Study involves candidate NVD-003 and the treatment of lower limb trauma
Novadip Biosciences – a company developing regenerative tissue products to accelerate large bone defect healing – announced positive data from its phase 1/2 clinical trial.
The research evaluated clinical activity and safety aspects of its investigational product, NVD-003, in patients with severe bone non-union (BNU) of the lower limb following trauma.
The candidate is an autologous tissue engineered product generated from the patients’ own adipose stem cells and was applied to nine patients with bone non-union of the lower limb who had previously undergone several surgical procedures.
Results demonstrated NVD-003’s ability to reverse severe bone deterioration and to achieve accelerated ossification. Furthermore, eight patients presented clinical healing during the two years of follow-up post-GS.
Meanwhile, the median and mean time to achieve clinical healing was six months and nine months, respectively. All patients achieved total weight bearing at six months and seven patients were walking normally at two years.
“This phase 1 study has shown that NVD-003 represents a convincing step forward in the development of an optimised bone graft substitute in terms of applicability and outcome,” commented Professor Torsten Gerich, chief of trauma service at the Centre Hospitalier de Luxembourg and principal investigator of the trial.
“NVD-003 is a very promising product with the potential to outperform autologous bone harvesting and other less potent bone graft substitutes such as DBM, ceramics and growth factors and prevent their accompanying comorbidities. Further investigations in larger scale clinical studies will be needed to confirm these promising results,” he added.
Professor Gunnar Andersson, chairman of Novadip’s Clinical Advisory Board, concluded: “This is a very nice study introducing a method that has spectacular results in this very difficult to treat group of patients. It may well be that this treatment alternative can replace current first line treatments.”
NVD-003 has received orphan drug and rare paediatric disease designations from the US Food and Drug Administration.
The risk of bone non-union following a fracture is more than 50% across all bones due to fracture severity, co-morbidities and medication use.