OncoZenge AB has commenced dosing in a toxicity study for its product candidate BupiZenge. The study design is based on an advisory meeting with the Swedish Medical Agency and aims to Document the safety of repeated oral topical administration of bupivacaine. Bupivacaine is the most widely used anesthetic for epidural anesthesia during childbirth, as well as for post-operative pain treatment.

The compound and its safety profile has been extensively studied since it was first discovered more than sixty years ago. BupiZenge® has a new and patented formulation which is administered via lozenges for prolonged pain relief in the mouth and pharynx. The study aims to generate supplemental safety data for bupivacaine regarding local and systemic toxicity upon repeated oral topical administration over a longer time period.

The study will comprise six weeks of dosing, followed by laboratory- and data analysis. The start of company's planned pharmacokinetic study in cancer patients with oral mucositis, which forms part of the remaining clinical program, is not dependent on the conclusion of the toxicity study. OncoZenge's strategy has been and remains to conduct a development program for product approval in Europe.

At the same time, the company wishes to ensure that investments made in clinical development generate data that will support regulatory approvals in both Europe and the US. Also, in conjunction with negotiations with potential commercial partners or buyers, it is necessary to have a documented understanding of the regulatory requirements to reach the US market.