EQ-5D

Phase 4 Study Evaluating Use of ADSTILADRIN® (nadofaragene firadenovec-vncg) in Real-World Setting

Retrieved on: 
Wednesday, January 24, 2024
Research, FDA, Clinical Trials, Biotechnology, Managed Care, Health, Pharmaceutical, Science, Oncology, Ageing, RWE, Mortality, Carcinoma in situ, Patient, PST, Progression-free survival, Ferring Pharmaceuticals, ASCO, CIS, EQ-5D, BCG, University, Society, Urinary bladder, Recurrence, Food, Carcinoma, Safety, Work, Disease, Bladder cancer, Doctor of Health Science, Progress, Real, Clinical trial, NMIBC, Physician, Pharmaceutical industry

ABLE-41 (NCT06026332) is an ongoing Phase 4 observational study evaluating the effectiveness, overall experiences, patterns of use, and safety of ADSTILADRIN® (nadofaragene firadenovec-vncg) in a U.S. real-world setting.

Key Points: 
  • ABLE-41 (NCT06026332) is an ongoing Phase 4 observational study evaluating the effectiveness, overall experiences, patterns of use, and safety of ADSTILADRIN® (nadofaragene firadenovec-vncg) in a U.S. real-world setting.
  • “I am thrilled to be part of this ongoing research and among the first uro-oncologists to be treating patients with ADSTILADRIN in a clinical setting.
  • Final results from this prospective, multi-institutional study are expected at the end of 2026.
  • Trials in Progress Poster Session B: Urothelial Carcinoma
    Abstract #TPS705, Friday, Jan. 26 at 5:45 - 6:45 p.m. PST

Quince Therapeutics to Acquire EryDel SpA and its Phase 3 Asset Targeting Ataxia-Telangiectasia with No Currently Approved Treatments and Estimated $1+ Billion Peak Sales Opportunity

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Monday, July 24, 2023
Health, Medical Devices, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, News, EU4, A-T, Therapy, AIDE, Bank statement, Clifford Chance, Clinical trial, NDA, Toxicity, DSM-IV codes, Quality, Dexamethasone, EMA, Cooley LLP, QOL, Acquisition, EQ-5D, HIV disease progression rates, Patient, Investment, Vineland Adaptive Behavior Scale, Quality of life, SPA, Steroid, Growth, Ageing, MAA, European Investment Bank, FDA, EIB, ITT, Deficit spending, Enzyme replacement therapy, OLE, International Cooperative Ataxia Rating Scale, Safety, Korea International Cooperation Agency, Pharmaceutical industry, Cryptocurrency, Medical imaging, Quince

EryDel has developed an autologous intracellular drug encapsulation (AIDE) technology and a Phase 3 lead asset, EryDex, targeting a rare fatal pediatric neurological disease, Ataxia-Telangiectasia (A-T), which currently has no approved treatments.

Key Points: 
  • EryDel has developed an autologous intracellular drug encapsulation (AIDE) technology and a Phase 3 lead asset, EryDex, targeting a rare fatal pediatric neurological disease, Ataxia-Telangiectasia (A-T), which currently has no approved treatments.
  • Commercial version of EryKit treatment consumables approved in Europe and currently under partial clinical hold pending response to FDA query.
  • A-T population estimated to be approximately 10,000 patients in the U.S., U.K., and EU4 countries with no currently approved therapies and $1+ billion estimated peak sales opportunity globally.
  • MTS Health Partners, L.P. is serving as financial advisor and Cooley LLP is serving as legal counsel to Quince.

New Round of Late-Breaking Clinical Trials Announced at VIVA21

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Wednesday, October 6, 2021
Consensus, Mortality, VIVA, CTO, Recurrence, Disrupt, SEB, Vascular disease, Freedom, Kaplan–Meier estimator, Bed, Medtronic, Blood vessel, Wynn Las Vegas, Amputation, Classification, Safety, Perforation, IVL, Chronic kidney disease, Wound healing, Multimedia, DCB Bank, Boston Scientific, DES, Brachiocephalic, Diabetes, AFS, Shock wave, Ascending limb of loop of Henle, Awareness, BMS, Observational study, Transatlantic, TASC, SEBS, PTA, EQ-5D, Atherectomy, Complex, DCB, HIV disease progression rates, Arm, Peripheral artery disease, Time Machine, Calcification, Education, Treatment, Death, Iliac, PAD, Prevalence, Research, AVF, Operational technology, Ioctl, Medical imaging, Pharmaceutical industry

Below are highlights of this morning's 4 late-breaking clinical trial presentations.

Key Points: 
  • Below are highlights of this morning's 4 late-breaking clinical trial presentations.
  • Participants were randomized to treatment with IN.PACT AV DCB (Medtronic; n = 170) or standard uncoated percutaneous transluminal angioplasty (PTA; n = 160).
  • Benefits were seen in all other subgroups, although the treatment effect was not statistically significant.
  • This is the largest randomized trial of device treatment for critical limb ischemia in this arterial segment to date.

Galapagos presents new data from the SELECTION Phase 3 program at the United European Gastroenterology Week (UEGW) 2021 congress

Retrieved on: 
Monday, October 4, 2021
Filgotinib, Medicines and Healthcare products Regulatory Agency, Review, Sandborn, TNF, PMDA, European Directive on Traditional Herbal Medicinal Products, Induction, Union, Health care, Methotrexate, Volume Ten, Safety, RA, EQ-5D, EMA, MHRA, Interview, European Medicines Agency, MTX, European, Adult, Work, Disease, Ulcerative colitis, Product, Inflammatory bowel disease, Tablet, Gilead, Inflammatory Bowel Diseases, Inflammation, Ministry of Health, Labour and Welfare, JAK1, Eisai, WPAI, IBQ, Gilead Sciences, Fibrosis, Mayo, MCS, Quality of life (healthcare), Week, Diagnosis, IBD, Galapagos NV, Patient, Disease-modifying antirheumatic drug, CHMP, European Union, Contraindication, Quality of life, Conditional sentence, Pharmaceutical industry, Medical device

In addition to the physical impact from flare ups, there is also a psychological impact associated with UC.

Key Points: 
  • In addition to the physical impact from flare ups, there is also a psychological impact associated with UC.
  • The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu .
  • Filgotinib in UC has been filed in the European Union, Great-Britain and Japan, and a global Phase 3 program is ongoing in Crohns Disease.
  • Clinically meaningful improvements in health-related quality of life among patients with ulcerative colitis treated with filgotinib: post hoc analysis of the phase 2b/3 SELECTION study.

Eisai: New Data on LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Versus Sunitinib

Retrieved on: 
Tuesday, June 8, 2021
Health, Medicine, Antineoplastic drugs, Clinical research, Health care, Medical terminology, Quality of life, Sunitinib, Sjögren syndrome, Pembrolizumab, Clinical endpoint, EQ-5D

"The additional data showed an improvement of specific health-related quality of life measures for patients who received LENVIMA plus KEYTRUDA compared with sunitinib, supporting the importance of this combination as a potential new first-line treatment option for patients."

Key Points: 
  • "The additional data showed an improvement of specific health-related quality of life measures for patients who received LENVIMA plus KEYTRUDA compared with sunitinib, supporting the importance of this combination as a potential new first-line treatment option for patients."
  • In an analysis of a secondary endpoint of HRQoL scores in the CLEAR/KEYNOTE-581 trial, LENVIMA plus KEYTRUDA and LENVIMA plus everolimus were evaluated to determine the impact on HRQoL compared to sunitinib in patients with advanced RCC.
  • LENVIMA plus KEYTRUDA demonstrated a similar TTD in 14 out of 18 HRQoL and disease-related symptom scores, and a delay in TTD for physical functioning, dyspnea, appetite loss, and EQ-5D visual analog scale compared to sunitinib.
  • LENVIMA plus KEYTRUDA demonstrated a delay in TUDD in 16 out of 18 HRQoL and disease-related symptom scores and a similar TUDD for cognitive functioning and financial difficulties compared to sunitinib.

Summit Therapeutics Reports Ridinilazole Significantly Improved Short and Longer-Term Quality of Life Measures in Patients with C. difficile Infection Compared to Standard of Care

Retrieved on: 
Thursday, October 3, 2019
Health, Articles, Healthcare quality, Health Economics, RTT, EQ-5D, Questionnaire construction, Quality of life, Vancomycin, Ridinilazole, Anxiety, Clinical trial

Our Phase 2 clinical trial documented significant early and longer-term improvements in patient quality of life over the current standard of care, commented Dr David Roblin, President of R&D of Summit.

Key Points: 
  • Our Phase 2 clinical trial documented significant early and longer-term improvements in patient quality of life over the current standard of care, commented Dr David Roblin, President of R&D of Summit.
  • The Phase 2 clinical trial called CoDIFy evaluated ridinilazole compared to vancomycin in 100 patients with CDI.
  • The EQ-5D-3L is a standard measure of health status which evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
  • By Day 40, patients treated with ridinilazole had improved significantly more than vancomycin in anxiety and depression.