Athenex, Inc. announced that it has received United States Food and Drug Administration (US FDA) allowance to proceed in the clinic with its proprietary oral form of Docetaxel. This allowance to proceed represents Athenex’s sixth successful oncology investigational new drug (IND) application by the US FDA (5 oral anticancer drugs, one ointment) and the third such clinical drug candidate in Athenex’s oral absorption platform. Docetaxel is an established and effective high potency anti-cancer drug.
Athenex has developed an oral form, called Oradoxel. The Athenex oncology oral absorption technology is based on a proprietary P-glycoprotein (Pgp) pump inhibitor (“Orascovery” platform) licensed exclusively from our business partner, Hanmi Pharmaceuticals, in 2011 for all major worldwide territories except Korea and Japan that were retained by Hanmi Pharmaceuticals. Athenex currently has the oral forms of paclitaxel and irinotecan in later stage clinical studies, which showed promising profiles in earlier clinical evaluations.
Gerald Fetterly, PhD, Athenex Vice President of Clinical Pharmacology added “We have learned in the clinic that converting existing intravenous high potency oncology drugs into oral forms opens the door to optimizing a wide array of patient dosing regimens which cannot be achieved with IV. Oral forms of dosing allow the patients to be exposed over a longer period of time to the potent active pharmaceutical ingredients and clinical studies have shown expected pharmacokinetic blood levels of exposure; leading to good clinical efficacy with less adverse side effects compared with the intravenous counterparts.”
In addition to its primary territories, Athenex is also developing Oraxol and Oratecan with Hanmi Pharmaceuticals, the originator of the Orascovery platform, in Korea and Japan, with PharmaEssentia in Taiwan and Singapore, and with ZenRx in New Zealand and Australia.
