NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, announced that data about hypoparathyroidism will be presented at the 2011 Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in San Diego, CA, September 16-20, 2011. NPSP558, the company's bioengineered replica of human parathyroid hormone (rhPTH 1-84), is currently in development as the first hormone replacement therapy for hypoparathyroidism. The presentations will include findings from investigator-initiated studies of rhPTH (1-84) and new information about the costs and co-morbidities associated with hypoparathyroidism.
"We believe the data being presented are very encouraging and further support the potential of using NPSP558 to treat the underlying cause of hypoparathyroidism by replacing the missing parathyroid hormone," said Francois Nader, MD, president and chief executive officer of NPS Pharmaceuticals. "These data also underscore the importance of individualizing replacement therapy for hypoparathyroidism patients, as we are doing it in our Phase 3 REPLACE study of NPSP558, which is on track for top-line results later this year."
"Hypoparathyroidism has widespread consequences ranging from asymptomatic presentation to fatal hypocalcemia" Bart Clarke, MD, associate professor of medicine at the Mayo Clinic. "It is the only endocrine disorder for which we do not have a replacement hormone available to treat the underlying condition. Doctors currently can only provide supportive care aimed at managing the symptoms associated with hypocalcemia through calcium and vitamin D supplements. Patients are faced with striking a balance between managing their symptoms and avoiding the long-term risks associated with current treatments, which can result in kidney stones, kidney damage, and even kidney failure. Patients need better treatment options, ideally the ability to achieve a more physiological outcome by delivering the missing hormone."
Identified below are the titles and links to the abstracts for the NPS and investigator-initiated research.
Oral Presentations:
PTH (1-84) Replacement Therapy in Hypoparathyroidism (HypoPT): A Randomized Controlled Trial on Pharmacokinetics and Dynamic Effects Following 24 Weeks of Treatment
Lead Author: Tanja Sikjaer, Aarhus University Hospital, Denmark
Abstract No. 1098
Sunday, September 18, 2011; 9:45 a.m.
Treatment of Hypoparathyroidism with PTH (1-84) Is Safe and Effective For Up to 4 Years
Lead Author: Natalie Cusano, Columbia University College of Physicians and Surgeons
Abstract No. 1097
Sunday, September 18, 2011; 9:30 a.m.
Poster Presentations:
Co-Morbid Medical Conditions Associated with Prevalent Hypoparathyroidism: A Population-Based Study
Lead Author: Bart Clarke, Mayo Clinic College of Medicine
Abstract No. SA0170
Saturday, September 17, 2011; 11 a.m. to 1 p.m.
Medical Care Costs for Persons with and without Prevalent Hypoparathyroidism: A Population-Based Study
Lead Author: Cynthia Leibson, Mayo Clinic, Department of Health Sciences Research
Abstract No. MO0170
Monday, September 19, 2011; 11:30 a.m. to 1:30 p.m.
Relationships Between Pharmacokinetic Profile of Human PTH(1-84) and Serum Calcium Response in Postmenopausal Women Following 4 Different Methods of Administration
Lead Author: John Fox, NPS Pharmaceuticals
Abstract No. MO0173
Monday, September 19, 2011; 11:30 a.m. to 1:30 p.m.
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