US-based medical device company Taris Biomedical has begun the Phase Ib clinical trial of TAR-200 (GemRIS) in patients with muscle-invasive bladder cancer (MIBC).
TAR-200 is a drug-device combination product which uses the TARIS System, designed to release gemcitabine continuously into the bladder over seven days.
The open-label Phase Ib trial intends to determine the preliminary efficacy and tolerability of gemcitabine using TAR-200.
It is expected to involve 20 patients diagnosed with MIBC before they undergo a radical cystectomy.
TARIS chief medical officer Christopher Cutie said: “Patients diagnosed with muscle-invasive bladder cancer often require complex treatment regimens, including systemic chemotherapy and radical cystectomy (complete surgical removal of the urinary bladder), a life-altering operation associated with significant morbidity and, in some cases, death.
“Unfortunately, one or both of these treatments are not suitable for many patients suffering from this potentially lethal disease.”
“TAR-200 has the potential to address patients underserved by the current standard of care.”
Gemcitabine is used to treat multiple cancers alone and in combination with other chemotherapeutic drugs.
The TARIS System is a controlled release dosage form to be used in the bladder. It uses passive delivery principles for a continuous release of drug in the bladder over weeks to months.
It involves minimally invasive in-office procedures to be deployed and retrieved from the bladder. The technology enables drug release customised to specific treatment regimens of the patients.