PharmaEngine has announced that the first patient has been dosed in a Phase Ib/II trial of PEP503 (NBTXR3) of head and neck squamous cell carcinoma (HNSCC) at Keelung Chang Gung Memorial Hospital (Lovers Lake Branch) in Keelung, Taiwan.
This is a prospective, open-label, single arm, non-randomised study (PEP503-HN-1002) of PEP503 in patients with HNSCC and the principal investigator is professor Cheng-Hsu Wang.
The primary aims of this study are to understand the optimal dose, safety and preliminary efficacy of PEP503 through intra-tumour injection in combination with the standard treatment of concurrent chemoradiotherapy (CCRT) in SCC of oral cavity.
A maximum of 42 patients may be enrolled in the Phase Ib/II study.
The firm's partner Nanobiotix is carrying out a head and neck cancer study (NBTXR3 Study-102) of NBTXR3 (PEP503) in combination with radiation in elderly patients with SCC of oral cavity and oropharynx, who are not suitable for chemotherapy and radiotherapy.
These two trials will then determine the optimal doses for patients who can or cannot receive chemotherapy with radiotherapy and NBTXR3 (PEP503).
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The lead project of the NanoXray pipeline of Nanobiotix, PEP503 is a nanoparticle formulation of hafnium oxide crystals for the local treatment of tumours to enhance the efficacy of radiotherapy.
In August 2012, PharmaEngine licensed the development and commercialisation rights of NBTXR3 in the Asia-Pacific region from Nanobiotix.
Nanobiotix reported the encouraging safety and efficacy results of NBTXR3 in a pilot phase 1 clinical study of soft tissue sarcoma at the 2014 ASCO Annual Meeting in Chicago.
In 2015 and 2016, the firm reported preliminary safety results and indicated promising signs of tumour volume response of adding NBTXR3 to a standard regimen of radiotherapy in the phase 1/2 head and neck cancer study (NBTXR3 Study-102).
In addition, Nanobiotix began a phase 1/2 clinical trial in liver cancers (liver metastasis and hepatocellular carcinoma) in Europe, and secured the approval of an Investigational New Drug (IND) application of phase 1/2 study in prostate cancer from the US FDA.
PharmaEngine began a phase 1b/2 study in rectal cancer in Taiwan in 2015.