Too much big RLFTF news on the way for us to be below dollars for long. This should be in a PR soon and that should be worth well over a dollar and then this below is due any day now. Quote: Data Monitoring Committee info! On July 16, the company said we'd get a scheduled data review in 4 weeks. That should be this week(hopefully)
-With resurgent COVID-19, enrollment has accelerated in Miami, Houston, and Irvine
-Data Monitoring Committee determined that so far RLF-100 has generated no drug-related Serious Adverse Events or other safety concerns that would mandate stopping. The study is to continue until the next scheduled data review in four weeks.
Primary endpoint is established as “Alive and free of Respiratory Failure.” Radnor, PA and Geneva July 16, 2020 – NeuroRx, Inc., in partnership with RELIEF THERAPEUTICS Holdings AG (OTC:RLFTF, SIX:RLF) today announced that the independent Data Monitoring Committee has reviewed the findings in the first 30 patients treated in Fast Track FDA trials of RLF-100 (Aviptadil) in patients with Critical COVID-19 with respiratory failure.
The study protocol enrolls patients with Critical COVID-19 and Respiratory Failure and randomly assigns them to intravenous RLF-100 or Placebo in the hopes of achieving remission from this most-serious stage of COVID-19. At the committee’s recommendation, the primary endpoint is changed to “alive and free of respiratory failure at 7-10 days.” This change in primary endpoint from mortality at 28 days is driven by the general decrease in mortality with advances in treatment for Critical COVID-19 and by initial observations in the clinical trial.
This first interim analysis was focused on verifying the apparent safety of the drug in the first 30 patients and the feasibility of the study to reach its endpoint. The committee determined that the study appeared capable of reaching a statistically significant endpoint within its 144 patient sample size and voted for the study to continue until its next scheduled evaluation in four weeks.
The committee is composed of Prof. Alfred Sommer, MD, MHS, Dean Emeritus of the Johns Hopkins Bloomberg School of Public Health, Prof. Rita Colwell, PhD, former Director of the National Science Foundation, and Congressman, Andy Harris, MD, MHS (MD District 1) a part time Professor of Anesthesia and Critical Care at Johns Hopkins School of Medicine.
RLF-100 (Aviptadil) received Fast Track designation from the US FDA for the treatment of Critical COVID-19 with respiratory failure. Aviptadil is a synthetic form of human Vasoactive Intestinal Peptide (VIP) which is known to protect the Alveolar Type II cell of the lung from many forms of injury. This cell is critical to transmission of oxygen to the blood and is the site of attack for the Coronavirus.
“This milestone represents the extraordinary effort of our partners and collaborators at the University of Miami, Houston Methodist Hospital, UC Irvine, and University of Louisville who gave 100% to providing patients with Critical COVID-19 a chance to benefit from a potentially life-saving drug. We thank the members of the Data Monitoring Committee for devoting their valuable time to performing this vital role in helping to evaluate the safety and effectiveness of RLF-100,” said Prof. Jonathan C Javitt, MD, MPH, CEO of NeuroRx and the National Study Chair.
Details of the study are posted on clinicaltrials.gov NCT04311697.
-Expanded access protocol, including for pregnant women, is becoming available to patients who are ineligible for enrollment in the FDA clinical trial of RLF-100, -RLF-100, a patented formulation of Aviptadil, is currently in development by NeuroRx and RELIEF THERAPEUTICS Holding AG under Fast Track Designation, and recently obtained positive safety opinion from the data monitoring committee.
Geneva and Radnor, PA, July 29, 2020 – RELIEF THERAPEUTICS Holding AG (SIX:RLF, OTC:RLFTF) “Relief” and its U.S. partner, NeuroRx, Inc. today announced that FDA has granted an Expanded Access Protocol for treatment of Respiratory Failure in COVID-19 with RLF-100 (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP). The protocol makes treatment available to patients who have exhausted standard therapies and are not eligible for the current phase 2/3 trial of RLF-100 because of confounding medical conditions and specifically makes the treatment available to pregnant women. Although the drug remains under investigation, rapid recovery from respiratory failure in COVID-19 has been seen in patients treated under FDA Emergency Use authorization.[1]
The expanded access protocol may be viewed on www.clinicaltrials.gov NCT04453839. Physicians who wish to enroll their patients in the protocol must submit the protocol to their local investigational review board and file FDA form 1572 with NeuroRx, Inc. Further information may be obtained from expandedaccess@neurorxpharma.com.
“By granting this Expanded Access protocol, FDA has made a potentially lifesaving drug immediately available to critically ill patients who have no other available treatment,” said Dr. Jonathan C. Javitt, MD, MPH, NeuroRx’s CEO. “We thank the FDA’s pulmonary division for its rapid and proactive implementation of the Coronavirus Treatment Acceleration Program, and we aspire to demonstrate broad safety and efficacy for RLF-100 in our ongoing clinical trial.”
The SARS-CoV-2 coronavirus that causes COVID-19 attacks the body by entering the small population of Alveolar Type II cells in the lung.[2] Without Type II cells, the lung cannot transmit oxygen, which why the coronavirus causes acute respiratory failure. 50 years of scientific research demonstrates that VIP binds specifically to the Type II cell and protects that cell against cytokines (inflammatory molecules) and a wide array of toxic and infectious injuries.”[3]
-Rapid recovery of patients on ventilators and ECMO (extracorporeal membrane oxygenation) was seen in patients with severe medical comorbidities after three days of treatment with RLF-100 under FDA Emergency Use IND authorization at multiple clinical sites.
-RLF-100 is being developed as the first COVID therapeutic to block replication of the SARS-CoV-2 virus in human lung cells and monocytes
-RLF-100 is a patented formulation of aviptadil (synthetic human Vasoactive Intestinal Polypeptide VIP), which has been granted FDA Fast Track Designation, FDA emergency use IND authorization, and an expanded access protocol.
Radnor, PA and Geneva, CH, August 3, 2020 – NeuroRx, Inc. and Relief Therapeutics Holdings AG (SIX:RLF, OTC:RLFTF) “Relief” today announced that RLF-100 (aviptadil) showed rapid recovery from respiratory failure in the most critically ill patients with COVID-19. At the same time, independent researchers have reported that aviptadil blocked replication of the SARS coronavirus in human lung cells and monocytes.
RLF-100 has been granted Fast Track designation by FDA and is being developed as a Material Threat Medical Countermeasure in cooperation with the National Institutes of Health and other federal agencies. Further research will be conducted.
The first report of rapid clinical recovery under emergency use IND was posted by doctors from Houston Methodist Hospital. The report describes a 54-year-old man who developed COVID-19 while being treated for rejection of a double lung transplant and who came off a ventilator within four days.[1] Similar results were subsequently seen in more than 15 patients treated under emergency use IND and an FDA expanded access protocol which is open to patients too ill to be admitted to the ongoing Phase 2/3 FDA trial.
Patients with Critical COVID-19 were seen to have a rapid clearing of classic pneumonitis findings on x-ray, accompanied by an improvement in blood oxygen and a 50% or greater average decrease in laboratory markers associated with COVID-19 inflammation.[2] clinicaltrials.gov NCT04311697.
The clinical findings may be based on evidence that VIP inhibits the replication of the SARS-CoV-2 virus in human lung cells and immune cells (monocytes). The work was reported by Brazilian researchers working in a level-4 biocontainment laboratory.[3] The same researchers reported a case-control study in which patients who survived being on ventilators for COVID-19 had significantly higher levels of VIP in their blood than those who died of respiratory failure.
“No other antiviral agent has demonstrated rapid recovery from viral infection and demonstrated laboratory inhibition of viral replication,” said Prof. Jonathan Javitt, CEO and Chairman of NeuroRx. “We are conducting placebo-controlled trials to see whether the observations made in the case-control and open-label studies will be confirmed for less ill patients with COVID-19-related respiratory failure. Our independent Data Monitoring Committee will be conducting an interim analysis of these data later this month.”
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