Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
On the psych side - another interesting article.
https://pharmacy.wisc.edu/two-first-in-kind-clinical-trials-explore-psilocybin-for-substance-misuse/
https://pubmed.ncbi.nlm.nih.gov/35762590/
Recently published - a month or so back.
New video out:
Revive Therapeutics Provides Update on Phase 3 Clinical Trial for Bucillamine in COVID-19
May 26, 2022 10:15 ET
| Source: Revive Therapeutics Ltd.
The Company received positive comments from the FDA to determine potential new clinical endpoints to support Emergency Use Authorization
TORONTO, May 26, 2022 (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, is pleased to provide an update on the Company’s U.S. Food & Drug Administration (“FDA”) 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 Company has received positive comments from the FDA in regards to the Company’s request to determine and agree on the Study’s potential new primary efficacy endpoints, including the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcome observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization. The FDA has agreed that the Company may unblind the pre-dose-selection data for the first 210 patients of the Study to further support the new primary endpoint. Before unblinding the pre-dose selection data for the first 210 patients, the Company will submit a Data Access Plan to the FDA in early June 2022 with the aim to unblind the pre-dose selection data and submit the amended Study protocol with the new primary efficacy endpoints to the FDA.
In addition, the Data Safety and Monitoring Board (“DSMB”) are scheduled to meet thereafter to evaluate the interim clinical and safety data and may make a recommendation on continuing the Study or advise on halting the Study early due to positive efficacy based on other clinical outcomes such as the rate of sustained clinical resolution of symptoms of COVID-19. The DSMB supported the continuation of the Study in its last meeting as there were no serious adverse events or safety concerns reported.
The Company believes that with the Omicron variant, including the BA.2 variant, being the dominant strain over the Delta variant, there is an urgent unmet need to treat symptom resolutions in addition to preventing hospitalizations.
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.
About Revive Therapeutics Ltd.
Revive 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 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. For more information, visit www.ReviveThera.com.
For more information, please contact:
Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of this release.
Cautionary Statement
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2021, which has been filed on SEDAR and is available under the Company’s profile
LSU chemist and collaborator discover a natural-based therapy to treat an aggressive form of breast cancer
https://www.lsu.edu/science/chemistry/news/2022/rivas_tnbc.php
I agree with you 100%.
This looks like a total over reaction.
There is still the dividend which is positive.
The shareholders will end up with 2 pieces of paper (2 stocks instead of 1).
The delay is the audit.
The questions will be the long term effect of the resignations of the executives for Tyde.
At the end of the day, shareholders end up with the same executives running the second company so this evenings sell off may be over-blown.
Looks like time to buy the dip.
Not 100% sure what happened but Raymond James in Canada started putting in big sell orders at market. Looks like a margin call or something (I am not certain, speculating only).
As I write this post they sold 1.33 million in Canada relentlessly.
Nothing fundamentally has changed as the company put out that update the other day, this appears to simply be in my opinion la margin call (forced sale) which may have triggered stop losses along the way.
Good luck to all.
Revive Therapeutics Enters Into Research Agreement with UCSF For Bucillamine As Potential Treatment For Severe COVID-19
May 03, 2021 09:15 ET
| Source: Revive Therapeutics Ltd.
TORONTO, May 03, 2021 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF, Frankfurt: 31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce that it has entered into a sponsored research agreement with University of California, San Francisco (“UCSF”) to explore the utility of Bucillamine as a treatment for severe COVID-19. The agreement will support research in the laboratory of Dr. John Fahy to test the efficacy of Bucillamine in pre-clinical models of COVID-19 and to design protocols that test the utility of Bucillamine in human trials.
Michael Frank, CEO of Revive commented: “We are excited to expand the use of Bucillamine as a potential treatment for severe COVID-19 with our research agreement with UCSF and Dr. Fahy as Principal Investigator. Revive is focused on proving Bucillamine’s clinical utility for all forms of COVID-19. Evaluating Bucillamine for severe COVID-19 along with our dedication in completing our ongoing Phase 3 clinical study for mild-to-moderate COVID-19, which has grown from 14 clinical sites to now 26 participating sites in 10 U.S. states, will position Bucillamine as a potential oral treatment option for mild-moderate to severe COVID-19.”
Dr. Fahy is the senior author of a recent study, titled “Thiol-based drugs decrease binding of SARS-CoV-2 spike protein to its receptor and inhibit SARS-CoV-2 cell entry” showing that thiol-based drugs, like Bucillamine, decrease the binding of SARS-CoV-2 spike protein to its receptor, decrease the entry efficiency of SARS-CoV-2 spike pseudotyped virus, and inhibit SARS-CoV-2 live virus infection. These findings uncovered a vulnerability of SARS-CoV-2 to thiol-based drugs and provide rationale to test thiol-based drugs such as Bucillamine as novel treatments for COVID-19.
Dr. John Fahy, MD, MSc is a Professor of Medicine in the Division of Pulmonary and Critical Care Medicine and the Department of Medicine at the University of California, San Francisco and is a director of UCSF’s severe asthma clinic. He also directs the UCSF Airway Clinical Research Center. His research receives funding from the National Institutes of Health for studies of lung disease and for studies of thiol-based drugs to treat mucus pathology in the lung. Dr. Fahy earned his medical degree at the University College Dublin. After internal medicine training in Dublin, he completed fellowship training in pulmonary and critical care medicine at UCSF. He is the Michael S. Stulbarg Endowed Chair in Pulmonary Medicine.
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.
About Revive Therapeutics Ltd.
Revive 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 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. For more information, visit www.ReviveThera.com.
For more information, please contact:
Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of this release.
Cautionary Statement
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2020, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.
UC Disclaimer
The information stated above was prepared by Revive Therapeutics Ltd. and reflects solely the opinion of the corporation. Nothing in this statement shall be construed to imply any support or endorsement of Revive, or any of its products, by The Regents of the University of California, its officers, agents and employees.
revive-therapeutics.png
Revive Therapeutics Files for FDA Orphan Drug Designation for Psilocybin in Traumatic Brain Injury
April 27, 2021 09:17 ET
| Source: Revive Therapeutics Ltd.
TORONTO, April 27, 2021 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce it has filed an application with the U.S. Food and Drug Administration ("FDA") to receive Orphan Drug Designation ("ODD") for Psilocybin to treat moderate to severe traumatic brain injury (“TBI”).
There are no FDA approved treatments for cognitive impairments due to TBI. Moderate to severe TBI is a subset of TBI and can lead to a physical, cognitive, emotional, and behavioral changes over the course of a person’s life. These changes may affect a person’s ability to function in their everyday life. Approximately 50% of people with severe TBI will experience further decline in their daily lives or die within 9 years of their injury. People with TBI are fifty times more likely to die from seizures and six times more likely to die from pneumonia.[1]
Psilocybin offers a potential solution to manage moderate to severe cases of TBI. Psilocybin has the potential with its neuroreparative effect to improve loss of cognitive function after TBI lessening disability. The clinical effect of psilocybin appears to be related to its attenuation of traumatically-induced glutamate excitotoxicity during the early post-injury period. In preclinical studies conducted at the National Health Research Institutes, which was part of the research program acquired from PharmaTher Holdings Ltd. (CSE: PHRM) (OTCQB: PHRRF), characterized the potential neuroreparative effect of psilocybin compared to being treated with a vehicle (saline) using a TBI mouse model. Adult mice were randomly assigned to 4 groups: (1) control, (2) TBI+vehicle, (3) TBI+low dose psilocybin, and (4) high dose psilocybin. Cognitive function was examined by the Morris water maze test after the injury. It was found that psilocybin, given after injury, improved cognitive function in TBI mice. Also, there were no adverse effects observed with psilocybin.
Michael Frank, CEO of Revive commented: “The FDA orphan drug application for psilocybin to treat moderate to severe TBI is an important milestone for Revive as we focus on building a robust product pipeline focused on novel uses and delivery forms of psilocybin to treat significant unmet medical needs. We are currently seeking to evaluate psilocybin in a clinical trial for moderate to severe TBI and advancing our development of a proprietary oral thin film psilocybin product for the potential treatment of certain neurological disorders, such as brain damage caused by all forms of TBI and stroke, and other related mental health and substance abuse disorders.”
The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes "orphan status"). The FDA grants ODD status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. ODD would qualify psilocybin for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain clinical drug testing costs, activities, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application filing fee of approximately USD $2,400,000.
About Revive Therapeutics Ltd.
Revive 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. For more information, visit www.ReviveThera.com.
For more information, please contact:
Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of this release.
Cautionary Statement
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2020, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.
Copied and pasted from Proactive Investors
https://www.proactiveinvestors.com/companies/news/923008/revive-therapeutics-has-repurposed-gout-drug-to-fight-coronavirus-and-is-pushing-into-psychedelic-medicine-923008.html
Click link or read article.
07:00 Thu 22 Apr 2021
Revive Therapeutics
Revive Therapeutics has repurposed gout drug to fight coronavirus and is pushing into psychedelic medicine
Snapshot
The company is enrolling patients in a Phase 3 clinical trial to evaluate Bucillamine in patients with coronavirus (COVID-19)
Revive Therapeutics - Revive Therapeutics
Quick facts: Revive Therapeutics
Price: 0.45 CAD
CSE:RVV
Market: CSE
Market Cap:
$116.65 m
Apr 23, 2021
View company profile
Specialty life sciences company focused on developing drugs for rare disorders and infectious diseases
Advancing clinical development of gout drug Bucillamine for infectious diseases, including COVID-19
Developing novel psilocybin and cannabidiol therapeutics for central nervous system and inflammatory disorders
What Revive Therapeutics does:
Revive Therapeutics Ltd (CSE:RVV) (OTCMKTS:RVVTF) is a life sciences company focused on the research and development of drugs for infectious diseases as well as central nervous system and inflammatory disorders.
Its cannabinoid pharmaceutical portfolio focuses on rare inflammatory areas such as liver disease. The company has been granted orphan drug status designation by the US Food and Drug Administration (FDA) for the use of CBD to treat auto-immune hepatitis and FDA orphan drug status designation for the use of CBD to treat ischemia and reperfusion injury from organ transplantations.
The Ontario-based company is also advancing the development of psychedelic medicine with psilocybin-based therapeutics to fight addictions and depression.
Revive has also joined the fight against the coronavirus (COVID-19) disease, which is caused by the SARS-CoV-2 virus, by repurposing its long-established, US government-approved rheumatoid arthritis treatment Bucillamine as a possible treatment for infected patients suffering from inflammation in their lungs.
How it is doing:
Revive Therapeutics has been making progress on both fronts in 2021.
In late March, the company told investors it was on track to meet its planned goal of enrolling up to 1,000 patients in its Phase 3 clinical trial for Bucillamine in coronavirus (COVID-19) in the second quarter of the year.
Revive noted that it was currently partnered with 14 clinical sites in six US states, including California, Florida, Illinois, Nevada, North Carolina and Texas, and was expanding that to up to 50 clinical sites to include coronavirus (COVID-19) 'hot spot' states such as Massachusetts, Michigan, New Jersey, New York, Pennsylvania, and South Carolina.
This Phase 3 confirmatory clinical trial will study Bucillamine in patients with mild to moderate COVID-19 and will enroll up to 1,000 patients who will be randomized to Bucillamine or a placebo for up to 14 days, the company said, with the main aim is to compare the frequency of hospitalization or death for those receiving Bucillamine therapy with those receiving placebo.
Revive noted then that, so far, there had been no serious adverse events or safety concerns that required the Independent to be notified or take action. It also noted that it had recently approached the Food and Drug Administration (FDA) on a potential filing of an Emergency Use Authorization (EUA) application, while the trial is ongoing, so as to receive this approval before the study is completed.
Away from coronavirus, Revive said in February that it had signed an asset purchase agreement with Newscope Capital Corporation to acquire the full rights to PharmaTher Inc.’s intellectual property relating to psilocybin for an aggregate consideration of up to C$10 million.
Then in March, Revive announced positive results of a pre-clinical study evaluating the efficacy of psilocybin in the treatment of mild traumatic brain injury (TBI) in a rodent model. The company said the study was conducted at the National Health Research Institutes (NHRI), which was part of the psilocybin program acquired from PharmaTher Inc, a subsidiary of Newscope Capital Corporation.
The study characterized the potential neuroreparative effect of psilocybin compared to being treated with a vehicle (saline) using a TBI mouse model. Revive noted that researchers found that psilocybin, given after injury, improved cognitive function in TBI mice. Also, there were no adverse effects observed with psilocybin.
Following the acquisition of the provisional patent application from PharmaTher (Psilocybin in the Treatment of Neurological Brain Injury), and rthe positive research results with psilocybin in the TBI model, Revive said it had filed an international Patent Cooperation Treaty application allowing it to seek protection of this invention in 153 countries, including the US, Europe, Canada, Japan, and China.
In January, Revive announced that it had entered into a sponsored research and an exclusive option-to-license agreement with North Carolina State University to develop a novel biosynthetic version of psilocybin. It is based on a natural biosynthesis enzymatic platform developed by NC State professor and researcher Dr Gavin Williams and provides a potentially simple and efficient method for rapidly producing natural products -- such as psilocybin -- using an engineered enzymatic pathway in E. coli.
Revive said it is seeking to develop and commercialize its own pharmaceutical-grade psilocybin with this biosynthesis technology at scale to support the company’s current psilocybin-based product pipeline that includes an oral thin film product currently being developed in collaboration with the University of Wisconsin-Madison and the intellectual property and research with psilocybin being developed by PharmaTher.
On the financing front, in February, Revive closed a previously announced bought deal prospectus offering of 46,000,000 units at a price of $0.50 per unit for aggregate gross proceeds of $23 million, which included the exercise in full of the 15% over-allotment option.
The company said it intended to use the net proceeds for Phase 3 ?clinical costs for Bucillamine for coronavirus (COVID-19), Phase 1 clinical ?costs for Psilocybin for methamphetamine use disorder ?study, and other Psychedelic formulation development work ?as well as working capital and general corporate purposes.
On the personnel front, at the end of December 2020, Revive announced the appointment of Dr John Fahy as a Scientific and Clinical advisor to the company. It said he will assist in the expansion and analysis of the clinical data on the ongoing US Food & Drug Administration (FDA) Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19.
Dr Fahy is a Professor of Medicine in the Division of Pulmonary and Critical Care Medicine and the Department of Medicine at the University of California San Francisco and is a director of UCSF’s severe asthma clinic.
And in January, Revive shares got a boost from the news that it was one of the 17 companies in the US and Canada that were included in the first psychedelics exchange-traded fund (ETF) managed by Horizons ETF Management. The Horizons Psychedelic Stock Index ETF index started trading on January 26, under the ticker PSYK on the NEO exchange.
Inflection points:
More news on Phase 3 clinical trial for Bucillamine in coronavirus
Phase 1 clinical ?costs for Psilocybin for methamphetamine use disorder ?study
Other Psychedelic formulation development work
What the boss says:
In a February 2021 statement regarding the clinical trial for Bucillamine in coronavirus, Revive CEO Michael Frank said: “With our funding completed, we are adding more clinical sites to meet our enrollment goals and be in a position to meet with the FDA to determine the best path forward for EUA approval."
“We are committed to achieving our mission in making Bucillamine the first orally administered drug to obtain FDA approval and EUA to treat mild to moderate COVID-19,” he added.
Contact the author at jon.hopkins@proactiveinvestors.com
Add related topics to MyProactive
Health Pharma & Biotech Deep dive Revive Therapeutics Coronavirus (Covid-19) Psychedelics
Sign up for Newsletter
Create your account: sign up and get ahead on news and events
NO INVESTMENT ADVICE
This record is published on behalf of Revive Therapeutics, which is a paid client of ProactiveInvestors. You understand that ProactiveInvestors receives either monetary or securities compensation for our services,...
ProactiveInvestors is a publisher. You understand and agree that no content in this record or published on ProactiveInvestors’ website (the “Site”) constitutes a recommendation that any particular security,...
FOR OUR FULL DISCLAIMER CLICK HERE
Exactly like this guy did - and he posted his findings on Twitter:
$RVVTF .they had some “amazing, quick recoveries from some patients who were in bad shape”. I heard this same message at 3 different sites across the country. BUCC works, this is a when NOT if story $$$
— Vic Topper (@luckytop4) April 15, 2021
$RVVTF As part of due diligence I literally called all sites listed. The nurses were pretty tight lipped about the trial but I persisted as a concerned potential patient. They said they had no idea which patient got drug vs placebo but... more
— Vic Topper (@luckytop4) April 15, 2021
Anything therapeutics please:
https://twitter.com/yodoctoryo/status/1378353509339439106?s=24
https://biotuesdays.com/2016/03/01/2016-3-1-revive-readies-key-clinical-studies-in-gout-and-kidney-stones/
Revive readies key clinical studies in gout and kidney stones
Leonard Zehr March 1, 2016
Revive Therapeutics (TSX-V:RVV; OTCQB:RVVTF) hopes to begin a pivotal Phase 2b clinical trial in mid-year with its Bucillamine drug candidate for the treatment of acute gout flares.
“We believe that the Phase 2b data in gout will be a partner-enabling study with a large pharmaceutical company,” CEO, Fabio Chianelli, says in an interview with BioTuesdays.com, noting that the clinical trial should be completed by the end of this year.
Mr. Chianelli explains that Bucillamine is an oral, small molecule drug with a 30-year history as a first-line treatment for rheumatoid arthritis in Japan and Korea. It is sold under the brand name, Rimatil. The drug’s safety has been established in 7,000 subjects from clinical studies and post-marketing evaluations.
“Our strategy, as the name Revive implies, is to repurpose existing drugs that are not approved in the U.S. and Europe and give them new life, with the potential of lower development risk and faster-to-market approval,” he adds.
In addition to gout, Revive also is developing Bucillamine in rare disease programs, including cystinuria, or kidney stones, which is slated to begin a Phase 2 study this year; and Wilson’s disease, which is a buildup of copper in the body.
Mr. Chianelli said the company has partnered with the Bucillamine’s originators for a secured drug supply and exclusive rights to use proprietary non-clinical, human clinical, post-marketing and manufacturing data.
Revive’s Phase 2b study expects to enroll up to 200 patients in the U.S. to assess the efficacy and safety of a low-and-high dose of Bucillamine over seven days, compared with placebo, in the treatment of acute gout flares.
The primary endpoint is treatment responders with a greater or equal to 50% reduction in target joint pain score at 72 hours post-dose, without using a rescue drug. According to Mr. Chianelli, the responder rate from placebo should be 15% to 18%.
In an earlier Phase 2a study with 74 patients, completed in December, Bucillamine was as good as or better than compared with Colcrys (generic name colchicine), a top selling gout drug in the U.S.
Gout is caused by an over production or under excretion of uric acid, leading to the formation of needle-like crystals in joints and soft tissues, and severe pain due to inflammation.
According to IMS Health, sales of colchicine in the U.S. market were approximately $688-million for the 12 months ended August 2014.
In one arm of the study, with a 900 mg dose of Bucillamine, 55% of responders had a ≥ 50% reduction in target joint pain score from baseline at 72 hours post-dose without using a rescue drug, compared with 46% in the comparator arm treated with Colcrys. In addition, Bucillamine demonstrated average pain was reduced by 71% after three days.
Bucillamine was well tolerated and there were no serious adverse events reported in subjects taking Bucillamine in the Phase 2a study.
Mr. Chianelli said Revive has worldwide rights to Bucillamine, with the exception of Japan, Korea and Taiwan. Bucillamine is not approved for the treatment of acute gout flares in the U.S. or Europe.
In January 2016, Revive announced the issuance of a U.S. patent, titled, “The Use of Bucillamine in the Treatment of Gout.” The term of the newly issued patent extends to November 2033.
Gout is caused by an over production or under excretion of uric acid, which leads to the formation of needle-like crystals in joints and soft tissues, and severe pain due to inflammation. Long-term acute gout flares can lead to chronic arthritis and joint damage. Drug options to treat gout include NSAIDS, corticosteroids, as well as Colcrys and Mitigare.
Gout patients also have a high prevalence to other diseases, including hypertension, diabetes, chronic kidney disease and coronary artery disease. Existing gout treatments, however, often have contraindications to these conditions, which can exacerbate complications.
According to Mr. Chianelli, more than eight million adults in the U.S. and 15 million globally have gout, with 40% to 60% of patients failing to reach their uric acid target and suffering from acute gout flares.
In September, Beacon Securities analyst, Doug Cooper, raised his 12-month price target for Revive to $3 from $2. The stock closed at 35 cents on Friday.
According to Mr. Cooper, “one of the key points of Bucillamine is not just its pain reduction attributes, but also that it has benign interaction with other medications. We believe this sets it apart from other gout flare drugs and is very important given the high level of comorbidities associated with gout.”
According to Revive, in a Phase 2a study completed in December, Bucillamine was as good as or better than compared with Colcrys, a top selling gout drug in the United States.
In an earlier report, Mr. Cooper estimated peak sales of Bucillamine for the treatment of gout at about $500-million.
Revive’s lead orphan drug program involves using Bucillamine to treat cystinuria, where stones made from cystine form in the kidney or bladder. Cystinuria, which affects some 20,000 people in the U.S., may result in urinary obstruction, kidney damage, severe infection and potentially lead to chronic kidney disease.
Mr. Chianelli points out that patents have expired on current drug treatments for kidney stones, including Thiola, which is sold by Retrophin (NASDAQ:RTRX) and Valeant Pharmaceuticals’ (NYSE:VRX) Cuprimine. Neither treatment has orphan drug status.
In a 1994 Japanese clinical study, Bucillamine was able to dissolve cystine twice as better than Thiola. Revive received orphan drug status for Bucillamine for the treatment of cystinuria in November, which provides seven years of market exclusivity in the U.S.
Revive’s lead orphan drug program involves using Bucillamine to treat cystinuria, where stones form in the kidney or bladder.
Mr. Chianelli says Revive will be applying for an IND in the second quarter this year to initiate a Phase 2 cystinuria study with up to 20 patients in the third quarter. The study will seek to demonstrate the safety of Bucillamine and a reduction of cystine in the urine over four months. Study results are expected at the end of 2016.
“Bucillamine has the potential to be the first new drug option for this indication since FDA approval of Thiola in the late 1980s,” he adds. The market opportunity for cystinuria is estimated at $500-million in the U.S. alone.
In addition to cystinuria, Revive also is repurposing an anti-depressant drug, Tianeptine, which has been sold in Europe and Asia since the 1980s, in order to treat symptoms of Rett Syndrome.
The rare neurological disorder is characterized by loss of hand motor skills, slowed brain and head growth, problems with walking and breathing, seizures and intellectual disability. Rett affects some 16,000 mostly females in the U.S. and 20,000 in Europe.
According to the Rett Syndrome Research Trust, “imagine the symptoms of autism, cerebral palsy, Parkinson’s, epilepsy and anxiety disorders … all in one little girl.”
Mr. Chianelli says Revive has partnered with Rettsyndrome.org, a leading advocacy group in the U.S., to establish proof-of-concept of Tianeptine. “The first set of results in Rett mouse models demonstrated positive improvement in motor coordination, motion, and clasping/startle.”
Additional preclinical data is expected in the second quarter this year, which will be used to seek orphan drug designation from the FDA in the third quarter and determine its future clinical development program, he adds.
“Overall, our clinical programs, mainly gout and kidney stone treatment, are leading to multiple significant value creating milestones in 2016,” Mr. Chianelli says. “We have a compelling investment proposition, de-risked programs, partnership potential and a low valuation, compared with our peers.”
acute gout flares bucillamine kidney stones RVV RVVTF
Bucillamine went head to head with Colchicine with very favorable results in 2015 for a Phase 2a gout study. Bucillamine appeared to have less side effects and more importantly is a very strong Thiol donor which sets it apart.
Recent articles from the University of San Francisco study show that Bucillamine is one of the strongest Thiol donors. That alone sets it apart from Colchicine by giving it strong anti-inflammatory and Thiol donor capability.
See link to article which I posted earlier:
https://www.globenewswire.com/news-release/2015/12/01/1279498/0/en/Revive-Therapeutics-Announces-Positive-Final-Results-from-Its-Phase-2a-Study-for-the-Treatment-of-Acute-Gout-Flares.html
Revive Therapeutics Announces Positive Final Results from Its Phase 2a Study for the Treatment of Acute Gout Flares
Email Print Friendly Share
December 01, 2015 07:00 ET | Source: Revive Therapeutics Ltd.
TORONTO, ONTARIO--(Marketwired - December 1, 2015) - Revive Therapeutics Ltd. ("Revive" or the "Company") (TSX VENTURE:RVV) (OTCQB:RVVTF), a company focused on commercializing treatments for gout, and rare diseases such as Cystinuria, Wilson's disease and Rett syndrome, today announced positive final results from its phase 2a proof-of-concept clinical study of REV-002 (Bucillamine), an oral anti-inflammatory agent, for the treatment of acute gout flares.
"I am very pleased with the clinical results as it provides justification for expanding our clinical and commercialization prospects for Bucillamine in the treatment of acute gout flares," said Fabio Chianelli, Chief Executive Officer of Revive. "In the study, Bucillamine was as good or better as compared to Colchicine, a gout drug in the U.S. with reported sales of $688 million for the 12 months ended August 2014 according to IMS Health. This early validation paves the way for a Phase 2b clinical study, which would be used as part of the new drug application to the FDA to seek approval of Bucillamine for the treatment of acute gout flares in the U.S."
The objective of the Phase 2a study was to evaluate the safety and tolerability, and the efficacy of two regimens of oral Bucillamine over seven days of treatment compared with Colchicine (Colcrys®) in the treatment of subjects with severe gout flare attack. The primary efficacy endpoint is the proportion of patients who responded to treatment defined as a ≥ 50% reduction in target joint pain score from baseline at 72 hours post-dose without using rescue drug.
The final primary endpoint results from the Phase 2a study from a total of 74 subjects that had completed the seven-day treatment period are as follows:
In Arm A (oral Bucillamine - total of 900mg over 7 days), 55% (12/22 subjects) had a ≥ 50% reduction in target joint pain score from baseline at 72 hours post-dose without using rescue drug;
In Arm B (oral Bucillamine - total of 1,800mg over 7 days), 46% (11/24 subjects) had a ≥ 50% reduction in target joint pain score from baseline at 72 hours post-dose without using rescue drug;
In Arm C, the active comparator arm, (oral Colchicine - 1.8mg over 1 hour), 46% (13/28 subjects) had a ≥ 50% reduction in target joint pain score from baseline at 72 hours post-dose without using rescue drug; and
Bucillamine was well tolerated and there were no serious adverse events reported in subjects taking Bucillamine.
"Bucillamine for the treatment of acute gout flares has a clear pathway to regulatory approval in the U.S., based on previously approved drugs by the FDA for this indication," said Dr. Lee Simon, senior clinical and regulatory affairs advisory to Revive. "These exploratory results reported above demonstrate that Bucillamine has a signal of efficacy similar to that observed with the comparator drug, Colchicine (Colcrys®), in this clinical study, which has been previously approved for this indication in the U.S. As a result, Revive is actively planning a potentially pivotal Phase 2b, adequate and well-controlled, multicenter, double blinded, placebo controlled trial. It is important to note, that in the U.S., regulatory approval requires a drug to be superior to placebo in the statistical analysis and to demonstrate this difference from placebo is clinically relevant in two replicate studies."
About the Phase 2a Proof-of-Concept Study
The Phase 2a study is an open-label, multicenter, active-controlled, parallel-group clinical trial designed to evaluate the safety and efficacy of two arms of Bucillamine 100mg tablet compared with the active comparator Colchicine (dosed acutely using the FDA-approved regimen) in the treatment of subjects with acute gout flares over a seven-day treatment period. A total of 20 clinical sites in the United States participated in the study and a total of 74 subjects who are confirmed with a qualifying severe gout flare attack was randomized into the study. Subjects were randomized in a 1:1:1 allocation ratio to either Arm A (oral Bucillamine - total of 900mg), Arm B (oral Bucillamine - total of 1,800mg) or Arm C (oral Colchicine - total of 1.8mg) over a seven-day treatment period.
The primary efficacy endpoint is the proportion of patients who responded to treatment. Treatment responders are defined as a ≥ 50% reduction in target joint pain score from baseline at 72 hours post-dose without using rescue drug. The target joint pain score is an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) used to assess joint pain intensity while experiencing a gout flare on a scale from 0 (no pain) to 10 (worst possible pain). The PI-NRS is completed using a diary where the subject is required to circle the most appropriate number that best describe their level of pain in the identified target joint during specific time points.
About Gout
There were 14.3 million diagnosed prevalent cases of chronic gout in the major pharmaceutical markets in 2012, which is forecast to increase to 17.7 million by 2021 (Source: Decision Resources 2012). Gout in the U.S. affects approximately 8.3 million (~3.9%) of American adults (Source: Arthritis Rheum. 2011 Oct; 63(10):3136-41). It is estimated that the gout disease treatment market value will increase from $989 million in 2013 to $2.28 billion by 2018 (Source: GlobalData 2014). Gout is a painful disorder caused by elevated serum uric acid (sUA) in the body due to under excretion of uric acid and/or over production of uric acid. Most patients on the most commonly employed regimens for uric acid lowering fail to achieve a satisfactory serum urate level. Poor control of gout can lead to acute attacks of severe pain, and chronic joint damage and impairment of health related quality of life. Accordingly, there are needs in the market for new therapies to control gouty inflammation and hyperuricemia.
Although gout is a treatable condition, there are limited treatment options, many of which have adverse side effects. Drug treatment for gout includes anti-inflammatory agents (non-steroidal anti-inflammatories (NSAIDs), corticosteroids, Colchicine) and serum urate-lowering therapies, which work by lowering body stores of uric acid. Treatment of gouty inflammation is complicated by the fact that gout patients have a high incidence of cardiovascular and metabolic comorbidities. Common comorbidities include hypertension (70-80%), coronary artery disease (>30-40%), chronic kidney disease (~30-50%), diabetes (~25-40%), gastrointestinal tract diseases, and congestive heart failure (Source: Keenan, RT et. al., Prevalence of contraindications and prescription of pharmacologic therapies for gout. Am. J. Med. 2011, 124: 155-163). Managing patients with these comorbidities is challenging because the majority of them have contraindication for one or more first-line approved medications to treat acute gout. Current drug therapy limitations include: 90% of gout patients having at least one contraindication to NSAIDs and glucocorticoids; 50% to 66% having at least one contraindication to Colchicine. Moreover, corticosteroids can cause hypertension and worsening of blood sugar, and NSAIDs have substantial renal and cardiovascular toxicity.
About REV-002 (Bucillamine)
REV-002 (Bucillamine) is being developed by Revive as a potential new treatment for acute gout flares. Bucillamine is a disease-modifying anti-rheumatic drug, which is prescribed for rheumatoid arthritis in Japan and South Korea.
About Revive Therapeutics Ltd.
Revive Therapeutics Ltd. (TSX VENTURE:RVV) (OTCQB:RVVTF) is focused on commercializing treatments for gout, and rare diseases such as Cystinuria, Wilson's disease and Rett syndrome. Additional information on Revive is available at www.ReviveThera.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This news release includes certain information and statements about management's view of future events, expectations, plans and prospects that constitute "forward looking statements", which are not comprised of historical facts. Forward-looking statements may be identified by such terms as "believes", "anticipates", "intends", "expects", "estimates", "may", "could", "would", "will", or "plan", and similar expressions. Specifically, forward looking statements in this news release include, without limitation, statements regarding: the granting of a patent for REV-002; the potential efficacy and commercial viability of REV-002 for treatment of gout and Bucillamine for the treatment of Cystinuria; expansion of the REV-002 clinical testing program; the Company's drug research and development plans, including REV-003 (Tianeptine) for the treatment of Rett Syndrome and REV-005 (Bucillamine) for the treatment of Wilson's Disease; the timing of operations; and estimates of market conditions. These statements involve known and unknown risks, uncertainties, and other factors that may cause actual results or events, performance, or achievements of Revive to differ materially from those anticipated or implied in such forward-looking statements. The Company believes that the expectations reflected in these forward-looking statements are reasonable, but there can be no assurance that actual results will meet management's expectations.
In formulating the forward-looking statements contained herein, management has assumed that business and economic conditions affecting Revive will continue substantially in the ordinary course and will be favourable to Revive, that clinical testing results will justify commercialization of the Company's drug candidates; that Revive will be able to obtain all requisite regulatory approvals to commercialize its drug candidates, that such approvals will be received on a timely basis, and that Revive will be able to find suitable partners for development and commercialization of its drug repurposing candidates on favourable terms. Although these assumptions were considered reasonable by management at the time of preparation, they may prove to be incorrect. Factors that may cause actual results to differ materially from those anticipated by these forward looking statements include: uncertainties associated with obtaining regulatory approval to perform clinical trials and market products; the need to establish additional corporate collaborations, distribution or licensing arrangements; the Company's ability to raise additional capital if and when necessary; intellectual property disputes; increased competition from pharmaceutical and biotechnology companies; changes in equity markets, inflation, and changes in exchange rates; and other factors as described in detail in Revive's public filings, all of which may be viewed on SEDAR (www.sedar.com). Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward looking statements and information, which are qualified in their entirety by this cautionary statement. Except as required by law, Revive disclaims any intention and assumes no obligation to update or revise any forward looking statements to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward looking statements or otherwise.
Neither the TSX-V nor its Regulation Services Provider (as that term is defined in the policies of the TSX-V) accepts responsibility for the adequacy or accuracy of this release.
Contact Information:
Revive Therapeutics Ltd.
Fabio Chianelli
Chief Executive Officer
(905) 605-5535 (ext. 10)
fabio@revivethera.com
www.revivethera.com
Wow. This is great and should also have a positive impact on Revive.
Happy reading in case you didn’t see it earlier:
https://psilocybinalpha.com/news/north-american-psychedelics-index-published-which-companies-will-be-in-the-first-psychedelic-etf
I hear it has been upsized and will be much bigger than $10 million.
This is what it needed.
This financing for Revive is great for the company.
The deal is apparently over subscribed which means the company is all cashed up and de-risked.
It will continue moving toward the endpoints and hopefully the company will get recognized for emergency use authorization.
Good luck to all.
Article:
Why Revive Therapeutics Ltd (RVVTF) Jumped 250% in One Month?
December 18, 2020 Maria Ray
Many companies have come into focus due to their work on formulating medicines meant for treating patients suffering from COVID-19 infection. One such company is Revive Therapeutics Ltd (OTCMKTS: RVVTF), which is best known for its work with psychedelics based medicines.
The stock is now in focus after it emerged that the company has started its Phase 3 trial for a COVID 19 medicine.
The stock has moved up as well and over the course of the past month, it has rallied by as much as 250%. The product in question is known as Bucillamine, which is better known for treating arthritis in South Korea and Japan.
At this point, Revive is the only company that is researching Bucillamine as a potential treatment for COVID 19 infection and that has placed the company in a possibly advantageous position. Revive got permission to conduct a trial from the United States Food and Drug Administration for the product earlier this year in July.
? Bitwise 10 Crypto Index Fund (BITW) is Going Crazy As Bitcoin Hits $23K
Maria Ray
Maria Ray
Stocks news editor and reporter I am Maria Ray, I have done my bachelor’s in English literature, and further on I did my master’s in Medicines. My most preferred genre of writing is health and biotech. I have been writing from the past 6 years about articles, web content, and blogs. In my career and education, I like to play along with work. I have also been a teacher in the past for 2 years. I use to teach business and technical writing in a very famous university. However, most recently I am working as an instructor, designer, and training writer. I enjoy socializing a lot. I am a very big extrovert when it comes to nature. A part of all this I enjoy exploring the world and traveling makes me happy.
https://www.docwirenews.com/abstracts/a-sensitive-indicator-for-the-severity-of-covid-19-thiol-6/
A SENSITIVE INDICATOR FOR THE SEVERITY OF COVID-19: THIOL
December 11, 2020
This article was originally published here
Turk J Med Sci. 2020 Dec 11. doi: 10.3906/sag-2011-139. Online ahead of print.
ABSTRACT
A SENSITIVE INDICATOR FOR THE SEVERITY OF COVID-19: THIOL Abstract Background/aim: Thiol status is a good reflector of the cellular redox and have vital roles in various cellular signaling pathways.The purpose of the study was to investigate thiol status in patients with SARS-CoV-2 infection.
METHODS: A total of 587 subjects (517 patients/70 healthy controls) were enrolled in the study.The patients were categorized into the groups regarding to the severity of disease (mild, moderate, severe, and critical).Thiol status of all groups were compared.
RESULTS: The patients had significantly diminished thiol levels compared to controls.Thiol levels were gradually decreased as the severity of the disease increased.Logistic regression analyses identified that thiol concentrations were an independent risk factor for the disease severity in each phase (mild group OR 0.975, 95%CI 0.965-0.986; moderate group, OR 0.964, 95%CI 0.953-0.976; severe group OR 0.953, 95%CI 0.941-0.965; critical group OR 0.947, 95%CI 0.935-0.960).Thiol test exhibited the largest area under the curve at 0.949, with the highest sensitivity (98.6%) and specificity (80.4%).
CONCLUSIONS: Depleted thiol status was observed in SARS-CoV-2 infection.Decline of the thiol levels by degrees while the severity of infection increased was closely related to the progression of the disease.This outcome highlights that thiols could be an impressible biomarker for predicting of the severity of COVID-19. Key words: COVID-19, inflammation, immune response, severity, thiol.
PMID:33306332 | DOI:10.3906/sag-2011-139
This is worth a second mention.
This is very significant.
Bucillamine is a potent thiol donor in pill form. It is 16 x more powerful than NAC.
It is not intravenous like others mentioned and very powerful.
https://www.biorxiv.org/content/10.1101/2020.12.08.415505v1
Dr. Yo (@YoDoctorYo) Tweeted:
@MarcLaplante9 Anything but Remdesivir- Ivermectin, bucillamine. The key is to look at the MOA. Remdesivir is not an effective antiviral!
https://twitter.com/YoDoctorYo/status/1320453666013413376?s=20
He talks about Bucillamine at 1:02:40 range
Hope that helps.
Dr. YO