Date: 2016-01-04
Type of information: Clinical trial autorization
phase: 1-2
Announcement: clinical trial authorization
Company: Nanobiotix (France)
Product: NBTXR3
Action
mechanism: nanoparticle. NBTXR3 is a nanoparticle consisting of hafnium oxide crystals and it is intended to enhance the local destruction of the tumor mass during radiotherapy. Once injected into the tumor, NBTXR3 accumulates in the cancer cells. Due to the physical properties of hafnium oxide, the particles emit huge amounts of electrons upon radiation. This leads to the formation of radicals within the tumor cell, which in turn damage the cancer cells and cause their targeted destruction. NBTXR3 particles are inert and emit electrons only during their exposure to radiotherapy. As a result, the destructive power of standard radiation therapy could be locally and selectively enhanced within the tumor cells.
Disease: prostate cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial details:
Latest
news: * On January 4, 2016, Nanobiotix announced that the FDA has approved its Investigational New Drug (IND) application on the 30th of December. This allows Nanobiotix to launch its first clinical study in the US for its lead product NBTXR3 in prostate cancer, a new and very significant indication. The FDA approval enables the Company to initiate a phase I/II prospective, open-label, two cohorts and non-randomized trial, in the large prostate cancer patient population. The first part of the trial should involve departments of radiation oncology of from three reference US oncology centers. Nanobiotix is seeking to develop NBTXR3 for patients with intermediate and high-risk prostate cancer, with the aim of providing effective tumor destruction and disease control. In addition to the prostate cancer trial, Nanobiotix is currently running trials in five indications across Europe and the Asia-Pacific Region: a registration trial in soft tissue sarcoma and Phase I/II trials in liver cancers (HCC and liver metastases), head and neck cancers and rectal cancer (in Asia by Nanobiotix’s partner PharmaEngine).
