PulmoStem™ is the most advanced product in our pipeline, with strong late-stage pre-clinical data supporting the move into clinical trials with patients with severe inflammatory and fibrotic components in the disease. Although a specific organ is often targeted, many diseases have a profound systemic inflammatory involvement, and here PulmoStem™ is also ideally suited as a therapeutic. Amniotics has recently completed building a GMP grade cell manufacturing facility at our premises in Sweden, allowing us to produce PulmoStem™ for an Investigational New Drug (IND) program including pre-clinical studies and clinical trials. On the successful completion of this program, we expect a high interest from other commercial entities in the Pharma-sector for further rapid development of PulmoStem™ clinical programs.
About different diseases that can be treated with PulmoStem™
PulmoStem™ is a therapy, which is expected to downregulate the cytokine storm which is associated with COVID-19 and in addition will regenerate the damaged tissue and reduce the post COVID-19 symptoms. Amniotics expects that this treatment will be an effective contribution in the intensive care of patients suffering from COVID-19.
Amniotics is preparing af clinical Phase I/II study in Spain with PulmoStem™ for the treatment of COVID-19 related ARDS. The clinical trial application was submitted in March and Amniotics expects that the first patients will be treated in the summer 2021.The study will include 9-18 patients that suffer from COVID-19 related ARDS. The result of the study is expected in Q1 2022. The primary endpoint is safety and tolerability for patients suffering form COVID-19 related ARDS. The secondary endpoints include biomarkers for immunomodulating and cell-regenerating effects. PulmoStem™ is intended to be administered as an intravenous injection. The injected stem cells home to damaged sites and aid healing, as well as reducing systemic inflammation.
Apoptotic cell (blue) heavily infected with SARS-COV-2 virus particles (yellow)
Courtesy: National Institute of Allergy and Infectious Diseases (NIAID)
Idiopathic Pulmonary Fibrosis (IPF)
IPF is a lung disease that is progressive and currently irreversible. It is characterized by progressive fibrosis and scarring within the lungs, altering their normal function. This build-up of scar tissue prevents the lungs from effectively transporting oxygen into the bloodstream. Common symptoms of IPF are shortness of breath (dyspnea) and a persistent dry, hacking cough, while some patients also develop lung cancer, pulmonary emboli, pneumonia, or pulmonary hypertension.
The diagnosis is protracted, and the treatments are scarce with many side-effects and a low survival rate. The incidence and prevalence of IPF is rising worldwide. In Europe there is for instance evidence of a doubling in patient numbers over a ten-year period in both the UK and Czech Republic. Furthermore, mortality in IPF is high, with a reported median survival of 2–3 years from diagnosis, and only around 20% survival at 5 years. There is currently no curative treatment for IPF. A new treatment option for IPF with few side-effects, which can stop or reverse the disease progression and increase the survival rate will be very valuable for the patients.
PulmoStem™ is a potential new treatment option for IPF, whereby injection of stem cells is expected to halt the fibrosis and initiate healing of the damaged tissue. Amniotics is preparing a clinical phase I/II with PulmoStem™ for the treatment of IPF. Amniotics is planning to file a clinical trial application in H2 2022 and the result of this trial is expected in H2 2023. PulmoStem™ is intended to be administered as an intravenous injection, after which the stem cells migrate into the damaged lung where they secrete bioactive molecules, reduce inflammation, promote tissue regeneration, and slow fibrosis.