RS Oncology Initiates Phase 2 Trial (MITOPE) for RSO-021 in Malignant Pleural Mesothelioma and Lung Metastases

Friday, February 02, 2024

RS Oncology (RSO), a clinical-stage biotechnology company focused on developing innovative therapies for mesothelioma and other diseases, has successfully administered the first dose to a patient in the Phase 2 dose expansion segment of its multicenter study, MITOPE (NCT05278975), in the United Kingdom.

Malignant pleural effusion (MPE), characterized by the accumulation of fluid in the lung lining, is a common clinical symptom affecting approximately 15% of end-stage cancer patients. RSO's experimental anti-cancer treatment, RSO-021, is administered weekly directly into the pleural space following MPE drainage through an indwelling pleural catheter. The Phase 1 dose escalation part of the MITOPE trial was recently completed in the fourth quarter of 2023, establishing a recommended Phase 2 dose and safety/tolerability profile for RSO-021 in a relapse setting.

The Phase 2 portion of MITOPE has been expanded to investigate RSO-021's anticancer activity in various patient groups:

  1. Individuals presenting with MPE due to malignant pleural mesothelioma (MPM) before standard-of-care (SOC) treatment (a window of opportunity arm).
  2. Patients with MPE who have experienced treatment failure with first-line SOC treatment and have relapsed disease.
  3. Individuals with local metastatic lung disease and MPE.
  4. Patients with MPE due to advanced metastatic breast, ovarian, and non-small cell lung cancers (in combination with systemic paclitaxel).

Prof. Dean Fennell, Director of the Mesothelioma Research Programme at Leicester University Hospitals, commented, "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."

Jarrett Duncan, CEO of RS Oncology, expressed enthusiasm, stating, "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. 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 demonstrated selective killing of malignant cells by upregulating oxidative stress through inhibition of the antioxidant signaling network, while sparing healthy cells.

 

Source: businesswire.com