Prognosis

Evexta Bio Reports Progress towards Clinical Development of Rupitasertib in Advanced Breast Cancer

Retrieved on: 
Monday, April 22, 2024
FDA, PAM, ABC, Safety, Food, Prognosis, AKT, Patient, S6K, CMC, Acquisition, CSO, LSX, Breast cancer, ESR1, Pharmaceutical industry

Following a Type B meeting held on March 13, 2024, the U.S. Food and Drug Administration (FDA) provided Evexta Bio with valuable input on various aspects of rupitasertib development, including CMC, preclinical and clinical topics, enabling the company to proceed with the Phase 2 study in advanced breast cancer.

Key Points: 
  • Following a Type B meeting held on March 13, 2024, the U.S. Food and Drug Administration (FDA) provided Evexta Bio with valuable input on various aspects of rupitasertib development, including CMC, preclinical and clinical topics, enabling the company to proceed with the Phase 2 study in advanced breast cancer.
  • Recent preclinical studies in ESR1mt breast cancer models have shown compelling synergistic effects of rupitasertib administered in combination with elacestrant.
  • These data support the preliminary clinical efficacy observed in the Phase 1 study and warrant the development of rupitasertib in ESR1mt ER+ HER2- advanced breast cancer patients.
  • In addition, S6K has been shown to be closely associated with the emergence of cancer resistance, particularly in breast cancer, through ER modulation.

Chemomab Reports New Peer-Reviewed Publication Reinforcing the Clinical Association of Its CCL24 Target with Disease Severity and Mortality in Patients with Systemic Sclerosis

Retrieved on: 
Thursday, April 18, 2024
Mortality, University, Fibrosis, University of Leeds, TEL, Systemic scleroderma, Synovitis, Nature, Skin, CMMB, Primary sclerosing cholangitis, Prognosis, Communication, Serum, Vascular disease, Physiology, Doctor of Philosophy, Calcinosis, Rheumatology, History, ILD, IND, PSC, Disease, Therapy, Risk, Patient, CSO, Scleroderma, Lung, Clinical trial, CCL24, Pharmaceutical industry

TEL AVIV, Israel, April 18, 2024 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics to treat rare fibro-inflammatory diseases with high unmet need, today announced the publication of a new study that further confirms the key role of its novel soluble protein target CCL24 in systemic sclerosis (SSc). The study, “Serum CCL24 as a Biomarker of Fibrotic and Vascular Disease Severity in Systemic Sclerosis,” was published in the current edition of the journal Arthritis Care and Research.1

Key Points: 
  • It explored the relationship between serum CCL24 levels and SSc severity and prognosis.
  • One in four patients in a real-life SSc population was found to have a high CCL24 serum concentration, despite standard of care treatment with immunosuppressive therapy.
  • The analysis found that higher CCL24 levels were linked to critical clinical variables associated with the most severe forms of SSc.
  • Crucially, high serum CCL24 was predictive of lung deterioration and a higher baseline CCL24 level was associated with higher 10-year SSc-related mortality.

Global Clinical Biomarkers Industry Research, 2023-2024 & 2033 - Discovery of Novel Biomarkers Expanding Precision Medicine Horizons, Increase in Industrial Activity in Clinical Biomarker Landscape - ResearchAndMarkets.com

Retrieved on: 
Monday, April 29, 2024
Health, Oncology, Biometrics, Breast cancer, Cancer, Genomics, Investment, Lung cancer, Blood, Prognosis, Malignancy, Infection, Region, Software, TPA, PSA, Glycoprotein, Research, NGS, Prostate cancer, ChromeOS, SSC, Serum, Thermo Fisher Scientific, Diagnosis, Drug discovery, Biomarker, Neoplasm, EGFR, Biotechnology, Growth, Gene, Medical imaging

The global clinical biomarkers market is a highly fragmented market, with many smaller and private companies constantly entering the market.

Key Points: 
  • The global clinical biomarkers market is a highly fragmented market, with many smaller and private companies constantly entering the market.
  • Key players in the clinical biomarkers market analyzed and profiled in the study involve established players that offer various kinds of products and services.
  • As per this research, the global clinical biomarkers market includes manufacturers and service providers offering proprietary biomarkers testing products and services for clinical diagnostics and research purposes.
  • Based on product, the global clinical biomarkers market was led by the product segment, with a 76.59% share in 2022.

Novotech Publishes Research Report on Acute Myeloid Leukaemia Clinical Trial Landscape for Clinical Stage Biotechs

Retrieved on: 
Thursday, April 11, 2024
Contract research organization, IDH2, FDA, Mutation, Acute myeloid leukemia, SWOT, Risk, Research, Prognosis, AML, USFDA, Leukemia, Pharmacotherapy, Therapy, Smoking, Incidence, Azacitidine, Protein, ROW, FLT3, Standard of care, Acute promyelocytic leukemia, Drug development, Biomarker, Clinical trial, IDH1, Growth, Pharmaceutical industry

BOSTON, April 10, 2024 (GLOBE NEWSWIRE) -- Novotech, the global full-service clinical Contract Research Organization (CRO) that partners with biotech companies to accelerate the development of advanced and novel therapeutics at every phase, has released an expert report, Acute Myeloid Leukaemia - Global Clinical Trial Landscape , offering critical data-backed analysis of the latest developments in Acute Myeloid Leukemia (AML) research.

Key Points: 
  • BOSTON, April 10, 2024 (GLOBE NEWSWIRE) -- Novotech, the global full-service clinical Contract Research Organization (CRO) that partners with biotech companies to accelerate the development of advanced and novel therapeutics at every phase, has released an expert report, Acute Myeloid Leukaemia - Global Clinical Trial Landscape , offering critical data-backed analysis of the latest developments in Acute Myeloid Leukemia (AML) research.
  • Importantly it also includes an in-depth SWOT analysis to guide strategic decision-making, prioritize research areas, and identify challenges for clinical stage biotechs.
  • The Acute Myeloid Leukaemia (AML) - Global Clinical Trial Landscape report notes that since 2019, the global biotech and biopharmaceutical industry initiated over 1,000 clinical trials for AML.
  • These reports offer current insights into global clinical trial activity, revealing which regions experience the highest trial volumes and the unique factors behind these trends.

C2N Diagnostics Expands Into Japan Through Mediford Corporation Partnership With Precivity™ Blood Testing for Alzheimer’s Disease and Brain Research Market

Retrieved on: 
Friday, April 26, 2024
Research, Managed Care, Pharmaceutical, Consumer, Mental Health, Health Technology, Clinical Trials, Science, Biotechnology, Neurology, Seniors, Health, Epidemiology, Biogen, Brain, Protein, Learning, Donanemab, Clarity, Prognosis, Partnership, PET, Pathology, Non-fungible token, Dementia, Alzheimer's disease, Hoshiko Yamane, DSM-IV codes, Peptide, Diagnosis, Biomarker, Ageing, Clinical trial, Medical imaging

Hoshiko, who’s based in Kyoto, Japan, has a well-established background as a neuroscientist focused on the commercialization aspects of the field.

Key Points: 
  • Hoshiko, who’s based in Kyoto, Japan, has a well-established background as a neuroscientist focused on the commercialization aspects of the field.
  • Other research has found that Japan has the highest proportion of people with dementia of any country.
  • We believe our partnership with Mediford Corporation will unlock many opportunities and possibilities.
  • Mediford Corporation is known for providing clinical and non-clinical analysis that supports each stage of drug research and development, including advanced treatment options.

Avistone Announces the Approval of Vebreltinib as the First MET-TKI Treatment for a Rare Brain Glioma Subtype in China

Retrieved on: 
Thursday, April 25, 2024
Oncology, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Glioma, Shanda, MET, Temozolomide, Safety, Radiation, NMPA, Glioblastoma, Isocitrate dehydrogenase, Prognosis, Survival, New Drug Application, Cisplatin, Death, Central nervous system, Lung cancer, Etoposide, OS, History, Risk, CNS, Therapy, IDH, Patient, Neoplasm, NSCLC, Pharmaceutical industry

This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration.

Key Points: 
  • This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration.
  • In November 2023, vebreltinib received conditional approval for the treatment of metastatic patients with MET Exon14 Skipping non-small cell lung cancer (NSCLC) from the NMPA.
  • Glioma is a refractory primary malignant intracranial tumor, accounting for approximately 46% of intracranial tumors [1].
  • The approval of vebreltinib for the ZM fusion-positive glioma indications is based on the positive results of the FUGEN study (NCT06105619).

bioAffinity Technologies Advances New Product Development Initiatives to Accelerate Next Phase of Growth

Retrieved on: 
Wednesday, April 24, 2024
Other Defense, FDA, Other Health, Radiology, Pharmaceutical, Surgery, Oncology, Medical Devices, Defense, Genetics, Military, Clinical Trials, Biotechnology, Science, Research, Health, Doctor of Philosophy, University, Chronic obstructive pulmonary disease, Lung cancer, DOD, Prognosis, University of Texas System, Artificial intelligence, Sputum, Molecular and Cellular Biology, BIAF, Lung, Patient, Principal, Observational study, Cellular senescence, New product development, Biopsy, BAMC, Bronchoalveolar lavage, BAL, COPD, Medical imaging

The second test under development analyzes sputum to improve detection of chronic obstructive pulmonary disease (COPD).

Key Points: 
  • The second test under development analyzes sputum to improve detection of chronic obstructive pulmonary disease (COPD).
  • COPD is an inflammatory lung disease that causes breathing-related problems and irreversible airflow obstruction for an estimated 16 million Americans, according to the Centers for Disease Control.
  • Dr. Elzi earned his Ph.D. in Molecular and Cellular Biology from the University of Washington, in conjunction with the Fred Hutchinson Cancer Research Center.
  • He subsequently performed post-doctoral research at the Bonfils Blood Center and University of Colorado Department of Surgery, where he studied the molecular mechanisms of transfusion-related lung injury.

PureTech Receives FDA Fast Track Designation for LYT-200 in Head and Neck Cancers

Retrieved on: 
Thursday, April 11, 2024
Oncology, Health, FDA, Clinical Trials, Research, Science, Biotechnology, Cancer, Fast Track, Venetoclax, Food, Prognosis, Survival, AML, Bone marrow, Patient, Tislelizumab, Acute myeloid leukemia, PRTC, Head, Clinical trial, BeiGene, Pharmaceutical industry

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation for LYT-200 in combination with anti-PD1 therapy for the treatment of recurrent/metastatic head and neck squamous cell carcinomas (“head and neck cancers”).

Key Points: 
  • PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation for LYT-200 in combination with anti-PD1 therapy for the treatment of recurrent/metastatic head and neck squamous cell carcinomas (“head and neck cancers”).
  • It is being evaluated in two ongoing clinical trials:
    a Phase 1/2 adaptive design trial in advanced/metastatic solid tumors, including head and neck cancers.
  • “By granting Fast Track designation to LYT-200 for head and neck cancers, the FDA continues to highlight areas of critical need within oncology as well as the potential for LYT-200,” said Aleksandra Filipovic, M.D., Ph.D., Head of Oncology at PureTech.
  • The FDA has also granted orphan drug designation to LYT-200 for the treatment of AML .

Mabwell Releases Preclinical Study Results of Multiple Innovative Drugs Released at the 2024 AACR Annual Meeting

Retrieved on: 
Tuesday, April 16, 2024
Integrin, Lung cancer, Safety, Colorectal cancer, Prognosis, Immunosuppression, STAT3, Growth, IND, ADCC, CCR8, Fibrosis, Neoplasm, AACR, Carcinoma, Vaccine

As an important inflammation factor, IL-11 plays a significant role in the development and progression of fibrosis and tumor.

Key Points: 
  • As an important inflammation factor, IL-11 plays a significant role in the development and progression of fibrosis and tumor.
  • Studies have shown that high expression of IL-11 is associated with the prognosis of various tumors such as lung cancer, hepatic cancer, and colorectal cancer.
  • IL-11 not only promotes the growth of tumor cells through the STAT3 pathway but also has a significant impact on immune cells in the tumor microenvironment.
  • 9MW3811 effectively blocks the formation of the IL-11/IL-11Ra/gp130 ternary complex by binding to IL-11, thereby inhibiting the activation of downstream signaling pathways.

NUH LAUNCHES NEW DIGESTIVE CENTRE TO PUSH NEW FRONTIERS IN EARLY CANCER DETECTION AND CARE EXCELLENCE

Retrieved on: 
Tuesday, April 16, 2024
Radiation, Cade, Cancer, CAQ, Mouth, Pancreas, Tissue, AI, Colorectal cancer, Prognosis, Annual report, Stomach, Surgeon, Digestate, Artificial intelligence, Stomach cancer, Consultant, Hepatology, Radiology, National University Hospital, Computer, Incidence, Patient, Endoscopy, Diagnosis, Biomarker, Associate, Liver cancer, Division, Head, NUH, Medical imaging

SINGAPORE, April 16, 2024 /PRNewswire/ -- The National University Hospital (NUH) is embarking on a major initiative to establish the National University Centre for Digestive Health, slated for completion in the first half of 2025. With a vision to be the region's leading academic centre for digestive health, the Centre will pioneer research, innovations and clinical practices with an amplified focus to elevate the standards of early disease detection, precise diagnosis, treatment and prevention of digestive illnesses.

Key Points: 
  • Early gastrointestinal lesions, which are abnormal changes involving the tissues in the stomach area, may be indicative of cancer.
  • As such, early detection and diagnosis are crucial for better prognosis and lay a strong foundation for successful treatment and recovery.
  • The team is also developing novel biomarkers to improve the precision of early colorectal cancer detection, as well as new pancreas and liver cancer assays.
  • As we continue to expand our infrastructure and embrace technological advances, the Centre is poised to redefine digestive health for the future."