Emisphere Technologies Announces the Launch of a Human Clinical Trial For Oral Parathyroid Hormone (PTH)

Emisphere Technologies Announces the Launch of a Human Clinical Trial For Oral Parathyroid Hormone (PTH)

Emisphere Technologies, Inc. (NASDAQ:EMIS) announced today that Novartis Pharma AG has launched a Phase I study in postmenopausal women to determine the safety and tolerability of oral PTH134, a combination of human PTH-1-34 and the absorption enhancer 5-CNAC using Emisphere's proprietary Eligen(R) technology, for the treatment of postmenopausal osteoporosis. The study is designed to assess the bioavailability profile of increasing doses of PTH-1-34 combined with different amounts of 5-CNAC administered orally. The trial is being conducted in Switzerland and is estimated to yield first interpretable results by the end of the year.

Osteoporosis is a disease associated with a gradual thinning and weakening of the bones, occurring most frequently in women after menopause. Thinner and weaker bones are increasingly susceptible to fractures. Untreated postmenopausal osteoporosis can lead to chronic back pain, disabling fractures, and lost mobility.

Not only are thinner bones a problem, but many groups have begun testing the use of parathyroid hormone pre or post stem cell transplant as a means of improving the viability of recently transplanted hematopoetic cells. The bone matrix provides physical and chemical signals that the cells need to properly divide asymmetrically.