Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company focused on the development of female oncology products in the precision medicine metastatic breast cancer arena, announced a collaboration with Exactis Innovation, a pan-Canadian Network of Centres of Excellence (NCE) in precision medicine, expanding a Phase 2 clinical trial of Sermonix’s lead investigational drug, lasofoxifene, into Canada.
The NCE is a Canadian government initiative that funds partnerships between universities, industry, government and not-for-profit organizations to create large-scale research networks integrating precision oncology across Canada.
With the recent Health Canada agreement to proceed, the open-label, randomized Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE 1, NCT03781063) study will now include Exactis Network sites in Quebec, Ontario, Nova Scotia and New Brunswick. The study, which began U.S. enrollment in September 2019, is assessing the efficacy of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation and progression-free survival as the primary endpoint.
“Sermonix is honored to collaborate with Exactis Innovation, a truly esteemed international center of excellence in precision medicine,” said David Portman, Sermonix founder and chief executive officer. “Our ELAINE trials are solely focused on women with ESR1 mutations, for whom there is such great need of targeted treatments that potentially can prolong and enhance their lives. Working with Exactis furthers that mission.”
With exclusive global rights to develop and commercialize lasofoxifene in the oncological arena, Sermonix is also adding ELAINE 1 study sites in Israel, further providing important international data as the company looks to fulfill its global mission of addressing the unmet needs of women with metastatic breast cancer.