SOURCE: Sermonix Pharmaceuticals LLC

Sermonix Pharmaceuticals LLC

August 03, 2016 10:59 ET

Sermonix Pharmaceuticals Convenes Breast Cancer Oncology Steering Committee to Explore Utility of Lasofoxifene

COLUMBUS, OH--(Marketwired - Aug 3, 2016) -  Sermonix Pharmaceuticals LLC, a specialty pharmaceutical company focused on late-stage women's health products, convened the inaugural meeting of its Oncology Steering Committee July 14th in New York City. The group, which included world-renowned experts focused on the prevention, diagnosis and treatment of breast cancer, discussed the utility of Sermonix's lead investigational drug, lasofoxifene, in breast cancer treatment and survivorship.

"Sermonix is engaging with some of the leading experts in the management of breast cancer patients and survivors, and the input we received at our meeting was invaluable," said Dr. David Portman, Chief Executive Officer and Chief Medical Officer of Sermonix. "Sermonix looks forward to contributing to this important therapeutic area and exploring other uses for lasofoxifene in the oncology space with the ongoing guidance from this esteemed group of researchers and clinicians."

Lasofoxifene, a third-generation selective estrogen receptor modulator (SERM), is one of the most well-studied drugs in its category. It has been evaluated in more than 15,000 women in a comprehensive worldwide phase I-III clinical development program that includes the PEARL, OPAL and other trials, showing a positive impact on vulvovaginal atrophy (VVA) in addition to a reduction in the risk of vertebral and non-vertebral fractures.

With breast cancer treatment routinely involving use of aromatase inhibitors that block estrogen production, side effects for survivors frequently include VVA and osteoporosis. These issues are increasing as survival rates rise and women live longer than ever post-breast cancer treatment.

"There is an unmet need for therapies that can address common genitourinary symptoms of breast cancer survivors," said steering committee member Dr. Michael Krychman, Executive Director of the Southern California Center for Sexual Health and Survivorship Medicine in Newport Beach, California. "These women suffer disproportionately from severe vulvovaginal atrophy that impacts not only their partner relationships, but also negatively impacts their psychosocial well-being. Many of these women either choose not to or cannot tolerate traditional estrogen therapy since it has a box warning for breast cancer, and as many as 20 percent are non-compliant on aromatase inhibitors due to the side effect profile."

Clinical studies have shown that in women with osteoporosis, lasofoxifene reduced the risk of vertebral fractures by 42 percent and non-vertebral fractures by 24 percent compared to placebo, and reduced estrogen-receptor positive breast cancer by 80 percent. Sermonix plans to seek FDA approval for the use of lasofoxifene to treat several women's health indications, including osteoporosis and symptoms of VVA. Approval in other territories will also be sought.

Dr. Larry Norton, Deputy Physician-in-Chief for Breast Cancer Programs at Memorial Sloan Kettering Cancer Center and a member of the steering committee, stated: "Many breast cancer treatments may have deleterious effects on bones, so there are survivors who, for this reason as well as natural aging, are at increased risk for osteoporosis and consequently osteoporotic fractures. While there are therapies that help in these cases, not everyone benefits and some do not tolerate these therapies well. So there is a need for alternative and additional bone-strengthening medications. Since lasofoxifene may also provide improvement in vulvovaginal atrophy, another common problem in breast cancer survivors, it could be useful in improving their health in several ways."

The Sermonix Oncology Steering Committee members are:

  • Shari Goldfarb, M.D., Medical Oncologist, Memorial Sloan Kettering Cancer Center
  • Rinath Jeselsohn, M.D., Instructor in Medicine, Harvard Medical School, Dana-Farber Cancer Institute.
  • Michael Krychman, M.D., Executive Director of the Southern California Center for Sexual Health and Survivorship Medicine in Newport Beach, California; Medical Director, Sexual Medicine, Hoag Hospital, Newport Beach, California
  • Larry Norton, M.D., Deputy Physician-in-Chief for Breast Cancer Programs at Memorial Sloan Kettering Cancer Center; Medical Director of the Evelyn H. Lauder Breast Center; Norna S. Sarofim Chair in Clinical Oncology; Breast Cancer Research Foundation Scientific Director
  • Richard Santen, M.D., Professor of Medicine: Endocrinology and Metabolism, University of Virginia School of Medicine. Immediate Past-President, The Endocrine Society

More on lasofoxifene
Lasofoxifene -- a SERM, also known as an estrogen agonist/antagonist -- was originally developed through collaboration between Ligand Pharmaceuticals and Pfizer. Pfizer developed lasofoxifene for osteoporosis. It did not receive FDA approval in 2009; however, in Europe lasofoxifene was approved for osteoporosis treatment by the EMEA that same year. Pfizer never marketed lasofoxifene in Europe and subsequently rights to lasofoxifene reverted to Ligand in 2011. Sermonix obtained licensing rights to oral lasofoxifene from Ligand in February 2015 and is currently pursuing regulatory approval.

About Sermonix
Sermonix Pharmaceuticals LLC is a specialty pharmaceutical company focused on bringing new and emerging late-stage women's health products through clinical development and regulatory approval. Founded in 2014, Sermonix has assembled a considerable management team with success in women's healthcare development. Dr. David Portman, Sermonix's founder and CEO, was principal investigator for the Phase II and Phase III lasofoxifene clinical trials and was actively involved during the drug's clinical development. Dr. Portman has experience in all stages of the regulatory approval process. James Symons, MS, PhD, is Vice President of Clinical Development at Sermonix and was the global clinical lead for the lasofoxifene development program for vulvovaginal atrophy as well as for multiple women's health submissions to the FDA during his tenure at Pfizer. Paul Plourde, Sermonix Oncology Team Leader, was previously with Astra-Zeneca, where he was instrumental in the development and approval of both tamoxifen and Arimidex®. Elizabeth Attias, MMSc, ScD, Vice President of Business Development, has experience in all stages of women's health product assessment, market development, launch and commercialization. Miriam Portman, M.D., is the Chief Operating Officer of Sermonix. She is former Co-director and Founder of the Columbus Center for Women's Health Research and has extensive experience in clinical research, with a focus on FDA regulatory issues, clinical trial conduct, budgets and contracts.

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