Nastech Initiates Intranasal Human Growth Hormone Phase I Clinical Trial
HAUPPAUGE, N.Y., Oct. 4 /PRNewswire/ -- Nastech Pharmaceutical Company, Inc. (Nasdaq: NSTK - news) announced today that it has commenced a Phase I clinical trial in the United States to evaluate the nasal administration of somatropin (recombinant human growth hormone, or rhGH). The objective of the Phase I study is to determine nasal absorption, tolerance, and safety of somatropin in healthy volunteers.
Somatropin, one of several endocrine hormones, is indicated for the long-term treatment of children with growth failure due to lack of adequate endogenous growth hormone secretion. In addition, there are several sub-indications in pediatrics and adults, including short stature associated with Turner syndrome, achondroplasia, chronic renal disease, intrauterine growth retardation, and growth hormone deficiency in adults. Somatropin, at 22,500 Daltons, has a slightly higher molecular weight than interferon alpha, which was successfully administered intranasally in a clinical trial conducted by Nastech earlier this year. Current manufacturers of somatropin include Pharmacia, Sereno, Eli Lilly, Novo Nordisk, and Genentech. Total worldwide sales exceed $1 billion annually.
``Initiation of Phase I clinical trials with somatropin is consistent with our strategy to assess the potential of intranasal formulations for macromolecules currently administered via injections and follows on the heels of our successful trial with interferon alpha,'' stated Steven C. Quay, M.D., Ph.D., Chairman, President and Chief Executive Officer of Nastech. ``The prospect of a needle-free alternative for somatropin is an exciting approach to improving safety and patient compliance, particularly among children.'' |
