Asian Pacific Development Center

Tonix Pharmaceuticals Announces Accelerating Completion of Enrollment in Phase 2 UPLIFT Study of TNX-601 ER (Racemic Tianeptine) for Major Depressive Disorder: Topline Data Now Expected in Fourth Quarter 2023

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Wednesday, July 26, 2023
Tianeptine, Cognition, Psychiatry, Neuron, Tonix Pharmaceuticals, NOR, DSM-IV codes, Bipolar disorder, PPAR, SL, Brain, MDD, Patient, Patent, Norepinephrine, RDC, Fibromyalgia, Mouse, Serotonin, Research, IND, Memory, Atrophy, Asian Pacific Development Center, Pharmaceutical industry, Depression

CHATHAM, N.J., July 26, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced that development of TNX-4300* (estianeptine), the single (S)-isomer of tianeptine will be prioritized over TNX-601 ER*, which is being studied in the Phase 2 UPLIFT1 trial for the treatment of major depressive disorder (MDD). TNX-4300 is in preclinical development for mood disorders, Alzheimer’s disease and Parkinson’s disease. Recent findings have shown estianeptine possesses the ability to improve memory and cognition in vivo as measured in the rat Novel Object Recognition (NOR) test, and the ability to restore neuroplasticity to neurons in cell culture. The finding that estianeptine is responsible for improving memory and cognition in vivo suggests a role for peroxisome proliferator-activated receptor PPAR-β/δ activation in memory. For these reasons, Tonix intends to accelerate completion of enrollment for the Phase 2 UPLIFT1 trial to reallocate resources to the preclinical development of TNX-4300 and now expects to report topline data from this study in the fourth quarter of 2023. Tonix is also accelerating completion of enrollment in the RESILIENT study of TNX-102 SL for the management of fibromyalgia so that approximately 450 patients will be enrolled, and topline results are expected in the fourth quarter of 2023.

Key Points: 
  • The finding that estianeptine is responsible for improving memory and cognition in vivo suggests a role for peroxisome proliferator-activated receptor PPAR-β/δ activation in memory.
  • For these reasons, Tonix intends to accelerate completion of enrollment for the Phase 2 UPLIFT1 trial to reallocate resources to the preclinical development of TNX-4300 and now expects to report topline data from this study in the fourth quarter of 2023.
  • Tonix is also accelerating completion of enrollment in the RESILIENT study of TNX-102 SL for the management of fibromyalgia so that approximately 450 patients will be enrolled, and topline results are expected in the fourth quarter of 2023.
  • Racemic tianeptine is an antidepressant that has been marketed outside the U.S. for more than 30 years.

Tonix Pharmaceuticals Announces Presentation of Data Supporting Development of Racemic and Single (S)-Isomer Tianeptine, Plastogen Anti-Depressants, at the American Society of Clinical Psychopharmacology Meeting

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Monday, June 5, 2023
Psychiatry, Volunteering, Neuron, Tonix Pharmaceuticals, Tianeptine, Human, Depression, I.P. Mission High School Jhalod, DSM-IV codes, Half-life, Neurogenesis, Culture, MC5, Pharmacokinetics, PPAR, Weight gain, ASCP, Bipolar disorder, MDD, Blood, RDC, Mouse, Research, Society, Treatment, Asian Pacific Development Center, Interim analysis, Pharmaceutical industry

CHATHAM, N.J., June 05, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the presentation of data detailing the mechanism of action and pharmacokinetics of TNX-601 ER (tianeptine hemioxalate extended release) and TNX-4300 (estianeptine) at the American Society of Clinical Psychopharmacology (ASCP) meeting in Miami, Fla. TNX-601 ER is being tested in a potentially pivotal Phase 2 trial for the treatment of major depressive disorder (MDD) for which results of a preplanned interim analysis are expected in the fourth quarter of 2023. TNX-4300 is in preclinical development for mood disorders, Alzheimer’s disease and Parkinson’s disease. The active ingredient of both products is the (S)-isomer of tianeptine.1 The (S)-isomer of tianeptine activates PPAR-β/δ, restores neuroplasticity in neuronal tissue culture and lacks µ-opioid liability. In contrast, the (R)-isomer of tianeptine lacks PPAR-β/δ activity and is an agonist at the µ-opioid receptor. The poster presentation is available on Tonix’s website: www.tonixpharma.com.

Key Points: 
  • TNX-4300 is in preclinical development for mood disorders, Alzheimer’s disease and Parkinson’s disease.
  • In contrast, the (R)-isomer of tianeptine lacks PPAR-β/δ activity and is an agonist at the µ-opioid receptor.
  • “The tianeptine marketed outside the U.S. for treating depression is a 1:1 racemic mixture of two mirror image isomers.
  • In humans, after an oral dose of TNX-601 ER the half-life of tianeptine in the blood is approximately 5-7 hours.

Tonix Pharmaceuticals Announces the Isolation and Characterization of the (S)-Isomer of Tianeptine, TNX-4300 (Estianeptine), Now Under Development for Psychiatric and Neurodegenerative Diseases

Retrieved on: 
Tuesday, May 23, 2023
Cognition, Psychiatry, Neuron, Tonix Pharmaceuticals, Acute stress disorder, Depression, Diabetes, PPAR, CNS, Weight gain, DSM-IV codes, Bipolar disorder, MDD, Asian Pacific Development Center, RDC, Research, PTSD, Pharmaceutical industry

CHATHAM, N.J., May 23, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the isolation and functional characterization of the two mirror image isomers of racemic tianeptine, which is marketed outside the U.S. as a treatment for major depressive disorder (MDD). Tonix scientists discovered that the (S)-isomer of tianeptine activates PPAR-β/δ, restores neuroplasticity in neuronal tissue culture and is free of µ-opioid receptor activity. In contrast, (R)-tianeptine activates the µ-opioid receptor and lacks PPAR-β/δ activity. Based on these discoveries, Tonix has begun preclinical development of the (S)-isomer, TNX-4300 (estianeptine)*, as a treatment for MDD, bipolar disorder, Alzheimer’s disease, and Parkinson’s disease. Tonix is planning to submit data supporting tianeptine’s mechanism of action for presentation at upcoming scientific conferences and for publication in peer reviewed journals.

Key Points: 
  • Tonix scientists discovered that the (S)-isomer of tianeptine activates PPAR-β/δ, restores neuroplasticity in neuronal tissue culture and is free of µ-opioid receptor activity.
  • In contrast, (R)-tianeptine activates the µ-opioid receptor and lacks PPAR-β/δ activity.
  • Based on these discoveries, Tonix has begun preclinical development of the (S)-isomer, TNX-4300 (estianeptine)*, as a treatment for MDD, bipolar disorder, Alzheimer’s disease, and Parkinson’s disease.
  • Tonix is planning to submit data supporting tianeptine’s mechanism of action for presentation at upcoming scientific conferences and for publication in peer reviewed journals.

Tonix Pharmaceuticals Announces Pharmacology and Medicinal Chemistry Results that Reveal the Molecular Mechanism of Action of Tianeptine, the Active Ingredient of TNX-601 ER, in Treating Depression

Retrieved on: 
Wednesday, May 17, 2023
Cognition, Yale University, Neuron, Acute stress disorder, FST, Depression, University, Diabetes, Rockefeller University, Sleep, PPAR, University of California, San Diego Performance-Based Skills Assessment, Dopamine, Gene expression, Research, CNS, Weight gain, Selective serotonin reuptake inhibitor, MDD, DSM-IV codes, Animal, Norepinephrine, Asian Pacific Development Center, RDC, Psychiatry, INT, Microglia, Serotonin, FDA, Pharmacology, PTSD, Pharmaceutical industry, Medical device, Silviculture, Tonix Pharmaceuticals

CHATHAM, N.J., May 17, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the molecular mechanism of action of tianeptine, the active ingredient of TNX-601 ER (tianeptine hemioxalate extended-release tablets), currently in Phase 2 clinical development for the treatment of major depressive disorder (MDD)*. Based on pharmacology and medicinal chemistry experiments, scientists at Tonix have established that tianeptine is an agonist for the nuclear peroxisome proliferator-activated receptor (PPAR) isoforms PPAR-β/δ and PPAR-γ, and tianeptine’s effects on these PPAR isoforms account for its ability to induce neuroplasticity in cultured neurons.

Key Points: 
  • Drugs that restore neuroplasticity are called plastogens.1-3 Consequently, tianeptine is a plastogen that acts directly on nuclear receptors that regulate gene expression in neurons and microglia.
  • “Understanding the mechanism of action of a molecule generally speeds its development and often points the way to broader clinical application,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.
  • “Despite its success in treating depression outside of the U.S. for more than 30 years, tianeptine’s mechanism has remained obscure.
  • “Tianeptine mimics naturally occurring polyunsaturated fatty acid in binding to PPARs.5 When compared to the traditional classes of antidepressants (SSRIs, tricyclics, etc.

P-Cure to support Hadassah Medical Organization in being the first to provide Proton Therapy to cancer patients in Israel

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Tuesday, June 28, 2022
Proton, TEL, FDA, Hadassah Medical Center, Patient, Eleazar Sukenik, Asian Pacific Development Center, Head, Travel, Brain, Hebrew University of Jerusalem, Cancer, Ministry, Neck, Proton therapy, CE, Neoplasm, Radiation, Physician, Ethics committee, Medical imaging, Health, Hadassah Women's Zionist Organization of America

TEL AVIV, Israel, June 28, 2022 /PRNewswire-PRWeb/ -- P-Cure Ltd. ("P-Cure"), the provider of the most compact 360° gantry-less adaptive proton therapy system that can be installed in a linac vault, announced today a collaboration with Hadassah Medical Organization ("Hadassah") in Jerusalem. The collaboration will provide cancer patients in Israel with access to proton therapy, the most targeted type of radiation therapy. The treatments will be carried out as a clinical research initiative with no economic burden to patients or medical insurers.

Key Points: 
  • The collaboration will provide cancer patients in Israel with access to proton therapy, the most targeted type of radiation therapy.
  • The treatments will be performed by the medical team of Hadassah at the P-Cure Clinical Research and Development Center.
  • Until now the patients in Israel, who were found eligible for proton therapy, have to travel abroad.
  • Proton therapy has proven its clinical benefits since the first hospital-based proton center started treating patients 32 years ago.

P-Cure Demonstrates the Proton Therapy Equipment Can Now Be Installed In Existing Radiation Therapy Rooms

Retrieved on: 
Friday, March 25, 2022
Proton, Radiation, CE, Research, Neoplasm, Cancer, Proton therapy, TEL, Physician, Asian Pacific Development Center, FDA, Patient, Medical imaging

TEL AVIV, Israel, March 25, 2022 /PRNewswire-PRWeb/ -- P-Cure Ltd., the provider of the most compact 360° gantry-less adaptive proton therapy system, announced today the opening of a clinical research and training site within its headquarters in Israel. The site is conveniently located in a 20-minute drive from either Tel Aviv or Jerusalem and hosts the world's most compact proton therapy system, which is installed within the footprint of a standard radiotherapy linac vault.

Key Points: 
  • This training will enable fast technology adaptation by new treatment providers not familiar with proton therapy.
  • "Instead of building a stand-alone facility, a cancer treatment center can expand its treatment options by installating a compact P-Cure Proton Therapy System in already existing linac vault."
  • Unlike x-ray treatment, with proton therapy there is small amount of entrance radiation, but virtually none travels beyond the tumor.
  • The compact P-Cure system installed inside existing radiation oncology departments removes the economic barrier to offering more patients the benefits of proton therapy," says Marash.

jCyte Announces Appointment of R. Heath Coats as Vice President of CMC, Regulatory Compliance and Quality Control

Retrieved on: 
Wednesday, October 6, 2021
Biotechnology, Pharmaceutical, Optical, Health, BLA, Review, Vaccine, Compliance, Asian Pacific Development Center, CGMP, European Medicines Agency, CMC, Parexel, Lonza, FDA, Software, Patient, RP, Â, Hood College, Quality control, Marketing, CDER, Quality, MS, Industry, Company, IND, Center, Ophthalmology, Retinitis pigmentosa, Technology, CAR, Documentation, Center for Biologics Evaluation and Research, Biomedical sciences, Organization, Coats, Technology transfer, CBER, Orphan drug, BS, EMA, Government, Time, Pharmaceutical industry

jCyte, Inc ., a private biotechnology company dedicated to improving the lives of patients with retinal degenerative diseases, announced the expansion of the companys leadership team with the appointment of R. Heath Coats as Vice President of CMC, Regulatory Compliance and Quality Control.

Key Points: 
  • jCyte, Inc ., a private biotechnology company dedicated to improving the lives of patients with retinal degenerative diseases, announced the expansion of the companys leadership team with the appointment of R. Heath Coats as Vice President of CMC, Regulatory Compliance and Quality Control.
  • Mr. Coats brings to jCyte over 30 years of regulatory compliance, quality, and CMC experience from a number of key roles in government, large contract manufacturing organizations, industry, consulting, and academia, with specific expertise with biologics, vaccines, and cell and gene therapies.
  • Of note, Mr. Coats participated in the inspections of multiple global manufacturing facilities for the first FDA licensed chimeric antigen receptor (CAR) T-cell therapy product Kymriah.
  • Mr. Coats holds a BS in Biology from Mount Saint Marys University (Maryland) and earned a MS in Biomedical Science from Hood College.