Boryung said on Wednesday that its new anticancer drug candidate, BR101801, for treating peripheral T cell lymphoma (PTCL) has been designated as an orphan drug by the U.S. Food and Drug Administration (FDA).

Peripheral T cell lymphoma is a malignant tumor originating from T cells, which are immune cells. BR101801 is a first-in-class lymphoma treatment substance that simultaneously triples the main growth and regulators of cancer cells namely, phosphatidylinositol-3-kinases like PI3K gamma (γ) and PI3K delta (δ), as well as in DNA-dependent protein kinases like DNA-PK.

According to the company, the results of the phase 1a clinical trial for this candidate substance were disclosed at the American Society of Hematology (ASH) in December last year. It passed phase 1a clinical trials last year and demonstrated its efficacy by showing complete remission in one PTCL patient and partial remission in three patients.

Based on the efficacy and safety of BR101801 as confirmed through clinical 1a, Recuon, a subsidiary of Boryung incharge of anti-cancer drug development, is currently conducting phase 1b and phase 2 clinical trials  of BR101801 in PTCL patients in Korea simultaneously.

"It is expected that this orphan drug designation will give momentum to the development of BR101801," said a Boryung official.

The FDA operates an orphan drug designation (ODD) system to support the development of treatments for rare and incurable diseases. Drugs successfully designated to this system can receive benefits such as shortening the clinical approval period as well as tax reductions during the development process.