CYP-004 / Cynata Therap - LARVOL DELTA

The SCUlpTOR trial: Stem cell therapy in knee osteoarthritis. (ANZCTR) - P3 | N=320 | Completed | Sponsor: University of Sydney | Active, not recruiting ➔ Completed

HEOR • Trial completion • Immunology • Osteoarthritis • Pain • Rheumatology

Cynata hits century mark in phase II aGvHD trial (Herald Sun) - "The 100-day primary evaluation period has been completed for the last participant enrolled in Cynata Therapeutics’ Phase II clinical trial of CYP-001 in adults with aGvHD...Results from the phase III SCUlpTOR trial of CYP-004 in knee osteoarthritis, which enrolled 321 patients and was being conducted by the University of Sydney, remain on track for release in Q2 CY26. The phase I/II NEREID kidney transplantation trial at Leiden University Medical Centre in the Netherlands is progressing, following a positive Data Safety Monitoring Board (DSMB) review of the first cohort of patients."

P3 data • Trial status • Acute Graft versus Host Disease

Stem cell therapy in knee osteoarthritis. (ANZCTR) - P3 | N=320 | Active, not recruiting | Sponsor: University of Sydney | Recruiting ➔ Active, not recruiting

Cost effectiveness • Enrollment closed • HEOR • Immunology • Osteoarthritis • Pain • Rheumatology

Efficacy and cost-effectiveness of Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis: protocol for a randomised placebo-controlled trial (the SCUlpTOR trial). (PubMed, BMJ Open) - "The aim of this study is to investigate the efficacy, safety and cost-effectiveness of allogeneic mesenchymal stem cells (Cymerus MSCs) for treating symptomatic tibiofemoral KOA and improving knee structure over 24 months....The coprimary outcomes will be the proportion of participants achieving patient-acceptable symptom state for knee pain at 24 months and quantitative central medial femorotibial compartment cartilage thickness change from baseline to 24 months. Main secondary outcomes include change in knee pain, Patient Global Assessment, physical function, quality of life and other structural changes. Additional data for cost-effectiveness analysis will also be recorded. Adverse events will be monitored throughout the study. The primary analysis will be conducted using modified intention-to-treat"

Clinical • HEOR • Journal • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Phase 3 Osteoarthritis Clinical Trial Commences (GlobeNewswire) - "Cynata Therapeutics Limited...is pleased to announce that the Phase 3 SCUlpTOR ('Stem Cells as a symptom- and strUcture-modifying Treatment for medial tibiofemoral OsteoaRthritis') Trial of CYP-004, Cynata’s Cymerus™ mesenchymal stem cell (MSC) product for osteoarthritis, has now commenced....Subject treatment will commence with an initial four patients from the University’s volunteers' database, who will be assessed for four weeks...Patients who are interested in participating in the trial should wait until wider enrolment commences before contacting study centres, which is expected to happen early in 2021. The aim of the trial is to assess the effect of Cymerus MSCs compared to placebo on clinical outcomes and knee joint structure over a two-year period, in 440 patients with osteoarthritis of the knee."

Enrollment status • Trial status • Osteoarthritis • Pain

Cynata looking to revolutionise stem cell therapy (The West Australian) - "Cynata will soon embark on a Phase 3 trial of its CYP-004 product, the company’s mesenchymal stem cell or 'MSC' product developed to treat osteoarthritis. The 448 person trial is being sponsored by The University of Sydney and will be funded by a project grant from the Australian Government National Health and Medical Research Council."

Review • Osteoarthritis • Pain

Patient Enrolment Opens in COVID-19 Clinical Trial (GlobeNewswire) - "Cynata Therapeutics Limited...is pleased to announce that the MEND (MEseNchymal coviD-19) Trial is now open for patient enrolment....The MEND Trial will investigate early efficacy of Cynata’s proprietary Cymerus™ mesenchymal stem cells (MSCs) in adults admitted to intensive care with COVID-19."

Cytokine release syndrome • Enrollment open • Infectious Disease • Novel Coronavirus Disease

Cynata Announces Ethics Approval and Expedited Regulatory Pathway for Phase 3 Osteoarthritis Clinical Trial (GlobeNewswire) - "Cynata Therapeutics Limited...is pleased to report important progress towards the commencement of recruitment in the Phase 3 clinical trial of CYP-004, its Cymerus™ mesenchymal stem cell (MSC) product for osteoarthritis....Phase 3 trial will be performed, and that is reflected in the final HREC-approved version of the protocol....The Company is pleased to announce that agreement has been reached on an expedited regulatory pathway for this trial....However...the Therapeutic Goods Administration (TGA), the TGA has advised that the trial can be conducted under the Clinical Trial Notification (CTN) scheme..."

Enrollment status • Regulatory • Osteoarthritis • Pain

Cynata Receives Ethics Approval to Commence Clinical Trial in COVID-19 and Clinical Development Update (GlobeNewswire, Cynata Therapeutics Limited) - "Cynata Therapeutics Limited...is pleased to announce that it has received ethics committee approval to commence a clinical trial to investigate...Cymerus™ mesenchymal stem cells (MSCs) in adults admitted to intensive care with COVID-19....This trial will build on Cynata’s strong pre-clinical study results in ARDS, sepsis and cytokine release syndrome, all of which are common hallmarks of severe COVID-19 cases....The study will be an open-label, randomised controlled clinical trial.....Twelve patients will be randomised to receive Cymerus MSC infusions....The primary efficacy endpoint will be improvement in PaO2/FiO2 ratio....Safety and tolerability up to Day 28 will also be a primary endpoint. Recruitment is expected to commence subject to finalisation of relevant agreements with study centres."

Cytokine release syndrome • New trial • Preclinical • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease

Cynata Therapeutics (ASX:CYP) receives an extra $618k R&D tax refund (The Market Herald) - "Cynata Therapeutics (CYP) has received a $618,667 research and development (R&D) tax refund for the 2018-2019 financial year....This additional cash extends Cynata's cash balance and enables further resources to be invested towards its clinical trial programs for CLI (reduced blood flow to limbs), osteoarthritis and graft-versus-host disease....Cynata has informed shareholders that its current Phase 2 trial plans for CLI and osteoarthritis remain on track."

Financing • Trial status

Cynata Advances Toward Phase 2 Clinical Trial of Cymerus(TM) MSCs in Patients with Osteoarthritis (GlobeNewswire, Cynata Therapeutics Limited) - "Cynata Therapeutics Limited...is pleased to provide an update on start-up activities of a Phase 2 clinical trial to evaluate Cynata’s Cymerus™ mesenchymal stem cells (MSCs) as a treatment for osteoarthritis, following the signing of an agreement with the University of Sydney. Key Highlights: Osteoarthritis is the third Phase 2 indication for Cynata...; 448-patient Phase 2 clinical trial in osteoarthritis expected to commence in Quarter 1 2020; Cynata retains full commercial rights to the use of Cymerus MSCs in osteoarthritis; One of the largest MSC trials to ever be conducted will showcase Cynata’s MSC manufacturing capability."

Clinical • Commercial • Enrollment status • Trial status