28 May 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Aslan Pharmaceuticals has revealed the results of its phase II clinical trial with Aslan001, a small-molecule pan-HER inhibitor, in gastric cancer. Aslan001 reduced cell proliferation in gastric tumors that were either coexpressing EGFR and HER2 or that were HER2 amplified. The pan-HER inhibitor was invented by Array BioPharma and licensed to Aslan in 2011.
The phase II, open-label, multicenter study was conducted at Seoul National University Hospital, South Korea, and was designed to evaluate the biological activity of Aslan001 in patients with recurrent/metastatic gastric carcinoma whose tumors were HER2 amplified or coexpressing EGFR and HER2.
The 23 patients, who had previously failed on one or more rounds of chemotherapy and, where eligible, trastuzumab, each received 500mg of Aslan001 orally twice daily as monotherapy for 28 days. Tumor biopsies taken before and after treatment were analysed using immunohistochemistry.
In this heavily pretreated population, Aslan001 led to a downregulation of signalling pathways responsible for cell proliferation, and a reduction in cell survival and cell proliferation. Toxicities observed were consistent with other drugs in this class and the previously reported profile of this compound. Aslan intends to begin a randomized phase IIb study in gastric cancer and is exploring the use of Aslan001 in other indications.
Dr Alan Barge, chief medical officer, Aslan, said that, "This is the first time a drug has shown activity in this patient population. The burden of gastric cancer is particularly severe in Asia. It is the most prevalent cancer in males in China, where it is estimated to affect over half a million people."