COLUMBUS, Ohio, Dec. 08, 2022 (GLOBE NEWSWIRE) — Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat ESR1-mutated metastatic breast and gynecological cancers, today announced that it will share a poster presentation at the 12th AACR-JCA Joint Conference: Breakthroughs in Cancer Research — Translating Knowledge into Practice, which is being held December 10-14 in Maui, Hawaii.
The poster describes a Phase 1 single-dose ethnobridging study evaluating the safety, tolerability and pharmacokinetics (PK) of oral lasofoxifene (5 mg) in healthy Japanese and Caucasian women. A total of 16 women (eight Caucasian and eight Japanese) were enrolled, and patient/baseline characteristics were similar between both groups. Lasofoxifene was well tolerated, with two grade one adverse events considered not related to treatment (calf soreness in a Caucasian woman and upper right arm bruise in a Japanese woman).
The PK data are currently being analyzed and will be presented at the conference. Results of this analysis are expected to show similar lasofoxifene PK profiles between Caucasian and Japanese women.
“We believe targeted lasofoxifene holds great promise for ESR1-mutated metastatic breast cancer patients not only in the U.S. and Europe, but globally,” stated David Portman, M.D., chief executive officer of Sermonix. “To that end, this analysis from this important ethnobridging study will potentially support the development of lasofoxifene for the treatment of ESR1-mutated metastatic breast cancer in Japan.”
Poster presentation details:
|Title:||Phase 1, Open-Label, Single Dose, Ethnobridging Study Evaluating the Safety, Tolerability and Pharmacokinetics of Lasofoxifene in Healthy Japanese and Caucasian Women|
|Session:||Poster session A|
|Date:||Sunday, December 11, 2022|
|Time:||5:30 p.m. – 7:30 p.m. local time (10:30 p.m. Sunday – 12:30 a.m. Monday, EST)|
About the AACR-JCA Joint Conference
The American Association for Cancer Research (AACR) and Japanese Cancer Association (JCA) are proud to offer this 12th AACR-JCA Joint Conference. This meeting series has a long tradition of bringing together outstanding researchers from the United States, Japan and around the world to share their findings and present the latest advances in basic, translational and clinical cancer research. Formal and informal interactions as well as international collaborations are fostered through this unique forum. Just as its predecessors have done, this AACR-JCA Joint Conference will take a broad view of contemporary cancer research and will be of interest to basic, translational and clinical investigators at all career levels.
Lasofoxifene is an investigational, targeted endocrine treatment, and next-generation 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.
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. The Sermonix management team, led by founder Dr. David Portman, has significant experience in all stages of the drug development, regulatory and commercialization processes. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience at AstraZeneca in the breast cancer drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in nuclear receptor biology. Miriam Portman, M.D., is co-founder and chief operating officer, with expertise in clinical trial conduct and patient recruitment. 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.
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