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Noxopharm (ASX:NOX) receives approval from U.S. FDA for Veyonda

Health Care
ASX:NOX      MCAP $17.53M
21 February 2020 14:00 (AEST)

Noxopharm (NOX) has received approval from the U.S. FDA for the Investigational New Drug Application (IND) for Veyonda.

The IND approves a Phase 1b study involving a combination of Veyonda and doxorubicin in adults with soft tissue sarcomas (when cancer cells form in the soft tissue of the body).

Noxopharm can now explore available funding opportunities to enable this study to begin.

“The IND approval, based on pre-clinical and clinical data presented to the FDA (Food and Drug Administration), is a validation of the clinical potential of Veyonda,” Noxopharm Chief Medical Officer Gisela Mautner commented.

“In addition, Veyonda has met the very high standard set by the FDA for being a safe and well-tolerated drug,” she added.

Veyonda works in tandem with chemotherapy and radiotherapy with the aim of increasing the number of cancer cells killed by those treatments.

It then acts as an immune-oncology drug by switching on the body’s first-line defence mechanism which is the main system responsible for fighting cancer.

According to Noxopharm, Veyonda works with, not against the body’s defences against cancer.

While inflicting damage on cancerous cells, chemotherapy and radiotherapy also deals damage to the defence mechanisms that the body relies on to fight the cancer.

The end result is a restricted effect against fighting cancers.

“Bringing Veyonda to market for late-stage prostate cancer remains our commercial imperative, however this IND grant for a less common cancer type contributes to that overall commercial objective in several ways,” CEO Graham Kelly said.

Noxopharm’s share price has spiked 27.7 per cent in mid-morning trade with shares trading for 30 cents apiece at 11:43 am AEDT.

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