CrystalGenomics said Monday that its Ivaltinostat has won orphan drug status from the U.S. Food and Drug Administration for treating acute myeloid leukemia (AML).

With the orphan drug designation, CrystalGenomics can receive up to a 50 percent tax cut for conducting clinical trials and exemption from the payment of fees to apply for FDA approval. Ivaltinostat is a molecularly targeted inhibitor disrupting histone deacetylase's function with excellent therapeutic effects and few side effects, the company said.

CrystalGenomics plans to expand the indications of Ivaltinostat to other diseases, including pancreatic and liver cancer. It is preparing to conduct phase 1 and 2a clinical trials of Ivaltinostat combined with an immune checkpoint inhibitor in patients with liver cancer in the U.S.

The American Society of Clinical Oncology (ASCO) has reported that an estimated 19,940 Americans of all ages would get AML and 11,180 would die of it this year. AML is the second most common type of leukemia diagnosed in children and adults, accounting for 32 percent of all adult leukemia cases.

"CrystalGenomics will develop Ivaltinostat as the best-in-class drug for various cancers," a company official said. "We will participate in the Biotech Showcase and 2021 J.P. Morgan Healthcare Conference to introduce our innovative drug pipeline and the progress of their global clinical trials."