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FDA permits clinical trials of Athenex oral cancer drug

The Buffalo biotech firm Athenex has received U.S. Food and Drug Administration permission to move forward with clinical trials for the oral form of Docetaxel, its highly potent cancer drug, the company announced this week.

Athenex soon will begin human studies in Oradoxel in the United States and New Zealand, and later in Asia, Flint Besecker, its chief operating officer, told The Buffalo News.

This is the sixth successful oncology investigational new drug, or IND, application granted by the FDA to the company and the third clinical drug candidate in Athenex’s oral absorption platform.

Kinex has reached licensing agreements with South Korea’s Hanmi Pharmaceuticals to further develop this oral delivery method for cancer drugs, which are now typically given through hours-long rounds of infusions.

Cancer medication taken orally is expected to be more tolerable, convenient and effective for patients, and the first company to perfect this process can expect to grab a big share of the multibillion-dollar cancer drug market.

Athenex now has its oral forms of paclitaxel, known as Oraxol, and irinotecan, known as Oratecan, in later stage clinical studies.

Athenex, formerly known as Kinex, late last year moved into a new headquarters and lab space in the Conventus building on the Buffalo Niagara Medical Campus. Formed in 2003, it has followed an ambitious growth track in recent years after raising tens of millions of dollars from Asian investors. The company has 325 employees in the United States and Asia and soon will see construction begin on two drug manufacturing and distribution facilities in China.

Gov. Andrew M. Cuomo has proposed spending $200 million to build a drug manufacturing center for Athenex in Dunkirk, creating hundreds of jobs, The News reported on Saturday, but few details are known about the project.