HUYA Bioscience International (HUYA) announced on April 15 the outcome of the first pre-IND (Investigational New Drug) consultation with the U.S. FDA for a development-stage compound sourced from China. 

The new compound, HBI-8000 (CS055 / Chidamide), licensed from Chipscreen Biosciences, Ltd. of Shenzhen, China, shows promise for the treatment of a broad range of cancers and is nearing completion of a Phase I trial in China.  HUYA holds exclusive development and commercialization rights to the compound worldwide outside of China, while Chipscreen maintains rights in China.

HUYA received positive pre-IND comments from the FDA Oncology Division. HUYA's IND-enabling nonclinical development plan and proposed U.S. Phase I clinical plan were acceptable to the agency.  In addition, the FDA indicated its willingness to accept both preclinical and clinical data generated in China as supportive information for the opening of a U.S. IND and initiation of a Phase I trial.  HUYA is on track to file an IND application for HBI-8000 in the second half of 2008.

According to Mireille Gingras, Ph.D., CEO of HUYA, "The acceptance of Chinese data as supportive for our U.S. IND and Phase I plans is tremendous validation of our Integrated Co-Development Model.  The ability to leverage data from China lowers risk and streamlines the clinical development process in the West.  The outcome of this pre-IND consultation validates HUYA's leadership in Sino/American pharmaceutical co-development."

HBI-8000 is an orally bioavailable histone deacetylase (HDAC) inhibitor derived from the benzamide class.  Histone deacetylase inhibitors are a new class of cancer drugs that induce selective regulation of gene expression in cancer cells.  HBI-8000 has exhibited activity and pharmaceutical properties that may translate into a superior clinical profile over other HDAC inhibitors currently marketed or in development.