Leicester researchers have started treatment with the first patient to the UK’s Phase 2 of a clinical trial into a treatment for mesothelioma, a lung condition which kills around six people every day in this country.
The MITOPE trial looks at a drug called RSO-21, which has been developed by US pharmaceutical company RS Oncology (RSO).
The first phase of the trial identified the appropriate dosages, and this second phase looks at its effectiveness for patients whose illness has relapsed, or who have other conditions, such as lung cancer or other cancers.
Malignant pleural effusion (MPE) is the build up of fluid in the lining membrane (pleura) of the lungs. MPE is a common clinical symptom in patients with various malignancies (~15% of end-stage cancer patients) and produces significant morbidity in the majority of affected patients.
In this trial, the novel, investigational anti-cancer treatment, RSO-021, is administered weekly directly into the pleural space following MPE drainage via an indwelling pleural catheter.
Professor Dean Fennell, who is Principle Investigator for the trial and Director of the Mesothelioma Research Programme at University Hospitals of Leicester NHS Trust, said: “Mesothelioma has notoriously been a difficult cancer to treat, especially since patients are often diagnosed in the more advanced stages. RSO-021 exhibits a unique mechanism of action that we believe could provide new hope to patients with this disease.”
RS Oncology is now investigating RSO-021 anticancer activity in patients:
- First presenting with Malignant Pleural Effusion (MPE) and before standard-of-care (SOC) treatment (a window of opportunity arm)
- With MPE who have failed first line SOC treatment and have relapsed disease.
- With local metastatic lung disease and MPE.
- With MPE due to advanced metastatic breast, ovarian and non-small cell lung cancers (in combination with systemic paclitaxel).
“RSO-021 is an exciting novel anti-cancer treatment that can potentially help a global population of cancer patients who are left with little to no options,” said Jarrett Duncan, CEO of RS Oncology. “Commencing the Phase 2 portion of our trial presents a major milestone for patients and their caregivers.”
RSO-021 is a novel small molecule treatment that irreversibly binds mitochondrial peroxiredoxin 3 (PRX3). Preclinical studies with RSO-021 have shown that inhibition of the antioxidant signaling network results in selective killing of malignant cells by upregulating oxidative stress; in contrast, healthy cells are spared.