Biopub Key Points Taken from medchem from investorhubs (Amazing post on the conference call that Algernon had):
VERY GOOD NEWS FROM THE CALL - READ ALL BELOW - THANK YOU medchem for the information!!!
Link to conference call published today: https://www.otcmarkets.com/stock/AGNPF/news/Algernon-CEO-and-CSO-to-be-Featured-on-BioPub-Webcast-Hosted-by-Dr-KSS-MD-PhD?id=258968 Link to post from investors hub: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=154972724 BioPub key points from today: 1) Mark and Chris "working 20 hour days". 2) The virus H5N1 has 50% mortality rate. Ifenprodil reduces mortality for this virus by 40% and reduced acute lung injury and lung inflammation. Drug approved in Asian countries. Shout out to the investigations for chronic cough and idiopathic pulmonary fibrosis study. Australia, 41% refundable tax credit. Ethics approval agency there is "easy to work with". Drug works so well for H5N1, should work in humans for COVID-19. 3) Drug also helps lungs in low oxygen environments (another separate study they found)! 4) Goal: Try to advance clinical trials as quickly as possible. Use repurposed drug that has known good safety profile. 5) Updates: Decided to move forward in South Korea where Ifenprodil is approved. Working with Novotech who invests in the company and is going to run the trial with physician investigators. Also plan to try to do CoVID trial in Australia. Now have positive feedback to aggresively move to Phase 2 IND trial in the USA. Also working with Health Canada. Positive feedback to run a trial also. 6) Mark Williamss update: Submitted for approval 40 patient trial in South Korea. To look at severe pneumonia. Goal: Try to quickly return lung function to normal levels. Try to decrease mortality. If we can avoid use of respirators, that would be excellent as the drug can decrease strain on the intensive care units. Filings done last week. Expedited review should be back imminent. "DOSING PATIENTS SOON!". Additional study trying to save patients already on ventilators. Could prevent death in that group. Adapted trial design to look at lung function or mortality as primary endpoint. This is an ideal study design. UPDATE MINUTE BY MINUTE. COMMISSIONED BIOSTATISTICIANS TO DESIGN THIS! Mechanism of action: Why does this work so well. Mark's thoughts: what could happen is that initial release of glutamate, there are NMDA receptor on neutrophils, increased CD11b, increase ICAM-1 excpression in the lung. Traffic neutrophils from lungs. Neutrophils could be releasing glutamate in the lungs and on T cells. NR2B subunit paper 2014 ifenprodil modulated t cell activity and reduced it. Its conceivable that (1) stop trafficking of neutrophils (2) decrease glutamate (3) decrease t cells (4) decrease the cytokine storm because this might be the biggest issue. Also high likelihood of anti-fibrotic effect. Recap: test with severe pneumonia in south korea. then another trial with patients on ventilators. Glutamate is a danger signal. It's the bodies approach to kick start the immune response. Too overactivated becomes pathological. "We are not exclusively covid". Our drug should work for other lung injury disease. Just COVID is the priority right now. Mark Williams continues: Responds to Dr. Kiss about his long winded question about fibrosis in the lung. Williams goes on to say that he thinks Ifenprodil will slow down fibrosis. Running four weeks trial for COVID. Phone rang. Mark says... Might be the clinical trial calling... Advantage to repurposing is doing things in months instead of years. Animal models: Ifenprodil may be an improvement for chronic cough as no loss of taste. Drug might be able to use prevent COVID-19. This would be huge because it could increase the number of people taking the drug. Dr. Kiss asks what is the plan, synopsis... Williams: Good feedback from Health Canada and FDA Adaptive design study Run those studies in North America Waiting to hear from Biostats guys Dont need a huge number of patients to see a signal Example: Start the trial, adapt by redoing power calculation to know the sample size needed once you have a signal showing Dr. Kiss: What happens if you get positive signal? Still going to do IPF studies even if COVID studies positive in fact COVID signal might indicate IPF patients will benefit. Might be able to get IPF information indirectly from COVID. Cost mitigation is the big difference between this work and normal trials. Compressing into days and weeks what normally takes months. Working urgently to file Health Canada Trial Application. Should be hearing back urgently from them as everything is expedited. Novotech: DOING WHATEVER IT TAKES. 10+ person meetings.