Standard of care

Peer-Reviewed Scientific Publication Proposes Unifying Single Toxin Theory of Brain Neurodegeneration that Identifies New Drug Targets and Treatments for Alzheimer’s Disease and Other Neurodegenerative Disorders

Retrieved on: 
Tuesday, March 26, 2024
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Toxicity, Brain, DSM-IV codes, APOE4, Patient, Biomarker, NDA, Standard of care, Prion, Doctor of Philosophy, MD, Protein, Neurotoxicity, Genotype, Treatment, Safety, ALS, Canadian International Council, Amyloid

In addition, our single toxin theory of brain neurodegeneration identifies new targets and approaches for the development of disease-modifying treatments,” said Martin Tolar, MD, PhD, Founder, President, and CEO of Alzheon.

Key Points: 
  • In addition, our single toxin theory of brain neurodegeneration identifies new targets and approaches for the development of disease-modifying treatments,” said Martin Tolar, MD, PhD, Founder, President, and CEO of Alzheon.
  • The application of biomarkers, in particular p-tau, synaptic markers, and brain volumetrics for the evaluation of disease course and therapeutic efficacy in AD trials.
  • Other neurodegenerative disorders follow the same pattern of protein dysregulation, impaired clearance, and increased aggregation, leading to neurotoxicity and loss of function.
  • In these diseases, a normal essential protein starts accumulating in the brain, misfolding and aggregating into soluble oligomers.

Syros Announces Completion of Enrollment of 190 Patients Necessary to Support Primary Endpoint Analysis in SELECT-MDS-1 Phase 3 Trial

Retrieved on: 
Monday, March 25, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Toxicity, New Drug Application, Patient, Venetoclax, NDA, Standard of care, Acute myeloid leukemia, Clinical trial, Azacitidine, Bone marrow, Food, RARA, Pharmaceutical industry

This initial cohort of 190 patients is necessary to support the complete response (CR) primary endpoint analysis.

Key Points: 
  • This initial cohort of 190 patients is necessary to support the complete response (CR) primary endpoint analysis.
  • Syros expects to report these pivotal data by the middle of the fourth quarter of 2024.
  • “We are pleased to announce the completion of enrollment of the 190 patients necessary to support the primary CR endpoint in SELECT-MDS-1.
  • Syros is also evaluating tamibarotene in combination with venetoclax and azacitidine in the SELECT-AML-1 Phase 2 clinical trial in newly diagnosed unfit acute myeloid leukemia patients with RARA gene overexpression.

Natera Announces Phase III Randomized CIRCULATE Trial in France, Evaluating Signatera™ in Stage II Colorectal Cancer

Retrieved on: 
Monday, March 18, 2024
Science, Other Science, Biometrics, Biotechnology, Oncology, Health, Genetics, Clinical Trials, ACT, Cordeliers, Survival, Colorectal cancer, Patient, DNA, Observation, Standard of care, Doctor of Philosophy, MD, FOLFOX, Gastroenterology, Circulating tumor DNA, NTRA, CRC, MRD, Neoplasm, Nursing

The study’s main objective is to determine the benefit of adjuvant chemotherapy (ACT) in stage II CRC patients with detectable circulating tumor DNA (ctDNA) post-surgery.

Key Points: 
  • The study’s main objective is to determine the benefit of adjuvant chemotherapy (ACT) in stage II CRC patients with detectable circulating tumor DNA (ctDNA) post-surgery.
  • Patients who are Signatera MRD-positive will be randomized to receive ACT (FOLFOX 6m) or pursue observation (no chemotherapy).
  • While the Japanese and U.S. trials evaluate the benefit of MRD-guided treatment in stage III and high-risk stage II CRC patients, the French trial is focused on stage II CRC.
  • “We believe this randomized study could establish a new standard of MRD-guided care in stage II colorectal cancer, potentially improving treatment decisions for thousands of patients.”
    Natera has joined the study in progress.

Longboard Pharmaceuticals Reports Full Year 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
Tuesday, March 12, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Clinical Trials, Other Health, Medication, Seizure, Standard of care, LGS, DEE, DS, Safety, SAD, FDA, DSM-IV codes, Pharmaceutical industry

Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today provided a corporate update and reported full year 2023 financial results.

Key Points: 
  • Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today provided a corporate update and reported full year 2023 financial results.
  • “I am extremely proud of what our team has accomplished starting with the immense effort that went into the PACIFIC Study in participants with DEEs.
  • We appreciate the tremendous support from our existing and new shareholders who play an integral part in the continued success of Longboard.
  • Of note, results were on top of current standard of care; participants were typically on 3-4 other anti-seizure medications.

Cellworks Personalized Therapy Biosimulation Study Produces Superior OS and DFS Predictions for Gastroesophageal Cancer Patients

Retrieved on: 
Monday, March 11, 2024
Technology, Biotechnology, Health, Other Health, Pharmaceutical, Oncology, Research, Software, General Health, Genetics, Health Technology, Science, Data Management, Clinical Trials, Biopsy, OS, HER2, Cancer, Radiation, Kingdom of Poland, Anthracycline, Survival, Disease, Neoadjuvant therapy, CBM, International Cancer Genome Consortium, TNM, University, Patient, Rated R, NGS, Biomarker, MSI, Artificial intelligence, Standard of care, DFS, TRI, MD, Medicine, TRG, Platinum, Publication, Biosimulation, OGA, Whole genome sequencing, PD-L1, Taxane, Medical imaging

The study also showed a significant association between a patient’s TRI score and disease-free survival (DFS) and tumor regression grade (TRG).

Key Points: 
  • The study also showed a significant association between a patient’s TRI score and disease-free survival (DFS) and tumor regression grade (TRG).
  • Despite progress in gastroesophageal cancer therapy, only a small proportion of patients attain long-term survival.
  • This study concluded that TRI scores for gastroesophageal adenocarcinoma patients predict OS and DFS beyond clinical factors.
  • These results highlight the clinical value of employing Cellworks biosimulation for personalized therapy selection and warrant additional clinical evaluation.

L-Nutra's Groundbreaking Study Revolutionizes Type 2 Diabetes Management Through Fasting Mimicking Nutrition Technology

Retrieved on: 
Thursday, April 4, 2024
Glycated hemoglobin, Metabolism, FMD, Type 2 diabetes, Disease, Insulin, Diabetes, Patient, Research, Fasting, Standard of care, Food, Doctor of Philosophy, Diet, Insulin resistance, Clinical trial, Type 2, Safety, Waist, BMI, Metformin, Movement, Prediabetes, Pharmaceutical industry

This randomized, controlled, assessor-blinded trial introduces a new paradigm in diabetes management, focusing on "glycemic management,'' a new metric used to measure efficacy by medication reduction.

Key Points: 
  • This randomized, controlled, assessor-blinded trial introduces a new paradigm in diabetes management, focusing on "glycemic management,'' a new metric used to measure efficacy by medication reduction.
  • Glycemic Management: FMD participants demonstrated superior glycemic management, with 53% showing improvement, compared to only 8% in the control group.
  • L-Nutra's patented and clinically backed nutrition technology food formulations are effective in supporting metabolism, cell renewal, and muscle protection by mimicking the reset and rejuvenation pathways of fasting.
  • "With the Fasting Mimicking Diet, we have successfully enhanced the natural rejuvenating power of fasting with food which has made the regression and remission of diabetes within every patient's reach.

Microbion's Topical Pravibismane Phase 1b Moderate or Severe Diabetic Foot Ulcer Infection Study is Published in International Wound Journal

Retrieved on: 
Thursday, April 4, 2024
DFI, Diabetes, Sepsis, Infection, Incidence, Risk, Ulcer, Patient, Mortality, Adjunct (grammar), University of Washington, University, Manuscript, Standard of care, Quality of life, Diabetic foot, Skin, Safety, Political moderate, Amputation, Medicine, Biofilm, Pharmaceutical industry

and VANCOUVER, BC, April 4, 2024 /PRNewswire/ - Microbion Corporation today announced that the company has published results from its topical pravibismane Phase 1b study in the peer-reviewed International Wound Journal.

Key Points: 
  • and VANCOUVER, BC, April 4, 2024 /PRNewswire/ - Microbion Corporation today announced that the company has published results from its topical pravibismane Phase 1b study in the peer-reviewed International Wound Journal.
  • The manuscript titled "Topical Pravibismane as Adjunctive Therapy for Moderate or Severe Diabetic Foot Infections: A Phase 1b Randomized, Multi-Center, Double-Blind, Placebo-Controlled Trial" is available for free download at International Wound Journal's website ( https://doi.org/10.1111/iwj.14817 ).
  • This therapeutic objective is currently being assessed in our recently completed, 12-week Phase 2 study in moderately infected, chronic diabetic foot ulcers."
  • The published manuscript describes in detail the Phase 1b study that was designed to evaluate the safety and efficacy of pravibismane in managing moderate or severe chronic diabetic foot ulcer infections.

Verismo Therapeutics Announces Submission of IND Application to the FDA for SynKIR™-310 in Relapsed/Refractory B-cell NHL

Retrieved on: 
Wednesday, April 3, 2024
Malignancy, MCL, Patient, B-cell lymphoma, Standard of care, Follicular lymphoma, Trial of the century, NHL, IND, Verismo, Clinical trial, Investigational New Drug, Therapy, Mantle cell lymphoma, FDA, NK, DLBCL, B cell, CD19, Food, Bone marrow, Pharmaceutical industry

PHILADELPHIA, April 3, 2024 /PRNewswire/ -- Verismo Therapeutics, a clinical-stage CAR T company developing the novel KIR-CAR platform technology, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its Phase 1 clinical trial of SynKIR™-310, for the treatment of relapsed/refractory (r/r) B-cell Non-Hodgkin Lymphomas (B-cell NHL), including Diffuse Large B Cell lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), and Marginal Zone Lymphoma (MZL).

Key Points: 
  • Commercially approved CAR T cell therapies have shown impressively high initial response rates in blood cancers.
  • Over time, however, these therapies result in relapse in an estimated 40-50% of patients1.
  • There are currently very limited treatment options for patients with r/r DLBCL who relapse following treatment with commercial CAR T cell therapies.
  • Initiation of the clinical trial is the culmination of years of focused research and diligent work by the Verismo team."

GenFleet and BeiGene Enter into Trial Collaboration for a Potentially First-in-class Combination Therapy to Initiate Phase Ib/II Study of GFH009 (CDK9 inhibitor) and BRUKINSA® (zanubrutinib) Treating Diffuse Large B Cell Lymphoma

Retrieved on: 
Thursday, March 28, 2024
B-cell lymphoma, Plasma, Shanghai Cancer Center, Rituximab, Apoptosis, Leukemia, International Journal of Hematology, Patient, Hospital, Doxorubicin, Vincristine, Fudan University, CC3, Standard of care, Acute myeloid leukemia, Epidemiology, Biomedical Chromatography, Prednisone, Peripheral T-cell lymphoma, PARP, National Cancer Center, Therapy, MYC, BTK, Safety, BeiGene, CDK9, Cyclophosphamide, DLBCL, Canadian International Council, MCL1, Follicular lymphoma, Pharmaceutical industry

The first patient was dosed in the trial led by prominent Henan Cancer Hospital and Fudan University Shanghai Cancer Center.

Key Points: 
  • The first patient was dosed in the trial led by prominent Henan Cancer Hospital and Fudan University Shanghai Cancer Center.
  • This study will be the first combination trial conducted by a Chinese biotech to combine CDK9 inhibitor and BTK inhibitor targeting DLBCL.
  • The trials of GFH009 treating peripheral T-cell lymphoma and acute myeloid leukemia have entered into phase II stage in China and the U.S. respectively.
  • Epidemiology of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) in the United States and Western Europe: population-level projections for 2020–2025, Leukemia & Lymphoma, 2021
    3.

New Survey Reveals Patients Receive Too Many Needlesticks

Retrieved on: 
Wednesday, March 27, 2024
Health, The Harris Poll, Risk, BDX, Patient, Hospital, RNS, Standard of care, United, Needle, Intravenous therapy, Nursing

FRANKLIN LAKES, N.J., March 27, 2024 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the results of a new survey conducted by The Harris Poll that reveals that many patients receive too many needlesticks in hospital procedures and amplifies misconceptions and lack of awareness from Americans on the risks of common medical procedures.

Key Points: 
  • Needlesticks are an often-overlooked challenge but can be one of the most traumatic aspects of a patient's hospital stay.
  • Moreover, 77% of patients are unaware that regardless of what conditions they may have, patients should expect no more than two needlestick attempts from one clinician.
  • Unsurprisingly, the survey highlights strong concern from nurses on the impact of repeated needlesticks to the patient care experience.
  • A strong majority of nurses agree that repeated needlesticks negatively impact the patient experience and say that alternatives are needed to reduce the number of needlesticks patients encounter (92% and 91%, respectively).