PARIS & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Regulatory News:
NANOBIOTIX (Paris:NANO) (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the local treatment of cancer, today announced that the Independent Data Monitoring Committee (IDMC) has completed the interim evaluation of the Phase II/III trial results (Act.In.Sarc) of NBTXR3 in soft tissue sarcoma.
The interim evaluation was based on an analysis of the results of two-thirds of the patients included in the Phase II/III study – 104 patients were analyzed out of a total of 156. Based on the safety and available efficacy data, the IDMC has recommended the continuation of the Phase II/III trial of NBTXR3 in soft tissue sarcoma.
“The IDMC’s recommendation to continue the ongoing phase II/III trial of NBTXR3 is very positive news for soft tissue sarcoma patients, and an important milestone in NBTXR3’s clinical development.” said Elsa Borghi, Nanobiotix’s Chief Medical Officer “Now, we look forward to seeing the full data analysis” she added.
The pivotal international Phase II/III study in soft tissue sarcoma was launched in Europe and Asia in October 2014 and aims to evaluate the safety and the efficacy of NBTXR3, a first in-class radio enhancer that could potentially target most solid tumors. The Phase II/III study is a prospective, randomized, multi-center, open label and active controlled two-armed study of 156 patients with locally advanced soft tissue sarcoma. The primary endpoint is the complete pathological response rate. The secondary endpoints are the objective response rate (ORR) by imaging (MRI); the evaluation of the safety profile in term of clinical and laboratory adverse events; the tumor volume changes; the resection margins and the limb amputation rate.
The IDMC is an international independent body of experts made up of scientists, statisticians and practicing physicians. Specifically, it was chartered to review and ensure: i) the data related to the primary endpoint, ii) the safety of all patients enrolled in the study, (iii) the quality of the data collected, and (iv) the continued scientific validity of the study design on two thirds of the patients treated.
The completion of recruitment for the Act.in.Sarc trial is planned by the end of Q2 2017. The full data analysis, except for long-term follow-up, is expected to be available at the end of 2017.
Based on the positive recommendation from the IDMC, the Company will communicate, over the coming weeks, its overall plan to move forward.
About NANOBIOTIX: www.nanobiotix.com
Nanobiotix (Euronext: NANO / ISIN: FR0011341205) is a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer. The Company’s first-in-class, proprietary technology, NanoXray, enhances radiotherapy energy with a view to providing a new, more efficient treatment for cancer patients.
NanoXray products are compatible with current radiotherapy treatments and are meant to treat potentially a wide variety of solid tumors including soft tissue sarcoma, head and neck cancers, liver cancers, prostate cancer, breast cancer, glioblastoma, etc., via multiple routes of administration.
NBTXR3 is being evaluated in: soft tissue sarcoma (STS), head and neck cancers, prostate cancer, and liver cancers (primary and metastases). Additionally, head and neck cancer and rectal cancer trials led by Nanobiotix’s Taiwanese partner, PharmaEngine, are underway in the Asia Pacific region. The Company filed in August 2016 for market approval (CE Marking) in Europe for its lead product NBTXR3.
The Company started in 2016 a new preclinical research program in Immuno-oncology with its lead product NBTXR3, which could have the potential to bring a new dimension to cancer immunotherapies.
Nanobiotix is listed on the regulated market of Euronext in Paris (ISIN: FR0011341205, Euronext ticker: NANO, Bloomberg: NANO: FP). The Company Headquarters are based in Paris, France, with an affiliate in Cambridge, Massachusetts.
This press release contains certain forward-looking statements concerning Nanobiotix and its business. Such forward-looking statements are based on assumptions that Nanobiotix considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the update of the reference document of Nanobiotix filed with the French Financial Markets Authority (Autorité des Marchés Financiers) under number D.16-0732-A01 on December 27, 2016 (a copy of which is available on www.nanobiotix.com) and to the development of economic conditions, financial markets and the markets in which Nanobiotix operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Nanobiotix or not currently considered material by Nanobiotix. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Nanobiotix to be materially different from such forward-looking statements.
This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Nanobiotix shares in any country. At the moment NBTXR3 does not bear a CE mark and is not permitted to be placed on the market or put into service until NBTXR3 has obtained a CE mark.