Two pharmaceuticals companies jointly testing a novel mesothelioma therapy are looking for 30 mesothelioma patients to join an early stage clinical trial now underway.
The companies are Five Prime Therapeutics Inc. and GlaxoSmithKline. The mesothelioma therapy being investigated is a protein-based, fibroblast growth factor (FGF) ligand trap called FP-1039.
FP-1039 — which also goes by the designation GSK3052230 — is designed to disrupt FGF signals sent to mesothelioma cells. FGF signaling permits mesothelioma cells to thrive and spread inside you.
The idea is that disrupting the signal will cause confusion among mesothelioma cells – enough confusion that, hopefully, it stops their growth and spread.
Disrupts Signals to Mesothelioma Cells
In technical terms, FP-1039 binds itself to FGF ligands that are found in the extracellular spaces of mesothelioma tumors. Most mesothelioma patients have abnormally high levels of these ligands.
Once this binding occurs, the ability of a mesothelioma FGF ligand to send out growth-triggering signals is drastically reduced. As a result, mesothelioma cells are deprived of needed stimulation.
Without that stimulation, mesothelioma cells have trouble dividing and forming new blood vessels. No division and no vessel formation mean no growth and spread. At least it means that in theory.
This is why the makers of FP-1039 are now testing it on humans — to get a solid handle on its safety, tolerability, dosage, response rate and duration of response.
Lewis T. “Rusty” Williams, M.D., is Five Prime’s CEO and president. He said he is heartened by the FP-1039 preliminary data emerging from the Phase 1b clinical trial his company and GlaxoSmithKline have been conducting.
Williams said this trial is open to enrolling 30 more patients. You can obtain more information about it by visiting https://clinicaltrials.gov/ — use identifier NCT01868022 when you search the site’s library of studies.
Mesothelioma Patient Clinical Trial
GlaxoSmithKline is in charge of the FP-1039 clinical trial. The company has designed the multicenter, non-randomized, uncontrolled, open-label trial to include three arms — A, B and C.
Arms A and B are made up of the squamous non-small cell lung cancer patients, while Arm C is made up entirely of mesothelioma patients.
The patients in Arm A have previously untreated metastatic squamous non-small cell lung cancer. They are receiving FP-1039 in combination with paclitaxel and carboplatin.
The patients in Arm B have squamous non-small cell lung cancer that progressed after previous therapy. They are receiving FP-1039 plus docetaxel.
The mesothelioma patients who make up Arm C are receiving FP-1039 with pemetrexed and cisplatin. Those are considered the gold standard of first-line mesothelioma chemotherapy.
Williams said not enough data were coming from Arm C because mesothelioma patient enrollment was lagging. Also, some patients could not be evaluated.
Accordingly, the companies decided to add more mesothelioma patients to Arm C. Those who qualify for enrollment will receive FP-1039 in a dose of 15 mg/kg.
The companies plan to share their findings about the clinical trial in June at the American Society of Clinical Oncology annual meeting.
Five Prime is a company engaged in research and development of innovative therapeutics for mesothelioma patients and for others who suffer with serious diseases.
Five Prime says its research scope encompasses “virtually every medically relevant extracellular protein.” A focus for the company is cancer pathways, particularly inflammation and immuno-oncology.