Combat Medical (Combat), a medical device company optimizing the delivery and efficacy of cancer therapeutics, today announced an update on its HIVEC® HEAT FDA registration trial at The American Urological Association (AUA) Annual Meeting. Underscoring the potential of the study to expand bladder-preserving treatment options for cancer patients, Professor Leyshon Griffiths, the trial's Chief Investigator, provided an update, outlining the study design and recruitment process.
For patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high risk non-muscle invasive bladder cancer (NMIBC), radical cystectomy remains the standard treatment. The Combat bladder recirculation system (BRS), developed using the Company's patented hyperthermic platform technology, delivers chemotherapy at precisely controlled temperatures with the aim of increasing anti-tumor activity while offering an alternative bladder-preserving treatment approach and an improved quality of life for patients.
The ongoing HIVEC HEAT trial aims to generate clinical data to evidence the efficacy of hyperthermic intravesical 80 mg mitomycin C chemotherapy for patients with BCG-unresponsive, high risk NMIBC. This is a setting in which treatment choices for patients are limited and life-changing surgery is often recommended. Professor Griffiths' presentation highlighted the design of the FDA registrational clinical trial, a phase 3, single arm study being conducted across 25 sites in the UK, set to enrol 238 patients. Patients receiving HIVEC treatment receive mitomycin C precisely heated to 43 °C and administered over 60 minutes. The 80 mg dose level, the dose at which penetration was shown to saturate in preclinical studies, is recirculated at a concentration of 1 mg/mL over a 48-week treatment period.
As previously reported, BCG-unresponsive patients receiving HIVEC treatment, delivered by the Combat BRS, demonstrated up to 83 % disease free survival after one-year post-treatment, with a bladder preservation rate of almost 80 % after two years. Alongside improved outcomes for patients, HIVEC has also demonstrated better tolerability and safety compared to alternative therapies in development, at a considerably lower treatment cost.
Bladder cancer is one of the most common cancers worldwide and treatment for both men and women remains challenging even when the disease is detected early. As we continue to strive to improve outcomes for patients with NMIBC, we are pleased to share an update on our MHRA-approved HIVEC HEAT clinical trial, which is recruiting patients across the UK. This update signifies an important step in the ongoing generation of evidence as we progress towards FDA registration, and we are confident that our BRS technology provides the necessary step-change in bladder cancer treatment."
Edward Bruce-White, Chief Executive Officer, Combat Medical