Nanobiotix's NBTXR3 Achieves Clinical Milestone Reaching Proof-Of-Concept in Phase I Trial of Soft Tissue Sarcoma
JCN Newswire / 2013年6月4日 15時6分
PARIS, FRANCE, June 4, 2013 - (JCN Newswire) - NANOBIOTIX (Euronext: NANO), a clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, announces 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.
Elsa Borghi, Chief Medical Officer of Nanobiotix, commented: "The Phase I interim results exemplify our first clinical validation of NBTXR3 and represent our successful transition of the NanoXray platform from preclinical models to a clinical stage. They have confirmed that NBTXR3 has the potential to become a safe and localized treatment to STS patients. In addition, the NBTXR3 results have demonstrated in all treated patients adequate distribution within the tumor, absence of leakage, optimal bioavailability over time and successful surgery. Encouraged by these results, we are looking forward to expanding clinical development of NBTXR3 in a variety of additional cancer indications."
STS are cancers arising from different types of tissues such as fat cells, muscles, joint structures, small vessels, etc. Patients with high risk STS have poor prognoses: They need surgery to remove the tumor and their only therapeutic option before surgery is radiotherapy. However, there is an important unmet medical need for these patients. Treatment with NBTXR3 nanoparticles and radiotherapy aims at destroying tumor more efficiently, to allow surgery and to enable complete malignant tissue extraction during surgery.
The results have been presented to oncologists, patients association and industry representatives during a focus group meeting in Chicago on Saturday 1st June 2013.
For further information, the presentation can be downloaded following this link: http://bit.ly/18Kblu5
Nanobiotix therapeutics aim at helping patients in the fight against cancer and changing the radiotherapy practice. Nanobiotix is committed to bringing science to healthcare and to improve patients' quality of life.
Nanobiotix (Euronext: NANO / ISIN: FR0011341205) is a 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 to provide a new, more efficient treatment for cancer patients. NanoXray products are compatible with current radiotherapy treatments and are meant to treat a wide variety of cancers via multiple routes of administration. Nanobiotix's lead product NBTXR3, based on NanoXray, is currently under clinical development for soft tissue sarcoma. The Company has partnered with PharmaEngine for clinical development and commercialization of NBTXR3 in Asia. The Company is based in Paris, France. For more information, please visit www.nanobiotix.com .
Nanobiotix's first-in-class, proprietary technology called NanoXray is at the forefront of a new era of nanomedicine, where nanoparticles are not just a vehicle for targeted drug delivery, but have become the principal active element. The NanoXray technology is based on the physical properties of hafnium-oxide nanoparticles and is used to enhance the efficacy of radiotherapy treatment for a variety of cancer indications.
Nanoparticles are designed to enter tumor cells and, upon activation by a standard dose of radiation, they emit large amounts of electrons resulting in the generation of free radicals that destroy cancer cells (the same mode of action than radiotherapy but largely amplified). Nanoparticle-enhanced radiotherapy therefore amplifies the lethal dose of energy locally within the tumor without changing the effect of the dose passing through surrounding healthy tissues.
By changing the coating of the nanoparticles, Nanobiotix is developing three different products that can be administered either by direct injection into the tumor (NBTXR3), intravenous injection (NBTX-IV) or topical application to fill tumor cavities after surgery (NBTX-TOPO). The product applied will depend on type of tumor and the patient's specific clinical needs. NanoXray products are classified as a medical device in Europe and as a drug in the US. They are compatible with current radiotherapy methods with respect to equipment and protocols, as well as with older radiotherapy equipment or any radiation based therapy (brachytherapy, proton therapy...).
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