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Amylyx Pharmaceuticals Announces Publication of Survival Analysis Comparing CENTAUR to Historical Clinical Trial Control

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火曜日, 10月 10, 2023
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, ACT, Amylyx Pharmaceuticals, ALS, ALS Association, Doctor of Philosophy, Survival analysis, Death, OLE, American Academy, Pro-Act by VTC, Innovation, Health informatics, Propensity score matching, MD, Risk, NCRI, Mass, Mortality, Massachusetts General Hospital, Survival, Hospital, Disease, Translation, CIB, Principal, AMX0035, Database, ITT, Harvard Medical School, Clinical trial, Medication, Common-pool resource, Pharmaceutical industry

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the publication of a post hoc analysis in the peer-reviewed medical journal, Annals of Clinical and Translational Neurology comparing the long term survival of participants in the CENTAUR study versus a historical clinical trial control group.

Key Points: 
  • Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the publication of a post hoc analysis in the peer-reviewed medical journal, Annals of Clinical and Translational Neurology comparing the long term survival of participants in the CENTAUR study versus a historical clinical trial control group.
  • The post hoc survival analysis published today compared CENTAUR clinical trial participants who received AMX0035 against a propensity score-matched, AMX0035-naïve external control cohort from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database.
  • These results using an external control aligned with prior analysis using statistical models adjusting for placebo-to-active crossover in CENTAUR ( RPSFTM ).
  • Amylyx donated data from the CENTAUR clinical trial to the PRO-ACT database.

Clene Reports Significant Long-Term Survival Improvement From CNM-Au8 Treatment in HEALEY ALS Platform Trial Compared to PRO-ACT Historical Controls

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月曜日, 9月 25, 2023
ACT, Database, Medicine, CNM, Survival, Clinical trial, Meta-analysis, Multiple sclerosis, SALT, Ventilation, MS, Open-label trial, Microsoft Access, Patient, Data, Risk, Common-pool resource, Principal, Massachusetts General Hospital, Death, ALS, Safety, OLE, Pharmaceutical industry

The HEALEY ALS Platform Trial is a perpetual multi-center, randomized, double-blind, placebo-controlled clinical trial program designed to evaluate the efficacy and safety of multiple investigational products in people living with ALS.

Key Points: 
  • The HEALEY ALS Platform Trial is a perpetual multi-center, randomized, double-blind, placebo-controlled clinical trial program designed to evaluate the efficacy and safety of multiple investigational products in people living with ALS.
  • Participants received CNM-Au8 in addition to ALS standard-of-care and were randomized to the drug or placebo during the 24-week double-blind period.
  • The PRO-ACT dataset is derived from pooled ALS clinical trial data from 29 completed Phase 2 and Phase 3 ALS clinical trials.
  • This database provides a useful and validated surrogate for survival status of past participants in ALS clinical trials with long-term follow-up.

Cytokinetics and The ALS Association Announce Release of Updated PRO-ACT Database Including Data From Cytokinetics’ Completed ALS Clinical Trials

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木曜日, 8月 4, 2022
ACT, Private Securities Litigation Reform Act, History, Common-pool resource, User experience, Treatment, Hospital, Research and development, Patent, Investigational New Drug, Death, Intellectual property, Publication, Pharmacology, SAN, HIV disease progression rates, Safe harbor, Association, Facebook, FDA, NCRI, Research, GLOBE, Securities and Exchange Commission (Nigeria), Partnership, Heart failure, Sale, Diagnosis, Massachusetts General Hospital, HCM, Patient, Cytokinetics, Neurodegeneration, Amyotrophic lateral sclerosis, LinkedIn, Assessment, ALS Association, Functional, Twitter, The Act, YouTube, Mechanics, Security (finance), The, Badminton Association of India, Muscle weakness, Act, Pro-Act by VTC, Life expectancy, Data, Management, Pharmaceutical industry, ALS

We thank the people living with ALS who participated in our clinical trials to make this possible.

Key Points: 
  • We thank the people living with ALS who participated in our clinical trials to make this possible.
  • The PRO-ACT database, which is sponsored by the ALS Association and managed by The Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital, houses the largest ALS clinical trials dataset, containing nearly 11,000 ALS de-identified patient records from 23 completed clinical trials.
  • The platform harmonizes and merges anonymized data from existing publicly and privately conducted ALS clinical trials to generate a unique, freely available resource for the scientific community to help with finding cures for ALS.
  • CYTOKINETICS and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.