PEP-Therapy reports positive results from GLP-toxicity study

KUALA LUMPUR, PEP-Therapy’s first-in-class drug candidate, PEP-010, has successfully completed Good Laboratory Practice (GLP) toxicity study, moving towards its first-in-human clinical trial.

The biotechnology company developing peptides as targeted therapies for oncology, said PEP-010 was well tolerated in rodent and non-rodent species.

The study confirmed the absence of systemic toxicity and neuro-behavioural effects, and that cardiovascular functions were unaffected by treatment at all dose levels.

Based on these results, the no-observed-adverse-effect level was defined and the starting dose for the coming phase I clinical trial, calculated.

The Phase I clinical batch and the regulatory documents are in preparation for the submission of a Clinical Trial Application in 2019.

In addition, PEP-Therapy has entered into a collaborative partnership for Phase I clinical trials with Institut Curie and Gustave Roussy, two leading European cancer centres.

The synopsis of the clinical study protocol has been drawn-up for advanced solid tumours. Pr Christophe Le Tourneau (Head of the Department of Drug Development and Innovation (D3i) at Institut Curie) will be the Principal Investigator.

The study was performed by a world leading CRO specialised in safety and toxicology studies and in accordance with the OECD principles of Good Laboratory Practice as accepted by regulatory authorities.

Source: BERNAMA (News Agency)