LONDON - Cortecs plc, which specializes in oral delivery of protein and peptide drugs, plans to start a Phase III trial of its oral vaccine Pseudostat for treatment of acute bronchitis later this year. This follows two successful Phase II trials.
In August 1997, the London-based company reported results from the first Phase II study, which showed that oral immunization with Pseudostat substantially reduced acute infections. Following immunization, the number of acute bronchitis episodes in the placebo group was 10 times higher than in the Pseudostat group. Before immunization, the rate of infection had been similar in both groups.
Initial data from the second Phase II trial, in chronic bronchitis and bronchiectasis, are still being assessed but have shown significant reductions of the infectious agent Pseudomonas and white cells in the sputum, along with a lower bacterial load. There were fewer episodes of acute bronchitis in patients receiving Pseudostat.
“Until now, no vaccine has shown efficacy in Pseudomonas lung infection and we are encouraged by these results,“ said Glen Travers, executive chairman.
These results also provide further evidence of the breadth of potential applications for the company's technologies. “Cortecs believes its oral delivery technologies for peptides and proteins are currently some of the most advanced and flexible in the field,“ said Travers.
An additional Phase II trial of Pseudostat has started in the U.K. in patients with cystic fibrosis. The double blind trial is expected to report this year.
Cortecs said it also has discussed with the FDA establishing a clinical program in cystic fibrosis in the U.S.
The company has a number of other oral vaccines in development, including Flustat oral influenza vaccine, which is in an ongoing Phase I trial. The company said preliminary results show “encouraging local and systemic responses.“
Moniliastat, an oral Candida albicans vaccine against thrush, is due to enter Phase I studies in late spring 1998, and Ulsastat against Helicobacter pylori is in preclinical trials, with a Phase I planned for 1998.
Cortecs outlined this progress as it reported results for the six months ending December 1997 showing losses of £9.1 million, compared with £4.3 million for the same period of 1996. About £1.2 million was attributed to the cost of relocating the company's main listing from Australia to the U.K.
Spending on R&D rose to £7.5 million from £4.6 million. There was £33.3 million cash, down from £56.4 million at the end of 1996.
Travers said R&D expenditures were increased to advance the programs in Pseudostat; Macritonin, oral calcitonin for osteoporosis; and Macrulin, oral insulin for Type II diabetes.
Cortecs has applied for registration of Macritonin in seven European companies and has completed a commercial Good Manufacturing Practices manufacturing facility.
Discussions are moving forward with distributors for Europe and North America. The company is in the process of establishing the protocols for a U.S. Phase III Macritonin trial in 1998. *