CTCAE

Lantheus and POINT Biopharma Announce Positive Topline Results from Pivotal SPLASH Trial in Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Monday, December 18, 2023
House (season 5), Risk, PSMA, NDA, Cancer, HR, PNT, Death, RLT, CTCAE, SPLASH, Patient, Safety, BC Cancer Agency, LNTH, Pharmaceutical industry

BEDFORD, Mass., and INDIANAPOLIS, Dec. 18, 2023 (GLOBE NEWSWIRE) -- December 18, 2023 – Lantheus Holdings, Inc. (Lantheus) (NASDAQ: LNTH) and POINT Biopharma Global Inc. (POINT) (NASDAQ: PNT) today announced statistically significant topline results from the pivotal Phase 3 SPLASH study evaluating the efficacy and safety of 177Lu-PNT2002, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT), in patients with metastatic castration-resistant prostate cancer (mCRPC) after progression on an androgen receptor pathway inhibitor (ARPI).

Key Points: 
  • BEDFORD, Mass., and INDIANAPOLIS, Dec. 18, 2023 (GLOBE NEWSWIRE) -- December 18, 2023 – Lantheus Holdings, Inc. (Lantheus) (NASDAQ: LNTH) and POINT Biopharma Global Inc. (POINT) (NASDAQ: PNT) today announced statistically significant topline results from the pivotal Phase 3 SPLASH study evaluating the efficacy and safety of 177Lu-PNT2002, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT), in patients with metastatic castration-resistant prostate cancer (mCRPC) after progression on an androgen receptor pathway inhibitor (ARPI).
  • “There is an urgent unmet need for targeted treatment options for mCRPC patients, particularly for those whose cancer has progressed on androgen receptor pathway inhibitors,” said Dr. Kim Chi, SPLASH Principal Investigator, Medical Oncologist, BC Cancer.
  • At the time of the analysis, interim overall survival (OS) results were immature (46% of protocol-specified target OS events reached), the HR was 1.11.
  • The companies expect additional, follow-up data in 2024 prior to the potential submission of a New Drug Application (NDA).

Lantheus and POINT Biopharma Announce Positive Topline Results from Pivotal SPLASH Trial in Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Monday, December 18, 2023
House (season 5), Risk, PSMA, NDA, Cancer, HR, PNT, Death, RLT, CTCAE, SPLASH, Patient, Safety, BC Cancer Agency, LNTH, Pharmaceutical industry

and INDIANAPOLIS, Dec. 18, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (Lantheus) (NASDAQ: LNTH) and POINT Biopharma Global Inc. (POINT) (NASDAQ: PNT) today announced statistically significant topline results from the pivotal phase 3 SPLASH study evaluating the efficacy and safety of 177Lu-PNT2002, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT), in patients with metastatic castration-resistant prostate cancer (mCRPC) after progression on an androgen receptor pathway inhibitor (ARPI).

Key Points: 
  • and INDIANAPOLIS, Dec. 18, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (Lantheus) (NASDAQ: LNTH) and POINT Biopharma Global Inc. (POINT) (NASDAQ: PNT) today announced statistically significant topline results from the pivotal phase 3 SPLASH study evaluating the efficacy and safety of 177Lu-PNT2002, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT), in patients with metastatic castration-resistant prostate cancer (mCRPC) after progression on an androgen receptor pathway inhibitor (ARPI).
  • “There is an urgent unmet need for targeted treatment options for mCRPC patients, particularly for those whose cancer has progressed on androgen receptor pathway inhibitors,” said Dr. Kim Chi, SPLASH Principal Investigator, Medical Oncologist, BC Cancer.
  • At the time of the analysis, interim overall survival (OS) results were immature (46% of protocol-specified target OS events reached), the HR was 1.11.
  • The companies expect additional, follow-up data in 2024 prior to the potential submission of a New Drug Application (NDA).

Orca Bio Presents Positive Data Demonstrating the Potential for Orca-T and Orca-Q to Expand Treatment to Additional Patient Groups at the 65th ASH Annual Meeting

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Saturday, December 9, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, MAC, Thiotepa, NRM, Safety, Toxicity, CTCAE, Incidence, ASH, Acute myeloid leukemia, Acute leukemia, Syndrome, Risk, University, Mortality, Patient, Busulfan, Infection, BFT, RFS, MDS, Graft-versus-host disease, HSCT, Cancer, Trial of the century, CML, Toxic epidermal necrolysis, Bone marrow, AML, RIC, MD Anderson Cancer Center, Physician, OS, Quality of life, Society, ALL, Face, Pharmaceutical industry, Vaccine, Dentistry, Medical imaging

The results presented at the 65th American Society of Hematology (ASH) Annual Meeting showed promising data with the use of Orca Bio’s cell therapies across several patient groups where there is significant unmet medical need.

Key Points: 
  • The results presented at the 65th American Society of Hematology (ASH) Annual Meeting showed promising data with the use of Orca Bio’s cell therapies across several patient groups where there is significant unmet medical need.
  • Results highlighted in an oral presentation showed Orca-T’s ability to deliver similar outcomes in older patients undergoing myeloablative conditioning (MAC) as younger patients.
  • In this subgroup from the ongoing multi-center Phase 1b clinical trial, Orca-T demonstrated promising results in this patient population (n=16).
  • The estimated incidence of CTCAE grade 2 and greater than grade 3 infections at one year were 9% and 15%, respectively.

Updated Data from the BRUIN Phase 1/2 Study of Pirtobrutinib in Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma Presented at the 2023 ASH Annual Meeting

Retrieved on: 
Tuesday, December 12, 2023
Medicine, Drug, Safety, NYSE, Arrhythmia, BTK, CTCAE, MCL, Lymphoid leukemia, Progression-free survival, ASH, Cytopenia, Dana–Farber Cancer Institute, Lymphocytosis, Bleeding, Clinical trial, Fatigue, Non-Hodgkin lymphoma, Rituximab, Patient, Abstract, Mantle cell lymphoma, PFS, SLL, Lymphoma, Infection, FDA, DOR, LLY, Exposition, Neutropenia, PVR, ORR, Lilly, Eli Lilly and Company, Chronic lymphocytic leukemia, Nausea, Diarrhea, Pulmonary toxicity, IRC, Chills, Society, OS, NHL, PV, HIV disease progression rates, Venetoclax, Pharmaceutical industry, Dietary supplement, CLL

These data, which were presented in oral and poster presentations at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, continue to support the role of pirtobrutinib in the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL).

Key Points: 
  • These data, which were presented in oral and poster presentations at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, continue to support the role of pirtobrutinib in the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL).
  • The labeling for pirtobrutinib contains warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, and embryo-fetal toxicity.
  • The BRUIN Phase 1/2 clinical trial is evaluating pirtobrutinib in patients previously treated for MCL, CLL/SLL, or other non-Hodgkin lymphomas (NHL).
  • All presentations of safety and efficacy data from the BRUIN Phase 1/2 trial utilized a cutoff date of May 5, 2023.

FDA Awards HistoSonics Clearance of its First-of-a-Kind Edison® Histotripsy System

Retrieved on: 
Monday, October 9, 2023
Surgery, Medical Devices, FDA, Clinical Trials, Health Technology, Biotechnology, Radiology, Health, Oncology, Congress, Infection, Food, Hepatocellular carcinoma, Blue, Breast, Rectum, Liver disease, Liver, Radiation, Safety, University, CTCAE, Patient, Education, High-intensity focused ultrasound, Thomas Edison, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Amaral, Colon, Science, Neoplasm, Needle, HCC, Physician, Medical imaging

Marketing authorization makes Edison the first and only histotripsy platform available in the Unites States.

Key Points: 
  • Marketing authorization makes Edison the first and only histotripsy platform available in the Unites States.
  • View the full release here: https://www.businesswire.com/news/home/20231009669222/en/
    HistoSonics Edison Histotripsy System (Photo: Business Wire)
    FDA authorization was based, in part, on data from the #HOPE4LIVER Trials in 13 trial sites across the US and Europe.
  • HistoSonics' Edison System uses proprietary technology and advanced imaging to deliver personalized, non-invasive histotripsy treatments with precision and control.
  • The Edison System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.

Medicomp Systems Reaches Healthcare Documentation and Interoperability Milestone with 10 Million Terminology Mappings

Retrieved on: 
Wednesday, October 4, 2023
Heart, UNII, MEDCIN, CPT, Health, ICD-10, RxNorm, NLP, SNOMED-CT, LOINC, Medicare, CCC, Organization, Documentation, CVX, Patient, DSM5, AI, HCPCS, SNOMED CT, SNOMED, CTCAE, Medical imaging

CHANTILLY, Va., Oct. 4, 2023 /PRNewswire/ -- Medicomp Systems, a physician-driven provider of diagnostically connected patient data solutions, announced today that it now has directly mapped over 10 million clinical codes and concepts across more than 12 terminologies to its MEDCIN clinical relevancy engine, helping clinicians quickly find patient-and-problem-specific information at the point of care and efficiently and accurately capture data for value-based care initiatives.

Key Points: 
  • Terminology mapping in healthcare refers to the process of aligning different medical terminologies or coding systems to ensure that they correspond and can be seamlessly interpreted and used across systems.
  • Medicomp now has more than 10 million mappings to foundational structures such as ICD-10-CM, CPT-4, LOINC, SNOMED-CT, RxNorm and other coding systems used for clinical documentation and billing which can be diagnostically filtered through MEDCIN, Medicomp's normalized clinical interface terminology at the heart of its clinical relevancy engine.
  • The filtered data can be used for multiple downstream purposes such as care coordination, value-based payment, and quality reporting.
  • These mappings can also be leveraged to dramatically increase accuracy of coding and structured clinical documentation using AI and NLP technologies.

ImmVira presented latest encouraging clinical results of two proprietary products at ASCO 2023

Retrieved on: 
Wednesday, June 7, 2023
Abstract, Index, Biopsy, Hypertriglyceridemia, AE, Urine, DCR, Pembrolizumab, DLT, Trae tha Truth, Head, Common Criteria, CD8, ORR, ASCO, Sarcoma, Lymphocytopenia, Patient, Evaluation, Colorectal cancer, Melanoma, Blood, HNSCC, Mesothelioma, Periodic breathing, PD-1, Breast cancer, Tumor microenvironment, Society, SD, PR, Saliva, CTCAE, Pharmaceutical industry, Medical imaging, Fever

12 evaluable HNSCC patients who progressed after platinum-based chemotherapy and anti-PD-1/PD-L1 therapy achieved confirmed ORR of 25% and DCR of 50%, respectively.

Key Points: 
  • 12 evaluable HNSCC patients who progressed after platinum-based chemotherapy and anti-PD-1/PD-L1 therapy achieved confirmed ORR of 25% and DCR of 50%, respectively.
  • Trial results showed that, MVR-T3011 IT had excellent safety profile and clinical compliance.
  • Phase I clinical data was also selected to be published at ASCO this year.
  • We are expecting to report more intravenous clinical results in both U.S. and China in the future.

Chemotherapy Induced Diarrhea Epidemiology Forecast 2023 - 2032 - ResearchAndMarkets.com

Retrieved on: 
Friday, March 24, 2023
Health, Oncology, TKI, CRPC, Capecitabine, Head, Pain, Incidence, Patient, Disease, CT, Therapy, Perception, Toxicity, Research, Classification, Endoscopy, Sepsis, Cervical cancer, Esophageal cancer, Diagnosis, NCI, Total, CTCAE, Neutropenia, Pancreatic cancer, Incident, Hypotension, Dehydration, Fever, Cancer, Lung cancer, Bladder cancer, Blood, Stomach cancer, National Cancer Institute, Chronic pain, Colorectal cancer, Irinotecan, Testicular cancer, Ovarian cancer, Epidemiology, Infection, EU4, Hospital, Quality of life, Stoma, Neck, Physical examination, Endometrial cancer, CID, United Kingdom, Breast cancer, Vaccine, Pharmaceutical industry, Dietary supplement, Dairy, Health insurance, Nursing, Diarrhea

The "Chemotherapy Induced Diarrhea - Epidemiology Forecast - 2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Chemotherapy Induced Diarrhea - Epidemiology Forecast - 2032" report has been added to ResearchAndMarkets.com's offering.
  • This "Chemotherapy-induced Diarrhea (CID) - Epidemiology Forecast - 2032" report delivers an in-depth understanding of the CID, historical and forecasted epidemiology as well as the CID market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
  • Chemotherapy-induced diarrhea (CID), also called chemotherapy-related diarrhea, can be associated with various chemotherapy agents but is most commonly described with fluoropyrimidines (particularly fluorouracil [FU] and capecitabine) and irinotecan.
  • The epidemiology segment also provides Chemotherapy-induced Diarrhea (CID) epidemiology data and findings across the United States, EU4 and the UK, and Japan.

New CDAHK Study Finds Severe Adverse Events Associated with Chiropractic Treatment Are Very Rare

Retrieved on: 
Friday, January 27, 2023
Linda, Spine, Data, Bone fracture, Osteoporosis, Scientific Reports, School, Death, Metropolitan University, Safety, University Hospitals Cleveland Medical Center, Risk, Common Terminology Criteria for Adverse Events, Neck pain, Woman, CTCAE, Joint, Patient, Engineering, Roger Hawkins (drummer), Georgetown University School of Nursing and Health Studies, Niazi, Incidence, Healthcare, Medical device, Pharmaceutical industry, Nursing, Chiropractic

Severe adverse events associated with chiropractic treatment were found to be very rare.

Key Points: 
  • Severe adverse events associated with chiropractic treatment were found to be very rare.
  • Researchers from the Chiropractic Doctors Association of Hong Kong found that two patients experienced severe adverse events during or after their chiropractic spinal manipulation.
  • The incidence of severe adverse events was 0.21 per 100,000 treatments, which suggested that such complications were reassuringly very rare.
  • "The incidence of severe adverse events was extremely low," said Dr. Eric Chun-Pu Chu, lead author and Chairman of CDAHK.

Medicomp Systems Awarded Patent for Intelligent Prompting of Protocols

Retrieved on: 
Wednesday, September 14, 2022
Knowledge, ROI, Workflow, Time, MD, RxNorm, SNOMED CT, HCPCS, Protocol, CTCAE, LOINC, MEDCIN, Industry, United States patent law, History, Physician, CEO, USPTO, ICD-10, Technology, United States Patent and Trademark Office, Solution, Patent, Work, SNOMED, Documentation, Diagnosis, CCC, US, Method, CPT, CVX, DSM5, UNII, EHR, Medical imaging, Medical device, Pharmaceutical industry

WASHINGTON, Sept. 14, 2022 /PRNewswire/ -- Medicomp Systems, a physician-driven provider of diagnostically connected patient data solutions, announced today that the United States Patent and Trademark Office (USPTO) has awarded Medicomp US Patent 10,600,505 for the intelligent prompting of protocols. This patent covers the methods of evaluating the medical findings in a patient medical record and identifying the relevant clinical protocols that are most applicable.

Key Points: 
  • WASHINGTON, Sept. 14, 2022 /PRNewswire/ -- Medicomp Systems, a physician-driven provider of diagnostically connected patient data solutions, announced today that the United States Patent and Trademark Office (USPTO) has awarded Medicomp US Patent 10,600,505 for the intelligent prompting of protocols.
  • "Clinical usability and clinician burnout are two of the biggest challenges in healthcare information technology," said David Lareau, CEO of Medicomp Systems.
  • In 2019, the USPTO issued Medicomp US Patent 10,319,466 for the intelligent filtering of health-related information.
  • Medicomp was awarded US Patent 9,864,838 in 2018 for clinically intelligent parsing.