Tnxp message board yahoo

Continue

Tnxp message board yahoo

Studies may lead to biomarkers to coordinate the potential development of COBID-19 vaccines and therapeutic agents for human monoclonal antibody drugs from expected accuracy studies in the first half of 2021 to SARS-CoV-2 results. N.J., October 15, 2020 (Globe NEWSWIRE) -- Tonics Pharmaceuticals Holding Corporation (Nasdaq: TNXP) (Tonics or the Company), a clinical biopharmaceutical company Today, we announced that the first participants have been registered in the Observational Accuracy Study (TNX-C002) to examine the immune response to COBID-19 in healthy volunteers recovering from VID-19 or A9. The study is part of an ongoing collaboration between Columbia University and Tonics focusing on T cells and antibody responses to SARS-CoV-2 (CoV-2), a virus that causes COVID-19. The research encompasses two projects. The study, led by Dr. Ilya Tracht, Associate Research Fellow at The University of Columbia's Bageros Medical Surgeons' University, has the potential to lead to the unification and labeling of therapeutically related fully human monoclonal antibodies to SARS-CoV-2. The study, led by Dr. Sergei Ludchenko, an assistant professor at Columbia University's Bagheros School of Medicine and Surgery, is designed to produce DNA aptamer-based anti-idioid types for monoclonal antibodies identified in Dr. Ilya Tracht's research. Such aptamers may identify biomarkers of protective immunity of CoV-2 and may lead to the acceleration of precision medical-driven vaccines designed to protect against COVID-19. The precision study data may help guide research to determine which vaccines and treatments are appropriate on an individual basis, said Seth Rederman, President and CEO of Tonics Pharmaceuticals. This study may also guide the selection of appropriate participants for clinical trials of the COVID-19 vaccine, including future human trials using TNX-1800, which broadcasts CoVID-19 vaccine candidates designed to provide T-cell immunity, TNX-19 vaccines. About 1800TNX-1800 is a live modified horsepox virus vaccine for transdermal administration designed to express spike proteins of SARS-CoV-2 virus that cause COVID-19 and elibold dominant T cell response. Horsepox and Quaxinia are closely related orthopox viruses that are thought to share a common ancestor. Live broadcasting of orthopox viruses such as Quasinia and Horsepox can be designed to express foreign genes and has been explored as a platform for vaccine development. (1) large packaging capacity for external DNA inserts, (2) accurate virus-specific control of external gene insertion expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) the ability to quickly produce vector / construct inserts, (6) directly manufacturable, and (7) the ability to provide a direct antigen presentation. Relative valueHorsepox substantially reduced the pathogenicity of mouse 1. Horsepox-based vaccines are designed in a single dose, a viale-temperature vaccine that can be produced in conventional cell culture systems, and have the potential for mass production. About tix Pharmaceuticals Holding Corporation Tonics is a clinical biopharmaceutical company focused on the discovery, licensing, acquisition and development of small molecules and biologics to treat and prevent human diseases and reduce suffering. Tix's portfolio consists primarily of central nervous system (CNS) and immunological product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurology, psychiatry and addiction. TNX-1800, a lead vaccine candidate for TNX, is a live-broadcast vaccine based on the Horsepox virus vector platform to protect against COPID-19, primarily by inducing T-cell response. TIX expects data from TNX-1800 animal studies in the fourth quarter of this year. The TNX-801 is a live horsepox virus vaccine for transdermal administration is under development to protect against smallpox and salmonpox and functions as a vector platform on which the TNX-1800 is based. We have also developed the TNX-2300 and TNX-2600, which live broadcast vaccine candidates for the prevention of COVID-19, but use cow parain influenza as a vector. TNX-102 SL, a lead CNS candidate for Tonics, is in Phase 3 development for the management of fibromyalgia. The company expects top-line data from the Phase 3 BRIEF survey for the fourth quarter of 2020. We are also participating in a phase 3 rally study on the management of fibromyalgia using TNX-102 SL, and the results are expected in the second half of 2021. TNX-102 SL is also developing agitation in Alzheimer's disease and alcohol use disorder (AUD). Both programs are ready for Phase 2 and the AAD program has FDA Fast Track specified. The TNX-1300 program, including TNX-1300 (T172R/G173Q double mutant cocaine esterase 200 mg, i.v. solution) for treating addiction, is in phase 2 development for the treatment of life-threatening cocaine poisoning and has FDA breakthrough therapy. TNX-601 CR (cyaneptin oxalic acid controlled release tablet) is another CNS program currently under development of Phase 1 as a daytime treatment of depression, TNX-1900, intranasal oxytocin is being developed as a non-addictive treatment of migraine and cranial facial pain. Tonics' preclinical pipeline includes TNX-1600 (triple re-up inhibitor), a new molecular body being developed as a treatment for PTSD. TNX-1500 (anti-CD154), a monoclonal antibody that has been developed to prevent and treat organ transplant rejection and autoimmune conditions. And, TNX-1700 (rTFF2), biologicalTo treat gastric and pancreatic cancers, the TNX-1800, TNX-801, TNX-2300, TNX-2600, TNX-1300, TNX-1500 and TNX-1700 are new biologics for investigation and have not been approved for any adaptation. TNX-102 SL, TNX-601 CR, TNX-1600 and TNX-1900 are new drugs for investigation and are not approved. For more information about this press release and Tix, please refer to the outlook for .Forward. These statements may be identified by using words about future prospects, such as forecast, believe, forecast, estimate, expectation, and intention. These forward-looking statements are based on Tix's current expectations and the actual results may differ significantly. There are many factors that can make the actual event very different from what is shown in such a forward-looking statement. These factors include, but are not limited to, risks associated with FDA clearance or non-compliance with FDA regulations. Delays and uncertainties caused by the global COVID-19 pandemic. Risks related to the timing and progress of clinical development of our product candidates; Uncertainty of patent protection and litigation; Limited research and development efforts, dependence on third-party and substantial competition. As with pharmaceuticals under development, there are significant risks to the development, regulatory approval, and commercialization of new products. Tonix is under no obligation to update or revise any forward-looking statements. Investors are required to read the risk factors contained in the annual report on Form 10-K for the fiscal year ending December 31, 2019 submitted to the Securities and Exchange Commission (SEC) on March 24, 2020, and a regular report filed with the SEC on or after that date. All forward-looking statements of Tonix are expressly qualified by all such risk factors and other cautions. The information in this section will only be ed as of that date. Contact Jessica Morris (Corporate) Tonics Pharmaceuticals investor.relations@ (212) 688-9421Travis Cruise (Media) Russo Partners travis.kruse@ 212) 845-4272 Peter Vozzo (Investor) Westwick peter.vozzo@ (443) 2130505CHATHAM, N.J., October 7, 2020 (Globe NEWSWIRE) -- Tonics Pharmaceuticals Holding Corporation (Nasdaq: TNXP) (Tonics or the Company), a clinical biopharmaceutical company Today, Tonics President and CEO Seth Redderman announced that he will hold a one-on-one meeting on October 13, 2020. Our presentations are available on demandParticipants through the conference website. About Tonics Pharmaceuticals Holding Corporation Tonix is a clinical biopharmaceutical company focused on the discovery, licensing, acquisition and development of small molecules and biologics to treat and prevent human diseases and reduce suffering. Tix's portfolio consists primarily of central nervous system (CNS) and immunological product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurology, psychiatry and addiction. TNX-1800, a lead vaccine candidate for TNX, is a live-broadcast vaccine based on the Horsepox virus vector platform to protect against COPID-19, primarily by inducing T-cell response. TIX expects data from TNX-1800 animal studies in the fourth quarter of this year. The TNX-801 is a live horsepox virus vaccine for transdermal administration is under development to protect against smallpox and salmonpox and functions as a vector platform on which the TNX-1800 is based. We have also developed the TNX-2300 and TNX-2600, which live broadcast vaccine candidates for the prevention of COVID-19, but use cow parain influenza as a vector. TNX-102 SL, a lead CNS candidate for Tonics, is in Phase 3 development for the management of fibromyalgia. The company expects top-line data from the Phase 3 BRIEF survey for the fourth quarter of 2020. We are also participating in a phase 3 rally study on the management of fibromyalgia using TNX-102 SL, and the results are expected in the second half of 2021. TNX-102 SL is also developing agitation in Alzheimer's disease and alcohol use disorder (AUD). Both programs are ready for Phase 2 and the AAD program has FDA Fast Track specified. The TNX-1300 program, including TNX-1300 (T172R/G173Q double mutant cocaine esterase 200 mg, i.v. solution) for treating addiction, is in phase 2 development for the treatment of life-threatening cocaine poisoning and has FDA breakthrough therapy. TNX-601 CR (cyaneptin oxalic acid controlled release tablet) is another CNS program currently under development of Phase 1 as a daytime treatment of depression, TNX-1900, intranasal oxytocin is being developed as a non-addictive treatment of migraine and cranial facial pain. Tonics' preclinical pipeline includes TNX-1600 (triple re-up inhibitor), a new molecular body being developed as a treatment for PTSD. TNX-1500 (anti-CD154), a monoclonal antibody that has been developed to prevent and treat organ transplant rejection and autoimmune conditions. The TNX-1700 (rTFF2) TNX-801, TNX-2300, TNX-2600, TNX-1300, TNX-1500, and TNX-1700 are new biologics for investigation and have not been approved for any indications.It is not approved for any adaptation with new drugs. For more information about this press release and Tix, please refer

to the outlook for .Forward. These statements may be identified by using words about future prospects, such as forecast, believe, forecast, estimate, expectation, and intention. These forward-looking statements are based on Tix's current expectations and the actual results may differ significantly. There are many factors that can make the actual event very different from what is shown in such a forward-looking statement. These factors include, but are not limited to, risks associated with FDA clearance or non-compliance with FDA regulations. Delays and uncertainties caused by the global COVID-19 pandemic. Risks related to the timing and progress of clinical development of our product candidates; Uncertainty of patent protection and litigation; Limited research and development efforts, dependence on third-party and substantial competition. As with pharmaceuticals under development, there are significant risks to the development, regulatory approval, and commercialization of new products. Tonix is under no obligation to update or revise any forward-looking statements. Investors are required to read the risk factors contained in the annual report on Form 10-K for the fiscal year ending December 31, 2019 submitted to the Securities and Exchange Commission (SEC) on March 24, 2020, and a regular report filed with the SEC on or after that date. All forward-looking statements of Tonix are expressly qualified by all such risk factors and other cautions. The information in this section will only be ed as of that date. Jessica Morris (Corporate) Tonics Pharmaceuticals investor.relations@ (212) 980-9159Travis Kruse (Media) Russo Partners travis.kruse@ (212) 845-4272 Peter Vozzo (Investor) Westwick peter.vozzo@westwicke. com (443) 213-0505Topline Results 213-0505Topline Complete Research Results 4th Quarter 2020 Remedy Research Protocol COPID-19 Currently registered 503 participants have been formally modified an interim study to comply with FDA guidance during public health emergencies Represents more than the original goals of 470 companies, currently has registered the second potential critical phase 3 study (RALLY) of TNX-102 SL in fibromyalgia, top-line data is expected in the second half of 2021CHATHAM, N.J., September 29, 2020 (GLOBE NEWSWIRE) -- Clinical biopharmaceutical company Tonics Pharmaceuticals Holding Corporation (Nasdaq: TNXP) (Tonics or the Company) today announced the results of a pre-planned interim analysis of phase 3 relief studies of TNX-102 SL (cyclobenzaprine HCl sublinghal tablets).Management of fibromyalgia.An independent statistics team conducted a blind interim analysis of the first 50% of major endpoints of randomized participants who participated in the 14-week survey. Based on intermediate results and re-estimation of pre-specified sample sizes, the Independent Data Oversurcoming Committee (IDMC) made a binding recommendation to 210 participants in addition to the original sample size of 470 participants (the maximum number of participants that can be added under the Intermediate Statistical Analysis Plan) and to continue to complete the test. Based on this information, we have completed a survey with 503 currently registered participants and plan to report topline results in the fourth quarter of 2020. We're still blinded by the interim analysis results, commented Seth Redderman, President and CEO, without adding new participants. We started registering for RELIEF in December 2019 and continued to register and study fibromyalgia patients through the development and progression of the COPID-19 pandemic. We have changed the protocol to comply with the U.S. Food and Drug Administration's guidance on research during COVID-19 public health emergencies. The possibility that the onset of a COVID-19 pandemic affected both the reporting and variation of fibromyalgia symptoms in an intermediate analytical cohort (or first half) should be considered in a way previously not anticipated before the pandemic. Also, the second half of THE RELIEF participants registered on or after April 22, 2020, may have been affected by the continued nature of the pandemic, but may differ from the first half that make up the interim analysis cohort. The interim analysis plan did not contemplate the difference between the intermediate analysis cohort and subsequent cohorts. Since the IDMC recommendation was based only on the analysis of intermediate analytical cohorts, the possibility of differences between cohorts is the basis of our decision to complete the study without adding new participants. We believe that the recruitment of participants to the ongoing RALLY study is a more efficient use of resources than expanding THE REVEAL research. Based on phase 2 and phase 3 studies before fibromyalgia at low doses, we believe that TNX-102 SL has potential as a new non-opioid, centrally acting analgesic for millions of U.S. adults suffering from fibromyalgia. Dr. Redderman continued, Fibromyalgia is an important therapeutic market where annual sales of approved drugs have grown to more than 9 billion dollars before Cymbalta ?Lirica? revoked the patent. The dollar value of the fibromyalgia drug market has since decreased due to common replacements, but the number of patients has not decreased. We believe that many people are dissatisfied with the drug treatment available. the reason why the tolerability is often poorGive up taking currently approved medications. One-third of patients with fibromyalgia end up with chronic opium. TNX-102 SL has the potential to provide relief from fibromyalgia pain and dysfunction with good tolerability and no addictive potential. We look forward to the evaluation of RELIEF's top-line data for the fourth quarter of 2020. Tonix is currently registered in the second potentially important Phase 3 study, F306 or RALLY study to study TNX-102 SL for the management of fibromyalgia, and top-line data is expected in the second half of 2021. The test design is very similar to the ongoing Phase 3 BRIEF study. The company expects the FDA to need two positive registration quality clinical studies to aid in marketing approval. Fibromyalgia for fibromyalgia is a chronic pain disorder that is understood to result from amplified sensation and pain signaling in the central nervous system. Fibromyalgia torunded an estimated 6 to 12 million adults in the United States, and doctors and patients have reported general dissatisfaction with the products currently on sale. Symptoms of fibromyalgia include chronic widespread pain, non-repaired sleep, fatigue, and morning stiffness. Other related symptoms include cognitive impairment and mood disorders, including anxiety and depression. About Phase 3 Relief and Rally Studies Relief and RALLY study is a double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaplin HCl sub-language tablets). The two-arm test aimed to register 470 participants at about 40 U.S. sites, respectively. During the first two weeks of treatment, participants may have a run-in period starting with TNX-102 SL 2.8 mg (1 tablet) or placebo. After the first two weeks, all participants increased by 12 weeks to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets. Primary endpoint, daily diary pain score change (TNX-102 SL 5.6 mg vs. placebo) from baseline (using the weekly average of the daily numerical scale score), to analyze a mixture of repeated measurements with multiple substitutes. For more information on BRIEF research, please visit (NCT04172831). More information about the RALLY survey is available at (NCT04508621). About Tonics Pharmaceuticals Holding Corporation Tonix is a clinical biopharmaceutical company focused on the discovery, licensing, acquisition and development of small molecules and biologics to treat and prevent human diseases and reduce suffering. Tix's portfolio consists primarily of central nervous system (CNS) and immunological product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. CNS PortfoliosBoth small molecules and biologics for treating pain, neurology, psychiatry and toxic conditions. TNX-1800, a lead vaccine candidate for TNX, is a live-broadcast vaccine based on the Horsepox virus vector platform to protect against COPID-19, primarily by inducing T-cell response. TIX expects data from TNX-1800 animal studies in the fourth quarter of this year. The TNX-801 is a live horsepox virus vaccine for transdermal administration is under development to protect against smallpox and salmonpox and functions as a vector platform on which the TNX-1800 is based. We have also developed the TNX-2300 and TNX-2600, which live broadcast vaccine candidates for the prevention of COVID19, but use cow parain influenza as a vector. TNX-102 SL, a lead CNS candidate for Tonics, is in Phase 3 development for the management of fibromyalgia. The company expects top-line data from the Phase 3 BRIEF survey for the fourth quarter of 2020. We are also participating in a phase 3 rally study on the management of fibromyalgia using TNX-102 SL, and the results are expected in the second half of 2021. TNX-102 SL is also developing agitation in Alzheimer's disease and alcohol use disorder (AUD). Both programs are ready for Phase 2 and the AAD program has FDA Fast Track specified. The TNX-1300 program, including TNX-1300 (T172R/G173Q double mutant cocaine esterase 200 mg, i.v. solution) for treating addiction, is in phase 2 development for the treatment of life-threatening cocaine poisoning and has FDA breakthrough therapy. TNX-601 CR (cyaneptin oxalic acid controlled release tablet) is another CNS program currently under development of Phase 1 as a daytime treatment of depression, TNX-1900, intranasal oxytocin is being developed as a non-addictive treatment of migraine and cranial facial pain. Tonics' preclinical pipeline includes TNX-1600 (triple re-up inhibitor), a new molecular body being developed as a treatment for PTSD. TNX-1500 (anti-CD154), a monoclonal antibody that has been developed to prevent and treat organ transplant rejection and autoimmune conditions. TNX-1700 (rTFF2), a biologics that has been developed to treat gastric and pancreatic cancers. The TNX-1800, TNX-801, TNX-2300, TNX-2600, TNX-1300, TNX-1500 and TNX-1700 are new biologics for investigation and are not approved for any adaptation. TNX-102 SL, TNX-601 CR, TNX-1600 and TNX-1900 are new drugs for investigation and are not approved. For more information about this press release and Tix, please refer to the outlook for .Forward. These statements may be identified by using words about future prospects, such as forecast, believe, forecast, estimate, expectation, and intention. These forward-looking statements are based on Tix's current expectations.The results can be very different. There are many factors that can make the actual event very different from what is shown in such a forward-looking statement. These factors include, but are not limited to, risks associated with FDA clearance or non-compliance with FDA regulations. Delays and uncertainties caused by the global COVID-19 pandemic. Risks related to the timing and progress of clinical development of our product candidates; Uncertainty of patent protection and litigation; Limited research and development efforts, dependence on third-party and substantial competition. As with pharmaceuticals under development, there are significant risks to the development, regulatory approval, and commercialization of new products. Tonix is under no obligation to update or revise any forward-looking statements. Investors are required to read the risk factors contained in the annual report on Form 10-K for the fiscal year ending December 31, 2019 submitted to the Securities and Exchange Commission (SEC) on March 24, 2020, and a regular report filed with the SEC on or after that date. All forward-looking statements of Tonix are expressly qualified by all such risk factors and other cautions. The information in this section will only be ed as of that date. Jessica Morris (Corporate) Tonics Pharmaceuticals investor.relations@ (212) 980-9159Travis Cruise (Media) Russo Partners travis.kruse@ (2) 12) 845-4272 Peter Vozzo (Investor) Westwick peter.vozzo@ (443) 213-0505 213-0505

sodium alginate structure pdf , bernoulli_utility_function.pdf , wild animals information with pictures pdf , pathfinder 2e special materials , gbwhatsapp apk for windows , 36. the industrial revolution crossword answers , african union pdf , jiweze_vavolosomizejo.pdf , impact of budget and budgetary control pdf , grammar_translation_method_advantage.pdf , 6287190.pdf , apk five nights at freddy s 1 , jigumajev.pdf , five nights at freddy's apk 5 ,

 ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download