Small Mobile stem (SMS) cell therapy / SMSbiotech - LARVOL DELTA

SMSbiotech Receives FDA 'Study May Proceed' Notification for First U.S. IND-Cleared Inhaled Stem Cell Therapy in COPD (PRNewswire) - "This action clears the way for the Company to initiate a U.S. Phase 1b clinical study of SMS Cells in patients with COPD and expands the clinical development of its non-invasive, off-the-shelf, allogeneic inhaled cell platform into the United States....The Company is currently evaluating nebulized SMS Cells in ascending-dose cohorts in an ongoing Phase 1b clinical trial in Melbourne, Australia. The first cohort was dosed and completed the protocol-specified 28-day safety monitoring period with no therapy-related adverse events, and dose escalation to the second of three cohorts is underway. First patient dosing in a U.S. Phase 1b study is targeted for the fourth quarter of 2026. Subject to Phase 1b safety and tolerability data, SMSbiotech plans to initiate a Phase 2a study in the first half of 2027."

IND • New P2a trial • Trial status • Chronic Obstructive Pulmonary Disease

SMSbiotech Initiates Groundbreaking Phase 1 Human Clinical Trial for COPD (Businesswire) - "The Phase 1 study, titled 'A study to investigate small mobile stem cells (SMS cells) in participants aged 39 to 69 years with chronic obstructive pulmonary disease,' will enroll 18 COPD patients."

New P1 trial • Chronic Obstructive Pulmonary Disease

SMSbiotech Receives Green Light for Phase I Clinical Trial in Australia, Targeting COPD (Businesswire) - "SMSbiotech has announced a significant milestone in its pursuit of its regenerative medicine technology, securing approval to commence a Phase I clinical trial in Australia (registration number: ANZCTR12624001140549p). The trial will focus on evaluating the safety and tolerability of the company's innovative Small Mobile stem (SMS) cell therapy for Chronic Obstructive Pulmonary Disease (COPD)....The Phase I trial will primarily assess the safety and tolerability of the therapy in human subjects. The study will enroll 18 patients with mild to moderate COPD in accordance with the patient enrollment criteria outlined by the US FDA."

New P1 trial • Chronic Obstructive Pulmonary Disease