BOTHELL, Wash., June 26 /PRNewswire-FirstCall/ -- In a preliminary Phase I clinical trial, a nasal spray dosage form of Parathyroid Hormone (PTH1-34) developed by Nastech Pharmaceutical Company Inc. provided comparable exposure levels to the approved subcutaneous product, Forteo(R) (teriparatide), in elderly subjects, according to data presented at ENDO(R) 2006, the 88th Annual Meeting of the Endocrine Society. If further development is successful and leads to regulatory approval, PTH1-34 nasal spray may offer an alternative to the daily injections of the currently approved product.
The Phase I study was conducted in 25 healthy human subjects between the ages of 66 and 77. Each subject received a single 20 ug subcutaneous injection of teriparatide followed by four 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 11 percent. All formulations tested were well tolerated and there were no clinically significant changes from baseline for vital signs, electrocardiograms, nasal examinations, or laboratory evaluations.
“The results of this study in the elderly are consistent with the previous PTH1-34 nasal spray human clinical study and further demonstrate the potential for PTH1-34 nasal spray to offer a patient-preferred route of administration for this effective therapeutic,” stated Steven C. Quay, M.D., Ph.D., Chairman, President and CEO of Nastech.
About PTH1-34
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. Forteo(R) (daily injections of PTH1-34) is 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.
About Nastech
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.
CONTACTS: Nastech Ed Bell Senior Investor Relations Manager (425) 908-3639 ir@nastech.com Noonan Russo Matthew Haines (Investors/Media) (212) 845-4235
Nastech Pharmaceutical Company Inc.
CONTACT: Ed Bell, Senior Investor Relations Manager, Nastech,+1-425-908-3639, ir@nastech.com; Investors/Media: Matthew Haines of NoonanRusso, +1-212-845-4235
Web site: http://www.nastech.com/
