South Korea-based HLB Therapeutics subsidiary Oblato has enrolled the first patient in the US for a Phase l trial of OKN-007 oral formulation to treat recurrent high-grade glioma.
The enrolment marks the first step to use oral OKN-007 in clinical trials for the treatment of glioblastoma, which is a rare and fatal disease.
The Phase l trial is anticipated to expand the potential of OKN-007 that will be approved for use in treating glioblastoma.
Four hospitals, including Providence Saint John’s Cancer Institute and Norton Healthcare, will serve as trial sites.
The trial has been designed to evaluate dose escalation and pharmacokinetic analysis of OKN-007.
Safety and preliminary efficacy data from the trial will be used to determine the OKN-007 dose for future clinical studies.
Oblato CEO Ki Hong Ahn said: “We have decided to develop an oral formulation in consideration of convenience for the patient, which is an important aspect for future commercialisation, and plan to have a strategy to increase the value of the new drug in the market with great unmet needs through diversification of treatment options.
“Through discussions with the FDA, we have already incorporated their suggestions on the clinical study protocol.”
in addition, Oblato is undertaking a Phase ll trial of OKN-007 injectable formulation plus temozolomide for patients with recurrent glioblastoma multiforme (GBM).
A total of 13 institutions, including Henry Ford Health System, are taking part in this trial.
In October last year, the trial concluded enrolling patients, some of whom are still receiving treatment.