To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Positive Results Reported In European Trial With Macritonin For Osteoporosis URL: http://www.pslgroup.com/dg/28052.htm Doctor's Guide May 13, 1997
LONDON -- May 13, 1997 -- Positive results on an ongoing double-blind European Phase II/III Macritonin(TM) clinical trials were announced today show the oral formulation of salmon calcitonin is a effective in the treatment of osteoporosis. Analyses by external consultants of three month end-point data has shown both biological and statistically significant responses in 400iu and 800iu doses. Macritonin(TM)was developed by Cortecs International, the United Kingdom based pharmaceutical company. Calcitonin is a well tolerated treatment for osteoporosis presently given by injection and (in some countries) intranasally. The trial analyses included data from 212 women aged between 55 and 77 years who had osteoporosis diagnosed by measurement of bone mineral density. Treatment in the trial is planned to continue for two years, during which the effects of Macritonin(TM) on bone mineral density will also be evaluated. There are three UK centers in the trial. The fourth and lead centre is the Centre for Clinical and Basic Research at Ballerup in Denmark which is among the World's foremost institutions for research in bone disease. CrossLaps(TM) is the term for a group of chemicals which are excreted in the urine when bone is broken down. A large European study (EPIDOS) showed that high levels of CrossLaps(TM) excretion correlate with increased risk of fractures. Results of treatment with 400iu and 800iu Macritonin(TM), when combined, showed a statistically significant reduction in the excretion of CrossLaps(TM) in the urine compared to the placebo control group who were receiving concomitant administration of vitamin D and calcium. Intranasal calcitonin was given as a positive control in the trial. Nasal calcitonin is already a registered product in a number of countries and has been shown to be effective in the treatment of osteoporosis. As expected nasal calcitonin also showed a significant reduction of CrossLaps(TM) excretion in urine in this trial. No serious side effects were observed in any treatment group. Dr. Michael Flynn, President of Cortecs International commented: "We are very pleased with this outcome which is consistent with the European Phase II result reported last year, while the similar efficacy of Macritonin(TM) 400iu and 800iu oral doses confirms what we saw in our Phase I trials. The statistical analyses, have also yielded information which will be very useful for our USA program. The broader implications for Cortecs relate to the potential for applying the oral delivery technologies to other macromolecules." This trial is planned to be pivotal for the European registration program and in the USA this trial is viewed as Phase II. Osteoporosis is a very common disease. At least 200 million people worldwide suffer from the disease. Almost half of all women will have bone fractures related to the disease by the time they reach 70. The disease in the USA alone costs over US$10 Billion per year and can have a high mortality rate. About one fifth of those with hip fractures, a result of osteoporosis, die from conditions related to the fracture itself or as a result of related surgery. In the UK the disease costs the National Health Service an estimated 750 million pounds per annum Cortecs specializes in the development of new pharmaceutical delivery systems and 'point-of-care' rapid diagnostics which provide the opportunity to advance the management of serious diseases. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.