Bucillamine

Revive Therapeutics Provides Update of Novel Bucillamine Formulation Development

Retrieved on: 
Wednesday, October 11, 2023
Infection, ASPR, Inflammation, Injury, Development, Office of Inspector General, U.S. Department of Health and Human Services, Defence Research and Development Canada, University, Organization, Therapy, Administration, Organ transplantation, FDA, Biomedical Advanced Research and Development Authority, RVV, CSE, Acute respiratory distress syndrome, Disorder, DRDC, BARDA, Administration for Strategic Preparedness and Response, HHS, Research, Pharmaceutical industry, Bucillamine

TORONTO, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, provides an update on the development of a next generation lyophilized formulation of Bucillamine.

Key Points: 
  • TORONTO, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, provides an update on the development of a next generation lyophilized formulation of Bucillamine.
  • Under an agreement with the University of Waterloo, formulation development is ongoing and aims to be completed by the end of December 2023.
  • The Company expects to have its novel lyophilized formulation of Bucillamine ready for clinical evaluation in 2024.
  • The Company intends to explore the novel Bucillamine formulation as a potential treatment for public health medical emergencies including, pandemic influenza, emerging infectious diseases, and medical countermeasure incidents and attacks.

Revive Therapeutics Announces Initiation of Novel Bucillamine Formulation Development

Retrieved on: 
Tuesday, August 22, 2023
ASPR, Defence Research and Development Canada, Cell biology, CSE, University, Biomedical Advanced Research and Development Authority, Therapy, Biochemistry, Doctor of Philosophy, HHS, U.S. Department of Defense Strategy for Operating in Cyberspace, Public, Office of Inspector General, U.S. Department of Health and Human Services, University of Saskatchewan academics, Injury, Research, Infection, Postgraduate education, Central Department of Chemistry, Tribhuvan University, Disorder, DRDC, Assistant, Inflammation, RVV, Development, Graduate, Administration, Organ transplantation, Administration for Strategic Preparedness and Response, Acute respiratory distress syndrome, FDA, BARDA, Dean (education), Pharmaceutical industry, Science, Bucillamine

In addition, the Company may explore the use of the novel Bucillamine formulation as a potent antioxidant and anti-inflammatory treatment for orphan indications in rare inflammatory disorders such as ischemia-reperfusion injury resulting from solid organ transplantation.

Key Points: 
  • In addition, the Company may explore the use of the novel Bucillamine formulation as a potent antioxidant and anti-inflammatory treatment for orphan indications in rare inflammatory disorders such as ischemia-reperfusion injury resulting from solid organ transplantation.
  • The Company has entered into a sponsored research agreement with the University of Waterloo to develop a novel lyophilized Bucillamine injectable formulation for public health medical emergencies and rare inflammatory disorders.
  • Upon completion of the formulation development, which is expected by end-2023, the Company will seek to initiate research studies in line with the Company’s commitment to advancing the clinical and commercial development of Bucillamine through the following strategic initiatives:
    Target Indications: Novel Bucillamine in an injectable version to expand on its potential therapeutic utility targeting rare disorders such as ischemia-reperfusion injury (i.e.
  • At this time, the Company will only provide regular updates via press releases as information becomes available.

Revive Therapeutics Announces Filing of Patent for Bucillamine in the Treatment of Exposure to Chemical Warfare Agents

Retrieved on: 
Friday, July 28, 2023
ASPR, Plastic, Biomedical Advanced Research and Development Authority, CSE, Petroleum, Therapy, U.S. Department of Defense Strategy for Operating in Cyberspace, Chemical warfare, Human services, Fertilizer, Office of Inspector General, U.S. Department of Health and Human Services, Research, Disorder, Ricin, RVV, Development, Administration, Pesticide, Patent, Privacy Office of the U.S. Department of Homeland Security, Administration for Strategic Preparedness and Response, Conventional weapon, Paper, Textile, BARDA, Nerve, Pharmaceutical industry, Bucillamine

TORONTO, July 28, 2023 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, today announced that it has filed a provisional patent application titled “Compositions, methods and uses of Bucillamine in the treatment of a victim exposed to a chemical warfare agent.”

Key Points: 
  • TORONTO, July 28, 2023 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, today announced that it has filed a provisional patent application titled “Compositions, methods and uses of Bucillamine in the treatment of a victim exposed to a chemical warfare agent.”
    The methods and compositions described in the patent application relate to Bucillamine as a potential treatment of a victim exposed to a chemical agent, including chemical warfare agents such as sulfur mustards, nitrogen mustards, nerve agents of G and V type, lewisite and adamsite.
  • According to the U.S. Department of Homeland Security, a chemical attack is the spreading of toxic chemicals with the intent to do harm, which may include chemical weapons (warfare agents) developed for military use, toxic industrial and commercial chemicals that are produced, transported, and stored in the making of petroleum, textiles, plastics, fertilizers, paper, foods, pesticides, household cleaners, and other products, and chemical toxins of biological origin such as ricin.
  • The Company is commencing to work with advisors in developing a strategic plan to present its case in repurposing Bucillamine as a potential medical countermeasure for chemical warfare agent exposures to the Biomedical Advanced Research and Development Authority (BARDA), a part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services.
  • At this time, the Company will only provide regular updates via press releases as information becomes available.

Revive Therapeutics Announces Results of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19

Retrieved on: 
Thursday, July 6, 2023
CSE, Probability, Therapy, DSMB, Post, Hospital, Fever, COVID-19, SARS, Research, Disorder, Cough, Data monitoring committee, RVV, Patient, Polymerase chain reaction, Viral load, Heart rate, Death, Study, Safety, Pharmaceutical industry, Bucillamine

Although the number of hospitalization events was small, it demonstrated a positive trend in the Post-dose selection phase of the Study.

Key Points: 
  • Although the number of hospitalization events was small, it demonstrated a positive trend in the Post-dose selection phase of the Study.
  • There was no significant overall improvement trend between the Bucillamine and placebo arms for observed clinical symptoms and viral load data.
  • Additional analyses of the Study data are ongoing, which could support certain strategic decisions on pursuing the development and commercialization of Bucillamine.
  • There can be no assurance that the Company will proceed with the clinical development and regulatory approvals of Bucillamine for COVID-19 in the U.S. and internationally.

Revive Therapeutics Provides Update of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19

Retrieved on: 
Tuesday, May 30, 2023
Long COVID, Institutional review board, CSE, Drug development, Therapy, Cystinuria, Fever, COVID-19, Coronavirus, SARS, Injury, Research, COVID, Disorder, Cough, RVV, Patient, IRB, Polymerase chain reaction, Hematology, Evaluation, Viral load, Heart rate, FDA, Study, Long, Safety, Pharmaceutical industry, Bucillamine

The Company plans to complete its initial evaluation of the Study’s data with an independent biostatistician team by the end of June.

Key Points: 
  • The Company plans to complete its initial evaluation of the Study’s data with an independent biostatistician team by the end of June.
  • At this time, the Company will only provide regular updates via press releases as information becomes available.
  • The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.
  • There can be no assurance that the Company will proceed with the clinical development and regulatory approvals of Bucillamine for COVID-19 in the U.S. and internationally.

Revive Therapeutics Provides Update of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19

Retrieved on: 
Friday, May 12, 2023
Long COVID, CSE, Therapy, DSMB, Hospital, Cystinuria, Fever, COVID-19, Coronavirus, Injury, Research, COVID, Disorder, Cough, Data monitoring committee, RVV, Patient, Heart rate, FDA, Death, Study, Long, Safety, Pharmaceutical industry, Bucillamine

The DSMB recommended that the Study be halted early due to statistical significance of the primary endpoint likely not going to be met should the Study continue towards completion.

Key Points: 
  • The DSMB recommended that the Study be halted early due to statistical significance of the primary endpoint likely not going to be met should the Study continue towards completion.
  • Based on the recommendation from the DSMB, the Company has halted the Study and will now proceed to unblind and seek an evaluation of the Study’s data, including the COVID-19 clinical symptoms data (i.e.
  • cough, fever, heart rate, and oxygen saturation) to determine the potential next clinical and regulatory steps for Bucillamine.
  • There can be no assurance that the Company will proceed with the clinical development and regulatory approvals of Bucillamine for COVID-19 in the U.S. and internationally.

Revive Therapeutics Announces Data Safety Monitoring Board Meeting Date on Phase 3 Clinical Study of Bucillamine in the Treatment of COVID-19

Retrieved on: 
Tuesday, May 2, 2023
CSE, Therapy, DSMB, Hospital, Fever, COVID-19, Coronavirus, Research, Disorder, Cough, RVV, Data monitoring committee, Patient, Heart rate, FDA, Death, Environment, Pharmaceutical industry, Bucillamine, Study

Revive expects to announce the recommendation of the DSMB meeting by May 17th, 2023.

Key Points: 
  • Revive expects to announce the recommendation of the DSMB meeting by May 17th, 2023.
  • The DSMB is expected to recommend continuing the Study if there is a trend toward achieving statistical significance or halting the Study early due to statistical significance likely not going to be met.
  • Should the DSMB recommend not to pursue the Study due to statistical significance likely not going to be met, the Company will accept the DSMB decision and seek an evaluation of COVID-19 clinical symptoms data (i.e.
  • At this time, the Company will only provide regular updates via press releases as information becomes available.

Revive Therapeutics Provides Update of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19

Retrieved on: 
Tuesday, April 18, 2023
Long COVID, CSE, Therapy, DSMB, Hospital, Cystinuria, Fever, COVID-19, Coronavirus, Injury, Research, COVID, Type, Disorder, Cough, CDC, Data monitoring committee, RVV, Patient, Heart rate, FDA, Death, Environment, Long, Safety, Pharmaceutical industry, Bucillamine, Study

After further regulatory discussions with various groups, the Company has now decided that it will have the Data Safety Monitoring Board (“DSMB”) review the Study’s Post-Dose selection data of approximately 500 subjects for efficacy.

Key Points: 
  • After further regulatory discussions with various groups, the Company has now decided that it will have the Data Safety Monitoring Board (“DSMB”) review the Study’s Post-Dose selection data of approximately 500 subjects for efficacy.
  • In the latter case, the Company would request a meeting with the FDA to determine the appropriate next steps toward obtaining potential regulatory approval.
  • At this time, the Company will only provide regular updates via press releases as information becomes available.
  • The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.

Revive Therapeutics To Submit Updated Briefing Package in Support of Upcoming Type C Meeting Granted by FDA for Amended Protocol Agreement of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19

Retrieved on: 
Thursday, January 12, 2023
University, COVID-19, CSE, RVV, Safety, FDA, Omicron, Therapy, Patient, Research, Disorder, Pharmaceutical industry, Bucillamine

The study evaluated the potential disruption of the SARS-CoV-2 virus spike protein by various FDA-approved mild anti-oxidants, which has shown that Bucillamine had the most potent effect on COVID-19 Omicron variants when compared to these anti-oxidants being explored as a potential treatment for COVID-19.

Key Points: 
  • The study evaluated the potential disruption of the SARS-CoV-2 virus spike protein by various FDA-approved mild anti-oxidants, which has shown that Bucillamine had the most potent effect on COVID-19 Omicron variants when compared to these anti-oxidants being explored as a potential treatment for COVID-19.
  • As recently reported by the Company, the FDA has granted the Company’s Type C meeting request to obtain agreement on the revised protocol endpoints for the Company’s Phase 3 clinical trial (the “Study”) ( NCT04504734 ) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.
  • The goal date for the FDA to provide its written responses is March 7, 2023.
  • The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.

Revive Therapeutics Announces Publication Showing Bucillamine’s Potential Impact on COVID-19 Omicron Variants

Retrieved on: 
Monday, January 9, 2023
COVID, University, COVID-19, CSE, RVV, Safety, FDA, Omicron, Therapy, Patient, Research, Disorder, Pharmaceutical industry, Bucillamine

Disruption of the spike protein to prevent viral entry into the host cells with a molecule that is already approved and deemed safe for human use could accelerate the development of a new treatment option for COVID patients.

Key Points: 
  • Disruption of the spike protein to prevent viral entry into the host cells with a molecule that is already approved and deemed safe for human use could accelerate the development of a new treatment option for COVID patients.
  • A copy of the publication can be found at https://www.biorxiv.org/content/10.1101/2023.01.06.522977v1.full#F7 .
  • The goal date for the FDA to provide its written responses is March 7, 2023.
  • The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.