LVEF

TAGRISSO® (osimertinib) Plus Chemotherapy Extended Median Progression-free Survival by Nearly 9 Months in EGFR-mutated Advanced Lung Cancer in FLAURA2 Phase III Trial

Retrieved on: 
Monday, September 11, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Electrolyte, Arm, Heart, LVEF, Fever, Aes, ILD, Medicine, QT, Cough, Cardiomyopathy, QT interval, Patient, Periodic breathing, Wireless ambulatory ECG, Safety, Pharmaceutical industry

In the ADAURA study, 1.5% (5/325) of TAGRISSO-treated patients experienced LVEF decreases ≥10% from baseline and a drop to

Key Points: 
  • In the ADAURA study, 1.5% (5/325) of TAGRISSO-treated patients experienced LVEF decreases ≥10% from baseline and a drop to
  • Conduct cardiac monitoring, including assessment of LVEF at baseline and during treatment, in patients with cardiac risk factors.
  • For symptomatic congestive heart failure, permanently discontinue TAGRISSO
    Keratitis was reported in 0.7% of 1479 patients treated with TAGRISSO in clinical trials.
  • EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples.

Cytokinetics Announces Start of ACACIA-HCM, a Pivotal Phase 3 Clinical Trial of Aficamten in Patients With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

Retrieved on: 
Wednesday, September 6, 2023
Atrial flutter, RER, NYHA, Research and development, Heart failure, Cohort, Atrial fibrillation, LVEF, Quality of life, Part, KCCQ, New York Heart Association Functional Classification, Cytokinetics, Patient, N-terminal prohormone of brain natriuretic peptide, SAN, Mercury (element), VO2, Assessment, III, HCM, Pharmaceutical industry, Medical imaging

“As the first Phase 3 clinical trial of aficamten in non-obstructive hypertrophic cardiomyopathy, ACACIA-HCM represents an important advancement in the development program for aficamten alongside our two ongoing Phase 3 clinical trials in obstructive HCM,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development.

Key Points: 
  • “As the first Phase 3 clinical trial of aficamten in non-obstructive hypertrophic cardiomyopathy, ACACIA-HCM represents an important advancement in the development program for aficamten alongside our two ongoing Phase 3 clinical trials in obstructive HCM,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development.
  • The primary endpoint is the change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score from baseline to Week 36.
  • ACACIA-HCM is expected to enroll 420 patients, randomized on a 1:1 basis to receive aficamten or placebo.
  • Patients who complete ACACIA-HCM will be eligible to participate in an open-label extension clinical trial.

LianBio Announces Results from Phase 3 EXPLORER-CN Trial of Mavacamten Presented at the European Society of Cardiology Congress and Simultaneous Publication in JAMA Cardiology

Retrieved on: 
Monday, August 28, 2023
NYHA, Heart failure, CYP2C19, Peking Union Medical College Hospital, Atrial fibrillation, JAMA Cardiology, LVEF, Health status of Asian Americans, European Society of Cardiology, Biomarker, GMR, Congress, New York Heart Association Functional Classification, LVOT, Patient, N-terminal prohormone of brain natriuretic peptide, Body mass index, CMR, Myocardial injury after non-cardiac surgery, ESC, Death, Phenotype, HCM, Safety, Pharmaceutical industry, Medical imaging, Medical device, Oxford Handbook of Clinical Medicine, Cardiology

Mavacamten also demonstrated improvement across all secondary endpoints, including LVOT obstruction, clinical symptoms, and health status.

Key Points: 
  • Mavacamten also demonstrated improvement across all secondary endpoints, including LVOT obstruction, clinical symptoms, and health status.
  • The data presented at ESC 2023 and published in JAMA Cardiology continue to demonstrate robust evidence of mavacamten’s therapeutic benefit.
  • As previously reported, safety results in the trial were consistent with previous studies of mavacamten in symptomatic oHCM, and no new safety signals were reported.
  • “The EXPLORER-CN trial demonstrates that the well-established therapeutic benefit of this drug also extends to Chinese patients.

Long-Term Follow-Up Data from Two Phase 3 Studies of CAMZYOS® (mavacamten) Demonstrate Consistent and Durable Response in Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy (HCM)

Retrieved on: 
Monday, August 28, 2023
Science, Cardiology, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, CSS, Bristol Myers Squibb, Cleveland Clinic, Education, Week, JAMA Cardiology, LVEF, Heart, Health status of Asian Americans, SRT, European Society of Cardiology, MBA, Key, BMY, TSS, Congress, Patient, N-terminal prohormone of brain natriuretic peptide, Hypertrophic cardiomyopathy, European, Heart failure, European Society for Medical Oncology, ESC, HCM, NYSE, LTE, Safety, Pharmaceutical industry, Mobile phone, Medical device, NYHA

Bristol Myers Squibb (NYSE: BMY) today announced new long-term follow-up results from two Phase 3 studies evaluating CAMZYOS® (mavacamten), a first-in-class cardiac myosin inhibitor, in adult patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced new long-term follow-up results from two Phase 3 studies evaluating CAMZYOS® (mavacamten), a first-in-class cardiac myosin inhibitor, in adult patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).
  • Overall, 75.9% of patients improved by ≥1 NYHA class from baseline at the start of the LTE study to Week 120.
  • Of the 14 patients who were in NYHA class I, 12 remained in NYHA class I at the latest available assessment.
  • “Studies like EXPLORER-LTE are important for understanding longer-term results that assess key cardiac measures and support the use of CAMZYOS in patients living with this chronic condition.”

Monopar Therapeutics Reports Second Quarter 2023 Financial Results and Recent Developments

Retrieved on: 
Thursday, August 10, 2023
National University of Singapore, National university, VOICE, LVEF, Receptor (biochemistry), RECIST, Cancer, Clinical trial, PET, G&A, Cardiotoxicity, Patient, Investment, ASTS, Doxorubicin, FIH, NUS, Pharmaceutical industry, Medical imaging, Extrusion, Cryptocurrency, Validation (drug manufacture)

WILMETTE, Ill., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-­stage biopharmaceutical company focused on developing innovative treatments for cancer patients, today announced second quarter 2023 financial results and summarized recent developments.

Key Points: 
  • WILMETTE, Ill., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-­stage biopharmaceutical company focused on developing innovative treatments for cancer patients, today announced second quarter 2023 financial results and summarized recent developments.
  • Results for the Second Quarter Ended June 30, 2023 Compared to the Second Quarter Ended June 30, 2022
    Cash, cash equivalents and short­-term investments as of June 30, 2023 were $10.2 million.
  • Net loss for the second quarter of 2023 was $2.2 million or $0.16 per share compared to net loss of $2.8 million or $0.22 per share for the second quarter of 2022.
  • G&A expenses for the three months ended June 30, 2023 were $733,000, compared to $685,000 for the three months ended June 30, 2022.

Monopar Provides Encouraging Camsirubicin Clinical Data Update

Retrieved on: 
Tuesday, August 8, 2023
Index, Sarcoma, GEIS, Hair loss, LVEF, RECIST, Cancer, Life expectancy, Cardiotoxicity, Patient, Risk, Doxorubicin, ASTS, MTD, Diagnosis, Toxic leukoencephalopathy, Therapy, Pharmaceutical industry

Both patients are set to receive additional cycles of camsirubicin treatment, as well, which may result in further tumor size reduction.

Key Points: 
  • Both patients are set to receive additional cycles of camsirubicin treatment, as well, which may result in further tumor size reduction.
  • The Phase 1b clinical trial data is continuing to support Monopar’s dose-response hypothesis with camsirubicin.
  • The Phase 2 plan is to evaluate camsirubicin head-to-head against doxorubicin in patients with ASTS, with GEIS as the study sponsor with support from Monopar.
  • Further information about this actively enrolling, open-label, dose-escalation Phase 1b clinical trial is available at www.ClinicalTrials.gov under study identifier NCT 05043649.

Lexicon Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, August 3, 2023
Diabetes, Investment, Trial of the century, Marketing, Life expectancy, Division, Patient, Risk, Research and development, R, American Diabetes Association, University, Heart failure, University of Michigan, Pharmacoeconomics, Randomness, Hospital, FDA, Chronic kidney disease, Efficacy, ID, Administration, AAK1, Webcast, Type, Research, Lexicon, User experience, MI, SG, Metabolism, ISPOR, LVEF, Harvard Medical School, Internal medicine, Heart, Lexicon Pharmaceuticals, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, International Society, Food, Pharmaceutical industry, Cryptocurrency, Dietary supplement, Heart failure with preserved ejection fraction, Endocrinology

THE WOODLANDS, Texas, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended June 30, 2023 and provided an update on key corporate milestones.

Key Points: 
  • “This was a an important and productive quarter for Lexicon with achievement of a transformational milestone for the company and important advancements in our business,” said Lonnel Coats, Lexicon’s chief executive officer.
  • The first late-stage study will be a Phase 2b dose optimization study, with start-up scheduled in the third quarter of 2023 and the initiation of dosing expected in the fourth quarter.
  • For the second quarters of 2023 and 2022, net loss included non-cash, stock-based compensation expense of $3.8 million and $2.8 million, respectively.
  • Lexicon management will hold a live conference call and webcast today at 5:00 pm ET / 4:00 pm CT to review its financial and operating results and to provide a general business update.

Capricor Therapeutics Announces Positive 24-Month Results from Ongoing HOPE-2 Open Label Extension Study of CAP-1002 in Duchenne Muscular Dystrophy

Retrieved on: 
Friday, June 30, 2023
Linda, Duchenne muscular dystrophy, Natural history, Atrophy, LVEF, PUL, Exosome, Outline, DMD, Patient, SAN, PPMD, MUSCULAR, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Conference, OLE, Food, Caregiver, Safety, Disease, Pharmaceutical industry

SAN DIEGO, June 30, 2023 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, today announced positive 24-month safety and efficacy results from its ongoing HOPE-2 open label extension (OLE) study with its lead asset, CAP-1002, for the treatment of Duchenne muscular dystrophy (DMD). Data from the OLE study demonstrated that the majority of patients had an improvement in left ventricular ejection fraction (LVEF), after two years of CAP-1002 treatment, which suggests preservation of cardiac function. Additionally, patients continue to show statistically significant benefit (p=0.021) after two years of treatment in the Performance of the Upper Limb (PUL v2.0) scale when compared to the original rate of decline of the placebo group from HOPE-2 after one year. Furthermore, the OLE study continues to show a favorable safety profile for long-term treatment of CAP-1002. These data will be featured in an oral presentation being webcast today at this year’s Parent Project Muscular Dystrophy (PPMD) Annual Conference.

Key Points: 
  • Furthermore, the OLE study continues to show a favorable safety profile for long-term treatment of CAP-1002.
  • These data will be featured in an oral presentation being webcast today at this year’s Parent Project Muscular Dystrophy (PPMD) Annual Conference .
  • Over time, there was an increasing correlation with PUL v2.0 and ejection fraction results (24-month OLE results r=0.75, p=0.02).
  • The HOPE-2-OLE study remains ongoing, and participants continue to be monitored for safety and functional performance.

EQS-News: Affluent Medical Presents Poster on First Successful Procedure with Epygon at the 2023 CSI Conference in Frankfurt

Retrieved on: 
Wednesday, June 28, 2023
Moyamoya disease, Heart, NYHA, Suture, Tricuspid valve, CSI, Diabetes, Cardiac rehabilitation, EACTS, Echocardiography, LVEF, Health status of Asian Americans, Minerva, Valve, Infarction, Euronext Paris, Mitral regurgitation, Patient, Mitral valve, Risk, CEST, Annual general meeting, European Association for Cardio-Thoracic Surgery, Aix-en-Provence, III, Medtech, New York Heart Association Functional Classification, Safety, Urinary incontinence, Medical device

Abstract Title: TRANSCATHETER MITRAL VALVE IMPLATATION WITH THE EPYGON PROSTHESIS: FIRST-IN-HUMAN

Key Points: 
  • Abstract Title: TRANSCATHETER MITRAL VALVE IMPLATATION WITH THE EPYGON PROSTHESIS: FIRST-IN-HUMAN
    “We are excited to inform the specialist audience about the first successful procedure with our Epygon system,” said Dr. Christophe Giot, Vice President Clinical Affairs.
  • “Our device is the only biomimetic transcatheter cardiac mitral valve in development that mimics the native mitral valve and physiological blood flow.
  • The objective of the study is to evaluate the safety and efficacy of Epygon valve implantation at 30 days.
  • Affluent Medical anticipates presenting interim results from the first five patients of the Minerva pilot study at the Annual Meeting of the European Association for Cardio-Thoracic Surgery (EACTS) in October 2023.

Cytokinetics Announces Start of MAPLE-HCM, a Phase 3 Clinical Trial of Aficamten Compared to Metoprolol in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Retrieved on: 
Tuesday, June 20, 2023
RER, Exercise, NYHA, Research and development, LVEF, Clinical trial, Blood, Metoprolol, KCCQ, New York Heart Association Functional Classification, Cytokinetics, N-terminal prohormone of brain natriuretic peptide, SAN, CPET, Pharmaceutical industry, Patient, HCM

SOUTH SAN FRANCISCO, Calif., June 20, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM), a Phase 3 clinical trial comparing aficamten as monotherapy to metoprolol as monotherapy in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), is open to enrollment. Aficamten is a next-in-class cardiac myosin inhibitor in development for the potential treatment of HCM.

Key Points: 
  • Aficamten is a next-in-class cardiac myosin inhibitor in development for the potential treatment of HCM.
  • “MAPLE-HCM is, to date, the first and only clinical trial directly comparing a cardiac myosin inhibitor to what is considered the standard of care therapy in patients with HCM.
  • We hope that MAPLE-HCM will generate evidence showing treatment with aficamten as first-line monotherapy is superior to monotherapy with metoprolol, which may help offer a simplified treatment approach in HCM.”
    MAPLE-HCM is a Phase 3, multi-center, randomized, double-blind active-comparator clinical trial of aficamten compared to metoprolol in patients with symptomatic obstructive HCM.
  • MAPLE-HCM is expected to enroll 170 patients, randomized on a 1:1 basis to receive aficamten or metoprolol.