[ET Net News Agency, 20 September 2019] Luye Pharma Group Ltd. (02186) said the group
has completed human pharmacokinetic study for goserelin acetate extended-release
microspheres for injection (LY01005) in the United States of America.
The clinical trial was designed to assess the pharmacokinetic (PK), pharmacodynamic (PD)
and safety profiles of a single dose of LY01005 compared with Zoladex. Nineteen prostate
cancer patients were recruited by four experienced U.S. clinical centres for this clinical
trial.
The results of the study showed that the release of LY01005 was more stable in the human
body than that of the comparator. There was no significant statistical difference in the
primary parameters of each PD index (Testosterone, Luteinizing Hormone (LH) and Follicle
Stimulating Hormone (FSH)), indicating that there was no significant difference in the
efficacy between LY01005 and Zoladex. The safety and tolerability of LY01005 were well
controlled and there were no serious adverse events leading to any withdrawal or death of
any patient. The group intends to discuss with the U.S. Food and Drug Administration (FDA)
on the further development of LY01005 in the U.S. (RC)