More Convenient, Oral Delivery Method for Insulin, Other Protein Drugs is Described in Diabetes Technology & Therapeutics.

NEW ROCHELLE, N.Y. -- The concept of an insulin pill and the production of other protein drugs for oral delivery took a major step forward with the report of a novel method of oral gene therapy in the June 2005 issue (Volume 7, Number 3) of Diabetes Technology & Therapeutics, a peer-reviewed journal published by Mary Ann Liebert, Inc. The paper is available free online at www.liebertpub.com/dia.

This emerging technology for peptide drug delivery would allow patients to take insulin and other protein drugs by mouth rather than by injection. In a paper entitled, "Oral Gene Therapy: A Novel Method for the Manufacture and Delivery of Protein Drugs," co-authors Stephen Rothman, Ph.D., Hsien Tseng, M.D., and Ira Goldfine, M.D., from the University of California, San Francisco, and Genteric, Inc. (Alameda, CA) present proof of principle for the concept of delivering a protein drug in the form of a DNA plasmid, a small circular DNA molecule that can be swallowed.

The plasmid carries the gene for a particular protein, which the body then manufactures in the cells of the small intestine and delivers directly into the bloodstream. This avoids the problem that plagues traditional protein drug delivery, in which orally delivered proteins are broken down in the gastrointestinal tract or are poorly absorbed, do not reach the bloodstream, and cannot exert their intended effect.

"This promising 'gene pill' technology could provide an effective alternative method for delivering protein and peptide drugs currently administered only through injection," says David C. Klonoff, M.D., Editor-in-Chief of the Journal and Clinical Professor of Medicine at the University of California at San Francisco. "It overcomes two critical, practical limitations of current protein drugs manufactured using conventional recombinant biotechnology-based methods: their poor oral bioavailability and the need to produce these drugs as injectables; and the high cost associated with purifying recombinant proteins from complex mixtures."

These plasmid-encoded proteins have a short-lived action and the drugs would need to be taken every one to two days. The advantage of this frequent dosing is that dosages can be altered from day to day, and the drug can be discontinued quickly in the event of side effects.

Diabetes Technology & Therapeutics is an authoritative peer-reviewed journal published bimonthly in print and online that presents new technology and new products for the treatment, monitoring, diagnosis, and prevention of diabetes and its complications. Technologies include noninvasive glucose monitoring, implantable continuous glucose sensors, novel routes of insulin administration, genetic engineering, the artificial pancreas, measures of long-term control, computer applications for case management, telemedicine, the Internet, and new medications.

Tables of contents and a free sample issue may be viewed online at www.liebertpub.com.

Mary Ann Liebert, Inc., is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Human Gene Therapy, Disease Management, and Metabolic Syndrome and Related Disorders. Its biotechnology trade magazine, Genetic Engineering News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 60 journals, books, and newsmagazines is available at www.liebertpub.com.