MONTPELLIER, France–(BUSINESS WIRE)–MedinCell (Paris:MEDCL) confirms that late-stage clinical trials in patients receiving intra-articular mdc-CWM at the time of Total Knee Replacement (TKR) are planned as follows:
> The first of two phase 3 studies will start in H2 2021
> An open label1 safety study to supplement the mdc-CWM long-term safety database will start in Q2 2021
Injected into the intra-articular space during Total Knee Replacement surgery and potentially active for as long as three months post-surgery, mdc-CWM is a sustained-release formulation of celecoxib for the reduction of post-operative pain & inflammation.
Total Knee Replacement is the first investigational indication.
The mdc-CWM program development is led and financed by MedinCell’s partner, Arthritis Innovation Corporation (AIC), who closed a $23 million CAD private equity financing in February 2021 to support clinical and manufacturing activities.
MedinCell is a clinical stage pharmaceutical company that develops a portfolio of long-acting injectable products in various therapeutic areas by combining its proprietary BEPO® technology with active ingredients already known and marketed. Through the controlled and extended release of the active pharmaceutical ingredient, MedinCell makes medical treatments more efficient, particularly thanks to improved compliance, i.e. compliance with medical prescriptions, and to a significant reduction in the quantity of medication required as part of a one-off or chronic treatment. The BEPO® technology makes it possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. Based in Montpellier, MedinCell currently employs more than 140 people representing over 25 different nationalities.
1 Open-label study: a clinical study in which both investigators and patients are aware of the treatment administered; in this case mdc-CWM.