Despite the pressing need for novel therapeutic approaches there is currently no suitable therapeutic agent on the market to support, improve and accelerate the healing process of bones and tendons, while minimising scarring in severe or complex cases and to additionally reduce healing time, pain, time of immobilization and costs for rehabilitation.
In a pragmatic approach we will identify the most relevant bone- or tendon-related injuries after completion of the small animal studies in 2018 as our primary indications for future development of our Extracellular Vesicles (= Exosomes).
Potential targets include Achilles tendon and rotator cuff tears, humeral head fractures, as well as tibia fractures and delayed or non-unions in general. These pathologies represent some of the most frequent orthopaedic indications worldwide.
The healing time for these injuries is extensive and often results in unsatisfactory repair, in part due to the overall low regenerative capacity of tendons or immunological constraints for bone tissue. Thus, there is a large unmet or poorly met clinical need for improved therapeutic options.
The results from our in vivo animal and in vitro studies indicate that Celericon´s exosome-containing VSF preparation can enhance tissue repair both as an injectable substance or as part of a combined medical device, either trapped in a degradable scaffold or e.g. as a coating on the surface of implants.
Importantly, we successfully established a robust and GMP-compliant process for the manufacturing of therapeutically active VSFs.
The ample preclinical in vivo and in vitro data support the translation of these findings into clinical testing in humans by the end of 2018.
We have several years of experience in the design of manufacturing processes and the control of supply chains. This enables us to precisely define the requirements and costs necessary for the manufacturing of VSFs for phase 1 and phase 2 clinical trials. Our recent successful operations have focussed on the implementation and use of scalable processes that facilitate calculation for subsequent industrial-scale processes for EV manufacturing to enable phase 3 trials and market authorization.