Taiwan-based commercial stage oncology company PharmaEngine has started dosing patients in a global Phase II/III trial of PEP503 (NBTXR3) to treat soft tissue sarcoma (STS), a type of sarcoma that develops in connective tissue.
PEP503, which is the lead project of the NanoXray pipeline of Nanobiotix, is a nanoparticle formulation of hafnium oxide crystals for the local treatment of tumours to improve the efficacy of radiotherapy.
At present, PEP503 has been classified as a class III medical device in some European and a few Asian countries.
The first patient in the trial, conducted by PharmaEngine in collaboration with Nanobiotix, has been dosed at Perpetual Succour Hospital, Cebu, Philippines.
The multi-national, randomised, open-label, two-arm Phase II/III trial, Study 301, will enrol around 180 patients, who will be recruited from Europe, South Africa and the Asia-Pacific region.
Primary objective of the trial is to improve the pathological complete response rate (pCR) by dosing PEP503 through intra-tumour injection and then activated by external beam radiation therapy (EBRT).
The efficacy of PEP503 combined with radiotherapy in the trial, led by global Principal Investigator Dr Sylvia Bonvalot from Institut Curie, Paris, France, will be compared with that of radiotherapy alone.
PharmaEngine will conduct an interim analysis once two-thirds of patients have been recruited to ensure the safety of all patients enrolled in the study.
In August 2012, PharmaEngine licensed the development and commercialisation rights of NBTXR3 in the Asia-Pacific region from Nanobiotix, which had reported positive results of the pilot study for NBTXR3 in 2014.
Last year, the preliminary safety results in the head and neck cancer study showed that patients tolerated NBTXR3 well, with promising signs of anti-tumour activity.
Additionally, Nanobiotix had begun a Phase I/II clinical trial in liver cancers including liver metastasis and hepatocellular carcinoma in Europe and received the approval of investigational new drug (IND) application of Phase I/II study in prostate cancer from the US FDA.
PharmaEngine started a Phase Ib/II trial in rectal cancer in Taiwan.
PharmaEngine president and CEO Grace Yeh said: "The promising results from Nanobiotix's Phase I/II clinical trials in STS and head & neck cancer encouraged us to accelerate the global clinical development and speed up the regulatory registration process as a medical device."