Sermonix Pharmaceuticals Announces Top-Line Data From ELAINE 1 Phase 2 Study of Lasofoxifene Versus Fulvestrant Is Accepted for a Late-Breaking Oral Presentation at ESMO Congress 2022

2022-08-25

合作

COLUMBUS, Ohio, Aug. 25, 2022 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company developing innovative therapeutics to specifically treat

ESR1-mutated

metastatic breast and gynecological cancers, today announced that top-line data from its Phase 2 study of lasofoxifene, its lead investigational drug, versus fulvestrant was accepted for a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) Congress 2022, which is being held September 9-13, 2022, in Paris. The open-label, randomized Evaluation of Lasofoxifene in

ESR1

Mutations (ELAINE 1, NCT03781063) study, which began U.S. enrollment in September 2019, assessed 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. Details of the presentation are as follows: Title: Open-label, randomized study of lasofoxifene (LAS) vs fulvestrant (Fulv) for women with locally advanced/metastatic

ER+/HER2- breast cancer (mBC)

, an

estrogen receptor 1 (ESR1)

mutation, and disease progression on

aromatase (AI)

and cyclin-dependent kinase 4/6 (CDK4/6i) inhibitors Presenter: Matthew P. Goetz Date, Time and Location: September 10 at 3:05 p.m. CEST, 7.2.E - Évry Auditorium Session: Mini Oral Session:

breast cancer

, metastatic Presentation Number: LBA20 About Lasofoxifene Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the

estrogen receptor

could potentially hold promise for patients who have acquired endocrine resistance due to

ESR1

mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in

ESR1

mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of

advanced ER+ breast cancer

. About Sermonix Sermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific oncology products and is currently undertaking two Phase 2 clinical studies of lasofoxifene, its lead investigational drug. Sermonix Pharmaceuticals was founded in 2014 by David Portman, M.D., a leading clinical researcher and expert in women’s health, menopause and selective estrogen receptor modulator (SERM) therapy. The Sermonix management team, led by Dr. Portman, has significant experience in all stages of the drug development and regulatory process. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience in the oncology drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in SERM biology. Miriam Portman, M.D., is chief operating officer. Elizabeth Attias, M.M.Sc., Sc.D., chief strategy and development officer, has extensive experience in pharmaceutical drug commercialization. Simon Jenkins, Ph.D., vice president of operations, has over 30 years of experience in global drug development leadership. Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lambert’s Pharmaceutical Division. Learn more at SermonixPharma.com. Contact information: Glenn Garmont LifeSci Advisors Managing Director, Investor Relations Corporate Communications ggarmont@lifesciadvisors.com 646-876-5521