US-based, biotechnology company NeOnc Technologies has begun a multi-centre Phase l/lla clinical trial of NEO100 to treat recurrent glioblastoma multiforme (GBM), with the first patient being treated at Cleveland Clinic, Ohio.
NEO100 is claimed to be the first GMP quality perillyl alcohol (POH) that has been approved by the US Food and Drug Administration (FDA) for conducting human clinical trials to treat brain tumours.
NEO100 is also a new chemotherapeutic agent that was initially investigated by the National Cancer Institute in the US.
In the previous studies, the drug was given orally and did not appear to be effective.
NeOnc stated that an ongoing clinical trial in Brazil using chemical grade POH has reported positive results in patients with recurrent GBM, with a number of patients with recurrent GBM achieving an extended survival period of more than four years, just by using intranasal POH.
NeOnc Technologies founder, chairman and CEO Dr Thomas Chen said: "Intranasal brain delivery results in the drug going first into the brain, maximising the exposure of the drug to the tumour, and minimising side effects in the body.
"This clinical trial offers a non-invasive, minimal toxicity trial for patients with recurrent GBM, with previous human validation."
The clinical trial includes two phases, firstly a dose escalation phase, followed by 25 patients being treated at the highest dose that is well tolerated.
NEO100 is administered four times a day, with each treatment lasting about 15 minutes, and therapy is continued for up to six months.
Minimal side-effects were experienced by the patients in Brazil.
Additional clinical sites in Wisconsin, Washington, California, Utah, Florida, and Brazil are being qualified for the Phase l/lla trial.
Around 40 patients are expected to be enrolled in the trial over the next 18 months.
The existing therapies are said to poorly treat the recurrent GBM and has become a serious unmet medical condition.
Only 3% to 5% of patients with GBM survive for more than five years.