PMID

Tonix Pharmaceuticals Achieves Enrollment of First 50 Percent of Participants in the RESILIENT Study, a Potentially Pivotal Confirmatory Phase 3 Study of TNX-102 SL for the Management of Fibromyalgia

Retrieved on: 
Monday, December 19, 2022
Pain, Hydrogen chloride, CVM, PMID, NDA, Tonix Pharmaceuticals, SL, IDMC, Tablet, Patient, Particle-size distribution, FDA, Fibromyalgia, Woman, Pharmaceutical industry

CHATHAM, N.J., Dec. 19, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first 50% of participants have been randomized in the Phase 3 RESILIENT study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia. An interim analysis by an Independent Data Monitoring Committee (IDMC) of the first 50% of randomized participants for a potential sample size adjustment or early stop for futility is expected in the second quarter of 2023.

Key Points: 
  • Despite dissatisfaction with currently marketed products, no new treatment for fibromyalgia has been approved by the FDA since 2009.
  • In December 2020, Tonix reported positive results from the first Phase 3 study (RELIEF) of TNX-102 SL 5.6 mg for the management of fibromyalgia (primary endpoint, p=0.010).
  • Several secondary measures in RELIEF highlighted the broad effects of TNX-102 SL across several cardinal symptoms of fibromyalgia beyond pain.
  • “We are pleased to have reached this important milestone in our ongoing development of TNX-102 SL for fibromyalgia.

Alterity Therapeutics Announces Allowance of New Composition of Matter Patent by the United States Patent and Trademark Office

Retrieved on: 
Thursday, December 29, 2022
Dementia, Protein, PMID, Iron, United States Patent and Trademark Office, DOI, Central nervous system, Pathology, Lisa Ng, Thought, Atrophy, Infection, SAN, Dopamine, Brain, Drug discovery, Social skills, Tremor, Parkinson's disease, Disease, Patent, Alzheimer's disease, Heredity, Biomarker, ISSN, ATH, Malnutrition, Rigidity, Shamsi Fazlollahi, Neurodegeneration, Multimedia, Fatigue, Constipation, ASX, Ageing, Therapy, Dehydration, S, Genetics, Pharmaceutical industry, Medical imaging, Vaccine, PD, Neuroscience, Parkinsonism, Alterity

MELBOURNE, Australia and SAN FRANCISCO, Dec. 29, 2022 /PRNewswire/ -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company"), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that a new composition of matter patent has been allowed by the United States Patent and Trademark Office (USPTO). The patent was allowed following expedited review by the USPTO. 

Key Points: 
  • Importantly, the patent covers iron chaperones which are small molecules capable of binding and redistributing excess iron in the central nervous system.
  • "This patent strengthens our portfolio of compounds for treating important neurodegenerative diseases such as Parkinson's and Alzheimer's," said David Stamler, M.D., Chief Executive Officer, Alterity.
  • "With this patent, our discovery team has created a new scaffold that extends our approach of targeting key proteins implicated in these diseases.
  • Progress in Neurobiology, Volume 155, 2017, Pages 96-119, ISSN 0301-0082, https://doi.org/10.1016/j.pneurobio.2015.09.012
    This announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited.

Abbott Launches the World's Smallest Implantable, Rechargeable Spinal Cord Stimulation System for Chronic Pain

Retrieved on: 
Monday, December 19, 2022
Virginias, Life, Pain, IPhone, Physician, Medical device, Quality of life, De Ridder, SCS, Hyperreflexia, NYSE, Parenteral nutrition, Chronic pain, Food, FDA, Comparison, Apple, BURST, Randomized controlled trial, Regulation of tobacco by the U.S. Food and Drug Administration, Skin, Clinical study design, XR, Spinal cord, Health, Eterna, NANS, Systematic review, Meta-analysis, Patient, Spine, Eucalyptus diversicolor, Deer, Proclaim!, MRI, Caregiver, Gauge (instrument), PMID, Electric battery, Dentistry, Pharmaceutical industry, Poultry, Brain

Clinically proven therapy: The Eterna SCS system features Abbott's proprietary BurstDR stimulation, which mimics natural firing patterns found in the brain7 to deliver superior**8 pain relief.

Key Points: 
  • Clinically proven therapy: The Eterna SCS system features Abbott's proprietary BurstDR stimulation, which mimics natural firing patterns found in the brain7 to deliver superior**8 pain relief.
  • "Eterna is the smallest rechargeable spinal cord stimulator on the market, provides the longest therapy between charges and offers an optimized recharging experience – all key features when selecting the best overall system.
  • For U.S. important safety information on the Abbott Eterna spinal cord stimulation system, visit: https://bit.ly/3Wgpude .
  • Comparison of Spinal Cord Stimulation Waveforms for Treating Chronic Low Back Pain: Systematic Review and Meta-Analysis.

Circulating Tumor Cell detection by Menarini Group's CELLSEARCH® System leading to genomic profiling of myeloma cells shows potential for non-invasive management of Multiple Myeloma patients at early stages of disease

Retrieved on: 
Wednesday, December 14, 2022
Biotechnology, Probability, Inflore, Dana–Farber Cancer Institute, Lymphatic system, PMID, BM, MD, Kaplan–Meier estimator, Society, Research, Hematology, Patient, Clinical, LDT, Multiple myeloma, Chromosomal translocation, Mortality, System, FDA, HIV disease progression rates, Disease, Incidence, Personal computer, Pathology, Liquid biopsy, Cell, Bone marrow, CTC, Risk, Chinese, Safety, CMMC, Resource, B cell, SMM, MSB, Silicon, Blood, ASH, MGUS, Medical imaging, Pharmaceutical industry, Medical device

HUNTINGDON VALLEY, Pa., Dec. 14, 2022 /PRNewswire/ -- Menarini Silicon Biosystems, a pioneer of liquid biopsy and single cell technologies, announced today the results of a study in which enumeration and genomic characterization of CTCs at varying stages of MM represents an invaluable tool to predict disease aggressiveness and pathology. This study was conducted in collaboration with Dana-Farber Cancer Institute researchers and published on December 7, 2022 in Cancer Discovery1.

Key Points: 
  • This study was conducted in collaboration with Dana-Farber Cancer Institute researchers and published on December 7, 2022 in Cancer Discovery1.
  • This type of blood cancer forms in plasma cells (PCs) located in the bone marrow (BM).
  • 1Dutta A, Alberge J-B, et al, MinimuMM-seq: Genome sequencing of circulating tumor cells for minimally invasive molecular characterization of multiple myeloma pathology, Cancer Discov CD-22-0482.
  • * The Circulating Multiple Myeloma Cell (CMMC) test is a CLIA-accredited laboratory developed test from Menarini Silicon Biosystems in USA.

Circulating Tumor Cell detection by Menarini Group's CELLSEARCH® System leading to genomic profiling of myeloma cells shows potential for non-invasive management of Multiple Myeloma patients at early stages of disease

Retrieved on: 
Wednesday, December 14, 2022
Biotechnology, Probability, Inflore, Dana–Farber Cancer Institute, Lymphatic system, PMID, BM, MD, Kaplan–Meier estimator, Society, Research, Hematology, Patient, Clinical, LDT, Multiple myeloma, Chromosomal translocation, Mortality, System, FDA, HIV disease progression rates, Disease, Incidence, Personal computer, Pathology, Liquid biopsy, Cell, Bone marrow, CTC, Risk, Chinese, Safety, CMMC, Resource, B cell, SMM, MSB, Silicon, Blood, ASH, MGUS, Medical imaging, Pharmaceutical industry, Medical device

HUNTINGDON VALLEY, Pa., Dec. 14, 2022 /PRNewswire/ -- Menarini Silicon Biosystems, a pioneer of liquid biopsy and single cell technologies, announced today the results of a study in which enumeration and genomic characterization of CTCs at varying stages of MM represents an invaluable tool to predict disease aggressiveness and pathology. This study was conducted in collaboration with Dana-Farber Cancer Institute researchers and published on December 7, 2022 in Cancer Discovery1.

Key Points: 
  • This study was conducted in collaboration with Dana-Farber Cancer Institute researchers and published on December 7, 2022 in Cancer Discovery1.
  • This type of blood cancer forms in plasma cells (PCs) located in the bone marrow (BM).
  • 1Dutta A, Alberge J-B, et al, MinimuMM-seq: Genome sequencing of circulating tumor cells for minimally invasive molecular characterization of multiple myeloma pathology, Cancer Discov CD-22-0482.
  • * The Circulating Multiple Myeloma Cell (CMMC) test is a CLIA-accredited laboratory developed test from Menarini Silicon Biosystems in USA.

Relmada Therapeutics Announces Top-line Results from Phase 3 RELIANCE I Trial for REL-1017 as an Adjunctive Treatment for Major Depressive Disorder

Retrieved on: 
Wednesday, December 7, 2022
Therapy, Neurodegeneration, Psilocybin, PMID, Major depressive disorder, Central nervous system, Risk, Combination, NMDA, Clinical Pharmacology & Therapeutics, NMDAR, NCE, Nature, Safety, Failure, CNS, MDD, Pharmaceutical industry, Patient

CORAL GABLES, Fla., Dec. 7, 2022 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced results of the RELIANCE I study (REL-1017-301), evaluating REL-1017 as an adjunctive treatment for Major Depressive Disorder (MDD).  The same factors that negatively affected the previously announced results from the RELIANCE III study, a limited number of high enrolling sites with unplausible placebo response, also affected RELIANCE I and the study did not achieve its primary endpoint, which was a statistically significant improvement in depression symptoms compared to placebo as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) on Day 28.  RELIANCE I evaluated the use of REL-1017 in addition to a standard antidepressant for patients who had inadequate response to at least one and up to three standard antidepressant therapies.

Key Points: 
  • REL-1017 (Esmethadone) as Adjunctive Treatment in Patients With Major Depressive Disorder: A Phase 2a Randomized Double-Blind Trial.
  • In a Phase 2 trial, REL-1017 demonstrated rapid, robust, and sustained antidepressant effects with statistically significant improvements compared to placebo.
  • Relmada Therapeutics is a late-stage biotechnology company addressing diseases of the central nervous system (CNS), with focus on major depressive disorder (MDD).
  • Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

SARS-CoV-2 Virus Kinetics Influenced by Viral Strain and Vaccination Status

Retrieved on: 
Tuesday, December 6, 2022
Vaccination, Social media, Chemistry, Severe acute respiratory syndrome coronavirus 2, Strain, HIV, PMID, Female, Microbiology Spectrum, Infection, Oak Crest, Biomedical Research, STEM, Research, Biology, History, COVID-19, Environmental science, DOI, Student, Male, Vaccine, Pharmaceutical industry, Tutoring, Science

MONROVIA, Calif., Dec. 6, 2022 /PRNewswire/ -- The Oak Crest Institute of Science announced the publication of results from a new research project in Microbiology Spectrum (DOI: 10.1128/spectrum.04469-22). The study followed two vaccinated participants – a male and female – who developed COVID-19 independently between December 27, 2021, and January 3, 2022, the only participants to become infected with SARS-CoV-2 over this period.  Using state-of-the-art molecular techniques to analyzed nasal swab samples collected at high frequency longitudinally, researchers sought to explore whether full vaccination affected early COVID-19 replication rates and/or viral loads through the various stages of infection.

Key Points: 
  • "Our ultimate conclusion in this study centers on three important points," said researcher, Manjula Gunawardana, M.P.H.
  • "The SARS-CoV-2 virus doubling times were similar for vaccinated and unvaccinated individuals infected with an earlier SARS-CoV-2 strain.
  • "Oak Crest already has a distinguished history of researchon viruses," said Paul Webster, Ph.D., and Senior Faculty at Oak Crest.
  • Clinical SARS-CoV-2 Kinetic Profiles Are Dependent on the Viral Strain and Host Vaccination Status .

Independent Prospective Study Defines Reference Range for CareDx’s AlloSure for Long-Term Lung Transplant Surveillance

Retrieved on: 
Thursday, December 1, 2022
University, Biotechnology, Education, Health, General Health, Pharmaceutical, Health Technology, Research, Hospitals, Surgery, Science, PMID, Lung, Kidney, Observational study, DNA, Transplant, Caregiver, Patient, Lung transplantation, Annual report, MD, National Association Medical Staff Services, Moon Mullican, Assistant, Plasma, Precision medicine, Vanderbilt University Medical Center, Department of Medicine – University of Pamplona, Dentistry

The independent observational study performed at Vanderbilt University Medical Center measured AlloSure dd-cfDNA levels in clinically stable lung transplant patients two years post-transplant during routine clinic appointments, every three months.

Key Points: 
  • The independent observational study performed at Vanderbilt University Medical Center measured AlloSure dd-cfDNA levels in clinically stable lung transplant patients two years post-transplant during routine clinic appointments, every three months.
  • In an analysis of fifty-one patients with at least three AlloSure dd-cfDNA measurements, the reference baseline was defined for using AlloSure in the long-term surveillance of lung transplant patients.
  • This study adds to the body of evidence supporting the use of AlloSure Lung.
  • This press release includes forward-looking statements related to CareDx, Inc., including statements regarding the potential benefits and results that may be achieved with AlloSure Lung on transplant patients and the value of the independent study on AlloSure Lung conducted by Vanderbilt University Medical Center (the Study).

Autobahn Therapeutics Announces Initiation of a Phase 1 Clinical Trial of ABX-002 for the Treatment for Major Depressive Disorder

Retrieved on: 
Tuesday, November 29, 2022
Mental Health, Health, Other Health, Clinical Trials, General Health, Biotechnology, PMID, PK, Pharmacokinetics, Tissue, Therapy, Brain, Physician, Caregiver, Patient, The Journal of Clinical Psychiatry, Grief, Magnetic resonance, Central nervous system disease, Serotonin, Disability, Autobahn, Grammatical mood, CNS, Depression, Suicide, Learned helplessness, Trial of the century, Safety, MDD, Pharmaceutical industry

Autobahn Therapeutics, a biotechnology company focused on restoring hope for people affected by CNS disorders, today announced the initiation of dosing in the companys Phase 1 clinical trial of ABX-002 in healthy volunteers.

Key Points: 
  • Autobahn Therapeutics, a biotechnology company focused on restoring hope for people affected by CNS disorders, today announced the initiation of dosing in the companys Phase 1 clinical trial of ABX-002 in healthy volunteers.
  • ABX-002 is a potent and selective, brain-boosting thyroid receptor beta (TR) agonist that Autobahn is evaluating as a potential adjunctive treatment for people with major depressive disorder (MDD) who are experiencing an inadequate response to their antidepressant.
  • We look forward to advancing ABX-002 in the clinic as we further our understanding of its potential impact for patients.
  • Inadequate Response to Treatment in Major Depressive Disorder: Augmentation and Adjunctive Strategies.

Aldeyra Therapeutics Submits New Drug Application to the U.S. Food and Drug Administration for Reproxalap for the Treatment of Signs and Symptoms of Dry Eye Disease

Retrieved on: 
Tuesday, November 29, 2022
Health, FDA, Other Health, Clinical Trials, Pharmaceutical, Optical, Biotechnology, Marketing, United, Risk, Therapy, Dry eye syndrome, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Duane syndrome, Security (finance), RASP, Chronic cough, Patient, Prevalence, Irritation, Pain, Dry, NDA, Allergic conjunctivitis, FDA, COVID-19, Growth, Result, Financial condition report, Lipid peroxidation, Food, Physician, Analysis, Toxicity, Annual report, Inflammation, Disease, Failure, Data analysis, Clinical trial, Safety, PMID, Tears, Conversation, Pharmacology, Biomarker, Asthma, Lubrication, Quality of life, Psoriasis, Alcoholic hepatitis, Eye, Pharmaceutical industry, Schirmer

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, an investigational new drug candidate, for the treatment of signs and symptoms of dry eye disease.

Key Points: 
  • Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, an investigational new drug candidate, for the treatment of signs and symptoms of dry eye disease.
  • With data suggesting activity within minutes of administration, reproxalap could provide an important treatment option for the millions of dry eye patients who generally regard currently available therapies as inadequate.
  • Reproxalap is the lead product candidate in Aldeyras RASP modulator platform, which includes systemic disease pipeline candidates ADX-629 and related analogs.
  • In addition to dry eye disease, reproxalap is in late-stage development for allergic conjunctivitis, a condition that is commonly associated with dry eye disease.