluating FPA008 in combination with the PD-1 immune checkpoint antibody, nivolumab, in six tumor types. Five Prime is also completing the open-label part of a Phase 1 trial in RA patients.
