[THE INVESTOR] Genexine has been granted approval to initiate phase 1 and 2 clinical trials of its recombinant thyroid stimulating hormone GX-30 from Korea’s drug regulatory body, the company said on May 26.

GX-30 is a diagnostic agent for the follow-up of patients with thyroid cancer for removal of residual cancer, possibility of recurrence and diagnosis of metastasis.


 

Genexine president and CEO H. Michael Keyoung

“We expect the clinical trial period to be shortened due to the simultaneous approval of phase 1 and phase 2 studies, and we expect conditional sales approval after phase 2 trials as it is an orphan drug,” Genexine said in a press release.

The first clinical program will be conducted on patients who underwent Thyroidectomy at the Catholic University of Korea Seoul St. Mary’s Hospital and Korea University Anam Hospital to evaluate the pharmacokinetics, tolerability and safety of the drug candidate. In the second study, the company will evaluate the efficacy of the drug by scanning the whole body using radioactive iodine, it said.

By Park Han-na (hnpark@heraldcorp.com)