Published early clinical findings showed a reduction of approximately 75% in recurrence of bladder cancer following LCS103 use compared with patients' prior recurrence history. The promising botanical formulation is now undergoing randomized evaluation at Rambam, Northern Israel's largest hospital.

TEL AVIV, Israel, Nov. 8, 2026 /PRNewswire-PRWeb/ -- For many bladder cancer patients, removing the first tumor is only the beginning. The disease can return repeatedly, requiring additional surgeries, treatments and years of medical surveillance.

Israeli clinical-stage biopharma company LifeBiotic is advancing a different approach. The company announced that its proprietary oral botanical formulation, LCS103, is being evaluated in a randomized Phase 2 clinical trial at Rambam Health Care Campus to investigate its potential to prevent recurrence of non-muscle-invasive bladder cancer (NMIBC) alongside standard care.

A Different Approach to a Cancer That Keeps Coming Back

About three-quarters of bladder cancers are diagnosed at the non-muscle-invasive stage. Despite available treatments, recurrence rates can reach 80% in certain patient groups over time, creating a significant burden for patients and healthcare systems.

Rather than focusing on a single molecular target, LCS103 combines multiple plant-derived bioactive components designed to influence several biological pathways simultaneously.

The underlying concept is to affect not only cancer cells, but potentially the biological environment that supports their recurrence — making the bladder less hospitable to renewed tumor growth. This proposed mechanism remains under investigation.

Promising Early Results Lead to Randomized Trial

The clinical program builds on a peer-reviewed case series published in Integrative Cancer Therapies in 2024.

Among 20 patients with bladder cancer who received LCS103 alongside conventional care, recurrence was documented in just three patients (15%) after starting the formulation, compared with 11 patients (55%) who had experienced recurrence beforehand — an approximately 75% relative decline in the proportion of patients experiencing recurrence.

Patients also reported improvements in urinary symptoms and general well-being, with no adverse events attributed to LCS103.

These encouraging early findings provided a strong rationale for advancing LCS103 into the randomized clinical trial now underway at Rambam.

The 60-patient, randomized, controlled trial will evaluate safety, cancer recurrence and quality of life.

Prof. Gilad Amiel, Director of the Department of Urology at Rambam Health Care Campus, commented:

"Bladder cancer recurrence remains a major clinical challenge, often requiring repeated procedures and long-term surveillance. If the randomized trial confirms the results observed in the earlier study, it could represent a real paradigm shift in the treatment of bladder cancer."

Yair Maimon, PhD, Founder and Scientific Lead at LifeBiotic, added:

"Cancer recurrence involves multiple interconnected biological processes. LCS103 was developed to influence several pathways simultaneously, rather than focusing on a single target. This trial will help determine whether that approach can translate into meaningful clinical benefit."

From Botanical Innovation to Pharmaceutical Development

LCS103 is manufactured using proprietary extraction processes. LifeBiotic also employs advanced computational tools and artificial intelligence to investigate the formulation's components and their potential biological activity.

The clinical trial represents a significant step in LifeBiotic's strategy to advance complex botanical formulations into clinically validated oncology medicines.

Gai Havkin, CEO of LifeBiotic, said:

"Our ambition is to bring a new class of multi-target botanical medicines into mainstream oncology, supported by rigorous clinical evidence and pharmaceutical development standards.

The trial at Rambam is a major milestone in that journey. In parallel, we are building the scientific, manufacturing and regulatory foundation to advance LCS103 toward a U.S. botanical drug IND, with the ultimate goal of offering patients a new option for preventing cancer recurrence."

The company's development strategy coincides with renewed regulatory attention to botanical medicines. In September 2026, the U.S. Food and Drug Administration (FDA) announced an initiative seeking public input on ways to advance botanical drug development and address the scientific and regulatory challenges of complex botanical formulations.

About LifeBiotic

LifeBiotic is an Israeli clinical-stage biopharma company developing proprietary, multi-target botanical formulations for oncology. Combining botanical research, controlled manufacturing and clinical development, the company aims to advance complex botanical formulations into evidence-based medicines.

Its lead program, LCS103, is being evaluated for the prevention of non-muscle-invasive bladder cancer recurrence, with planned development through the U.S. botanical drug pathway.

Website: https://www.lifebiotic.com

Clinical Trial: ClinicalTrials.gov — NCT07728474

Published Study: Prevention of Bladder Cancer Recurrence With the Botanical Formula LCS103: A Case Series Study, Integrative Cancer Therapies (2024).

Important Information: LCS103 is investigational for bladder cancer recurrence prevention. The published findings were obtained in a small, uncontrolled retrospective case series and do not establish treatment efficacy. LCS103's efficacy and safety for this indication have not been established in a randomized controlled trial, and it is not FDA-approved for the prevention or treatment of bladder cancer.

Media Contact

Gai Havkin, LifeBiotic Medical Research, 972 544225122, gai@lifebiotic.com, https://lifebiotic.com

View original content to download multimedia:https://www.prweb.com/releases/lifebiotic-launches-randomized-phase-2-trial-of-botanical-drug-candidate-for-bladder-cancer-recurrence-prevention-302931758.html

SOURCE LifeBiotic Medical Research