Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK) presents data today from a Phase I pharmacokinetic study of Parathyroid Hormone (PTH1-34) nasal spray demonstrating a similar pharmacokinetic profile to the approved subcutaneous product, Forteo(R) (teriparatide). The data are being presented at the American Association of Clinical Endocrinologists Annual Meeting in Chicago.
The Phase I study was conducted in 12 healthy human subjects between the ages of 20 and 40. Each subject received a single 20 ug subcutaneous injection of teriparatide followed by successive doses of an intranasal formulation of PTH1-34 to allow for pharmacokinetic comparison in the same subject. The bioavailability of each PTH1-34 nasal spray formulation relative to the subcutaneous injection was also measured.
In the study, the PTH1-34 nasal spray formulations had bioavailability relative to the subcutaneous injection of up to 15 percent. Intersubject variability for the intranasal formulations was similar to, or lower than, the subcutaneous injection, suggesting that intranasal dosing may provide consistent exposure among individuals.
All formulations tested were well tolerated and there were no clinically significant changes from baseline for vital signs, electrocardiograms, nasal examinations, or laboratory evaluations. In the study, there were two occurrences of hypercalcemia following subcutaneous administration of teriparatide, and no cases of hypercalcemia following any of the nasal spray doses.
“Nastech has applied our robust drug delivery technology and formulation science expertise to formulate a PTH1-34 nasal spray that was well tolerated in Phase I studies, and had a similar pharmacokinetic profile to the existing injectable product,” stated Steven C. Quay, M.D., Ph.D., Chairman, President and CEO of Nastech. “These are important achievements, and clearly support further development of this product candidate.”
PTH1-34 is a fragment of the naturally occurring human parathyroid hormone that is an important regulator of calcium and phosphorus metabolism. When given by daily injection, PTH1-34 has been shown to increase bone mineral density and significantly reduce both vertebral and non-vertebral fractures in postmenopausal women. Daily injections of PTH1-34 are approved for the treatment of postmenopausal osteoporosis. In February 2006, Nastech and P&G entered into a development and commercialization collaboration for PTH1-34 nasal spray.
Nastech is a pharmaceutical company developing innovative products based on proprietary molecular biology-based drug delivery technologies. Nastech and its collaboration partners are developing products for multiple therapeutic areas including respiratory disease, inflammatory conditions, obesity and osteoporosis. Additional information about Nastech is available at http://www.nastech.com
Nastech Forward Looking Statements
Statements made in this press release may be forward-looking statements within the meaning of Federal Securities laws that are subject to certain risks and uncertainties and involve factors that may cause actual results to differ materially from those projected or suggested. Factors that could cause actual results to differ materially from those in forward-looking statements include, but are not limited to: (i) the ability of Nastech to obtain additional funding; (ii) the ability of Nastech to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) Nastech’s and/or a partner’s ability to successfully complete product research and development, including preclinical and clinical studies and commercialization; (iv) Nastech’s and/or a partner’s ability to obtain required governmental approvals; and (v) Nastech’s and/or a partner’s ability to develop and commercialize products that can compete favorably with those of competitors. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Nastech’s most recent periodic reports on Form 10-K and Form 10-Q that are filed with the Securities and Exchange Commission. Nastech assumes no obligation to update and supplement forward-looking statements because of subsequent events.
Nastech Pharmaceutical Company Inc.