Sermonix Launches Phase 2 Trial to Evaluate Investigational Oral Lasofoxifene as a Targeted Precision Treatment for Women With ESR1 Mutations in Metastatic Breast Cancer
Linical Accelovance Group will serve as research partner for study that compares
lasofoxifene to fulvestrant
COLUMBUS, OH (Oct. 9, 2018) – Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development and commercialization of female-specific oncology products, today announced the launch of a Phase 2 trial for the treatment of metastatic breast cancer. The program is an open-label, randomized, multi-center study evaluating the activity of its lead investigational drug, oral lasofoxifene, versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation.
“Clinical data have shown a significant reduction in the incidence of ER+ breast cancer in postmenopausal women with osteoporosis who were treated with lasofoxifene,” said Paul Plourde, MD, Sermonix vice president of clinical development. “Additional non-clinical and clinical study results provide further impetus for undertaking a Phase 2 trial in a targeted way that compares lasofoxifene to fulvestrant, a current, widely used injectable medication for advanced metastatic breast cancer.”
Linical Accelovance Group, a mid-size global contract research organization, will serve as Sermonix’s research partner for the study, enrolling 100 patients in 27 sites across the U.S.
“Sermonix selected Linical Accelovance to be our clinical research development partner for this program because we are impressed with the organization’s integrated clinical trial services, as well as its operational capabilities in the development of oncology drugs,” said Sermonix Chief Operating Officer Dr. Miriam Portman.
The trial will utilize oral lasofoxifene for advanced breast cancer patients with ESR1 gene mutations. The primary clinical endpoint will be progression-free survival (PFS).
“Sermonix is developing lasofoxifene as a personalized medicine treatment for patients with ER+ metastatic breast cancer that have progressed after endocrine and other therapies,” said Sermonix Chief Executive Officer Dr. David Portman. “We look forward to seeing how it performs in the Phase 2 trial versus fulvestrant.”
Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. (NASDAQ: LGND). Lasofoxifene has been studied in comprehensive non-oncology clinical trials recruiting more than 15,000 women worldwide and has demonstrated efficacy for treating vulvovaginal atrophy (VVA), and postmenopausal osteoporosis.
Oral Lasofoxifene’s binding affinity and activity in mutations of the estrogen receptor may hold promise for patients who have acquired resistance and mutations of the estrogen receptor, a common mutation in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations has recently been discovered and Sermonix has exclusive rights to develop and commercialize oral lasofoxifene in this area. Oral Lasofoxifene, a potent, well-tolerated and bioavailable SERM, if approved could play a critical role in the personalized treatment of advanced ER+ breast cancer.
Sermonix Pharmaceuticals LLC is a privately held biotechnology company with a targeted focus towards bringing female-specific oncology products through proof of concept, preclinical and clinical development, and regulatory approval. Sermonix was founded in late 2014 by David Portman, MD, a leading clinical researcher and expert in women’s health, menopause and selective estrogen receptor modulator (SERM) therapy.
About Linical Accelovance
Linical Accelovance is a market-leading, midsized, global contract research organization with a significant footprint across North America, Europe and Asia-Pacific. Linical Accelovance is the ideal partner for drug developers looking to expand their program into new markets. With operations in more than 20 countries, Linical Accelovance is uniquely capable of conducting large-scale, multinational studies, while delivering a personalized, hands-on service approach. Linical Accelovance’s areas of expertise include oncology, hematology, vaccines and general medicine trials across Phases 1-4. Providing global full CRO services to pharmaceutical companies, biotechs, CROs and academic institutions, Linical Accelovance supports client needs by leveraging operational knowledge and patient recruitment strategies that result in successful clinical trials.
David Portman, MD
CEO and Founder, Sermonix Pharmaceuticals
Linical Accelovance Group