Stempeucel OA (mesenchymal stem cell therapy) / Stempeutics, Alkem Labs - LARVOL DELTA

Phase 3 Trial Results for Stempeutics Cell Therapy in Knee Osteoarthritis Published in American Journal of Sports Medicine (AJSM) (Businesswire) - P3 | N=146 | CTRI/2018/09/015785 | Sponsor: Stempeutics Research Pvt Ltd | "Stempeutics...announced the publication of the Knee OA Phase 3 trial results in the premier journal, the American Journal of Sports Medicine (AJSM). The results of the randomized, double-blind, controlled study in 146 patients showed that single injection of Stempeucel-OA (bone marrow-derived mesenchymal stromal cells) significantly improved WOMAC total score compared with the placebo group at 6 and 12 months, and also significantly improved WOMAC pain, stiffness, and physical function sub-scores as well as VAS scores at 6 and 12 months. MRI T2 mapping showed no worsening of deep cartilage in the medial femorotibial compartment of the knee in the Stempeucel-OA group at the 12-month follow-up, whereas in the placebo group, there was significant and gradual worsening of cartilage."

P3 data • Immunology • Inflammation • Osteoarthritis • Pain • Rheumatology

Stempeutics partners with Kemwell for stem cell therapeutics (BioSpectrum India) - "Stempeutics Research...announced that it has signed a strategic deal with Kemwell Biopharma for global commercialization of its stem cell product Stempeucel®....Stempeutics is working on three key indications i.e. Critical Limb Ischemia (CLI), Osteoarthritis (OA) and Diabetic Foot Ulcer (DFU). For marketing the products in India, it has partnered with Cipla for the CLI indication and with Alkem Labs for OA indication. Stempeutics is now exploring registration and commercialization of Stempeucel® in the developed markets i.e. the US, Europe and Japan and has initiated discussions with US FDA, EMA and Japan PMDA. Funds received from Kemwell will be utilized for achieving key regulatory milestones in the US, Europe and Japan."

Financing • Licensing / partnership