Athenex has received U.S. Food and Drug Administration (FDA) allowance to proceed with clinical trials in patients of its oral form of the docetaxel anticancer drug, Oradoxel.
It is Athenex's sixth successful oncology investigational new drug application with the FDA and the third clinical drug candidate in the company's oral absorption platform. Docetaxel is an established and effective high-potency anticancer drug, the company noted. It has been approved to treat squamous cell carcinoma of the head and neck that is locally advanced that cannot be treated with surgery, and it is being studied in the treatment of other types of cancer, according to the National Cancer Institute.
The oncology oral absorption technology is based on a proprietary P-glycoprotein (Pgp) pump inhibitor (Orascovery platform) licensed from the company's business partner, Hanmi Pharmaceuticals.
"Our Pgp pump inhibitor has been demonstrated to enhance the oral absorption of well-known oncology drugs that today are only available to patients as intravenous medicines," stated Douglas Kramer, MD, Athenex vice president of clinical development and regulatory affairs, in a press release. "We are excited for the possibilities to make a difference in helping more cancer patients."
Converting existing intravenous high-potency oncology drugs into oral forms enables the optimization of an array of patient dosing regimens that cannot be achieved with IV, the company noted.
"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," stated Gerald Fetterly, PhD, Athenex vice president of clinical pharmacology.
