web analytics

The Exciting Story of Bucillamine; Revive Therapeutics Ltd (OTCMKTS: RVVTF)

0

Revive Therapeutics Ltd (OTCMKTS: RVVTF) is an exciting story developing in small caps that has seen some nice moves in recent months running to $0.50 in early July. The stock is currently trading at the bottom of its range and has a significant shareholder base accumulating at current levels.

Revive just announced its expanded access protocol (“EAP”) for compassionate use of Bucillamine in the treatment of COVID-19 received approval from the independent Institutional Review Board (“IRB”). The EAP for compassionate use is a multi-center, open label study of Bucillamine in hospitalized patients with severe COVID-19 and is being done to complement the Company’s Phase 3 COVID-19 study in the U.S.  Revive expects to have patients enrolled in the United States this month.

Revive Therapeutics Ltd (OTCMKTS: RVVTF) operating out of Toronto, Ontario is a life sciences Company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its recent acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation.

On July 31 the FDA approved the Company to proceed with a randomized, double-blind, placebo-controlled confirmatory Phase 3 clinical trial protocol to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19. Preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells.1 N-acetyl-cysteine (NAC) has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to increase antioxidant activity of cellular glutathione2,3,4,5. Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years. Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than NAC 6. The drug is non-toxic with high cellular permeability. The basis of the clinical study will analyze if Bucillamine has the potential, via increasing glutathione activity and other anti-inflammatory activity, to lessen the destructive consequences of SARS-CoV-2 infection in the lungs and attenuate the clinical course of COVID-19.

To Find out the inside Scoop on RVVTF Subscribe to Microcapdaily.com Right Now by entering your Email in the box below

RVVTF

On September 16 Revive announced its expanded access protocol (“EAP”) for compassionate use of Bucillamine in the treatment of COVID-19 received approval from the independent Institutional Review Board (“IRB”). The EAP for compassionate use is a multi-center, open label study of Bucillamine in hospitalized patients with severe COVID-19 and is being done to complement the Company’s Phase 3 COVID-19 study in the U.S.  Revive expects to have patients enrolled in the United States this month. The EAP for compassionate use provides physicians with access to Bucillamine under Revive’s existing Investigational New Drug (“IND”) application for COVID-19.  According to the FDA, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

The expanded access study is titled, “Multi-Center, Open-Label, Expanded Access Study of Bucillamine in Hospitalized Patients with Severe COVID-19 (EA-ARISE)”.  Patients will receive Bucillamine 200 mg orally, 3 times a day (TID), for up to 14 days. The objective is to monitor the safety and efficacy of Bucillamine (600 mg/day) and any clinical symptoms when administered up to 14 days in hospitalized patients with severe COVID-19.  Following completion of the treatment course, follow up safety assessments will be performed by a study nurse 14 and 42 days following the end of treatment.

“With the IRB approval of the expanded access protocol by Advarra, a premier IRB services company in North America, hospitalized patients with severe COVID-19 may access Bucillamine under the FDA compassionate use program under medical supervision by their physician,” said Michael Frank, Revive’s Chief Executive Officer. “The EAP serves as an option for patients that are not eligible for inclusion criteria in our Phase 3 clinical study in COVID-19 and the resulting data from the EAP will be valuable in supporting our clinical development of Bucillamine.”

We have a Monster Pick Coming. Subscribe Right Now!

Currently trading at the bottom of its range Revive may be the covid stock that is getting overlooked; clinical trial protocol to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19. Preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells.1 N-acetyl-cysteine (NAC) has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to increase antioxidant activity of cellular glutathione2,3,4,5. Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years. Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than NAC 6. The drug is non-toxic with high cellular permeability. The basis of the clinical study will analyze if Bucillamine has the potential, via increasing glutathione activity and other anti-inflammatory activity, to lessen the destructive consequences of SARS-CoV-2 infection in the lungs and attenuate the clinical course of COVID-19. Revive just announced its expanded access protocol (“EAP”) for compassionate use of Bucillamine in the treatment of COVID-19 received approval from the independent Institutional Review Board (“IRB”). The EAP for compassionate use is a multi-center, open label study of Bucillamine in hospitalized patients with severe COVID-19 and is being done to complement the Company’s Phase 3 COVID-19 study in the U.S.  Revive expects to have patients enrolled in the United States this month. We will be updating on Revive on a daily basis so make sure you are subscribed to microcapdaily.com so you know what is going on with Revive.

Sign Up now for our 100% FREE Penny Stock Newsletter

Disclosure: we hold no position in Relief either long or short and we have not been compensated for this article.
Share.

Leave A Reply

Sign up now for our 100% FREE Penny Stock Newsletter

Privacy Policy. we will never share your email with anyone.