CardioVascular BioTherapeutics Signs Agreement with Kendle for Phase II Clinical Trial.LAS VEGAS Las Vegas (läs vā`gəs), city (1990 pop. 258,295), seat of Clark co., S Nev.; inc. 1911. It is the largest city in Nevada and the center of one of the fastest-growing urban areas in the United States. -- CardioVascular BioTherapeutics, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :CVBT CVBT Cardiovascular Biotherapeutics, Inc CVBT Central Virginia Battlefields Trust (Fredericksburg, VA Civil War history organization) ) today announced it has signed a master service agreement with leading global clinical research organization (CRO) Kendle (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : KNDL). Kendle will support CVBT in its 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 ensuring that the protocol and study adhere to adhere to verb 1. follow, keep, maintain, respect, observe, be true, fulfil, obey, heed, keep to, abide by, be loyal, mind, be constant, be faithful 2. 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. regulatory requirements. Kendle has worked with CVBT to finalize the protocol that will be submitted to the FDA. The clinical trial is evaluating CVBT's drug candidate, with Cardio Vascu-Grow(TM) as its active ingredient, that is injected into no-option heart patients to stimulate the growth of new blood vessels Blood vessels Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names. , a process called angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization. an·gi·o·gen·e·sis n. . The Phase II clinical trial is planned to be an international, multi-site clinical trial performed in the U.S., Canada and Europe, for patients not eligible for traditional interventional therapies such as bypass or stenting procedures. Kendle is now screening sites for participation in the Phase II clinical trial. Thomas J. Stegmann, M.D., co-founder and chief clinical officer of CVBT stated, "By our collaboration with Kendle, a premier global full-service clinical research organization, and expansion of the number of clinical trial sites within the United States and internationally, we hope to accelerate the enrollment of patients in the Phase II trial as compared to enrollment in Phase I, which was completed in March of 2006." About Kendle Kendle International Inc. (Nasdaq: KNDL) is among the world's leading global clinical research organizations and reports it is the fourth-largest provider of Phase II-IV clinical development services. Kendle delivers innovative and robust clinical development solutions - from first-in-human studies through market launch and surveillance - to help the world's biopharmaceutical companies maximize product life cycles and grow market share. Its global clinical development business is focused on five regions - North America, Europe, Asia/Pacific, Latin American and Africa - to meet customer needs. With the expertise of associates worldwide, Kendle has conducted clinical trials or provided regulatory, pharmaco vigilance and validation services in 70 countries. Additional information and investor kits are available upon request from Kendle, 1200 Carew Tower, 441 Vine Street, Cincinnati, OH 45202 or from its web site at www.kendle.com. About CardioVascular BioTherapeutics CVBT is a biopharmaceutical company developing drug candidates with Cardio Vascu-Grow(TM) as the active ingredient for a number of diseases characterized by inadequate blood flow to a tissue or organ. The company is currently conducting two FDA-authorized clinical trials: one in 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. in no-option heart patients, and one in impaired wound healing wound healing Physiology The repair of a wound Steps Inflammation, repair and closure, remodeling, final healing; repair of incisions may be either simple–'clean' wounds with little loss of tissue heal by 'primary intention', or 'dirty' wounds heal by seen in diabetics. Additionally, the company has completed pre-clinical studies in animal models of peripheral artery disease of the legs and stroke recovery. A foreign proof-of-concept clinical trial relating to chronic back pain believed to be caused by impaired or blocked lumbar arteries has also been initiated. Cardio Vascu-Grow is a trademark of CardioVascular BioTherapeutics, Inc. This news release contains forward-looking statements that involve risks and uncertainties. Actual results and outcomes may differ materially from those discussed or anticipated. For example, statements regarding expectations for new research, progress with clinical trials or future business initiatives are forward-looking statements. Factors that might affect actual outcomes include, but are not limited to, results of future clinical and pre-clinical trials, differences in patient outcomes, FDA approval of CVBT drug candidates, market acceptance of CVBT products by customers, new developments in the industry, future revenues, future expenses, future margins, cash usage and financial performance. For a more detailed discussion of these and associated risks, see the company's most recent documents filed with the Securities and Exchange Commission. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion