Signature Cord Prime (SIG001) / Arugula Sci - LARVOL DELTA

Arugula Sciences Announces Company Launch with FDA Phase 1 Approval for Osteoarthritis Therapy (Businesswire) - "Arugula Sciences...announced that it has, in collaboration with its clinical partners, advanced its first therapeutic product, Signature Cord Prime™ (SIG001), with FDA approval for a Phase 1 clinical trial (NCT05234489) in the US. This Phase 1 study is an open-label, dose-ranging assessment of safety, tolerability, preliminary efficacy, and dose effects in patients with symptomatic osteoarthritis of the knee. Signature Cord Prime™ is the first human umbilical cord allograft product to receive FDA approval to be studied as an intra-articular injection to treat the signs and symptoms of knee osteoarthritis."

Licensing / partnership • New P1 trial • CNS Disorders • Immunology • Osteoarthritis • Pain

Study to Assess Signature Cord Product in Patients With Symptomatic OA of the Knee (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Thomas Klootwyk, MD

New P1 trial • Immunology • Osteoarthritis • Pain • Rheumatology

Signature Cord Prime Receives Investigational New Drug (IND) Approval from FDA for Phase 1 Study in Patients with Symptomatic Osteoarthritis of the Knee. (PRNewswire) - "Signature Biologics...today announced that the U.S. Food and Drug Administration (FDA) has approved an IND Application to proceed with the study of Signature Cord Prime™ in patients with symptomatic osteoarthritis (OA) of the knee with our Principal Investigator...Signature Biologics applied for the IND for Signature Cord Prime™ to begin clinical study of the product, working towards a full Biologics Licensing Application (BLA) with FDA's Center for Biologics Evaluation and Research (CBER)."

IND • Osteoarthritis • Pain