Athenex and Eli Lilly have collaborated to conduct a Phase Ib study of oraxol and cyramza (ramucirumab) to treat patients with advanced gastric (stomach) and esophageal cancer.
Athenex’s oraxol features a combination of an oral form of paclitaxel and the oral absorption molecule, HM30181A, a P-glycoprotein (P-gp) pump inhibitor.
The HM30181A is not systemically absorbed and suppresses P-gp pump in the gastrointestinal tract, allowing compounds such as paclitaxel to enter the bloodstream and be bioavailable via oral administration.
Eli Lilly’s cyramza is an antiangiogenic therapy and acts as a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds and blocks activation of VEGF Receptor 2 by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D.
The Phase Ib trial is slated to begin enrolling patients next year at sites across the US and Asia, with Athenex sponsoring the clinical trial and Lilly to supply CYRAMZA.
Athenex chief medical officer Dr Rudolf Kwan said: “A major component of cancer treatment consists of intravenous chemotherapy.
“Many oncologists are currently limited by the amount of standard intravenous chemotherapy a patient can tolerate.
“Oraxol is the first drug candidate from an innovative technology platform that enables the oral administration of a chemotherapy drug usually administered by the intravenous route (paclitaxel).
“The effect of the compound is limited to the intestinal cells, as it is not significantly absorbed in humans. Oral dosing of paclitaxel potentially provides longer drug exposure over a target drug concentration and may offer the opportunity for chronic chemotherapy, which will be evaluated for increased efficacy.”
Oraxol is also undergoing a Phase III metastatic breast cancer trial, where it is being compared with intravenously administered paclitaxel.