New Bladder Cancer Therapy to Start Clinical Trials

Source: Cancer Research UK

An experimental treatment for bladder cancer will move into an early phase clinical trial under an agreement signed between Cancer Research UK and Cancer Research Technology (CRT), the charity’s commercial arm, and Canadian biotechnology company Sitka Biopharma Inc., a spin-off of The Centre for Drug Research and Development (CDRD) and the University of British Columbia (UBC), financed by Quark Venture.

The new treatment called STK-01 is being developed to improve delivery of chemotherapy for non-muscle invasive bladder cancer (NMIBC), in patients whose tumour has not yet penetrated into the muscle layer of the bladder wall.

Standard treatment for NMIBC involves removal of the tumour followed by intravesical therapies (delivered by catheter directly into the bladder) to eliminate residual disease and prevent recurrence and progression. STK-01 uses a unique nanoparticle polymer technology to deliver the chemotherapy drug docetaxel.

Docetaxel is an effective chemotherapy drug but it can be difficult to deliver enough of the drug to the bladder to treat the cancer. STK-01 may overcome this resulting in the tumour being exposed to much higher levels of the drug. In preclinical studies STK-01 has been shown to greatly enhance docetaxel penetration and retention in the bladder wall, and is extremely effective at eliminating tumours in mouse models.

Under the agreement, Cancer Research UK and Sitka will share the cost of the development and production of STK-01 for the clinic.

Cancer Research UK’s Centre for Drug Development (CDD) will then fund and manage a Phase I clinical trial of STK-01 in bladder cancer patients, to evaluate drug safety, toxicity, drug delivery and how it compares with giving docetaxel alone.

The trial will take place across the Experimental Cancer Medicine Centres (ECMC) network, a nationwide initiative funded by Cancer Research UK and the UK’s four Health Departments.

Dr Michael Parr, Sitka Biopharma’s President and Chief Scientific Officer, said: “This agreement is very significant for Sitka as it will validate our preclinical therapy and take another step closer to providing an effective treatment for bladder cancer patients. Working with Cancer Research UK, CRT and CDD – world leaders in the development of cancer treatments – has helped us reach a significant value-creation point for Sitka, taking it from a pre-clinical to clinical stage company. 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.”

Dr Nigel Blackburn, Cancer Research UK’s director of drug development, said: “More than 5,000 people die from bladder cancer each year in the UK and we urgently need to find new and better ways to treat patients. We hope this experimental approach will improve survival for patients with invasive disease by increasing the amount of chemotherapy that can reach the tumour.

“Without our innovative CDP scheme it might have been years before this treatment reached patients so we‘re pleased to work with Sitka Biopharma to accelerate development of this promising technology.”