Clinical Trial Collaboration Created for Gastric Cancer Drug

Athenex, Inc announced a novel partnership with Eli Lilly and Company to conduct a phase 1b clinical trial for the treatment of patients with advanced gastric cancer.

Gastric cancer is a leading cause of cancer-related deaths worldwide, with an estimated 26,370 cases expected to be diagnosed in the United States alone in 2016. This type of cancer is even more common in Eastern countries and those that are less developed.

In the clinical trial, scientists will evaluate the safety and tolerability of Oraxol plus Cyramza (ramucircumab), Lilly’s VEGF receptor 2 antagonist, according to a press release from Athenex. Scientists will test this combination in patients with gastric and esophageal cancers.

Oraxol is combination drug of HM30181A, a P-glycoprotein pump inhibitor, and an oral version of the common chemotherapy drug paclitaxel. Inhibiting the P-glycoprotein pump inhibitor allows compounds to enter the bloodstream when they would likely be excreted through the gastrointestinal tract.

The oral nature of oraxol could potentially improve cancer treatment since patients are receiving an effective dosage of the drug. Other intravenous infusion drugs may not work as effectively, since the drugs may never reach the bloodstream.

Enrollment in the phase 1b clinical trial is expected to start in 2017, and will be conducted in the United States and Asia. Athenex will be funding the trial, while Lilly will be supplying Cyramza.

Oraxol is currently being evaluated in a head-to-head phase 3 clinical trial of metastatic breast cancer compared with paclitaxel, according to Athenex. In a phase 2 clinical trial of oraxol in patients with advanced gastric cancer, an overall survival of 10.7 months was discovered.

Athenex determined that Cyramza may provide when administered with Oraxol, since the drug has received FDA approval as both a monotherapy and in combination with paclitaxel for patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, according to the press release.

This new treatment also has the potential to lower drug costs and reduce side effects since the drugs are more easily absorbed, and the treatment may be shortened because of this.

“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 which enables the oral administration of a chemotherapy drug usually administered by the intravenous route (i.e., paclitaxel),” said Rudolf Kwan, MBBS, MRCP, Athenex’s chief medical officer. “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.”