AsianScientist (Aug. 19, 2015) – ASLAN Pharmaceuticals (ASLAN), a biotech company headquartered in Singapore, has received orphan drug designation for their pan-HER inhibitor ASLAN001 (varlitinib) from the US Food and Drug Administration (FDA) office of orphan products development (OOPD). The designation is for the orphan drug to treat cholangiocarcinoma, a rare and very aggressive form of bile duct cancer.
The FDA awards orphan drug designation to advance the evaluation and development of drugs and products that demonstrate promise for the diagnosis or treatment of rare diseases or conditions. The OOPD evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance scientific development of such medical products. Orphan drug designation will provide ASLAN certain incentives including extended marketing exclusivity to develop ASLAN001 in cholangiocarcinoma.
ASLAN001 is currently being tested in phase II studies in breast cancer and cholangiocarcinoma. Studies in gastric cancer are also being planned.
“Cholangiocarcinoma is a very rare cancer in the US, but one of the big killers in Asia,” said Dr. Bertil Lindmark, chief scientific officer of ASLAN.
Cholangiocarcinoma is a heterogeneous cancer, which may show genetic variation in different populations. Its low prevalence in the West makes it difficult to study. In Asia, the incidence is over ten times higher. The access to patients and physicians with knowledge of the disease will be key in studying the effects of ASLAN001 in this disease.
“The orphan drug designation is an important step in the development of ASLAN001. With no approved targeted therapies for cholangiocarcinoma, the prognosis for patients in both Asia and the West is poor,” said Dr. Carl Firth, chief executive officer of ASLAN.
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Source: Aslan Pharmaceuticals.
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