Status:
Completed
Clinicaltrials.gov identifier:
Sponsor:
FKD Therapies Oy
Enrollment:
40
Study Design:
Phase II, randomized trial comparing two different doses of rAd-IFN (Instiladrin) in high grade BCG-refractory or BCG-relapsing NMIBC patients. The primary endpoint is RFS at 12 months following four instillations. The secondary endpoint is toxicity and adverse event evaluation. This trial has been completed but results are pending.
Rationale:
Interferon (IFN) is postulated to be important in BCG-responsive tumors but intravesical IFN ineffective due to short exposure to urothelium. Intravesical IFN production is facilitated by co-administration of recombinant adenovirus (rAd)-mediated IFN-α2b protein, with the excipient Syn3 which improves viral mediated transduction of the urothelium. In a phase I trial of 17 patients, rAd-IFN was well tolerated and 43% (6/13) of patients with detectable IFN-α in the urine achieved complete remission at 3 months that lasted on average for 31 months.
Comments:
IFN is a logical next step in immunotherapy and adenoviral mediation transduction may improve significantly upon intravesical administration. The impressive complete remission rates in the phase I and II trials are very encouraging. Also it will be interesting to see the duration of IFN detection in the urine post-treatment to establish adequate dosing of Instiladrin. A phase III single-arm registration trial is planned with activation expected in 2016.
Results:
Preliminary results were presented at the 2015 AUA Annual Meeting. Of 34 evaluable patients at the time of the abstract, 10 patients (29%) had achieved a complete remission at 12 months. Tolerability in these patients was excellent with some minor urinary urgency post-instillation that was managed with oral anticholinergics.
