Advancing prostate cancer chemoprevention

Evaluating the bioavailability and microbiome modulation of
a curcumin and ursolic acid combination therapy

Background

Prostate cancer (PCa) remains a significant health concern, necessitating effective chemoprevention strategies. However, no approved chemopreventive agents exist, highlighting the need for innovative approaches. This study aimed to evaluate the safety, bioavailability, and microbiome alterations of a combination therapy involving curcumin (CURC) and ursolic acid (UA) in PCa models.

Technology overview

The study employed a Phase I clinical trial with 18 subjects, administering CURC (1200 mg/day) and UA (300 mg/day) alone and in combination over a two-week period. Safety, bioavailability, and microbiome alterations were assessed as primary endpoints. The study focused on evaluating the impact of the combination therapy on enhancing UA bioavailability and modulating the gut microbiome, both crucial factors in PCa prevention.

Key findings

The combination therapy demonstrated safety and tolerability, with no grade 3 or 4 adverse events observed. Minor changes in safety laboratory values were noted. Importantly, the combination led to a significant increase in median serum levels of UA compared to its administration alone. Furthermore, the combination exhibited a favorable impact on gut microbiome status, evidenced by a reduction in a microbiome score predictive of PCa risk.

Commercial applications

• The findings hold promise for the development of novel chemopreventive strategies targeting prostate, colorectal, and breast cancers.
• Commercial applications may include the development of combination therapies containing UA and CURC for PCa prevention.
• Additionally, the modulation of the gut microbiome by this combination could have implications for addressing various health conditions beyond PCa, such as obesity, diabetes, cardiovascular disease, and liver disease.

Benefits

• Enhanced bioavailability of UA
• Favorable modulation of the gut microbiome
• Demonstrated safety and tolerability
• Paves the way for further clinical investigations and the development of more effective chemopreventive agents
• Potential applicability of this combination in addressing other health conditions underscores its versatility and clinical significance

Opportunity

Future studies may explore longer dosing periods and alternative formulations of CURC to optimize its bioavailability. Additionally, further research is warranted to elucidate the mechanisms underlying the observed effects on UA bioavailability and gut microbiome modulation. This presents an opportunity for collaboration between academia, pharmaceutical companies, and biotech firms to advance the development of innovative chemopreventive agents and therapeutic interventions targeting PCa and related diseases.