Peroxisome

Tonix Pharmaceuticals Completes Clinical Stage of Phase 2 UPLIFT Study of TNX-601 ER for the Treatment of Major Depressive Disorder

Retrieved on: 
Monday, October 16, 2023
Weight gain, Food, Active ingredient, Brain, Neuron, GM, Atrophy, Society, Peroxisome, DSM-IV codes, Medicine, FDA, ITT, Neuroplasticity, Depression, Tonix Pharmaceuticals, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, MDD, PPAR, Oxidative stress, Pharmaceutical industry, Tianeptine

CHATHAM, N.J., Oct. 16, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced the completion of the clinical phase of the Phase 2 potential registration-quality, double-blind, randomized, multicenter, placebo-controlled UPLIFT1 study of TNX-601 ER2 (tianeptine hemioxalate extended-release tablets) as a potential treatment for major depressive disorder (MDD). Topline results from the intention-to-treat (ITT) sample (N=132) are expected in early November 2023.

Key Points: 
  • Topline results from the intention-to-treat (ITT) sample (N=132) are expected in early November 2023.
  • TNX-601 ER is being developed as a monotherapy and first-line treatment for MDD and works by a distinct mechanism of action as compared to traditional monoaminergic antidepressants.
  • Tonix recently reported that tianeptine activates peroxisome proliferator-activated receptors PPAR-β/δ and PPAR-γ.
  • “Tianeptine restores connectivity between neurons, or neuroplasticity, and limits the effects of oxidative stress in the brain in animal models of depression.

Tonix Pharmaceuticals Announces Data Supporting the Memory- and Cognition-Enhancing Effects of Racemic Tianeptine and (S)-Tianeptine, but not (R)-Tianeptine, in the In Vivo Rat Novel Object Recognition (NOR) Test

Retrieved on: 
Monday, July 24, 2023
Tianeptine, Cognition, Psychiatry, Learning, Neuron, Tonix Pharmaceuticals, Depression, NOR, Therapy, DSM-IV codes, Neurogenesis, Bipolar disorder, PPAR, Brain, Weight gain, MDD, Patient, Peroxisome, Norepinephrine, RDC, Mouse, Serotonin, Research, IND, Memory, Atrophy, Learning Research and Development Center, Pharmaceutical industry

CHATHAM, N.J., July 24, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced data supporting the memory- and cognition-enhancing effects of two Tonix drug candidates, TNX-601 ER (tianeptine hemioxalate extended release) and TNX-4300 (estianeptine), the single (S)-isomer of tianeptine. TNX-601 ER is being tested in the potentially pivotal Phase 2 UPLIFT1 trial for the treatment of major depressive disorder (MDD), with topline results expected in the first quarter of 2024. TNX-4300 is in preclinical development for mood disorders, Alzheimer’s disease and Parkinson’s disease.* The findings reported today show that tianeptine and estianeptine improve memory and cognition as measured in the rat Novel Object Recognition (NOR) test. The finding that estianeptine is responsible for improving memory and cognition suggests a role for PPAR-β/δ activation in memory.

Key Points: 
  • * The findings reported today show that tianeptine and estianeptine improve memory and cognition as measured in the rat Novel Object Recognition (NOR) test.
  • The finding that estianeptine is responsible for improving memory and cognition suggests a role for PPAR-β/δ activation in memory.
  • Tianeptine is an antidepressant that has been marketed outside the U.S. for more than 30 years.
  • Tianeptine is also a racemic drug composed of a 1:1 mixture of two mirror-image isomers.

Hepion Pharmaceuticals to Present Two Posters at EASL International Liver Congress™ 2023

Retrieved on: 
Thursday, June 15, 2023
Abstract, EASL, FXR, Therapy, PPAR agonist, NASH, Artificial intelligence, Gene expression, Doctor of Philosophy, Scripps Research, Peroxisome, Fatty liver disease, Conditional sentence, HEPA, NAFLD, European Association for the Study of the Liver, Vaccine, Liver

EDISON, N.J., June 15, 2023 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on artificial Intelligence (“AI”)-assisted therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, announced that two abstracts have been accepted for poster presentations at the European Association for the Study of the Liver (EASL) International Liver Congress™ 2023 taking place June 21 - 24, 2023 in Vienna, Austria and digitally.

Key Points: 
  • The first poster, to be presented by The Scripps Research Institute’s Winston Stauffer, PhD, demonstrates the role of cyclophilin B in the development of NAFLD and NASH in preclinical models, confirming rencofilstat’s mechanism of action as a cyclophilin inhibitor can offer protection against the development of these diseases.
  • The second poster, to be presented by Hepion’s Chief Scientific Officer, Daren Ure, PhD, demonstrates that rencofilstat positively changes gene expression networks and lipid profiles in preclinical models toward resolution of NASH.
  • The changes in gene expression observed in the studies overlapped with the effects of peroxisome proliferator-activated receptors (PPARs) and farnesoid X receptor (FXR) agonists – therapeutics used to treat chronic cholestatic and metabolic liver diseases.
  • Details of the accepted abstracts for poster presentations are as follows:

Tonix Pharmaceuticals Announces Presentation of Licensed Antiviral Drug Technology at the 2nd Wnt & β-catenin Targeted Drug Development Conference

Retrieved on: 
Thursday, January 26, 2023
Prader–Willi syndrome, Long COVID, Virus, Pandemic, Psychiatry, CNS, Disease, Peroxisome, MDD, COVID-19, Failure, Coronavirus, Security (finance), Smallpox, University of Alberta, Cancer, Government, Infection, Cell biology, Therapy, Degenerative disease, Orphan drug, RPV, University, Drug development, Fibromyalgia, Conference, SL, Central nervous system, Breakthrough therapy, WNT, Monkeypox, CD40L, FDA, Severe acute respiratory syndrome coronavirus 2, Hydrogen chloride, Risk, Neurology, Autoimmunity, Professor, Research, Pain, Annual report, Pharmaceutical industry, CD154, Tonix Pharmaceuticals

Tonix has previously announced that it exercised an option to license the antiviral technology platform.

Key Points: 
  • Tonix has previously announced that it exercised an option to license the antiviral technology platform.
  • A copy of the presentation is available on the Tonix Pharmaceuticals corporate website at www.tonixpharma.com .
  • As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products.
  • All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements.

Nuclear Receptors and Cancer Research: Current Trends and Applications, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Friday, August 26, 2022
Molecular biology, Biomedical sciences, Food, Cancer, Research, PPAR, Pennsylvania State University, Texas A&M College of Veterinary Medicine & Biomedical Sciences, Aryl hydrocarbon receptor, Veterinary medicine, Biochemistry, Immunology, Peroxisome, FXR, Industry, Medical imaging, Pharmaceutical industry

TORONTO, Aug. 26, 2022 /PRNewswire-PRWeb/ -- Nuclear receptors have long been a focus in cancer research. The role of dysregulated nuclear receptor mediated signaling pathways in tumorigenesis has been well documented in a variety of cancers. This makes nuclear receptors important therapeutic targets for identifying new therapies to combat cancer.

Key Points: 
  • The featured speakers will give insights into nuclear receptors and the human relevance of animal models.
  • TORONTO, Aug. 26, 2022 /PRNewswire-PRWeb/ -- Nuclear receptors have long been a focus in cancer research.
  • This makes nuclear receptors important therapeutic targets for identifying new therapies to combat cancer.
  • For more information, or to register for this event, visit Nuclear Receptors and Cancer Research: Current Trends and Applications.

Poxel Announces the Publication of Two Preclinical Articles on X-Linked Adrenoleukodystrophy for PXL065 and PXL770

Retrieved on: 
Tuesday, July 5, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Diagnosis, NASH, Patient, ABCD1, HSCT, Gait, Growth, Company, Lists of diseases, Haemophilia, Pioglitazone, Euronext Paris, AMPK, Therapy, AMN, Spinal cord, White matter, Fatty liver disease, Metabolic disorder, TZD, Prevalence, Woman, Chronic inflammatory demyelinating polyneuropathy, Journal of Inherited Metabolic Disease, Experiment, Brain, Journal of Pharmacology and Experimental Therapeutics, Degenerative disease, Phenotype, Man, Peroxisome, Inflammation, Peripheral nervous system, Partnership, Weakness, Adrenoleukodystrophy, POC, Sciatic nerve, Cell, Adenosine, Death, Hematopoietic stem cell transplantation, Journal, Incontinence, VLCFA, Metabolism, Disease, Plasma, ALD, Publication, Risk, Pathology, Pharmaceutical industry, Medical device, Imeglimin, Euronext, Pharmacology

POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announces the publication of two preclinical articles on X-Linked Adrenoleukodystrophy (ALD) for PXL065 and PXL770.

Key Points: 
  • POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announces the publication of two preclinical articles on X-Linked Adrenoleukodystrophy (ALD) for PXL065 and PXL770.
  • An article on PXL065 has been published in The Journal of Inherited Metabolic Disease (JIMD) and is entitled Therapeutic potential of deuterium-stabilized (R)-pioglitazone - PXL065 - for X-linked adrenoleukodystrophy.
  • These publications describe similar beneficial preclinical profiles of PXL770 and PXL065 in models of ALD.
  • Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan.

CymaBay Therapeutics Announces Presentations During The International Liver Congress™ 2022

Retrieved on: 
Wednesday, June 8, 2022
Woman, Conditional sentence, Itch, Congress, Alkaline phosphatase, University, NL, Seladelpar, Fibrosis, Carbon tetrachloride, EASL, European Association for the Study of the Liver, Liver cancer, Farnesoid X receptor, Hepatitis, Fatigue, Thyroid hormone receptor, Doctor of Philosophy, Peroxisome, Associate, Priority, Bile, Annual report, Security (finance), Disease, U.S. Securities and Exchange Commission, Inflammation, Cholestasis, Primary biliary cholangitis, ALP, Gene, CA, Telmisartan, Lipid metabolism, PBC, Therapy, Patient, Thyroid, THR, Risk, University of California, San Diego Performance-Based Skills Assessment, Food and Drug Administration, NASDAQ, European Medicines Agency, Twitter, Association, Erasmus MC, LinkedIn, FXR, Medical device, Pharmaceutical industry, Copper, Biostatistics, GLOBE, Liver

NEWARK, Calif., June 08, 2022 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced that multiple seladelpar presentations will be delivered during The International Liver Congress 2022 of the European Association for the Study of Liver (EASL) which will be held in London, UK from June 22nd 26th.

Key Points: 
  • NEWARK, Calif., June 08, 2022 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced that multiple seladelpar presentations will be delivered during The International Liver Congress 2022 of the European Association for the Study of Liver (EASL) which will be held in London, UK from June 22nd 26th.
  • Dr. Dennis Kim, Chief Medical Officer of CymaBay Therapeutics, commented, We are excited to have the opportunity to present once again this year at the International Liver Congress.
  • Presentations at The International Liver Congress 2022 include:
    Congress attendees can visit CymaBay throughout the meeting at booth 93.
  • A full list of presentations can be found on The International Liver Congress 2022 website.

Tonix Pharmaceuticals Extends Research Collaboration with the University of Alberta to Develop Antiviral Drugs Against SARS-CoV-2

Retrieved on: 
Wednesday, May 18, 2022
Department, University of Alberta, Severe acute respiratory syndrome coronavirus 2, Cell biology, Peroxisome, Prader–Willi syndrome, Pain, Company, SL, Long COVID, Private Securities Litigation Reform Act, U.S. Securities and Exchange Commission, Cocaine, Disease, Nasdaq, Autoimmunity, Degenerative disease, Monkeypox, Vaccine, Government, Coronavirus, Psychiatry, Hydrogen chloride, IFN, COVID-19, Failure, Cell, Fibromyalgia, Research, FDA, CNS, Infection, Smallpox, Virus, Orthornavirae, RNA, CD154, Technology, Central nervous system, Neurology, University, III, Risk, Therapy, SEC, Cancer, Security (finance), Annual report, GLOBE, Pharmaceutical industry, Professor, Tonix Pharmaceuticals

Antiviral therapeutics are needed to mitigate the effects of SARS-CoV-2 and future coronavirus outbreaks, and Professor Hobmans work is designed to facilitate the identification and testing of novel broad-spectrum antiviral drugs.

Key Points: 
  • Antiviral therapeutics are needed to mitigate the effects of SARS-CoV-2 and future coronavirus outbreaks, and Professor Hobmans work is designed to facilitate the identification and testing of novel broad-spectrum antiviral drugs.
  • SARS-CoV-2 is very sensitive to interferon (IFN) treatment and therefore, drugs that upregulate IFN production and/or signaling may reduce virus replication.
  • The research collaboration is focused on the development and testing of Wnt/-Catenin signaling pathway inhibitors as broad-spectrum antivirals against SARS-CoV-2 and other emerging viruses, said Professor Tom Hobman.
  • Peroxisomes are key antiviral signaling platforms that are important for IFN induction and antiviral defense.

Poxel Announces PXL065 and PXL770 Granted Orphan Drug Designation from the U.S. FDA for X-Linked Adrenoleukodystrophy

Retrieved on: 
Tuesday, May 17, 2022
Oncology, Health, FDA, Clinical Trials, Pharmaceutical, Biotechnology, Death, Risk, POC, Metabolic disorder, Company, Disease, Conditional sentence, AMN, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NASH, ALD, Food, White matter, Lists of diseases, Metabolism, Haemophilia, HSCT, Patient, Woman, TZD, Weakness, Adrenoleukodystrophy, ABCD1, Adenosine, Cell, Fatty liver disease, FDA, Spinal cord, Brain, Partnership, Pioglitazone, Forward-looking statement, Peripheral nervous system, Man, Euronext Paris, Peroxisome, VLCFA, AMPK, Therapy, Hematopoietic stem cell transplantation, Degenerative disease, Gait, Prevalence, Incontinence, Diagnosis, Growth, Chronic inflammatory demyelinating polyneuropathy, ODD, Pharmaceutical industry, Euronext, Imeglimin

Poxel CEO, Thomas Kuhn, commented: The award of Orphan Drug Designation to both PXL065 and PXL770 by the FDA is an additional regulatory milestone for the development of these potential medicines in X-linked adrenoleukodystrophy, for which there is currently no approved therapy.

Key Points: 
  • Poxel CEO, Thomas Kuhn, commented: The award of Orphan Drug Designation to both PXL065 and PXL770 by the FDA is an additional regulatory milestone for the development of these potential medicines in X-linked adrenoleukodystrophy, for which there is currently no approved therapy.
  • We remain excited to pursue treatments for ALD as this represents an area with very high unmet medical need.
  • For the rare inherited metabolic disorder, adrenoleukodystrophy (ALD), the company intends to initiate Phase 2a proof of concept studies with PXL065 and PXL770 in patients with adrenomyeloneuropathy (AMN).
  • 1 For more information on Orphan Drug Designation, see : https://www.fda.gov/industry/developing-products-rare-diseases-condition...
    View source version on businesswire.com: https://www.businesswire.com/news/home/20220517005860/en/

Poxel Announces PXL770 Awarded FDA Fast Track Designation for X-linked Adrenoleukodystrophy

Retrieved on: 
Monday, April 11, 2022
Health, FDA, Genetics, Other Health, General Health, Pharmaceutical, Biotechnology, Risk, FTD, AMN, Conditional sentence, Metabolic disorder, TZD, AMPK, Incontinence, White matter, Medicine, ALD, Chronic inflammatory demyelinating polyneuropathy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Haemophilia, NDA, VLCFA, Disease, ABCD1, Hematopoietic stem cell transplantation, Fatty liver disease, Peripheral nervous system, Adrenoleukodystrophy, Diagnosis, Peroxisome, Adenosine, POC, NASH, Sex linkage, Brain, Lists of diseases, Life, Metabolism, Fast Track, Forward-looking statement, Death, Gait, Growth, Euronext Paris, HSCT, Man, Accelerated approval (FDA), Review, Priority review, Weakness, Degenerative disease, FDA, Patient, Partnership, Spinal cord, Company, Cell, Woman, Food, Prevalence, Pharmaceutical industry, Medical device, Imeglimin, Euronext

Poxel CEO, Thomas Kuhn, commented: "Having PXL770 awarded Fast Track Designation by the FDA soon after our other promising product, PXL065, is a strong recognition of the potential of both our programs in adrenoleukodystrophy, a significant unmet medical need.

Key Points: 
  • Poxel CEO, Thomas Kuhn, commented: "Having PXL770 awarded Fast Track Designation by the FDA soon after our other promising product, PXL065, is a strong recognition of the potential of both our programs in adrenoleukodystrophy, a significant unmet medical need.
  • FTD provides Poxel with substantially enhanced access to FDA, including opportunities for face-to-face meetings and written consultations throughout the remaining development of PXL770.
  • Introduced under the FDA Modernization Act (1997), Fast Track Designation (FTD) may be awarded by the FDA to investigational drugs which treat a serious or life-threatening condition, and which fill an unmet medical need.
  • The FDA notes that 'the purpose of the Fast Track program is to get important new drugs to the patient earlier1.