AVI BIOPHARMA INITIATES PHASE II CARDIOVASCULAR CLINICAL STUDY.BioPharma, Inc. (Nasdaq:AVII), Portland, Ore., has initiated patient enrollment in Germany for the company's APPRAISAL Phase II clinical study. The APPRAISAL trial is designed to evaluate AVI's Resten- MP(TM) in the prevention of cardiovascular restenosis when delivered intravenously in conjunction with the placement of one or more bare- metal stents. Resten-MP is AVI-4126 delivered via intravenous injection using AVI's patented microparticle delivery technology. In preclinical studies, Resten-MP was as effective as AVI-4126 delivered by catheters or stents in preventing cardiovascular restenosis. "Restenosis continues to impede effective long-term interventional cardiology," said Peter D. O'Hanley, Ph.D., M.D., M.P.H., senior vice president of clinical development and regulatory affairs at 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. . "Even with widespread use of drug-eluting stents (DES) in the U.S., several patient populations, such as those with diabetes, still experience restenosis and could benefit from alternative therapies." The drug component in Resten-MP, AVI-4126 (Resten-NG(R)), was found to prevent restenosis in the AVAIL Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II . In this multicenter study, Resten-NG was injected directly into the coronary artery using a special drug delivery catheter at the time of stent placement. Resten-NG in the therapeutic dose arm demonstrated statistically significant efficacy in preventing restenosis determined by both quantitative angiography and intravascular ultrasound compared with a control arm and a subtherapeutic sub·ther·a·peu·tic adj. Below the dosage levels used to treat diseases: subtherapeutic feeding of penicillin to livestock. sub dose arm. Further, Resten-NG significantly reduced the neointimal growth that contributes to the failure of angioplasty intervention. The binary restenosis rate was reduced by 75 percent among patients who received a therapeutic dose. "AVI is also conducting a Phase II clinical study with Resten-MP delivered intravenously at the University of Nebraska Medical Center In 1991, a technology transfer office was created known as UNeMed. In 1997, the UNMC hospital merged with the nearby hospital operated by Clarkson College to become what was later renamed The Nebraska Medical Center. in combination with the Taxus stent," said Denis Denis, king of Portugal: see Diniz. R. Burger, Ph.D., chief executive officer of AVI. "Taken together, the two ongoing studies are designed to evaluate the benefit of AVI-4126 in combination with drug-eluting stents, and whether the long-term complications seen in some drug-eluting stent data can be avoided by using Resten-MP in combination with bare-metal stents." AVI-4126 is a third-generation 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). agent that targets the key regulatory gene involved in cardiovascular restenosis, the transcription factor referred to as c-myc. C-myc is believed to regulate the many downstream genes that produce the pathology of restenosis, including cell migration and adhesion, collagen formation, secretion of extra-cellular matrix, and cell proliferation. About the Study The primary therapeutic endpoint of the study is the subsequent reduction in luminal diameter (late loss) from the time of intervention to follow-up at six months, as measured by quantitative angiography and intravascular ultrasound. Reduction in late loss is the standard indicator cardiologists use to gauge long-term stent efficacy. The University of Essen in Germany is the principal investigative center. Prof. Dr. med. Raimund Erbel, director of cardiology at the center, has appointed PD Dr. Stefan Sack as the principal investigator to coordinate the study with the other German centers participating in the trial, including the University of Heidelberg and the Coburg Clinical Center. AVI is conducting this study in collaboration with Harvard Clinical Research Institute (HCRI HCRI Harvard Clinical Research Institute HCRI Health Communication Research Institute, Inc. ), an internationally recognized organization specializing in the management of coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. and stents. A validated historical database with over 20,000 patients will be used by HCRI as the comparator comparator Instrument for comparing something with a similar thing or with a standard measure, in particular to measure small displacements in mechanical devices. In astronomy, the blink comparator is used to examine photographic plates for signs of moving bodies. in this initial advanced clinical phase study. Donald Cutlip, M.D., chief medical officer at HCRI, said, "This statistically robust clinical study should determine if Resten-MP has clinical benefit to patients that would receive a bare-metal coronary artery stent. If Resten-MP can significantly reduce late lumen loss at six months compared to the historical control, there is every confidence that pivotal studies would demonstrate the therapeutic value of the drug." About AVI BioPharma AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using third-generation NEUGENE(R) antisense drugs. AVI's lead NEUGENE antisense compound is designed to target cell proliferation disorders, including cardiovascular restenosis, 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. . In addition to targeting specific genes in the body, AVI's antiviral program uses NEUGENE antisense compounds to combat disease by targeting single-stranded RNA viruses, including West Nile virus West Nile virus, microorganism and the infection resulting from it, which typically produces no symptoms or a flulike condition. The virus is a flavivirus and is related to a number of viruses that cause encephalitis. , hepatitis C virus
For more information, visit http://www.avibio.com or call 503/227-0554. |
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