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CINCINNATI — Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ:VIVO) today announced that its wholly owned subsidiary, Meridian Life Science, Inc. (MLS), formerly Viral Antigens, Inc., completed manufacturing of a clinical infectious inoculum of respiratory syncytial virus (RSV) in its biopharmaceutical facility located in Memphis, TN. The RSV clinical material will be used by a contract biopharmaceutical client to conduct human challenge studies in order to establish optimal infectious levels in healthy adult volunteers. The client, Alnylam Pharmaceuticals, has commenced a clinical program to evaluate the anti-viral activity of its therapeutic product for treatment of RSV infection.

Respiratory synytial virus (RSV) is the most important cause of pneumonia and bronchiolitis in infants and small children. RSV infections appear in large outbreaks every winter. RSV is very contagious, and most children have experienced infection by two years of age. Immunity to RSV does not prevent re-infections. Re-infections tend to be less severe than primary infections and occur throughout life. RSV also can be an unusual cause of significant respiratory illness in normal and elderly adults.

"Meridian Life Science played an important role in Alnylam’s ability to undertake an experimental infection study for the development of ALN-RSV01, an RNAi therapeutic for the treatment of RSV," said Barry Greene, Chief Operating Officer of Alnylam. "This study represents a significant step forward for Alnylam as it advances this program toward generation of human proof-of-concept anti-viral data."

Richard L. Eberly, President, Meridian Life Science, Inc., commented, "We are pleased to have successfully produced the RSV clinical material that will be utilized for important studies advancing the clinical program for Alnylam’s therapeutic treatment for RSV. The combination of Alnylam’s clinical expertise with our scientific and technical capabilities led to the development and production of important clinical viral materials needed for the initiation of human clinical trials."

Dr. Preston Dorsett, Vice President of Science and Technology, Meridian Life Science, Inc., commented, "The manufacturing process utilized clinical viral isolates and cell culture to generate infectious respiratory syncytial virus for use in the human challenge study."

MLS’s contract biopharmaceutical manufacturing facility produces proteins and other biologicals for biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines. This business focuses on materials that will be used in Phase I and II clinical trials. This past year, MLS completed manufacturing of a recombinant protein for the National Institutes of Health for use in a Phase I/II clinical trial of a vaccine for parvovirus. The proteins that are produced in this facility are intended for use as "injectibles". As such, they are produced under cGMP Regulations for Biologics and Human Drugs under the auspices of the FDA.

Meridian is a fully integrated life science company that manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies. Utilizing a variety of methods, these products and diagnostic tests provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions, such as gastrointestinal, viral and respiratory infections. Meridian’s diagnostic products are used outside of the human body and require little or no special equipment. The Company’s products are designed to enhance patient well-being while reducing the total outcome costs of healthcare. Meridian has strong market positions in the areas of gastrointestinal and upper respiratory infections, serology, parasitology and fungal disease diagnosis. In addition, Meridian is a supplier of rare reagents, specialty biologicals and related technologies used by biopharmaceutical companies engaged in research for new drugs and vaccines. The Company markets its products and technologies to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices, diagnostics manufacturers and biotech companies in more than 60 countries around the world. The Company’s shares are traded through NASDAQ’s Global Select Market, symbol VIVO. Meridian’s website address is www.meridianbioscience.com.

COPYRIGHT 2007 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning

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New Cervical Cancer Screening Method Offers First Pap Test Advancement in 50 Years

CHICAGO — Kicking off the new year with an eye toward improving accuracy and efficiency in Pap testing for the deadly Human Papillomavirus (HPV), CytoCore, Inc. (OTCBB:CYCR) today announced a fast-tracked marketing trial to demonstrate their e2 Collector’s[TM] superior, more thorough cell sampling technology.

The first major change to the Pap test in 50 years, CytoCore’s e2 Collector balloon device reflects the late-stage bio-scientific research company’s aggressive commitment to advancing affordable early screening and treatment for uterine, endometrial and cervical cancers that claim the lives of hundreds of thousands of women worldwide every year.

"The e2 is the only procedure that ensures collection of sample cells from the entire cervix," said Dr. Floyd Taub, founder of the company that developed the HPV virus test and a CytoCore Scientific Advisory Board member. "Its patented design automatically collects cells from the endocervix (inside) and ectocervix (outside) in one pain-free step. This simple but elegant device will replace the current weak link in the cervical cancer screening process."

"Since inception the Pap smear test has been limited by the imprecise scraping technique for collecting cells," added Dr. Taub. "Neither the microscopist nor HPV DNA analysis can detect pre-cancerous (dysplasia) nor cancer cells, nor the viruses associated with the cancer, if they are not included in the sample sent to the lab."

Unlike many developments, the benefits of the e2 Collector can be obtained without the need for expensive equipment, reagents, laboratories, ‘learning curve’ or skilled practitioners. It allows less skilled persons to collect better samples.

"Cytocore’s confirmation trial will clearly show the heightened results offered by the e2 Collector balloon collection method versus the traditional spatula-and-brush devices in routine use today," said Dr. George Gorodeski, director of the Medical Advisory Board. "When it comes to taking on cervical cancer-causing HPV, our cell sampling procedure is not only less invasive for the patient and easier for the physician; it also brings an entirely new standard of accuracy to our current Pap testing. Its sensitivity to the presence of virulent HPV strains will also be enormously useful for clinicians in their decision-making process when treating women diagnosed with borderline cervical lesions."

The HPV test is currently being adopted as a standard of care and routine component of any thorough Pap screening. Approximately ten of the 30 identified genital HPV types can lead to development of cervical cancer, according to the Centers for Disease Control website, and the American Cancer Society estimates that nearly 10,000 women were diagnosed in the U.S. this year. Most of those women diagnosed with invasive cervical cancer have not had regular Pap testing. Some 120 million Pap tests are currently administered annually worldwide, including more than 55 million tests performed in the United States alone.

The e2 Collector trial is expected to take 45-60 days and conclude early in 2007. CytoCore is currently ramping up manufacturing and expects to begin production and sales immediately after Federal Drug Administration approval, which is anticipated for the second quarter.

"This trial is expected to provide us with the definitive proof on the Collector’s performance advantages," said Dr. Augusto Ocana, CEO of CytoCore. "My focus is on getting the product to market for widespread international adoption with the right distribution partners. Based on initial conversations with my domestic and international connections, I believe we will exceed the Company’s previous revenue assumptions for the Collector and believe our market range will be between $150mm-$450 mm worldwide. This device is long overdue, and will be the first major improvement in the experience, performance and accuracy of the Pap test in over 50 years. I believe this cost saving device will be used worldwide."

For further information about the e2Collector and CytoCore’s full suite of products for the diagnoses and treatment of reproductive cancers, visit www.CytoCoreInc.com. For further information about cervical cancer, visit the American Cancer Society’s webpage: www.cancer.org.

About CytoCore Inc.

CytoCore develops cost-effective cancer screening systems, which can be utilized in a laboratory or at the point-of-care, to assist in the early detection of cervical, endometrial, and other cancers. The InPath[TM] System is being developed to provide medical practitioners with highly accurate, low-cost, cervical and uterine cancer screening systems that can be seamlessly integrated into existing medical models. More information is available at: www.CytoCoreInc.com.

Dr. George Gorodeski has a significant financial interest in this research consisting of equity and fees from the Company as a consultant and Director of the Scientific Advisory Board of CytoCore. Dr. Gorodeski’s invention licensed to CytoCore may generate royalty income for Dr. Gorodeski, for University Hospital Case Medical Center of Cleveland.

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