FDA Okays Clinical Trial of Injectable Brain Cancer Drug

Last week, the FDA authorized NuvOx Pharma to initiate a phase 2 clinical trial for its experimental drug, NVX-108, in patients with hypoxic solid brain cancer.

Hypoxia is a condition where a region of the body is deprived of oxygen supply at the tissue level. Tumors are hypoxic, which means they grow so large and dense that they exclude blood vessels, resulting in a lack of oxygen in their cores.

Since hypoxia can make a tumor less susceptible to treatment, targeting oxygen deprivation has been explored as a potential method to re-sensitizing the tumor to various therapies.

NVX-108 is an injectable drug that has shown promise treating glioblastoma multiforme. The drug is injected into the bloodstream and travels to the lungs to obtain oxygen. After it has received the oxygen, the drug then reaches hypoxic tissue where it delivers the oxygen, according to a press release.

The drug works by reducing tumor hypoxia to increase sensitivity to cancer therapies, including chemotherapy and radiation.

NVX-108 has already completed a phase 1b/2 clinical trial in patients with glioblastoma multiforme who are receiving radiation therapy and chemotherapy.

In the escalation phase of the study, the patients were treated at doses of 0.1 cc/kg and 0.17cc/kg NVX-108. These patients were observed to have increased radiation necrosis on post-treatment surgeries, meaning that cancerous tissue was killed, according to a press release.

The researchers found significant evidence of tumor re-oxygenation with no substantial changes in the oxygenation of healthy brain tissue, according to NuvOx. Early results suggest that the drug may also increase overall survival.

If proven effective in further clinical trials, the groundbreaking treatment could provide additional treatment approaches for patients with the deadly cancer.

“Tumor hypoxia is known to be a problem in many tumor types, including GBM. Hypoxic tumors are resistant to radiation therapy and certain kinds of chemotherapy,” said principal investigator, Baldassarre Stea, MD, PhD. “By increasing tumor oxygen levels, NVX-108 is designed to improve the effectiveness of these therapies in order to kill cancer cells more effectively and increase patient survival. Clinical trials are needed to see if NVX-108 can become approved by regulators.”