Thursday, May 30, 2013

ASLAN Pharma's Phase 2 drug ASLAN001 shows activity in heavility pretreated gastric cancer patients

ASLAN Pharmaceuticals Pte Ltd today announced the results of a phase 2 clinical trial with ASLAN001, a small - molecule pan - HER inhibitor, in gastric cancer. ASLAN001 reduced cell
proliferation and cell survival in gastric tumours that were either co expressing EGFR and HER2 or that were HER2 amplified. ASLAN001 was invented by Array BioPharma Inc (NASDAQ: ARRY) and licensed to ASLAN in 2011.

This is the first time a drug has shown activity in this patient population.  
The phase 2, open-label, multi-centre 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 tumours were HER2amplified or co-expressing 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.

Tumour biopsies taken before and after treatment were analysed using immunohistochemistry.  In this heavily pretreated population, ASLAN001 led to a down regulation 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 randomised phase 2b study in gastric cancer and is exploring the use of 
ASLAN001 in other indications.

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