EDMONTON, ALBERTA--(Marketwire - February 10, 2009) - Ceapro Inc. (TSX VENTURE: CZO) is pleased to announce today that it has signed a research and commercial development agreement with San Francisco Bay Area based IR2Dx Inc., a company specialized in the development of clinical assays for diagnostic uses in the evaluation and treatment of metabolic syndrome, cardiovascular inflammation, and insulin resistance.
This alliance sets the foundation for a clinical research project which will be conducted in Germany and in Canada under the direction of Prof. Dr. Andreas Pfutzner, (MD, Ph.D.) who is the founder of the well known Institute for Clinical Research (IKFE), based in Mainz, Germany. The clinical research project will compare the oral glucose tolerance test to CeaProve. The primary end point will be the demonstration of the superiority of the CeaProve test meal compared to the liquid formulation currently used as a standard for a glucose tolerance test.
The glucose tolerance test is used for the assessment of blood glucose control and diagnosis of type 2 diabetes patients. The glucose tolerance test is run millions of times per year, having widespread use as a standard procedure to assess metabolic and blood glucose regulation. However, the glucose tolerance test is widely perceived to have significant weaknesses and limitations, including variability, false negatives, required time of over two hours, and side effects, which are addressed or minimized with CeaProve.
Upon completion of a pilot phase, it is expected that this multi-site clinical trial will enroll 500 patients. This multi site trial is expected to take around twelve months. This will be a prospective randomized, head to head comparison of CeaProve and the glucose tolerance test. It is expected that regulatory approvals could be obtained on the basis of equivalence, but the alliance expects to demonstrate a number of superiorities for the CeaProve procedure. The alliance also intends to determine some of the biochemical bases of the observed performance advantages of CeaProve.
Regarding the business terms, the development cost will be jointly covered by Ceapro and IR2Dx. Ceapro will remain responsible for the manufacturing of the product and will receive royalties on net sales in addition to regulatory milestones. IR2Dx will have worldwide marketing rights for the hospital, clinic and physician market, exclusive except in Canada, where Ceapro has retained co promotion rights.
“We are very pleased with the signing of this alliance, whereby we aim to demonstrate the superiority of CeaProve by collaborating with our highly experienced partners IR2Dx and IKFE. Furthermore, the formation of this alliance is another step in delivering on our recently announced priority actions for value creation in line with Ceapro’s core expertise” said Gilles Gagnon, Acting President and CEO.
Robert Maurer, CEO of IR2Dx, said “We believe that this alliance will allow us to develop the clinical data to underpin the observed superiority of this product in clinical use, as compared with the existing glucose tolerance test. IR2Dx and Ceapro will use this clinical data to introduce this superior product and improve clinical assessment of metabolic regulation and blood glucose control.”
About Ceapro Inc.
Ceapro Inc. is a Canadian growth-stage biotechnology company. Primary business activities relate to the development and commercialization of active ingredients for personal care and cosmetic industries using proprietary technology and natural, renewable resources. The commercial line of natural active ingredients include beta glucan, avenanthramides, colloidal oatmeal and flours, oat powder, oat oil, oat and lupin peptides.
About IR2DXx
IR2Dx is a metabolic syndrome diagnostics company. The company has tests to address the key medical questions involved in treating the underlying conditions leading to diabetes, stroke, cardiovascular death, cancer, hypertension, and many other serious diseases. These tests allow physicians to do risk stratification, early detection, assessment of stage and severity, and drug intervention and monitoring. IR2Dx is privately held and located in Mainz Germany and the San Francisco Bay Area.
About IKFE
IKFE is a private clinical studies institute in Mainz, Germany. Its primary focus is pharmaceutical clinical studies in the areas of cardiovascular disease, diabetes, metabolic syndrome, and insulin resistance. The institute has run over 200 clinical studies for sixty clients since its foundation in 1998 by Professor Andreas Pfutzner, M. D., Ph. D. The institute has 110 employees, including a CRO, laboratory, and academy. It does full service clinical study design and performance, laboratory research, and clinical and scientific marketing training.
About the Diabetes potential market
One of the diseases in which CeaProve will be used clinically is Type 2 diabetes. Type 2 diabetes is found in almost every population and epidemiological evidence suggests that without effective prevention and control programs, the prevalence will continue to rise globally. The International Diabetes Federation (IDF) estimated 194 million people worldwide, or 5.1%, in the age group 20-79 had diabetes in 2003. This estimate is expected to increase to 333 million, or 6.3% of the adult population, by 2025. These numbers reflect similar estimates by the World Health Organization (WHO) that estimated 171 million cases of diabetes worldwide in 2000 and an increase to 366 million by 2030.
About CeaProve™
CeaProve is a new and dramatically different test for the fast, accurate, point-of-care detection and management of diabetes and pre-diabetes. CeaProve incorporates both of the conventional approaches for screening for diabetes and pre-diabetes - the fasting test and the glucose challenge test - into a single screening test completed within an hour. This “two-in-one” test can identify individuals with impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT), effectively identifying those at risk for diabetes and pre-diabetes.
The product CeaProve consists of six (6) highly calibrated wafers containing 50g of glycemic carbohydrate, fat, and protein. Once consumed the glycemic carbohydrate causes a measurable rise in blood glucose that can be determined with a glucose meter. The level of this rise in blood glucose following an oral glucose challenge is indicative of a person’s diabetic status. Through the planned clinical studies, the partnership expects to demonstrate a number of advantages in side effect profile, detection of true positives, shorter time to completion, superior side-effect profile, and improved palatability.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Contacts:
Ceapro Inc.
Gilles Gagnon
Acting CEO and Director
(Edmonton): 780-917-8376
Sun International Communications
Nicole Blanchard, B.Sc., B.Comm.
Managing Partner
(Montreal): 450-973-6600
nicole.blanchard@isuncomm.com
