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CytoCore Announces the Licensing of a New Bio-Marker That Identifies Uterine Pre-Cancerous and Cancer Cells Feb 17, 2006 1:56:00 PM Copyright Business Wire 2006 CHICAGO--(BUSINESS WIRE)--Feb. 17, 2006--
As part of the recently signed technology transfer agreement, CytoCore, Inc. (OTCBB: MCDG.OB), a bio-technology development company committed to bringing new cancer solutions to market, today announced that it has licensed a new cancer bio-marker from Dr. George Gorodeski, the inventor, and University Hospitals Cleveland.
The new biomarker, labeled CGI5 is unique among the few apoptosis markers that were found in preliminary experiments to distinguish pre-cancerous and cancer cells from the corresponding normal cells. Cells that transform into cancer cells usually display two distinctive characteristics: rapid, uninhibited proliferation, and a slowing of programmed cell death (apoptosis). Current bio-marker technology has typically focused on proteins associated with cell proliferation. CytoCore's CGI5 bio-marker tracks the changes in the dying or apoptotic process. The initial lab results have produced excellent sensitivity and specificity (measures of bio-marker accuracy) in testing for both Cervical and Endometrial cancers.
Dr. David Weissberg, CytoCore's CEO stated: "We are very excited by the prospects this bio-marker brings to CytoCore. Early indications suggest that when combined with the other more standard proliferation bio-markers such as EGFR and IGFR, through triangulation, produces an assay with increased accuracy for identifying both cervical and endometrial cancers. The tests also suggest that the marker may have more general applications in other types of epithelial cancers, such as skin cancer. This marker when combined with our existing CVX assay has produced some very accurate initial test results in Dr. Gorodeski's lab. We will be working with Dr. Gorodeski to put together the plans for initial trials on this marker."
The CGI5 marker offers CytoCore commercial potential in several areas.
One, when combined with the Company's existing CVX assay, the new combined Assay, called the GCI Assay, significantly increased the accuracy of the initial tests for cervical cancer screening. Trials will begin on this new combination Assay as soon as it is optimized for operation with the AIPS automated microscopy platform.
Two, if the lab test results are verified in the trials, the level of accuracy of GCI Assay could allow it to become a diagnostic test. The requirements and accuracy required by a diagnostic are higher than for a screening test. However if accuracy is replicated in trials for this new Assay as a diagnostic, it will open up significant new markets for this Assay when utilized with the AIPS platform in analyzing tissue samples.
Dr. George Gorodeski, a Gynecologist at University Hospitals of Cleveland and Professor of Reproductive Biology, Oncology and Physiology and Biophysics at CASE (Case Western Reserve) University stated: "This is an unusual marker, and when combined with more well known markers, has produced some very interesting test results. It is especially gratifying to see these test results with different types of uterine epithelial tissues, thereby potentially providing screening and diagnostic modalities for two common gynecological cancers - cervical and endometrial. The CVX-GCI Assay with the AIPS platform could improve screening for cervical dysplasia and cancer, while the GCI assay could address endometrial cancer."
"Endometrial cancer typically occurs in postmenopausal women and its principal symptom is uterine bleeding usually occurring after the cessation of normal menstrual periods. The occurrence of abnormal uterine bleeding in pre- and peri-menopausal women is relatively common occurring in about 15% of women. Although it is rarely associated with endometrial cancer, it is often a source of significant concern both for the patient and her physician. If our results are confirmed in a larger controlled study I believe that the assay could be developed into a simple, accurate bedside point-of-care screening method for endometrial cancer. This test would provide a rapid-answer reassurance to women who test negative, and would advise prompt additional intervention in cases of a positive suspected result. Such a test is currently lacking and would be an important adjunct for the physician practicing in this area."
Dr. Gorodeski added that he, in collaboration with other physicians at the Department of Obstetrics and Gynecology at University Hospitals of Cleveland plan to soon develop a clinical study protocol and obtain the Institution's approval to begin a clinical trial to test the accuracy of the novel CGI5 marker. "We are all eager to see the results of the expanded trial and the performance of this new marker and Assay".
This new marker and Assay substantially expands CytoCore's InPath System capabilities. Assuming the trials bear out the lab results, this new Assay will be able to identify uterine cancer risks to the cervix and the endometrium expanding the InPath System cancer screening coverage for the entire arc from the onset of sexual activity throughout a woman's life.
About University Hospitals of Cleveland: Founded in 1866, University Hospitals of Cleveland is a 947-bed tertiary medical center specializing in adult/pediatric medical and surgical specialties. UHC is also the primary affiliate of Case Western Reserve University. Together, they form the largest center for biomedical research in the State of Ohio. As the research arm of University Hospitals of Cleveland, the Center for Clinical Research focuses on translational research, taking fundamental advances in biomedical research and applying them to improvements in healthcare. This is achieved through a balanced approach involving federal-funded research, sponsored research agreements with the pharmaceutical, biotechnology and medical device industries, and a century-long partnership with Case Western Reserve University. The Center for Clinical Research is designed to aggressively translate fundamental advances in scientific knowledge into advances in the clinical medicine by establishing new alliances with the pharmaceutical, biotechnology and medical device industries. More information is available at: http://www.uhhs.com/
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, gastrointestinal, and other cancers. The InPath(TM) System is being developed to provide medical practitioners with a highly accurate, low-cost, cervical cancer screening system that can be integrated into existing medical models or at the point-of-care.
Certain statements in this release are forward-looking. These statements are based on CytoCore's current expectations and involve many risks and uncertainties, such as the company's inability to obtain sufficient financing, the possibility that clinical trials will not substantiate CytoCore's expectations with respect to the InPath(TM) System, and other factors set forth in reports and documents filed by CytoCore with the Securities and Exchange Commission. Actual results may differ materially from CytoCore's current expectation depending upon a number of factors affecting the Company's business. These factors include, among others, risks and uncertainties detailed in the Company's periodic public filings with the Securities and Exchange Commission, including but not limited to the Company's Annual Report on Form 10-K for the year ended December 31, 2004 and its Quarterly Reports on Form 10-QSB for the quarters ended June 30, 2005 and September 30, 2005. Except as expressly required by law, CytoCore undertakes no obligation to publicly update or revise any forward-looking statements contained herein.
Source: CytoCore, Inc.
---------------------------------------------- For Molecular Diagnostics Inc. Gene Martineau 212-348-1852 ebm*interport.net
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CytoCore Announces Licensing the First Drug Delivery System That Therapeutically Addresses Cervical Cancer Lesions
Thursday , February 23, 2006 09:15 ET
CHICAGO, Feb 23, 2006 (BUSINESS WIRE) -- CytoCore, Inc. (OTCBB: MCDG.OB) today announced that it has licensed from University Hospitals of Cleveland a new Drug Delivery System (DDS) developed by physician George Gorodeski, M.D., Ph.D., that will for the first time give the physicians the ability to apply FDA approved drugs to existing cervical lesions.
The DDS is comprised of an applicator handle and drug-delivery modality in the form of a patch that provides a timed-release delivery of the therapeutic agent directly to the surface of the cervix. The handle is a further development of CytoCore's e2 Collector handle, which has been specifically designed to quickly, safely and accurately position and deposit the patch on the cervix.
Current Pap screening programs often find the presence of cervical dysplasia or lesions in early stages. The present treatment options are either surgical removal of the lesion, or repeated follow-ups with Pap testing. While only a fraction of cervical dysplasia cases progress to invasive cervical cancer, the atmosphere of medical uncertainty on a finding of dysplasia, and the limited treatment options (surgery or wait) place an unnecessary burden on the physicians and their patients, and could explain, in part, the rising number of cervical surgeries, some of which may be unnecessary.
Abnormally growing cervical cells, including dysplastic cells, can be treated with different types of anti-viral or other inhibiting medications to control their growth. Early attempts at applying such drugs to cervical lesions typically led to unacceptable toxic effects to the surrounding tissues, so the practice was abandoned. The new DDS will, for the first time, offer the physician a therapeutic treatment option for cervical lesions. This new device will allow for a drug or combination(s) of FDA approved drugs to be applied directly and specifically to the cervix. CytoCore believes that the nature of the device patent filed will allow for the drug manufacturer to file for a new use patent on the drugs used with the patch.
Dr. David Weissberg, CytoCore's CEO stated, "Currently, the limited surgical treatment option for cervical lesions produces an unnecessary risk and burden on the patient and the physician. This new device will give the physician a simple, proven, safe way to treat a cervical lesion. Because of the gradual steady pace of drug release by the patch, proven drugs can be chosen which should produce a locally potent effect on the lesion, but should limit adverse systemic or toxic side effects on neighboring tissues. This product will provide an effective non-surgical therapeutic solution for the huge gap in treatment that exists when dealing with precancerous cervical lesions. We are very excited with how this product expands and completes CytoCore's InPath System. With this product, we have the only end to end product solutions in this sector. The InPath System includes cell collection, identification, localization, and now treatment of cervical dysplasia."
Dr. George Gorodeski stated, "With the support of UHC, I have been working on this device for several years, and I am delighted for the opportunity to bring this product forward with CytoCore's help. CytoCore's energy and momentum make them the perfect partner as this product is designed to complement the InPath System. We expect to begin development of the applicator handle, and will be working with pharmaceutical manufacturers to develop and test a variety of drug combinations that would be appropriate for the patch. I would anticipate entering trials on this product before the end of the year."
About University Hospitals Health System
University Hospitals Health System is the region's premier healthcare delivery system, serving patients at more than 150 locations throughout northern Ohio. Committed to advanced care and advanced caring, University Hospitals Health System offers the region's largest network of primary care physicians, outpatient centers and hospitals. The System also includes a network of specialty care physicians, skilled nursing, elder health, behavioral health, rehabilitation and home care services, managed care and insurance programs and occupational health and wellness. The Health System's tertiary medical center, University Hospitals of Cleveland, is an affiliate of Case Western Reserve University. Together, they form the largest center for biomedical research in the State of Ohio; included are Rainbow Babies & Children's Hospital, among the nation's best children's hospitals; Ireland Cancer Center, a National Cancer Institute-designated Comprehensive Cancer Center (the nation's highest designation); and MacDonald Women's Hospital, Ohio's only hospital for women. Nearly 25,000 physicians and employees comprise University Hospitals Health System and its partner hospitals, ranking it northern Ohio's second largest employer. University Hospitals Health System's goal is to provide comprehensive primary and community-based care-the kind of healthcare people need most-as well as access to the highest quality specialty care when necessary.
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 a highly accurate, low-cost, cervical cancer screening and treatment system that can be integrated into existing medical models or at the point-of-care. More information is available at: www.Molecular-Dx.com
Certain statements in this release are forward-looking. These statements are based on CytoCore's current expectations and involve many risks and uncertainties, such as the company's inability to obtain sufficient financing, the possibility that clinical trials will not substantiate CytoCore's expectations with respect to the InPath(TM) System, and other factors set forth in reports and documents filed by CytoCore with the Securities and Exchange Commission. Actual results may differ materially from CytoCore's current expectation depending upon a number of factors affecting the Company's business. These factors include, among others, risks and uncertainties detailed in the Company's periodic public filings with the Securities and Exchange Commission, including but not limited to the Company's Annual Report on Form 10-K for the year ended December 31, 2004 and its Quarterly Reports on Form 10-QSB for the quarters ended June 30, 2005 and September 30, 2005. Except as expressly required by law, CytoCore undertakes no obligation to publicly update or revise any forward-looking statements contained herein.
SOURCE: CytoCore, Inc.
CytoCore, Inc. Gene Martineau, 212-348-1852 ebm*interport.net
Copyright Business Wire 2006
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