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| |  Cortecs Prepares for Oral Insulin Studies in Diabetic Patients LONDON—Nov. 12, 1996 -- Cortecs International (NASDAQ:DLVRY/ LSE:COR/ASX:CRI) today released an information update on the status of clinical trials being undertaken by the Company. The second stage of the Phase I trial has been completed in six healthy subjects. They received oral insulin or oral placebo given via a tube passing through the mouth into the upper intestine. Each subject was studied twice, once receiving placebo and once receiving oral insulin in randomized order. At the same time as the insulin or placebo was given, a glucose solution was administered via an intravenous injection. Blood samples were collected before starting the experiment and at various timed intervals afterwards. The results showed that mean insulin level increases in the blood following oral insulin were greater than after the placebo and declined more slowly. Furthermore mean glucose levels and 'c' peptide levels declined more rapidly with oral insulin versus placebo. The 'c' peptide is a marker in the blood by which the body's production of natural insulin may be measured. The results of this study support the results obtained in pig studies and in the first Phase I trial in fasting healthy subjects reported recently. The glucose load enables more of the insulin to pass through the liver and be measured in the general circulation and enables an effect on blood glucose content to be demonstrated. The more rapid fall of 'c' peptide levels suggests that there was some suppression of the body's own release of insulin. This would be expected if the oral insulin were being absorbed. In early 1997 trials are planned using an encapsulated form of oral insulin which will be administered by mouth to healthy volunteers and to diabetic patients. Dr. Michael Flynn, President of Cortecs, commented: "The oral insulin program is on schedule. We are very pleased with these latest results and are now proceeding carefully to the next stage which will include diabetic patients." Pivotal Data for Oral sCT Submission to be Harvested in January 1997 Instead of December 1996 An additional study in healthy elderly volunteers has been completed to determine whether there was any restriction in the time of day for dosing with calcitonin. The trial carefully evaluated the excretion of bone breakdown markers over a 48 hour period in subjects who were institutionalized for the trial. The unexpectedly large diurnal fluctuations of bone marker excretion and an average bone turnover some three times higher than in young healthy adults indicate that repeated dose studies on bone marker excretion will be the most preferable route to the company's registration application. About 180 patients will provide data from repeated dose studies during January 1997 and the company expects that those data may be submitted as pivotal information for the European submission rather than a large single-dose dose response trial which will be completed in December 1996. The recent Phase I trial showed that, using injected calcitonin, dosing in the morning or evening produced similar effects in reducing bone turnover and it is therefore probable that oral calcitonin would not be constrained to morning or evening dosing but could be given at either time according to convenience. The large diurnal variation seen during the study would completely mask the expected effect of single dose oral calcitonin. Dr. Michael Flynn, commented: "We obtained new information from this trial which could not have been detected in the literature and which clearly points to the best way forward with respect to early registration of our product. The fact that, for calcitonin itself, efficacy was similar in the morning and evening is also encouraging from the aspect of flexibility of deciding when to dose a particular patient. The large diurnal variation in this recent study has led us to expect that the most appropriate pivotal data for our European registration application will come from the three month time point of our ongoing Phase II/III trial in January 1997, as opposed to the dose-ranging single-dose study due for completion in December 1996". New Positive Data for Chronic Bronchitis Therapeutic Vaccine Results are now available from an interim analysis of a double-blind clinical trial now in progress in Australia to evaluate the effects of Pseudostat in patients with chronic bronchitis. Results from 41 patients provided data for analysis by an independent statistician. The Company and the investigators remain blinded on this study until it is completed and analyzed in mid-1997. 22 patients received Pseudostat and 19 received placebo. All patients received a course of oral capsules for three days at the start of the trial and oral boosters after twenty-eight and fifty-six days. The trial aims to discover if the number of episodes of acute infection can be reduced with Pseudostat and if lung infection, measured by the number of white cells (Pus) in the sputum can also be reduced. Closely following the pattern of response seen in the open Bronchiectasis trial reported earlier this year, the white cells in the sputum all declined rapidly after each booster of Pseudostat, but not after the placebo. The first booster dose caused a significant (p< 0.02) reduction of sputum white cells to a level which was significantly lower than that in the placebo group (p< 0.02). During the three months of observation 9, (41%) of the Pseudostat patients had an acute infection versus 11, 58% of the placebo group. The mean duration of infection in those of the Pseudostat group was only 3.8 days versus 9.8 days in those receiving placebo. Pseudostat is designed to boost a patient's own immune response to the bacteria most commonly associated with chronic bronchitis, Pseudomonas aeruginosa and Haemophilus Influenzae. The results obtained from this early stage of the trial are very encouraging. Two trials are at present in progress in chronic bronchitis and one in cystic fibrosis. Further trials are planned to commence during 1997. First Human Trial to Commence With Novel Oral Flu Vaccine Cortecs ' oral influenza vaccine, Flustat is scheduled to commence clinical testing in November 1996. The first trial will investigate the ability of the vaccine to stimulate an immune response and to prime the mucous linings of the respiratory tract to mount a rapid defensive response if exposed to influenza virus. Awaiting Ethics Committee Approval for First Human Trial of Oral Vaccine Against Thrush Moniliastat is an oral vaccine against Candida albicans, the organism responsible for the disease "Thrush". The target indication is vaginal thrush in women with repeated and persistent infections. Pending ethical committee approval, recruitment for this trial will commence in December 1996. The trial will investigate immune responses in healthy female volunteers. Human Oral Testosterone Trial for 1997 A formulation of oral testosterone is being completed using Cortecs' HALO technology. First clinical tests are expected in 1997. Testosterone given by the oral route it is largely destroyed in the liver immediately after absorption from the intestine and sometimes causes liver damage during the process. Cortecs' HALO technology is designed to avoid uptake by the liver after absorption to avoid this effect and enable lower, safer doses to be administered. Cortecs International is a British-based company quoted on the London Stock Exchange, the Australian Stock Exchange and on Nasdaq. The Company 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 such as: OSTEOPOROSIS Oral Calcitonin - an oral therapy for the prevention of bone breakdown. In Phase II/III. Osteosal - a rapid doctors' office test in collaboration with Osteometer to detect increased bone breakdown indicating the risk of the disease osteoporosis and also to monitor the adequacy of therapy. In development. HELICOBACTER PYLORI Helisal - a rapid doctors' office whole blood test for the detection of H. pylori. in the market and a rapid saliva test in development. A 'one step whole blood' test for the detection of H. pylori. In development. Oral Therapeutic Vaccine - in development to stimulate immunity. Oral Therapeutic - in research to improve eradication results. DIABETES Glycosal - three rapid doctors' office tests in collaboration with Exocell to assist in the management and identification of diabetes. In development. CYSTIC FIBROSIS & CHRONIC BRONCHITIS Pseudostat - oral therapeutic antigen to treat and prevent lung infection with Pseudomonas aeruginosa now in Phase II trials. INFLUENZA Flustat - an oral vaccine against influenza entering human trials in 1996. THRUSH Moniliastat - an oral therapeutic vaccine against vaginal thrush. Enters human trials in 1996 financial year. MALE HORMONE DEFICIENCY Halo Testosterone - an oral male hormone replacement therapy in development to treat male hypogonadism. Cortecs also markets a range of ethical and OTC medicines and diagnostic products. "Safe Harbor" Statement under the US Private Securities Litigation Reform Act of 1995: Some or all of the statements in this document that relate to future plans, expectations, events, performances and the like are forward-looking statements, as defined in the US Private Securities Litigation Reform Act of 1995. Actual results or events could differ materially from those described in the forward looking statements due to a variety of factors, including those set forth in the Company's filings with the US Securities and Exchange Commission.
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