Date: 2014-02-10
Type of information: Results
phase: 1
Announcement: results
Company: Nanobiotix (France)
Product: NBTXR3
Action
mechanism: 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: soft tissue sarcoma (STS)
Therapeutic area: Cancer - Oncology
Country: France
Trial
details: The trial is a prospective, open-label, dose-escalation, single arm, non-randomized trial. NBTXR3 will be administered to the patients prior to surgery by a single intra-tumoral injection followed by standard radiotherapy procedure. After completion of the regular treatment procedure, the patients will undergo surgery to resect the soft tissue sarcoma. Along with the safety and feasibility endpoints, the primary tumor tissue will then be available for the evaluation of the pathological response rate. 27 patients diagnosed with soft tissue sarcoma will be enrolled in the Phase I study and will receive NBTXR3 as an intra-tumoral injection with radiotherapy prior to surgery (first-line treatment). The primary endpoints of the clinical trial are the feasibility of NBTXR3 administration and safety. Preliminary data are expected by the end of 2012.
NBTXR3 has been classified in the EU as class III medical device. In the US, it has been classified as a drug by the FDA. NBTXR3 has been classified in the EU as class III medical device and is currently being tested in a European Phase I trial to establish feasibility and safety of NBTXR3 in patients with advanced soft tissue sarcoma. Further clinical trials are in preparation in Europe, in Asia-Pacific (through the PharmaEngine partnership) and in the US, where NBTXR3 is classified as a drug.
Latest
news: * On February 10, 2014, Nanobiotix, a clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, has announced its development plan for the CE marking of NBTXR3, the first product from the NanoXray pipeline. The positive results from the pilot phase of NBTXR3 in patients with advanced soft tissue sarcoma (STS), allow Nanobiotix to finalize and to announce its development plan for the launch of NBTXR3 on the market. On 10 February 2014, the Independent Data Monitoring Committee (IDMC) met and gave a positive assessment of the recent pilot STS data which showed that NBTXR3 had a good safety profile, which is infrequent in oncology. Expert opinions, combined with encouraging signs of efficacy, have led to further product development in this indication. The aim of NBTXR3 is to facilitate complete tumor resections and provide a significant clinical benefit to patients.
* On June 3, 2013,Nanobiotix, a clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, has announced positive Phase I interim results of its lead nanoparticle-based product, NBTXR3, in patients with Soft Tissue Sarcoma (STS). The open-label, single-arm Phase I clinical trial (NCT01433068) is designed to primarily assess the safety and feasibility of NBTXR3, administered by injection to 27 adult patients with STS with radiotherapy treatment according to established protocols.
Interim results from this on-going Phase I clinical trial in 12 patients have demonstrated that a single injection of NBTXR3 provides adequate distribution of nanoparticles within the tumor for over five weeks of radiation therapy, without leakage of nanoparticles to the adjoining healthy tissues and with marginal passage to systemic circulation, even for large tumors (up to 3,684 mL in size). These results were consistent to all patients tested, were independent of tumor histology, bone invasion and tumor size, and allowed subsequent surgical resection of the tumor, as planned.
The treatment was safe with no serious adverse events and allowed the patients to complete all their radiotherapy sessions. Few mild or moderate adverse events related to NBTXR3 were observed, with spontaneous resolution in the twelve treated patients. No grade 3 or 4 adverse event was observed.The company is now looking forward to expanding clinical development of NBTXR3 in a variety of additional cancer indications. The results have been presented to oncologists, patients association and industry representatives during a focus group meeting in Chicago on Saturday 1st June 2013.
* On November 13, 2012, Nanobiotix has announced that the Independent Data Monitoring Committee (IDMC) has reviewed the data of the first 6 patients treated in the phase I study with the lead product NBTXR3 for the treatment of advanced soft tissue sarcoma of the extremity. Based on the review of the safety data, the IDMC has unanimously recommended continuing the enrollment in the study according to the protocol. This trial is realized in the Institut Gustave Roussy, France. The IDMC consists of 3 independent members and has the responsibility of ensuring the safety of all patients enrolled in the study, the quality of the data collected and the continued scientific validity of the study design. The IDMC has reviewed the data of the first group of patients, focusing on patient’s safety and tumor surgery feasibility. In this first group of patients, all the primary endpoints were reached, NBTXR3 demonstrated good safety and surgery was feasible with limb preservation in all patients.
The IDMC interim safety analysis found no evidence of local or general toxicity and accordingly the study is continuing. Based on their analysis, the committee has recommended starting the second group of patients without protocol amendments.
* On November 25, 2011, Nanobiotix has announced that the first patient has been treated in this study.
* On September 13, 2011, Nanobiotix has announced that its lead compound NBTXR3 has received the formal authorization from the French Medicine Agency, AFSSAPS, to start the first clinical trial. 27 patients diagnosed with soft tissue sarcoma will be enrolled in the Phase I study and will receive NBTXR3 as an intra-tumoral injection with radiotherapy prior to surgery (first-line treatment). The primary endpoints of the clinical trial are the feasibility of NBTXR3 administration and safety. Preliminary data are expected by the end of 2012. Further clinical trials are in preparation in Europe and in the US. NBTXR3 has been classified in the EU as class III medical device. In the US, it has been classified as a drug by the FDA.
