$RLFTF 8/20/2020 Relief Therapeutics and NeuroRx note submission of clinical results from 21 patient study for publication
by Relief Therapeutics | Aug 20, 2020
Geneva, Switzerland and Radnor, PA August 20, 2020 – RELIEF THERAPEUTICS Holdings SA (SIX:RLF) and NeuroRx, Inc. announce that clinical findings in the first 21 patients treated with RLF-100 (aviptadil) under FDA Emergency Use Investigational New Drug (IND) authorization and Expanded Access Protocol authorization have been submitted by investigators at the Houston Methodist Hospital as a preprint to the SSRN server maintained by Elsevier[1]. The manuscript has been submitted for peer review to a leading scientific journal.
The Expanded Access Protocol (previously announced by Relief and NeuroRx) is designed to treat patients whose co-morbidities exclude them from enrollment in the ongoing phase 2/3 placebo-controlled trial of RLF-100. Further details can be found on www.clinicaltrials.gov NCT04453839.
Relief notes that an earlier draft of this manuscript was circulated in financial forums by unauthorized persons. Only the manuscript on the SSRN server available under the above link should be considered to represent the official findings of the study. The findings of Dr. Youssef and his team demonstrate that some critically ill patients with COVID-19 experienced substantial clinical improvement when treated with RLF-100. We await the results of the ongoing placebo-controlled trial in order to assess the magnitude of clinical effect.
https://relieftherapeutics.com/relief-therape...blication/
This paper was revised and reposted yesterday by Jonathan Javitt. This is a different paper to the one that was leaked yesterday from Houston Methodist. This shows that Aviptadil/RLF-100 has more use cases than just COVID-19...
https://privpapers.ssrn.com/sol3/papers.cfm?a...id=3662952
Title: Treatment of Sepsis-related Acute Respiratory Distress Syndrome with Vasoactive Intestinal Peptide
Purpose: To assess the clinical safety and possible effectiveness of Vasoactive Intestinal Peptide in the treatment of Acute Respiratory Distress Syndrome (ARDS) related to sepsis
Results: No drug-related serious adverse events were seen. Hypotension was seen in association with two infusions and diarrhea in association with one, but did not necessitate cessation of therapy. Bigeminy was seen in association with one infusion without sequelae. Seven of eight patients demonstrated a successful course during intensive care and were successfully removed from mechanical ventilation and discharged from intensive care. The eighth patient succumbed to purulent secretions in the lungs. Of those who were discharged from the ICU, six demonstrated successful 30 day survival. The seventh died from a cerebral infract at day 30, deemed unrelated to treatment with VIP. Serum levels of Tumor Necrosis Factor a were obtained in 6 patients at baseline and 24 hours and were seen to decrease with treatment in five patients.
Conclusions: Initial clinical results of treatment with VIP in patients with ARDS demonstrated a safety profile consistent with previous studies in normal volunteers. The successful clinical course seen in 7 of 8 patients in the setting of an expected 50% survival may suggest that VIP shows promise in the treatment of other infectious conditions that damage the pulmonary epithelium, particularly COVID-19.
Official Clinical Results Link
https://clinicaltrials.gov/ct2/show/NCT04453839
by Relief Therapeutics | Aug 20, 2020
Geneva, Switzerland and Radnor, PA August 20, 2020 – RELIEF THERAPEUTICS Holdings SA (SIX:RLF) and NeuroRx, Inc. announce that clinical findings in the first 21 patients treated with RLF-100 (aviptadil) under FDA Emergency Use Investigational New Drug (IND) authorization and Expanded Access Protocol authorization have been submitted by investigators at the Houston Methodist Hospital as a preprint to the SSRN server maintained by Elsevier[1]. The manuscript has been submitted for peer review to a leading scientific journal.
The Expanded Access Protocol (previously announced by Relief and NeuroRx) is designed to treat patients whose co-morbidities exclude them from enrollment in the ongoing phase 2/3 placebo-controlled trial of RLF-100. Further details can be found on www.clinicaltrials.gov NCT04453839.
Relief notes that an earlier draft of this manuscript was circulated in financial forums by unauthorized persons. Only the manuscript on the SSRN server available under the above link should be considered to represent the official findings of the study. The findings of Dr. Youssef and his team demonstrate that some critically ill patients with COVID-19 experienced substantial clinical improvement when treated with RLF-100. We await the results of the ongoing placebo-controlled trial in order to assess the magnitude of clinical effect.
https://relieftherapeutics.com/relief-therape...blication/
This paper was revised and reposted yesterday by Jonathan Javitt. This is a different paper to the one that was leaked yesterday from Houston Methodist. This shows that Aviptadil/RLF-100 has more use cases than just COVID-19...
https://privpapers.ssrn.com/sol3/papers.cfm?a...id=3662952
Title: Treatment of Sepsis-related Acute Respiratory Distress Syndrome with Vasoactive Intestinal Peptide
Purpose: To assess the clinical safety and possible effectiveness of Vasoactive Intestinal Peptide in the treatment of Acute Respiratory Distress Syndrome (ARDS) related to sepsis
Results: No drug-related serious adverse events were seen. Hypotension was seen in association with two infusions and diarrhea in association with one, but did not necessitate cessation of therapy. Bigeminy was seen in association with one infusion without sequelae. Seven of eight patients demonstrated a successful course during intensive care and were successfully removed from mechanical ventilation and discharged from intensive care. The eighth patient succumbed to purulent secretions in the lungs. Of those who were discharged from the ICU, six demonstrated successful 30 day survival. The seventh died from a cerebral infract at day 30, deemed unrelated to treatment with VIP. Serum levels of Tumor Necrosis Factor a were obtained in 6 patients at baseline and 24 hours and were seen to decrease with treatment in five patients.
Conclusions: Initial clinical results of treatment with VIP in patients with ARDS demonstrated a safety profile consistent with previous studies in normal volunteers. The successful clinical course seen in 7 of 8 patients in the setting of an expected 50% survival may suggest that VIP shows promise in the treatment of other infectious conditions that damage the pulmonary epithelium, particularly COVID-19.
Official Clinical Results Link
https://clinicaltrials.gov/ct2/show/NCT04453839
1
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