Clinical-stage biopharma company LifeBiotic has announced it has launched a randomised Phase II clinical trial investigating its botanical formulation LCS103 for the prevention of non-muscle-invasive bladder cancer (NMIBC) recurrence.
The 60-patient randomised controlled trial will evaluate the formulation's safety, impact on cancer recurrence and effects on patients' quality of life alongside standard care.
The clinical programme builds on a 2024 case series published in Integrative Cancer Therapies, which investigated LCS103 in 20 patients receiving conventional bladder cancer treatment.
According to the findings, recurrence was documented in three patients (15%) after introducing LCS103, compared with 11 patients (55%) who had previously experienced recurrence.
The company said that this represented an approximately 75% relative reduction in the proportion of patients experiencing recurrence.
Patients also reported improvements in urinary symptoms and general well-being, with no adverse events attributed to the formulation.
However, the findings were based on a small case series rather than a controlled clinical trial.
LCS103 is an oral botanical formulation combining multiple plant-derived bioactive components designed to influence several biological pathways simultaneously.
LifeBiotic aims to target not only cancer cells but also the biological environment that may contribute to tumour recurrence, though this proposed mechanism remains under investigation.
Prof Gilad Amiel, Director of the Department of Urology at Rambam Health Care Campus, said that bladder cancer recurrence remains a significant clinical challenge, often requiring repeated procedures and long-term surveillance.
If the randomised trial confirms the results observed in the earlier study, it could represent a real paradigm shift in the treatment of bladder cancer.
LifeBiotic is also developing its manufacturing and regulatory strategy to advance LCS103 towards a US FDA botanical drug Investigational New Drug (IND) application.
The company's development programme comes amid renewed regulatory interest in botanical medicines, with the FDA announcing an initiative in September to gather public input on advancing botanical drug development and addressing challenges associated with complex formulations.
The Phase II trial is an important step toward determining whether LCS103's early clinical findings can be replicated in a controlled setting.
