Cortecs International, the UK-based drug delivery and rapid diagnostics firm, came a step closer to getting its first human therapeutic products to market with the announcement of two sets of positive clinical trial results at its annual general meeting on November 14.
Preliminary Phase II results from a trial of oral salmon calcitonin, which is currently ongoing in Europe, reveal that Cortecs' product can decrease bone resorption at clinically appropriate doses (400iu), as measured by surrogate markers such as urinary excretion of deoxypyridinoline and Cortecs' own proprietary CrossLaps assay, licensed from US firm Osteometer. 24 patients have been enrolled into the study, and data on nine of them was presented at the AGM by Michael Flynn, president of the company. Patients treated with oral calcitonin showed a significant reduction in the rate of bone breakdown, as measured by the assays.
While these results are clearly preliminary, they are sufficiently encouraging to trigger the setting up of a larger study, said Dr Flynn. This will be a three-month, randomized, double-blind, cross-over trial, which will test different doses of oral calcitonin. Cortecs hopes that Phase II data may be sufficient to get a product registration in Europe, assuming the regulatory authorities will review the product on an equivalence basis to injected and nasal forms of calcitonin. If this is the case, a submission could be filed in the fourth quarter of 1996. In the USA, bio-equivalence will almost certainly not be acceptable, and a clinical program will begin there in 1996. This program will likely include a Phase III bone mineral density trial.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze