Canada-based biotechnology firm Sitka Biopharma has entered an agreement with Cancer Research UK and Cancer Research Technology (CRT) to start a Phase I clinical trial of STK-01 for treatment of patients with bladder cancer.

STK-01 uses a nanoparticle polymer technology to improve delivery of a chemotherapy drug called docetaxel in non-muscle invasive bladder cancer (NMIBC) patients whose tumour has not penetrated the muscle layer of the bladder wall.

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While docetaxel is an effective chemotherapy drug, it is considered difficult to be delivered in the amounts required for cancer treatment.

Cancer Research UK drug development director Dr Nigel Blackburn said: “We hope this experimental approach will improve survival for patients with invasive disease by increasing the amount of chemotherapy that can reach the tumour.”

"We hope this experimental approach will improve survival for patients with invasive disease by increasing the amount of chemotherapy that can reach the tumour."

Under the agreement, Cancer Research UK and Sitka will finance STK-01’s clinical development and production, while Cancer Research UK’s Centre for Drug Development (CDD) will fund and manage the Phase I trial.

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Set to be conducted at the Experimental Cancer Medicine Centres (ECMC) network in the UK, the trial is designed to investigate the safety, toxicity, delivery of STK-01, when compared with docetaxel monotherapy.

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Sitka Biopharma president and chief scientific officer Dr Michael Parr said: “Results of this work will be applied to new therapeutic technologies in development for other forms of cancer, such as ovarian cancer, and provide effective treatments for even more patients.”

STK-01 is reported to have demonstrated increased docetaxel penetration and retention in the bladder wall of preclinical models. 

Image: CT showing bladder wall with cancer. Photo: courtesy of James Heilman.