NEW YORK – Sermonix Pharmaceuticals said on Wednesday that it has partnered with Exactis Innovation to expand a Phase II study of its investigational drug lasofoxifene into Canada.
The Phase II ELAINE-1 trial is comparing the activity of lasofoxifene versus fulvestrant in post-menopausal, estrogen receptor-positive, HER2-negative, locally advanced or metastatic breast cancer patients with ESR1 mutations. In the trial, which began enrollment in the US a year ago, researchers will compare patients' progression-free survival on these two agents.
Sermonix recently received the go ahead from Health Canada to proceed with this trial, and the partnership with the Exactis Network will allow the firm to launch the study at sites in Quebec, Ontario, Nova Scotia, and New Brunswick.
Exactis Innovation is a network of centers of excellence in Canada involving universities, industry, government, and non-profit organizations focused on advancing precision oncology in the country. Within the network, cancer centers collect clinical and molecular data on cancer patients within a registry, called Personalize My Treatment. The cancer centers in the network will use data in this registry to identify patients with ESR1 mutations who may be eligible for partaking in ELAINE-1.
"The synergy between Sermonix's precision medicine focus — through its ELAINE-1 study of lasofoxifene — and the Exactis network and PMT registry creates an ideal collaborative opportunity," said Exactis Chief Medical Officer Gerald Batist. "We look forward to identifying and enrolling Canadian women into this trial, extending the frontier of research in the ESR1-mutated breast cancer arena and offering Canadian patients participation in this very promising clinical trial."
Sermonix licensed lasofoxifene, a selective estrogen receptor modulator, from Ligand Pharmaceuticals and has exclusive global rights to develop and commercialize the drug in oncology indications. The company said in a statement that in addition to opening study sites in Canada it is also adding ELAINE-1 study sites in Israel.