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Nanobiotix hails FDA approval for lead cancer product

Last updated: 09:42 04 Jan 2016 GMT, First published: 10:50 04 Jan 2016 GMT

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NBTXR3 is a nano-medicine injected directly into a cancer tumour and works to make traditional radiotherapy more targeted and much more effective.

Shares in cancer-focused nanomedicine pioneer Nanobiotix (EPA:NANO) advanced on Monday as it reported the FDA in the US had approved its lead product NBTXR3 as an investigational new drug (IND).

Shares in Paris are up 4.67% at the time of writing to €16.60 but were at €16.73 earlier as traders welcomed the latest key development in progress.

It means the company can now begin a phase I/II prospective, open-label clinical trial for prostate cancer in the USA.

The first part of the trial should involve departments of radiation oncology from three US cancer centres, the group said.

Prostate cancer is the second most common form of cancer in the US among men.

One out of seven men in the US will be diagnosed with the disease - the second leading cause of cancer death.

NBTXR3 is a nano-medicine injected directly into the tumour and works to make traditional radiotherapy more targeted and much more effective.

Laurent Levy, Nanobiotix chief executive, told investors today: "The FDA approval opens the regulatory pathway for our lead product NBTXR3 in the US, the largest market for cancer therapeutics.

"Expansion in new indications and global development of NBTXR3 are key to establish this technology as a new standard of care".

As well as this prostate cancer trial, Nanobiotix is currently running five trials across Europe and the Asia-Pacific region.

These are a registration trial in soft tissue sarcoma and Phase I/II trials in liver cancers - heptocellular and liver.

It also has trials for head and neck cancers and rectal cancer, in Asia by Nanobiotix's partner PharmaEngine.

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