Chiasma to Host an Expert Panel on Acromegaly and the MPOWERED® Phase 3 Trial Results
NEEDHAM, Mass., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ: CHMA), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases on burdensome and painful injections, today announced that it will host an expert panel on acromegaly and the results from its recently completed MPOWERED® Phase 3 clinical trial on Monday, November 30, 2020 at 11:00 am Eastern Time.
The call will feature presentations by Key Opinion Leader (KOL) Maria Fleseriu, MD, FACE, lead investigator of the MPOWERED study, who will discuss the topline data from Chiasma’s Phase 3 MPOWERED study as well as the unmet medical need in acromegaly and the treatment burden that patients experience with monthly somatostatin analog injections. Additionally, a renowned patient advocate and Acromegaly Community President Jill Sisco will discuss the patient experience switching to MYCAPSSA®. Dr. Fleseriu and Ms. Sisco will be available to answer questions following the formal presentations.
Chiasma's management team will also provide an overview of the MPOWERED Phase 3 topline data, which were announced on November 18th. MPOWERED (Maintenance of acromegaly Patients with Octreotide capsules compared with injections – Evaluation of REsponse Durability), was a global, randomized, non-inferiority, open-label, and active-controlled 15-month trial that was designed to support a potential marketing application of MYCAPSSA® in the European Union.
Maria Fleseriu, MD, FACE is a Professor of Medicine and Neurological Surgery and Director of the Pituitary Center at Oregon Health and Science University in Portland, Oregon and Immediate Past President of the Pituitary Society. Dr. Fleseriu has a long-standing clinical and research interest in the pathophysiology and treatment of pituitary and adrenal disorders. She is a frequent plenary guest speaker at national and international meetings on treatment of Cushing’s, acromegaly and growth hormone deficiency, is global principal investigator in clinical trials, and has authored over 170 manuscripts in prestigious journals, including guidelines, consensus papers and book chapters.
Dr. Fleseriu has been awarded the title of “Doctor Honors Causa” by the University of Medicine and Pharmacy “Carol Davila” Bucharest, she serves on the Board of Directors and chairs Physician Education Committee for Pituitary Society, she serves on several committees for the Endocrine Society, Pituitary Society, and American Association of Clinical Endocrinology and she is past chair of the Endocrine Society Guidelines Committee and the Hypopituitarism task force.
Dr. Fleseriu is Chief Editor of Pituitary Endocrinology for Frontiers in Endocrinology, Section Head for Pituitary and Neuroendocrine F 1000, Associate Editor for European Journal of Endocrinology, Reviews in Endocrinology and Metabolism, Senior Editor for Endocrinology, Diabetes and Metabolism CR and a member of the editorial board of Pituitary. She has been involved in leadership positions of educational programs sponsored by the Endocrine Society, the Pituitary Society, and patient advocacy groups to teach physicians and patients about pituitary tumors and neuroendocrine disorders. She has served on multiple scientific advisory boards for biotechnology and pharmaceutical companies and participated in study design and has been global principal investigator for several Cushing’s and acromegaly studies.
Dr. Fleseriu received her medical degree from the University of Medicine and Pharmacy, Timisoara, Romania and completed endocrinology training at University Hospital Sibiu, National Institute of Endocrinology “C.I Parhon” (with focus on pituitary disorders), Romania and Centre Hospitalier Luxembourg in Luxembourg. She pursued additional residency in internal medicine at Case Western Reserve University and an endocrinology fellowship at Cleveland Clinic in USA.
Jill Sisco is President of Acromegaly Community, Inc., a patient organization that helps educate patients and loved ones regarding this rare disease and provides guidance on how to cope with their difficult illness. Since her diagnosis in 2005, Jill has been an influential advocate towards a better quality of life for Acromegaly patients worldwide. In 2008, Jill became a leader in patient advocacy and has sat on several Acromegaly advisory boards. Jill has presented the patient perspective to FDA, co-authored several medical journal articles and abstracts regarding Acromegaly, and manages the widely visited patient community website and social media support groups. By organizing and hosting the biennial International Acromegaly Community Conference which engages patients, specialists, and pharmaceutical companies, Jill shows how passionate she is about providing an emotional and communal support network for people touched by acromegaly. She works tirelessly to enable forward thinking that will facilitate research, assist patients with their treatment plans, and provide positive outcomes for the future of acromegaly patients everywhere. Jill is highly respected in her community and has been a pioneer in building awareness around Acromegaly. Through her dedication, Jill leads by example and is a proponent of patients taking control of their lives and their disease and advocating for their best health possible.
MPOWERED™ Phase 3 Clinical Trial
INDICATION AND USAGE
IMPORTANT SAFETY INFORMATION
Blood sugar, thyroid levels, and vitamin B12 levels should be monitored and treated accordingly.
Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.
Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.
To report SUSPECTED ADVERSE REACTIONS, contact the product information department at 1-844-312-2462 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
The full Prescribing Information for MYCAPSSA is available at www.MYCAPSSA.com.
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