Avecho Biotechnology Limited’s (ASX:AVE) improved Propofol TPM formulation has passed a pivotal milestone in the successful completion of safety studies supporting its use for a continuous 24 hour infusion.
Propofol is a general anaesthetic used for the induction and/or maintenance of sedation during surgical procedures.
CEO, Dr Paul Gavin, said Avecho has been developing a reformulated version of the product, leveraging the capabilities of its TPM to support the removal of problematic lipid excipients and creating a transparent, physician preferred, formulation.
This result proves we have overcome the observed deficiencies of our previous propofol formulation,” Dr Gavin said,
“While safe for the induction and short term maintenance of anaesthesia, the previous vehicle was not acceptable for a complete 24 hour infusion. This was a major impediment to securing a licensing deal.”
The prior formulation had been developed in collaboration with Terumo Corporation, Japan. Researchers at Charles River Laboratories, USA, had shown the vehicle used for that version of the Propofol TPM formulation was not safe for a complete 24 hour infusion, as indicated on the label of the commercial products.
Without the ability to infuse for 24 hours, the labelled indication for the Propofol TPM product would be restricted to the induction and short term maintenance of anaesthesia. Given the size of the Japanese market, Terumo was unwilling to consider launching a propofol product with a restricted indication, and determined not to support further development of the Propofol TPM product.
“Despite this setback, significant commercial interest remained for a reformulated propofol product – so Avecho has since elected to further optimise its formulation. Today’s announcement is a critical achievement, as we have now proven our improved TPM formulation passes the required toxicology tests and we can continue to pursue this promising market opportunity,” said Dr Gavin.
This improved formulation vehicle was re-tested at Charles River Laboratories, USA. Rats received a human equivalent dose of the formulation vehicle in a continuous 24 hour infusion. The rats survived the 24 hour treatment period in good health, as well as a subsequent seven day observation period. Blood work demonstrated no adverse changes when compared to the control group that received a 24 hour infusion of saline. The amount of TPM and excipients used in the improved Propofol TPM formulation are therefore considered safe for the 24 hour infusion, as indicated by the label of the commercial formulation.
“We look forward to continuing our licensing discussions and are confident these new results will be of significant interest. Our immediate aim is to partner the product in order to facilitate its continued development toward commercialisation,” said Dr Gavin.