ASLAN Pharmaceuticals, a clinical-stage biopharmaceutical company targeting cancers that are both highly prevalent in Asia and orphan indications in the United States and Europe, today announced the completion of recruitment of 52 patients for the phase 2 part of its global phase 2/3 study investigating varlitinib as first line therapy in HER1/HER2 co-expressing advanced or metastatic gastric cancer patients.
ASLAN Pharmaceuticals (NASDAQ:ASLN) (TPEx:6497), a clinical-stage biopharmaceutical company targeting cancers that are both highly prevalent in Asia and orphan indications in the United States and Europe, today announced the completion of recruitment of 52 patients for the phase 2 part of its global phase 2/3 study investigating varlitinib as first line therapy in HER1/HER2 co-expressing advanced or metastatic gastric cancer patients.
Varlitinib is a potent, reversible, small molecule pan-HER inhibitor and is currently being developed by ASLAN across multiple indications including a global pivotal trial in biliary tract cancer.
Initiated in 2017, the global phase 2/3 study is a double blind, randomised two-arm study that aims to determine the efficacy of varlitinib in combination with mFOLFOX6 (a combination chemotherapy regimen) in comparison to mFOLFOX6 alone in the first line setting. Topline data for the phase 2 study is expected in Q4 2018.
Dr Bertil Lindmark, Chief Medical Officer, ASLAN Pharmaceuticals, said: “We are pleased to complete the patient recruitment for the first part of this important global phase 2/3 study for varlitinib in gastric cancer. We had initially planned to enrol 40 patients but strong recruitment allowed us to enrol the maximum of 52 patients. We expect to recruit an additional 350 patients as we progress on to the second part of the trial if the primary endpoint for phase 2 is met. With limited treatment options currently available, varlitinib has the potential to make a significant impact in one of the world’s most prevalent and deadly cancers.”
Gastric cancer currently ranks fourth in cancer incidence worldwide1, is the second most common cause of cancer-related deaths worldwide2 and is one of the most common types of cancer in Asia3. Varlitinib has been granted Orphan Drug Designation status by the US FDA in gastric cancer in 2016.
ENDS
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About varlitinib (ASLAN001)
Varlitinib (ASLAN001) is a highly potent, oral, reversible, small molecule pan-HER inhibitor that targets the human epidermal growth factor receptors HER1, HER2 and HER4. These receptors can be mutated or overexpressed in many tumors, which can cause excessive proliferative activity and uncontrolled growth. Therefore, by inhibiting the activation of the HER receptors, varlitinib could inhibit proliferation and control tumor growth. Varlitinib is currently being studied in gastric, biliary tract, breast and colorectal cancers. Varlitinib has been granted orphan drug designation in the United States for gastric cancer and cholangiocarcinoma, a sub-type of biliary tract cancer, and was awarded orphan drug designation for the treatment of biliary tract cancer by the Ministry of Food and Drug Safety in South Korea.
About ASLAN Pharmaceuticals
ASLAN Pharmaceuticals (NASDAQ:ASLN) (TPEx:6497) is a clinical-stage oncology-focused biopharmaceutical company developing novel therapeutics for global markets. ASLAN targets diseases that are both highly prevalent in Asia and orphan indications in the United States and Europe. Led by a senior management team with extensive experience in global and regional development and commercialisation, ASLAN is headquartered in Singapore and has offices in Taiwan and China. ASLAN’s portfolio is comprised of four product candidates which target validated growth pathways applied to new patient segments, novel immune checkpoints and novel cancer metabolic pathways. ASLAN’s partners include Array BioPharma, Bristol-Myers Squibb, Almirall and CSL. For additional information please visit www.aslanpharma.com.
Forward looking statements
This release and the accompanying financial information contains forward-looking statements. These statements are based on the current beliefs and expectations of the management of ASLAN Pharmaceuticals Limited and/or its affiliates (the “Company”). These forward-looking statements may include, but are not limited to, statements regarding the Company’s business strategy, the Company’s plans to develop and commercialise its product candidates, the safety and efficacy of the Company’s product candidates, the Company’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for the Company’s product candidates. The Company’s estimates, projections and other forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and inherently involve significant known and unknown risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation the risk factors described in the Company’s US Securities and Exchange Commission filings and reports (Commission File No. 001-38475), including the Company’s prospectus dated May 8, 2018 filed with the US Securities and Exchange Commission on such date.
All statements other than statements of historical fact are forward-looking statements. The words “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify estimates, projections and other forward-looking statements. Estimates, projections and other forward-looking statements speak only as of the date they were made, and, except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection or forward-looking statement.
1https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4768187/
2https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5808709/
3https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4000485/
