Adocia Announces Failure of Phase 3 Trial
News Aug 26, 2016
Adocia has announced topline results from a Phase 3 clinical trial of BioChaperone PDGF (BC PDGF) in the treatment of diabetic foot ulcer (DFU), which was conducted in India.
In this trial, BC PDGF did not meet the primary endpoint of a statistically significant improvement over placebo in complete wound closure after twenty weeks of treatment. There were no safety concerns attributed to BC PDGF.
“We are surprised and disappointed by these topline results, which are inconsistent with previously reported positive Phase 1/2 clinical results. Therefore, we have initiated a thorough review of the study to analyse the discrepancy in the data” said Gérard Soula, CEO of Adocia. “However, diabetic foot ulcer has proved an extremely difficult condition to address, as seen in multiple recent late - stage clinical trial failures. The main reason is the lack of uniformity in the standard of care of these types of wounds. In this context, we have decided to halt all development work in this indication. As announced previously, we are focusing our efforts on our portfolio of innovative injectable therapeutics for the treatment of diabetes.”
This randomized, double-blind, multicenter, outpatient study enrolled 252 diabetic patients from India with a chronic DFU. In addition to standard of care, each group of patients was treated every two days for a maximum of 20 weeks with either a placebo spray (saline solution) or a spray containing BC PDGF.
PhoreMost and Plexxikon Collaborate to Identify Novel Drug TargetsNews
PhoreMost, the UK-based biopharmaceutical company dedicated to drugging ‘undruggable’ disease targets, today announced it has signed a collaborative agreement with Plexxikon Inc., the small molecule structure-guided R&D centre of Daiichi Sankyo.READ MORE
Anti-Malaria Drugs Delivered With CaffeineNews
Many drug delivery systems, such as capsules and tablets, can be difficult to swallow, especially for children. Making delivery systems out of polymer gels is an attractive option, but usually requires hazardous levels of heavy metals to be used. Now, scientists have found a way to build these gels from caffeine molecules.READ MORE
Lonza Opens World’s Largest Dedicated Cell-and-Gene-Therapy Manufacturing Facility in TexasNews
First-of-its-kind, state-of-the-art manufacturing facility with capacity to produce treatment for thousands of patients suffering from rare genetic disorders or life-threatening diseases.READ MORE
Comments | 0 ADD COMMENT
World Congress on Advanced Biomaterials and Tissue Engineering
Jun 20 - Jun 21, 2018