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ASLAN's Varlitinib Fails to Meet Endpoint in Phase II Study

ASLAN Pharmaceuticals Limited ASLN announced that a phase II study, evaluating its pipeline candidate — varlitinib — for the treatment of first-line gastric cancer, failed to meet the primary endpoint of showing significant reductions in tumor size. The study was examining varlitinib plus mFOLFOX6 compared with placebo plus mFOLFOX6 as a first-line therapy for the treatment of HER1/HER2 co-expressing advanced or metastatic gastric cancer.

Data from the study, obtained from an independent central review, proved that patients having received varlitinib + mFOLFOX6 showed an average tumor reduction of 22% compared with the 12.5% decrease for those administered with mFOLFOX6 alone following a 12-week treatment regime. However, this difference did not reach statistical significance.

Notably, the combo of Varlitinib and mFOLFOX6 was well-tolerated in the program. The company also stated that a trend toward an improvement in progression free survival was observed in the study.

Shares of ASLAN have plummeted 51.3% in the past six months, wider than the industry’s decrease of 14.1%.

Varlitinib is an oral, reversible, small molecule pan-HER inhibitor targeting the human epidermal growth factor receptors HER1, HER2 and HER4. Apart from gastric cancer, the candidate is being studied for biliary tract, breast and colorectal cancers.

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Varlitinib enjoys an orphan drug designation in the United States for gastric cancer and cholangiocarcinoma, a sub-type of biliary tract cancer (BTC).

We would like to remind investors that earlier this month, ASLAN completed patient enrolment in the global TreeTopp study, analyzing a combination of varlitinib and Roche’s RHHBY Xeloda (capecitabine) as compared to Xeloda plus placebo for second-line biliary tract cancer. Top-line results from the study are expected in the second half of 2019.

Another cancer candidate in ASLAN’s portfolio is ASLAN003, currently being developed as a potential treatment for acute myeloid leukaemia (AML). The company plans to begin a phase II study in the United States during the first half of 2019.

Zacks Rank & Stocks to Consider

ASLAN carries a Zacks Rank #3 (Hold) at present. Better-ranked stocks in the healthcare sector include Vanda Pharmaceuticals Inc. VNDA and Acorda Therapeutics, Inc. ACOR, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Vanda’s earnings estimates have moved 11.1% north for 2019 over the past 90 days. The stock has surged 46.1% in the past six months.

Acorda’s loss per share estimates have been narrowed 1.9% for 2019 in the last 90 days.

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