Vancouver-based Sitka Biopharma Inc. said it is moving into the early-phase clinical trials for an experimental treatment for bladder cancer following the third and final tranche of a $2.4 million seed investment from Quark Ventures.
The early phase clinical trial under an agreement signed earlier between Cancer Research UK and Cancer Research Technology (CRT), the charity’s commercial arm, and Sitka, a spin-off of The Centre for Drug Research and Development (CDRD) and the University of British Columbia (UBC), financed by Quark Venture.
“As our major investor at the outset, Quark Venture’s foresight and support have been a key factor in advancing our technology platform to clinical trials in bladder cancer,” said Dr. Michael Parr, Sitka Biopharma’s president, and chief scientific officer. “The final $900,000 investment will be used to support initial clinical trials including completion of GMP manufacturing and GLP studies that support the Clinical Trials Application submission.”
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.
“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,” said Dr. Nigel Blackburn, Cancer Research UK’s director of drug development . “We hope this experimental approach will improve survival for patients with the invasive disease by increasing the amount of chemotherapy that can reach the tumour.”
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