AsianScientist (Jun. 3, 2013) – ASLAN Pharmaceuticals Pte Ltd announced this week results of a Phase II clinical trial with ASLAN001, a small-molecule pan-HER inhibitor, in gastric cancer, a major public-health problem in Asia.
ASLAN001 was invented by Array BioPharma Inc and licensed to ASLAN in 2011. ASLAN001 (ARRY-543) is a novel, selective and oral HER2/EGFR inhibitor, and has previously shown clinical activity in both HER2 positive and EGFR positive tumors in US studies.
“This is the first time a drug has shown activity in this patient population,” said Dr. Alan Barge, ASLAN’s Chief Medical Officer. “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.”
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.
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.
According to ASLAN, 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 in gastric tumors that were either coexpressing EGFR and HER2 or that were HER2 amplified. 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.
Headquartered in Singapore, ASLAN Pharmaceuticals focuses on oncology and inflammatory diseases that are more prevalent in Asia. ASLAN currently has three drugs in clinical development, and partnerships with Array BioPharma, Bristol Myers Squibb, and Almirall.
Source: ASLAN Pharma.
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