On July 20, 2015 Radius reported that Debasish Roychowdhury, M.D., who previously served as Seragon’s Acting Chief Medical Officer, has been elected to the company’s Board of Directors. Dr. Roychowdhury is a leader in the pharmaceutical industry with a strong background in oncology research and development, and regulatory and commercial operations, having previously served in key senior leadership roles at Sanofi, GlaxoSmithKline and Eli Lilly (Press release, Radius, JUL 20, 2015, View Source [SID:1234506529]). Debasish played a key role in the development and advancement of Seragon’s selective estrogen receptor degraders (SERDs) platform for breast cancer and other hormone-driven cancers.
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Radius Health also announced today that it has formed an Oncology Clinical Advisory Board (OCAB) comprised initially of two renowned leaders in the field of oncology: Professor Mitch Dowsett, FMedSci, PhD, and Professor George W. Sledge Jr.
"We are delighted to have attracted someone with Debasish’s experience and leadership in the field of oncology to join our Board of Directors. In addition, we are honored to have the esteemed counsel of two of the leading authorities in the field of breast cancer research, Professor Dowsett and Professor Sledge, join our newly formed OCAB," said Radius Health CEO, Robert E. Ward. "We are excited about the value these accomplished individuals are expected to bring to Radius as we seek to accelerate the development of RAD1901 in breast cancer."
Debasish has a distinguished track record in the field of oncology having been involved in the approval of nine oncology drugs, including Almita, Tykerb and Jevtana. Currently, he is President of Nirvan Consultants, LLC and in this capacity he serves in senior advisory roles for biotechnology companies to help advance their pipeline of therapeutics. Debasish also serves as a member of the Board of Directors for Lytix Biopharma AS.
Prior to the acquisition of Seragon by Roche, Debasish was one of the founding members of the Seragon Clinical and Scientific Advisory Board and served as Seragon’s Acting Chief Medical Officer. Previously, Debasish was the Senior Vice President of Global Oncology and Head of the Global Oncology Division at Sanofi until November 2013. Prior to that, he served as the Vice President for Clinical Development at GlaxoSmithKline and directed the oncology global regulatory group at Eli Lilly and Company. In his academic career, Debasish served as a faculty member at the University of Cincinnati. He trained at the All India Institute of Medical Sciences and University of California, San Francisco.
Oncology Clinical Advisory Board (OCAB)
Radius is pleased to announce the formation of the OCAB with its first two members, both of whom are world renowned scientific and clinical authorities in the field of oncology: Professor Mitch Dowsett, and Professor George Sledge.
Professor Mitch Dowsett, FMedSci, PhD, is Head of the Academic Department of Biochemistry and Head of the Centre for Molecular Pathology at the Royal Marsden Hospital in London, UK. He is also Professor of Biochemical Endocrinology at the Institute of Cancer Research, Professor of Translational Research in the Breakthrough Breast Cancer Centre, Team Leader for Breast Cancer Research for the Biomedical Research Centre for Cancer and Leader of the Endocrinology Team at the Breakthrough Breast Cancer Centre. Dr. Dowsett’s main scientific interests have been related to the endocrine basis of the majority of breast cancers, and his studies to understand the mechanisms of response and resistance to estrogen deprivation in the treatment of breast cancer. His studies led to the development of aromatase inhibitors.
Dr. Sledge is Professor and Chief of Medical Oncology at Stanford University Medical Center, and specializes in the study and treatment of breast cancer. Dr. Sledge directed the first large, nationwide study on the use of paclitaxel to treat advanced breast cancer. His recent research focuses on novel biologic treatments for breast cancer. He has published over 300 articles in medical journals about breast cancer and chaired several clinical trials involving new breast cancer treatments. Dr. Sledge serves as Editor-in-Chief of the journal Clinical Breast Cancer and is past President of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). He served as Chairman of the Breast Committee of the Eastern Cooperative Oncology Group from 2002 to 2009 where he played an important role in the development of several nationwide clinical trials. He has also served as Chair of ASCO (Free ASCO Whitepaper)’s Education Committee, member of the Department of Defense Breast Cancer Research Program’s Integration Panel, member of the Food and Drug Administration’s Oncology Drug Advisory Committee (ODAC) and is currently a member of the External Advisory Committee for the Cancer Genome Atlas (TCGA) project.
About the Investigational Drug RAD1901
Radius is developing the investigational drug RAD1901 as a potential treatment for estrogen-receptor-positive (ER+) breast cancer. The drug also has potential as a treatment for other ER+ cancers, such as ovarian or endometrial cancer. The National Cancer Institute estimates that approximately 70% of breast cancers are ER+ and may grow in response to exposure to estrogen. Endocrine therapy is intended to block the estrogen signal or reduce the production of estrogen. More information about breast cancer and endocrine therapy may be found on the National Cancer Institute website View Source
RAD1901 is an investigational, non-steroidal small molecule that is designed to selectively bind and degrade the estrogen receptor. RAD1901 has demonstrated potent anti-tumor activity in xenograft models of ER+ breast cancer in preclinical testing and complete suppression of the FES-PET signal after six days of dosing in a maximum tolerated dose clinical study. In preclinical models thus far, RAD1901 has shown good tissue selectivity, does not appear to stimulate the uterine endometrium, and appears to protect against bone loss in an ovariectomy-induced osteopenia rat model. In addition, we believe that RAD1901 also has the ability to cross the blood-brain barrier. Radius recently reported preclinical activity of RAD1901 in combination with either mTOR or CDK inhibitors, the results demonstrated potent tumor shrinkage in a patient-derived tumor explant animal model.
Radius has begun a Phase 1 multicenter, open-label, two-part, dose-escalation study of the investigational drug RAD1901 in postmenopausal women with advanced estrogen receptor positive and HER2-negative breast cancer. The study is designed to determine the recommended Phase 2 dose of RAD1901, and includes a preliminary evaluation of the potential anti-tumor effects. The incidence of dose limiting toxicities will be assessed during the first 28 days. Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines every 8 weeks until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months of treatment. Plasma concentrations of RAD1901 will be assessed every 28 days for up to 12 months of treatment. The details of the Phase 1 study of RAD1901 are posted on www.clinicaltrials.gov.
Radius is also developing RAD1901 at lower doses as a Selective Estrogen Receptor Modulator for the potential treatment of vasomotor symptoms. Historically, hormone replacement therapy ("HRT") with estrogen or progesterone was considered the most efficacious approach to relieving menopausal symptoms such as hot flashes. However, because of the concerns about the potential long‑term risks and contraindications associated with HRT, Radius believes a significant need exists for new therapeutic treatment options to treat vasomotor symptoms. In a Phase 2 proof of concept study, RAD1901 at lower doses demonstrated a reduction in the frequency and severity of moderate and severe hot flashes. Radius intends to commence a Phase 2b trial in vasomotor symptoms in the second half of 2015.