It promises to be significant year for Nanobiotix SA (EPA:NANO) in 2017 as the French cancer-focussed biotech developer closes in on a green-light for its lead product in Europe.
Nanobiotix has updated on its seven ongoing clinical trials which aim to prove the efficacy of NBTXR3, a first-in-class radio-enhancer nanoparticle for use in radiotherapy.
The nanoparticle is injected into cancerous tumours and it helps treatment by increasing absorption of the radiotherapy dose, thus enhancing the efficacy of the radiotherapy treatment whilst neither the toxicity or damage to healthy tissues increase.
Importantly, the company told investors that more than two thirds of patients have now been recruited into its “act.in.sarc” Phase II/III trial, and a Phase I/II trial in treatment of prostate cancer trial is now recruiting in the United States.
Elsa Borghi, Nanobiotix chief medical officer, said: “We made significant progress this year with the global clinical development of NBTXR3 across seven clinical trials and we are looking forward to potentially obtain a CE mark in 2017.
“Our filing was based on the scale and significance of the results already seen.
“The clinical and regulatory progress sets the stage for 2017, as we are getting closer to establishing NBTXR3 in combination with radiotherapy as a new treatment modality for patients suffering from solid cancers.”
NBTXR3 is now being evaluated in soft tissue sarcoma (STS), head and neck cancers, prostate cancer, and liver cancers.
Nanobiotix highlighted that 115 patients have now been randomized and 153 have signed the informed consent in the STS pivotal clinical trial.
The company expects to release the conclusion of the interim analysis conducted by an independent committee of experts in the coming months. Analysis begins four months after the 104th patient has been randomised.
PharmaEngine, Nanobiotix’s partner in Taiwan, has started a new clinical trial in Asia for head and neck patient’s population receiving chemotherapy in combination with radiotherapy.
A US trial in prostate cancer is now being recruited in two hospitals (one in Los Angeles, and one in Philadelphia), while a hospital in Boston will join the trial soon.
Story by ProactiveInvestors