AVI BioPharma and Interventional Technologies Initiate Collaboration for Human Clinical Trials in Cardiovascular Restenosis.Business Editors, Health/Medical Writers PORTLAND, Ore.--(BW HealthWire)--March 10, 2000 AVI's Novel NEUGENE(R) Drug, Resten-NG, Will be Used in Combination With IVT's Drug Delivery Catheter to Treat Restenosis in Upcoming Phase II Studies. AVI BioPharma (Nasdaq:AVII)(Nasdaq:AVIIW)(Nasdaq:AVIIZ) and Interventional Technologies (IVT IVT intravenous transfusion. ) today announced they have initiated a collaboration in human clinical trials of Resten-NG(TM), AVI's gene-targeted therapeutic drug for cardiovascular restenosis. Under terms of collaboration IVT will supply their Infiltrator(R) intramural intramural /in·tra·mu·ral/ (-mu´r'l) within the wall of an organ. in·tra·mu·ral adj. Occurring or situated within the walls of a cavity or organ. delivery catheters for the upcoming Phase II trials at New York's Lenox Hill Hospital Lenox Hill Hospital, on Manhattan's Upper East Side, is a 652-bed, acute care hospital and a major teaching affiliate of NYU Medical Center. Founded in 1857 as the German Dispensary, today's 10-building Lenox Hill Hospital complex has occupied its present site since 1868 when it , and 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. will use this catheter in its Resten-NG development program. Resten-NG will be delivered into the coronary arteries of patients undergoing balloon angioplasty. The Infiltrator has proven to be remarkably effective in delivery of Resten-NG in preclinical studies conducted by AVI. These studies also indicated that Resten-NG was considerably more potent and less toxic than other 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). agents in clinical development. Full results from these studies will be presented at the American College of Cardiology The American College of Cardiology (ACC) is a nonprofit medical association established in 1949 to educate, research and influence health care public policy. The president for the 2006–2007 year is Steven E. Nissen. [1] The organization has 39 chapters in the U.S. Annual Meeting March 11-16 in Anaheim, California. Phase I human trials with Resten-NG are currently in progress. Resten-NG is AVI's first compound from its novel third generation NEUGENE(R) antisense technology platform to enter clinical trials. "We were pleased to have identified an exceptional delivery catheter for Resten-NG to support our upcoming Phase II trials," Denis Denis, king of Portugal: see Diniz. R. Burger, Ph.D., President and Chief Executive Officer of AVI said. "We believe that the introduction of Resten-NG into the clinic in conjunction with use of the Infiltrator will demonstrate that our proprietary NEUGENE antisense will fulfill the promise that other antisense technologies have thus far failed to meet." Dr. Burger continued, "After years of comprehensive research, we have developed an antisense chemistry that overcomes the pharmaceutical limitations still inherent in other antisense approaches, positioning AVI as a leader in this field. Because NEUGENE compounds were designed and synthesized with novel chemistries, they have pharmaceutical advantages not possible with other antisense technologies." Commenting on the collaboration, Robert E. Reiss, Interventional Technologies Chairman and Chief Executive Officer, said, "We are very pleased to be working with AVI and the world class researchers associated with this project. Precise volumetric volumetric /vol·u·met·ric/ (vol?u-met´rik) pertaining to or accompanied by measurement in volumes. vol·u·met·ric adj. Of or relating to measurement by volume. deposition directly into the arterial wall will maximize Resten-NG's therapeutic benefits while demonstrating the Infiltrator's fast and efficient intramural delivery." The Infiltrator has been registered with the U.S. 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. as a Device Master File and has been awarded the CE Mark for European distribution. Resten-NG targets the genetic sequence c-myc, a gene responsible for initiating cell replication. Extensive preclinical studies of the compound in treating restenosis have shown highly significant preservation of vessel passageways and prevention of arterial wall thickening. Delivering Resten-NG to the site of angioplasty blocks the growth and proliferation events in the vessel walls. Approximately 1.2 million balloon angioplasty procedures are performed each year with a market exceeding $1 billion annually. Interventional Technologies is a leader in developing engineering solutions for treating cardiovascular diseases. Its lead product, the Cutting Balloon(TM) microsurgical dilatation dilatation /dil·a·ta·tion/ (dil?ah-ta´shun) 1. the condition, as of an orifice or tubular structure, of being dilated or stretched beyond normal dimensions. 2. the act of dilating or stretching. system, is utilized around the world and currently awaits FDA approval. The company also markets the TEC(R) Thrombectomy thrombectomy /throm·bec·to·my/ (throm-bek´tah-me) surgical removal of a clot from a blood vessel. throm·bec·to·my n. Excision of a thrombus. System to remove plaque and thrombus thrombus /throm·bus/ (throm´bus) pl. throm´bi a stationary blood clot along the wall of a blood vessel, frequently causing vascular obstruction. (blood clots) from diseased arteries and the Trackwire(R) family of guidewires. Other products in development include the LP-Stent(TM), which carries the CE Mark and is undergoing US Clinical Trials, The Irradiator(TM) radiopharmaceutical delivery system, the Fullflow(R) non-balloon perfusion dilatation system, a precious-metal alloy stent for saphenous vein bypass grafts and a covered stent. The company's facilities are located in San Diego and Murrieta, California, as well as Letterkenny, Ireland. AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using two technology platforms: cancer immunotherapy and gene-targeted drugs. Its lead clinical agent, AVICINE(TM), a therapeutic cancer vaccine, is undergoing a Phase II trial in pancreatic cancer, and will soon enter a Phase III pivotal trial in colorectal cancer and a Phase II trial in prostate cancer. The first application of its NEUGENE compounds, Resten-NG, 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 I trials for restenosis. More information about AVI is available 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 pre-clinical and clinical testing, the effect of regulation by the FDA 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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