Metabolism

Phio Pharmaceuticals Announces Patent Granted by USPTO, Strengthening the Company’s Intellectual Property Position in Treating Aging Skin and Skin Disorders

Retrieved on: 
Wednesday, March 6, 2024
Lentigo, Pigment, Metabolism, Melasma, Elasticity, UVR, Ageing, Patent, Phio Pharmaceuticals, Skin, Hyperpigmentation, Gene silencing, TYR, Downregulation and upregulation, Iodosobenzene, MMP1, Vaccine

The compounds treat age-related skin disorders including photo-aging and dermal hyperpigmentation, targeting the down-regulation of the Matrix metalloproteinase-1 (MMP1) and Tyrosinase (TYR) proteins.

Key Points: 
  • The compounds treat age-related skin disorders including photo-aging and dermal hyperpigmentation, targeting the down-regulation of the Matrix metalloproteinase-1 (MMP1) and Tyrosinase (TYR) proteins.
  • Ultraviolet radiation (UVR) exposure is a known contributor to skin cancer and aging, inducing the hyperactivity of MMP1 which increases collagen breakdown and reduces collagen synthesis.
  • “We have a robust patent portfolio for Phio’s INTASYL siRNA technology,” said Robert Bitterman, CEO of Phio Pharmaceuticals.
  • “The addition of this recent patent grant for treatment of photodamaged skin is complementary to our current initiative in treating skin cancer.”

iTeos Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Wednesday, March 6, 2024
Investment, NSCLC, Therapy, The, Cancer, Metabolism, Merck, Research, Research and development, Equilibrative nucleoside transporter 1, SITC, AACR, Koch Institute, Hub, ENT1, Immunity, Comprehension, Adenosine, Lymphocyte, Merck & Co., Administration, Patient, TIGIT, Survival, Place of birth, HNSCC, Immune system, Pharmaceutical industry

WATERTOWN, Mass. and GOSSELIES, Belgium, March 06, 2024 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update.

Key Points: 
  • and GOSSELIES, Belgium, March 06, 2024 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update.
  • “With the recent developments in the TIGIT field, we believe belrestotug is in an advantageous position and are excited for its future prospects.
  • We look forward to sharing updates from our Phase 2 trials focused on 1L NSCLC and 1L HNSCC in 2024.
  • On December 7, 2023, iTeos announced the appointment of David K. Lee to the Company’s Board of Directors.

embecta-sponsored Educational Symposium and Abstracts at ATTD Highlight Role of Insulin Pumps in the Management of Type 2 Diabetes

Retrieved on: 
Wednesday, March 6, 2024
Knowledge, Division, Endocrinology, T2D, Inborn errors of metabolism, Metabolism, Education, Treatment, Insulin, Physician, Quality of life, ATTD, Faculty, DNP, University, Type 2 diabetes, EMBC, MDI, Fortezza, Case Western Reserve University, Patient, D.O, Poster, Needlestick injury, Risk, Lipohypertrophy, Obesity, Research, Fortezza da Basso, Time in Europe

Additionally, six embecta-sponsored abstracts focusing on injection and insulin pump therapies have been selected for presentation as scientific posters at ATTD 2024.

Key Points: 
  • Additionally, six embecta-sponsored abstracts focusing on injection and insulin pump therapies have been selected for presentation as scientific posters at ATTD 2024.
  • Entitled “Unlocking the potential of insulin pumps for personalized T2D care,” the symposium aims to highlight the significance of insulin pump therapy among the extensive treatment options available for type 2 diabetes (T2D).
  • The six embecta-sponsored abstracts set for presentation as scientific posters, include robust data about insulin therapy via both pumps and multiple daily injections (MDI).
  • Another poster highlights data showing that in individuals with type 2 diabetes, insulin pump therapy eases constraints imposed by diabetes management and improves quality of life.

ACTG CROI Presentations Show That Semaglutide Improves Metabolic-Associated Steatotic Liver Disease Among People Living With HIV

Retrieved on: 
Tuesday, March 5, 2024
Infection, Liver, Bangladesh Technical Education Board, Metabolism, Woman, P.T, Fungal infection, NIAID, Prediabetes, CROI, Liver injury, Inflammation, Quality of life, ACTG, ALT, Weight loss, Waist, Weight, Organ dysfunction, University of Southern California, Conference, Health, Glucagon-like peptide-1 receptor, University, SLIM, ART, Triglyceride, BMI, UM1, Insulin resistance, HIV, Non-alcoholic fatty liver disease, Research, University of North Carolina, Dietary supplement

Yesterday, the SLIM LIVER poster “Effects of Semaglutide on Muscle Structure and Function in the SLIM LIVER study” was presented.

Key Points: 
  • Yesterday, the SLIM LIVER poster “Effects of Semaglutide on Muscle Structure and Function in the SLIM LIVER study” was presented.
  • Together, these presentations demonstrate that semaglutide was highly effective in improving, and in some cases, resolving completely, metabolic dysfunction-associated steatotic liver disease (MASLD, formerly known as non-alcoholic fatty liver disease) among people living with HIV.
  • SLIM LIVER is the first study evaluating semaglutide as a treatment for MASLD among people living with HIV.
  • MASLD is common among people living with HIV and likely acts synergistically with HIV to accelerate liver injury and organ dysfunction.

ACTG Presents Study at CROI Elucidating Mechanism of CMV on Aging-Related Pathways in HIV

Retrieved on: 
Monday, March 4, 2024
Infection, Chairperson, Bangladesh Technical Education Board, Diabetes, CMV, Metabolism, Merck, Cancer, Endothelial dysfunction, Fungal infection, NIAID, CROI, Inflammation, Blood, IL-6, Ageing, ACTG, Splenic infarction, Risk, Conference, Cytomegalovirus, University, ART, Biomarker, Merck & Co., University of California, UM1, Insulin resistance, Poster, Letermovir, Probability, Atherosclerosis, Plasma, TNF, HIV, University of North Carolina, Immune system, Brain

CMV is a chronic and usually asymptomatic virus carried by 60 percent of adults in the general population and more than 95 percent of people living with HIV.

Key Points: 
  • CMV is a chronic and usually asymptomatic virus carried by 60 percent of adults in the general population and more than 95 percent of people living with HIV.
  • Prior to the availability of effective antiretroviral therapy (ART) for HIV, CMV caused life-threatening infections in the eyes, brain, and gut in people with compromised immune systems due to advanced HIV.
  • “Investigators have found associations between CMV and heart disease, cancer, and other aging-related complications among people living with HIV,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California, Los Angeles.
  • ACTG is led by Dr. Currier and Joseph J. Eron, M.D., University of North Carolina (ACTG Vice-Chair).

Tenaya Therapeutics Announces Publication of Preclinical HDAC6 Inhibitor Data for Heart Failure with Preserved Ejection Fraction in Nature Communications

Retrieved on: 
Monday, February 26, 2024
SAN, Metabolism, Inflammation, Food, HDAC6, HDAC, Exercise, Tubulin, Heart failure, Safety, Therapy, Acetylation, Patient, Hypertrophy, Fibrosis, SGLT2, MTAC, Oxidative stress, Nature Communications, Heart, HFD, Plasma, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced the publication of preclinical research related to Tenaya’s small molecule inhibitors of histone deacetylase 6 (HDAC6), including TN-301, in the February 26, 2024, issue of Nature Communications. The article, titled “Targeting HDAC6 to Treat Heart Failure with Preserved Ejection Fraction in Mice,” details the potential of inhibiting HDAC6 for the treatment of Heart failure with preserved ejection fraction (HFpEF), a form of heart failure that effects more than three million people in the U.S. alone1.

Key Points: 
  • The article, titled “Targeting HDAC6 to Treat Heart Failure with Preserved Ejection Fraction in Mice,” details the potential of inhibiting HDAC6 for the treatment of Heart failure with preserved ejection fraction (HFpEF), a form of heart failure that effects more than three million people in the U.S. alone1.
  • Tenaya’s highly selective small molecule inhibitors of the enzyme HDAC6 were discovered using the company’s modality-agnostic target discovery and validation capabilities.
  • For preclinical studies, Tenaya researchers used TYA-018, an HDAC6 inhibitor structurally and functionally similar to the company’s clinical candidate, TN-301.
  • The selective effects of HDAC6 inhibition were reaffirmed through genetic deletion studies, in which treatment of Hdac6 knockout mice did not display any of the beneficial effects that wild-type HFpEF mice did following treatment.

Draft guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations

Retrieved on: 
Tuesday, March 12, 2024
Filtration, Vespula, Toxicity, Histamine, EAACI, Immunotherapy, Asthma, Report, Allergy, Skin, Pregnancy, PR, EEC, MITES, RNA, Criterion, History, CMR, Contraindication, HEP, Draft, Guideline, Patient, Ames test, Diagnosis, Dermatitis, Venom, Literature, Trial of the century, Reproduction, Silicon–germanium, SPT, Food allergy, Cosmetics, EECS, Absorption, Marketing, Safety, Data collection, Directive 2001/83/EC, GMP, ID50, Antibody, Documentation, European, Type IV hypersensitivity, Genotoxicity, Applicant (sketch), Aeroallergen, CHMP, PRIME, Immunoglobulin G, Type, Publication, Biology, Pollen, DNA, Environment, Immune system, Toolbox, NLN, AIT, Atopic dermatitis, Fatality, Chapter, Anaphylaxis, Process validation, ICH, Antigen, Rhinitis, Clinical trial, Erythema, Knowledge, Prescription, Human, Network, Medication, Scope, VIT, ICT, EMA, Collection, Macrophage, Outline, Metabolism, Registry, Inflammation, Immunoglobulin E, Nature, European Pharmacopoeia, Food, Risk, Prevalence, Mastocytosis, Observation, Cytokine, NPP, Patient safety, Disease, Finished, Medical device

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Key Points: 
    • 16

      Guideline on allergen products development for
      immunotherapy and allergy diagnosis in moderate to lowsized study populations

      17

      Table of contents

      18

      Executive summary ..................................................................................... 3

      19

      1.

    • Specific effects ................................................................................................. 17

      14
      15

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      12.

    • Management for allergies may involve avoidance of the allergen, medications to relieve

      66

      symptoms, or allergen immunotherapy (AIT) to desensitize the immune system to the allergen.

    • 71

      Recommendations are made on the clinical development, potential study designs and safety

      72

      considerations for allergen products within the scope of the guideline.

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      While allergen specific immunotherapy is the only known disease modifying therapy for type I allergies,

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      there is no such treatment available for type IV allergies.

    • 93

      Several guidelines applicable for allergen products are available (see section 3) and provide advice on

      94

      quality and clinical development according to the current knowledge.

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      However, this guideline does not cover the indication of atopic dermatitis or asthma as these

      128

      conditions will require separate clinical trials (see Section 6).

    • 129

      In addition, the guideline does not cover medicinal allergen products manufactured using recombinant

      130

      DNA technology, synthetic peptides, DNA or RNA constructs and/or cell preparations as they differ

      131

      substantially to the allergen products as discussed above.

    • 1

      156

      ?

      Guideline on the clinical development of products for specific immunotherapy for the treatment

      157
      158

      of allergic diseases - CHMP/EWP/18504/2006
      ?

      159
      160
      161

      Guideline on Allergen Products: Production and Quality Issues EMEA/CHMP/BWP/304831/2007

      ?

      Guideline on process validation for finished products - information and data to be provided in
      regulatory submissions - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1, Corr.1

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      ?

      Recommendations on common regulatory approaches for allergen products - CMDh/399/2019

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      4.

    • In any

      199

      case, a reduced validation should include all relevant manufacturing process steps that are considered
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      product specific.

    • 290

      Diagnostic allergen products (Type I allergy)

      291

      A possible target indication is diagnosis of type I hypersensitivity (immediate-type allergy) by prick,

      292

      intracutaneous or provocation testing.

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      7.1.

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      8.

    • Clinical development of products for AIT: Study design,
      efficacy and safety

      378

      In general, the clinical development should be performed according to current guidelines.

    • In such single trial, the suitability as a test allergen as well as the

      376

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      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      dose finding for the therapeutic allergen could be investigated.

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      8.2.1.

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      In general, sensitivity and specificity of the product should be determined.

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      10.2.

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      4.

    • Allergol Immunopathol, 1989;

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      17(2):53-65

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Biktarvy® Demonstrates High Rates of Viral Suppression in People With HIV and Comorbidities

Retrieved on: 
Wednesday, March 6, 2024
Biotechnology, AIDS, Hospitals, Health, Pharmaceutical, ARV, Week, Research, Doctor of Philosophy, CROI, Science, CAPRISA, TLD, Fever, Coinfection, TB, STR, Common, Health care, Organization, DTG, Drug resistance, Genotype, HBV, Fungal infection, Principal, Rifampicin, Seroconversion, Tablet, ALT, TDF, Conference, Safety, Biomarker, Pharmacokinetics, Integrase, Metabolism, Emtricitabine, Aes, Gilead Sciences, MD, FDA, Upper respiratory tract infection, Food, Cell, Risk, Prevalence, COVID-19, Death, Patient, HIV/AIDS, Tuberculosis, INSIGHT, HIV, Vaccine

“People with HIV and comorbid conditions or pre-existing treatment resistance can often face complex and evolving treatment needs.

Key Points: 
  • “People with HIV and comorbid conditions or pre-existing treatment resistance can often face complex and evolving treatment needs.
  • The ALLIANCE trial is the first randomized clinical trial of TAF- vs TDF-based regimens in treatment naïve adults with HIV /HBV coinfection.
  • Additionally, ALLIANCE participants treated with Biktarvy exhibited numerically higher levels of HBV viral suppression and seroconversion.
  • The primary outcome measure is viral suppression rates at Week 24, defined as HIV-1 RNA ˂50 copies/mL.

Society for Laboratory Automation and Screening (SLAS) Selects CytoTronics’ Pixel System for 2024 New Product Award

Retrieved on: 
Tuesday, March 5, 2024
Software, Research, Pharmaceutical, Hardware, Biometrics, Apps, Applications, Technology, Semiconductor, Health Technology, Science, Biotechnology, Health, Laboratory automation, Metabolism, Multimedia, Electrophysiology, SLAS, Epithelium, Conference, Society, Cell biology, Exhibition, ISSCR, Television

CytoTronics, Inc. , a pioneer of semiconductor-based platforms for discovery in cell biology, is pleased to announce that their Pixel ™ system received the 2024 New Product Award from the Society for Laboratory Automation and Screening (SLAS).

Key Points: 
  • CytoTronics, Inc. , a pioneer of semiconductor-based platforms for discovery in cell biology, is pleased to announce that their Pixel ™ system received the 2024 New Product Award from the Society for Laboratory Automation and Screening (SLAS).
  • Award selection was announced at the SLAS2024 International Conference and Exhibition in Boston, MA on February 6th, 2024.
  • View the full release here: https://www.businesswire.com/news/home/20240305158077/en/
    CytoTronics' Pixel™ system received the 2024 New Product Award from the Society for Laboratory Automation and Screening (SLAS).
  • Front-runners are interviewed on-site at the conference by a panel of industry veterans with deep expertise in laboratory automation and screening techniques to determine final award recipients.

Oragenics, Inc. Prepares Drug for Phase II Clinical Trials to Treat Concussion

Retrieved on: 
Tuesday, March 5, 2024
Pharmaceutical, Health, Clinical Trials, Mental Health, CTE, Nasal administration, Active ingredient, Metabolism, IIA, Traumatic brain injury, Concussion, API, Nasal cavity, Animal, GMP, Common, Traffic, Safety, Patient, DSM-IV codes, Phase, Chronic traumatic encephalopathy, NCE, Brain, Pharmaceutical industry

The drug candidate is expected to be combined with its novel intranasal device, for the treatment of mild Traumatic Brain Injury, aka concussion.

Key Points: 
  • The drug candidate is expected to be combined with its novel intranasal device, for the treatment of mild Traumatic Brain Injury, aka concussion.
  • A 40-patient Phase I human study showed ONP-002 to be safe and well-tolerated.
  • Phase II patients will be recruited between the ages of 18-55 in the acute phase following concussion.
  • “Preclinical intranasal targeting of the brain has been shown to improve outcomes in animals and safety margin following concussion.