AVI BioPharma Announces Efficacy of Oral Administration of its Proprietary NEUGENE Antisense Agents in Rats.Business Editors & Health/Medical Writers PORTLAND, Ore.--(BW HealthWire)--March 21, 2002 Study is First to Demonstrate Feasibility of Oral Antisense Therapy AVI BioPharma, Inc. (Nasdaq:AVII) (Nasdaq:AVIIW) (Nasdaq:AVIIZ) today announced the publication of a peer reviewed study in the Journal of Pharmaceutical Sciences demonstrating effectiveness of its third-generation NEUGENE(R) antisense antisense, DNA or RNA manipulated in a laboratory so that its components (nucleotides) form a complementary copy of normal, or "sense," messenger RNA (mRNA; see nucleic acid). drugs when administered orally in rats. The results are an important step toward the development of NEUGENE compounds as orally administered therapeutic agents. Study investigators evaluated the effects of oral versus intravenous administration of two separate NEUGENE compounds. Bioavailability bioavailability /bio·avail·a·bil·i·ty/ (bi?o-ah-val?ah-bil´i-te) the degree to which a drug or other substance becomes available to the target tissue after administration. bi·o·a·vail·a·bil·i·ty n. data was then integrated with in-vivo efficacy of the compounds in two models using distinct gene targets. Results showed that each compound blocked its target gene. "The results of this study have powerful human implications," said Patrick L. Iversen, Ph.D., senior vice president of research and development for AVI (Audio Video Interleaved) A Windows multimedia video format from Microsoft. It interleaves standard waveform audio and digital video frames (bitmaps) to provide reduced animation at 15 fps at 160x120x8 resolution. Audio is 11,025Hz, 8-bit samples. . "With this information, we are much closer to developing oral antisense therapies that will provide patients around the world with more efficacious and cost-effective drugs to treat a broad range of diseases." The most common challenge of orally administered agents is assuring their integrity and availability to the site of action once the agents are exposed to the gastrointestinal tract gastrointestinal tract n. The part of the digestive system consisting of the stomach, small intestine, and large intestine. Gastrointestinal tract . The studies demonstrate AVI's NEUGENES can pass through the intestinal lining, enter the bloodstream, and be carried to the liver's site of action. Results from the study showed that with oral administration, the availability of study compounds was nearly 80 percent of the availability observed from intravenous injection. In fact, the orally administered NEUGENES proved more effective than intravenous administration in blocking certain genetic targets. AVI's NEUGENE antisense compounds have been tested in more than 200 human subjects and have been shown to be safe. NEUGENE administration in these tests has included intravenous, subcutaneous and oral routes. AVI has developed third-generation antisense compounds that are more stable, specific, efficacious and safe than other antisense or gene-targeting agents. The company's NEUGENE compounds are distinguished by a morpholino-type backbone, which replaces the natural or modified backbones of competing antisense or gene-targeting technologies. About AVI BioPharma AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using two technology platforms: NEUGENE antisense drugs and cancer immunotherapy. Its lead cancer agent, AVICINE(R), a therapeutic cancer vaccine, has completed three Phase II trials in colorectal and pancreatic cancer pancreatic cancer Malignant tumour of the pancreas. Risk factors include smoking, a diet high in fat, exposure to certain industrial products, and diseases such as diabetes and chronic pancreatitis. Pancreatic cancer is more common in men. and is in a Phase III pivotal trial in colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. . The first application of its NEUGENE compounds, Resten-NG(TM), is designed to treat cancer, cardiovascular restenosis and other cell proliferation disorders by inhibiting the production of a cellular transcription factor, the oncogene oncogene Gene that can cause cancer. It is a sequence of DNA that has been altered or mutated from its original form, the proto-oncogene (see mutation). Proto-oncogenes promote the specialization and division of normal cells. c-myc. It is currently in Phase II trials for restenosis and in Phase I/II trials for cancer and polycystic kidney disease Polycystic Kidney Disease Definition Polycystic kidney disease (PKD) is one of the most common of all life-threatening human genetic disorders. . More information about AVI is available on the Company's Web site at http://www.avibio.com/. "Safe Harbor" Statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995: The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including, but not limited to, the results of research and development efforts, the results of preclinical and clinical testing, the effect of regulation by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and other agencies, the impact of competitive products, product development, commercialization and technological difficulties, and other risks detailed in the Company's Securities and Exchange Commission filings. |
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