Cardiotoxicity

Atea Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Business Update

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tisdag, maj 14, 2024
Plasma, SOC, Risk, FDA, Ageing, Electrocardiography, Week, Fast Track, HCV, Kinetics, RNA, Research, QRS, Standard of care, QT, Bemnifosbuvir, Patient, QT interval, Infection, Cardiotoxicity, SVR4, Security (finance), Second generation, Administration, COVID-19, Food, Clinical trial, Viral, Safety, Hospital, Viral load, SVR, Doctor of Philosophy, NS5A, EASL, BID, Heart rate, Tax, NS5B, Immunodeficiency, Death, Cirrhosis, PR, Development, Pharmaceutical industry

BOSTON, May 14, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today reported financial results for the first quarter ended March 31, 2024 and provided a business update.

Key Points: 
  • BOSTON, May 14, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today reported financial results for the first quarter ended March 31, 2024 and provided a business update.
  • Final results from the 60-patient lead-in cohort confirmed a 98% SVR4 rate across all genotypes from 58 of 59 patients.
  • Topline results from all patients enrolled in the Phase 2 study are anticipated in the second half of 2024.
  • In April 2024, Atea presented Phase 1 data showing that bemnifosbuvir does not alter cardiac repolarization.

Delix Announces DLX-001 Demonstrates Evidence of CNS Penetration and Brain Activity Without Psychotomimetic, Dissociative, or Hallucinogenic Effects in Ongoing Phase 1 Trial

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måndag, maj 13, 2024
Science, Neurology, Biotechnology, Research, Pharmaceutical, Health, Mental Health, Clinical Trials, Patient, Pharmacokinetics, CSF, Dissociative, SAD, EEG, Ketamine, MDD, DMT, Therapy, Safety, Food, Biological Psychiatry (journal), MD, Hallucination, Cardiotoxicity, Quantitative electroencephalography, Psychiatry, DSM-IV codes, Cerebrospinal fluid, Vivo, Society, ASCP, Psilocybin, CHDR, Pharmaceutical industry

The Company also announced preclinical data showing the effects of DLX-001 on antidepressant, structural, and functional plasticity assays.

Key Points: 
  • The Company also announced preclinical data showing the effects of DLX-001 on antidepressant, structural, and functional plasticity assays.
  • Part B is an open-label crossover design study to investigate the effect of food on the PK of DLX-001.
  • No psychotomimetic, hallucinatory, or dissociative effects have been observed, as reflected by no change over time on a robust battery of assessments.
  • DLX-001 exhibited both rapid—within 24-hours, and enduring—up to 14 days, antidepressant-like activity after a single dose in multiple behavioral models.

Moleculin Announces Presentation of Positive Data Demonstrating High Anti-Cancer Activity of Annamycin and Non-Cardiotoxic Properties

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onsdag, april 10, 2024
Cardiotoxicity, RTCA, Mouse, STS, Doxorubicin, Heart, Animal, Molecule, Pathology, AML, Potent, Anthracycline, DNA, Patent, Patient, Physiology, Virus, Toxicity, Acute myeloid leukemia, AACR, United States patent law, Pharmaceutical industry

HOUSTON, April 10, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced positive preclinical data regarding the Company's next-generation anthracycline, Annamycin, was presented at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 5-10, 2024 in San Diego, CA.

Key Points: 
  • The poster titled, Non-cardiotoxic Properties of Annamycin, a Clinically Evaluated Anthracycline and Potent Topoisomerase 2β Poison , was presented in the "Late-Breaking Research: Experimental and Molecular Therapeutics 2" session held on Monday, April 8th.
  • These data, documenting lack of cardiotoxicity of Annamycin and aligned with the data demonstrated to date in our ongoing clinical trials, bolster our confidence in Annamycin potential to offer patients a safe and effective treatment option.
  • Annamycin and doxorubicin cytotoxicity was assessed in a panel of cancer cell lines cardiomyocytes (murine and human).
  • For more information about the ongoing trials, please visit clinicaltrialsregister.eu : EudraCT 2020-005493-10 or clinicaltrials.gov : NCT05319587; and clinicaltrials.gov : NCT04887298, respectively.

HUTCHMED Highlights Data to be Presented at AACR Congress 2024

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fredag, april 5, 2024
IOV, Tao, Medicine, Savolitinib, VEGFR, Immunotherapy, Patient, MMAE, ERK, Relapse, Neoplasm, University, Huachung University, Cisplatin, Lymphoid leukemia, Lymphoma, Chongqing Medical University, Cholangiocarcinoma, Tyrosine-protein kinase SYK, Classification, Efficacy, MET, ADC, Cardiotoxicity, Nanjing Medical University, Non-receptor tyrosine kinase, Safety, Ferroptosis, Macrophage, Pancreatic cancer, Dual role, National Taiwan University Hospital, GPR34, Oncology, Guangzhou Medical University, MD Anderson Cancer Center, Daratumumab, HCM, NPM1, MLL, 301 Hospital, Acute leukemia, Pharmaceutical industry

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 05, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Association of Cancer Research (“AACR”) Annual Meeting 2024, taking place on April 5-10, 2024 in San Diego, California.

Key Points: 
  • HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 05, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Association of Cancer Research (“AACR”) Annual Meeting 2024, taking place on April 5-10, 2024 in San Diego, California.
  • Initial preclinical data will be presented for HMPL-506, a novel, highly potent and differentiated menin-MLL inhibitor for the treatment of certain types of acute leukemia.
  • Compared with five other menin inhibitors in clinical development, HMPL-506 showed the stronger inhibitory potency in MLL-rearranged and NPM1 mutant leukemia cell line models.
  • Furthermore, HMPL-506 in combination with azacytidine, venetoclax or gilteritinib synergistically improved the anti-tumor effect against MLL-rearranged leukemias both in vitro and in vivo.

Aprea Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Business Update

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tisdag, mars 26, 2024
Ovarian cancer, Cyclin, IND, Therapy, Anemia, Research, University, Cell cycle, MD Anderson Cancer Center, PLK1, DDR, Investigational New Drug, Safety, Pharmacokinetics, Synthetic lethality, WEE1, U.S. FDA, Mutation, Acceleration, Part, HERG, ATR, KOL, Acquisition, Cancer, AACR, Research and development, Poster, FDA, Cyclin E, Toxicity, Aplastic anemia, Administration, Conference, APRE, PLK3, PLK2, Division, Data, Cardiotoxicity, Pharmaceutical industry

DOYLESTOWN, Pa., March 26, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

Key Points: 
  • “Aprea had a very productive 2023 with significant progress across our diversified pipeline of synthetic lethality-based cancer therapeutics.
  • An update from Part 1 of the trial was featured in a poster presentation at the AACR-NCI-EORTC International Conference in October 2023.
  • Select Financial Results for the Fourth Quarter ended December 31, 2023
    As of December 31, 2023, Aprea reported cash and cash equivalents of $21.6 million.
  • Research and Development (R&D) expenses were $2.0 million for the quarter ended December 31, 2023, compared to $0.5 million for the fourth quarter of 2022.

ATCC and Tissue Dynamics Announce a Strategic Collaboration to Bring a Transformative Heart Organoid Model to Market

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tisdag, februari 27, 2024
Technology, Health Technology, Cardiology, Software, Biotechnology, Hardware, Health, Pharmaceutical, Artificial Intelligence, Nature Biomedical Engineering, Doctor of Philosophy, BIRD Foundation, Intelligence, DVM, Drug development, Arrhythmia, Al-Quds, Physiology, Organoid, Bionics, Safety, Cardiotoxicity, Hebrew University of Jerusalem, BIRD, Research, Partnership, Medical device

The collaboration will be done under the Israel-U.S. Binational Industrial Research and Development Foundation (BIRD) framework, which awarded both companies a two-year grant.

Key Points: 
  • The collaboration will be done under the Israel-U.S. Binational Industrial Research and Development Foundation (BIRD) framework, which awarded both companies a two-year grant.
  • The BIRD Foundation, established in 1977, bolsters transformative partnerships that stimulate, promote, and support industrial research and development in a wide range of technology sectors.
  • Tissue Dynamics partnered with the Hebrew University of Jerusalem to develop the world’s first mature self-paced multi-chambered cardiac organoid model , using ATCC cells, that emulates critical aspects of human physiology.
  • Tissue Dynamics’ partnership with ATCC aims to advance this cardiac organoid model for industrial use.

Phenovista Appoints Pharmaceutical Industry Veteran and Toxicology Expert Eckhard von Keutz, PhD to its Scientific Advisory Board

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torsdag, februari 8, 2024
Biotechnology, Health, Science, Pharmaceutical, Research, Cell proliferation, Bayer, Workflow, Senior, Research fellow, Toxicology, Doctor of Philosophy, Liver, Cardiotoxicity, Management

Phenovista , a life sciences services company developing and implementing multiplexed, high content imaging-based phenotypic assays for target validation, lead optimization, and mechanism of action studies, today announced the appointment of Eckhard von Keutz to its Scientific Advisory Board.

Key Points: 
  • Phenovista , a life sciences services company developing and implementing multiplexed, high content imaging-based phenotypic assays for target validation, lead optimization, and mechanism of action studies, today announced the appointment of Eckhard von Keutz to its Scientific Advisory Board.
  • Most recently, Dr. von Keutz served as the Senior Vice President and Head of Translational Science (Preclinical and Early Clinical Development) at Bayer Pharmaceuticals.
  • “We are excited to welcome Eckhard to our Scientific Advisory Board,” said James Evans, PhD, Chief Executive Officer of Phenovista.
  • “Phenovista’s ability to support and de-risk mission-critical R&D decision-making is unmatched in the industry,” said Dr. von Keutz.

Moleculin Announces 2023 Year-End Annamycin Clinical Trials Preliminary Data and 2024 Expectations for Multiple Data Readouts and Transition to Pivotal Phase 2B/3

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onsdag, januari 24, 2024
Northwestern University, Neutrophil, Patient, Research, OS, Acute myeloid leukemia, Anthracycline, Culture, Survival, Mouse, CRS, Thrombocytopenia, Safety, Allergy, STS, GBM, PFS, Febrile neutropenia, Bone marrow, Cardiotoxicity, NIH, Glioblastoma, Brain, Zika virus, FDA, Virus, HIV, Aplastic anemia, National Institutes of Health, AML, Clinical trial, Bangladesh Technical Education Board, SARS-CoV-2, Pharmacokinetics, ITT, Pharmaceutical industry

"Over the course of 2023, we delivered on our promise for a year of important data from our Annamycin clinical development programs.

Key Points: 
  • "Over the course of 2023, we delivered on our promise for a year of important data from our Annamycin clinical development programs.
  • We are well-positioned to continue building upon our encouraging growing body of preliminary clinical data and transition to pivotal Phase 2B/3 clinical trials by year-end 2024.
  • With our recent financing in December 2023, we have extended our runway into the fourth quarter of 2024, as well.
  • WP1122 successfully completed a Phase 1 clinical trial, which established a recommended safe dose for future potential Phase 1B or Phase 2 clinical trials.

Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Date of authorisation: 09/02/2018, Revision: 21, Status: Authorised

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tisdag, januari 2, 2024
Marketing, Stomach, INN, Risk, HER2, Breast, Tissue, Heart, Cancer, Neoplasm, Cardiotoxicity, Infection, Anatomy, Paclitaxel, IIA, Breast cancer, ATC, European, Allergy, Metastasis, Blood, Capecitabine, MBC, EBC, Safety, Heart failure, MGC, Patient, Medical Subject Headings, Agency, European Commission, Cyclophosphamide, Immune system, Docetaxel, Carboplatin, International, Language, Cisplatin, Select, Enzyme inhibitor, Medicine, FISH, Radiation, Lymph, Arm, European Medicines Agency, Fluorouracil, Doxorubicin, Medical device

Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Date of authorisation: 09/02/2018, Revision: 21, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Date of authorisation: 09/02/2018, Revision: 21, Status: Authorised

Enveric Biosciences Reports Year End Progress for Preclinical Development of Lead Prodrug Candidate EB-373

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onsdag, december 27, 2023
Biotechnology, Natural Resources, Pharmaceutical, General Health, Health, Mental Health, Cannabis, Clinical Trials, Toxicology, DRF, Metabolism, Research, Depression, Absorption, Psilocybin, HERG, Human, Addiction, Clinical trial, Disulfiram-like drug, Rat, ADR, Dog, Anxiety, Mental health, Animal, Cardiotoxicity, CNS, Safety, Therapy, Vomiting, Pharmaceutical industry

In addition, cardiac, respiratory, CNS safety pharmacology studies, an in vitro hERG current study, and genotoxicity studies have been completed and are undergoing analyses.

Key Points: 
  • In addition, cardiac, respiratory, CNS safety pharmacology studies, an in vitro hERG current study, and genotoxicity studies have been completed and are undergoing analyses.
  • Enveric expects to finalize all preclinical activities involving EB-373 in the first quarter of 2024 in preparation for a first-in-human clinical trial.
  • “Our research team has continued to diligently advance the preclinical program for our lead novel psilocin prodrug, EB-373, as we anticipate initiating first in human trials in 2024,” said Joseph Tucker, Ph.D., Director and CEO of Enveric.
  • Results from this study also demonstrated rapid conversion of EB-373 to the active metabolite psilocin, consistent with previously reported pharmacokinetic (PK) studies.