Adaprev

Adaprev (an injectable solution of Mannose 6 Phosphate) is being developed for the prevention and reduction of scarring and adhesions between the tendon and surrounding tissues following tendon repair. It is hoped that Adaprev will improve function, which is often impaired following surgical repair of lacerated flexor tendons in the hand. This is an attractive market opportunity with over 550,000 procedures to repair severed hand tendons per year in the USA alone and an equivalent number in the EU. Patients developing tendon adhesions suffer from impaired motor function, pain and approximately 30% require subsequent tenolysis surgery to try to release the adhesions. Importantly, plastic, reconstructive and hand surgeons perform most of the flexor digital tendon repairs: the same target prescribers for Adaprev as for Juvista.

The first patient enrolment in Renovo’s trial to evaluate the safety, tolerability and preliminary performance of Adaprev in improving recovery of tendon function in patients undergoing surgical repair of flexor tendons in the hand occurred in November 2009.

The trial is a randomised, double-blind, standard care-controlled study in 44 male and female patients being conducted in ten UK centres and is due to report in the first half of 2011.

Adaprev has been designated a Class III medical device in the UK. Renovo will be seeking advice regarding its status as a Device in other territories. Assuming this first trial is successful Renovo anticipates that it will need to undertake one further trial for Adaprev prior to seeking approval to market.

Independent of Renovo, an academic group at Stanford University USA have confirmed the efficacy of Mannose-6-Phosphate in experimentally reducing tendon adhesions and improving the range of digit motion in a preclinical model of tendon injury. (Bates et al (2006) J. Bone and Joint Surg 88:2465-2472)