Hanmi Pharmaceutical said Monday that Athenex finished registering patient applicants for its global phase 3 clinical trials for Oraxol, an oral anti-cancer drug, last Thursday.

The medication is an oral dosage form of the widely used intravenous administered tubulin-stabilizing chemotherapeutic agent paclitaxel. The company licensed out the drug to Athenex, a U.S. biopharmaceutical company in 2011.

The phase 3 clinical trial is an international randomized controlled clinical trial comparing Oraxol against paclitaxel in patients with metastatic breast cancer, with target sample size of 360 patients. Athenex plans to prove the superiority of clinical efficacy of Oraxol compared with paclitaxel.

The independent Drug Safety Monitoring Board (DSMB) unanimously recommended the continuation of the study after the company conducted a first interim analysis when 90 patients completed their 18 weeks of treatment in October of last year. The DSMB noticed that neuropathy was rare with Oraxol treatment and recommended the rapid patient recruitment toward the scheduled second interim analysis at 180 patients.

The company expects to finish the second interim analysis in the third quarter of this year.

“We are delighted that we are going to deliver an interim analysis of the topline Oraxol phase 3 study results again as planned,” said Johnson Lau, CEO and board chairman of Athenex. “The company is also proud that Oraxol has recently obtained the Promising Innovative Medicine (PIM) designation by the United Kingdom Health Authority MHRA and the allowance of two IND (HM30181A and oral paclitaxel capsules) by the Chinese FDA.”