EudraCT

IntelGenx Announces First Parkinson’s Disease Patients Dosed with Montelukast VersaFilm® in Phase 2 ‘MONTPARK’ Clinical Trial

Retrieved on: 
Monday, April 8, 2024
Karolinska University Hospital, EudraCT, PD, L-DOPA, Patient, IGX, Doctor of Philosophy, MD, TSX, Clinical trial, Pharmaceutical industry

SAINT LAURENT, Quebec, April 08, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that Montelukast VersaFilm® has been administered to the first Parkinson’s Disease (“PD”) patients in the Phase 2 (‘MONTPARK’) clinical trial.

Key Points: 
  • SAINT LAURENT, Quebec, April 08, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that Montelukast VersaFilm® has been administered to the first Parkinson’s Disease (“PD”) patients in the Phase 2 (‘MONTPARK’) clinical trial.
  • MONTPARK (EudraCT number 2023-504278-39-00) is a Phase 2, randomized, double-blind, placebo-controlled, parallel arm, multicentre trial that will investigate the efficacy of oral high-dose Montelukast on the progression of early-to-moderate PD.
  • The study will enroll up to 90 patients who will receive 30 mg Montelukast VersaFilm® or placebo twice daily for 18-months, followed by a 3-month washout period.
  • Eligible candidates must be on levodopa treatment at the time of enrolment and may also be on other dopaminergic symptomatic agents.

ACT EU Clinical Trials Analytics Workshop - January 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 25 January 2024, 13:00 (CET) to 26 January 2024, 13:00 (CET)

Retrieved on: 
Sunday, February 4, 2024
ACT, CTIS, Clinical trial, Artificial intelligence, ICH, EudraCT, Location, Data analysis, Medical device

These data are used to support regulatory decision-making, but their potential uses extend far beyond that scope.

Key Points: 
  • These data are used to support regulatory decision-making, but their potential uses extend far beyond that scope.
  • During this event, stakeholders will have the opportunity to present/discuss how they are using or planning to use these data.
  • These discussions will help guide EU decision-makers on improving access and usability of clinical trials data.
  • After the event a prioritised list of use cases will be published as part of a clinical trials analytics research agenda, the delivery of which may be tied to public funding calls.

ACT EU Clinical Trials Analytics Workshop - January 2024, European Medicines Agency, Amsterdam, the Netherlands, from 25 January 2024, 13:00 (CET) to 26 January 2024, 13:00 (CET)

Retrieved on: 
Tuesday, January 2, 2024
ACT, Artificial intelligence, CTIS, ICH, Clinical trial, Data analysis, Location, EudraCT, Medical device

These data are used to support regulatory decision-making, but their potential uses extend far beyond that scope.

Key Points: 
  • These data are used to support regulatory decision-making, but their potential uses extend far beyond that scope.
  • During this event, stakeholders will have the opportunity to present/discuss how they are using or planning to use these data.
  • These discussions will help guide EU decision-makers on improving access and usability of clinical trials data.
  • After the event a prioritised list of use cases will be published as part of a clinical trials analytics research agenda, the delivery of which may be tied to public funding calls.

Mithra Completes Pediatric Study of ESTELLE® in Adolescent Patients

Retrieved on: 
Wednesday, December 20, 2023
Estetrol, Adolescence, Woman, EMA, Bleeding, Brussels Stock Exchange, Ageing, Liège, European Medicines Agency, PIP, MITRA, Safety, Female, SPC, EudraCT

Study recruited more than 100 adolescents, with primary aim to evaluate safety profile

Key Points: 
  • Study recruited more than 100 adolescents, with primary aim to evaluate safety profile
    Liege, Belgium, 20 December 2023 – 17:45 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the completion of a pediatric study of its marketed contraceptive ESTELLE® in adolescent women.
  • The primary endpoint of the study, which is being conducted in Estonia, Finland, Georgia, Latvia, Poland and Sweden, is to evaluate the safety of ESTELLE® in post-menarchal subjects.
  • Graham Dixon, Chief Scientific Officer of Mithra, commented, “The completion of this pediatric study on schedule is another important milestone for Mithra.
  • Mithra is undertaking this study under a Pediatric Investigation Plan (PIP) agreed with the European Medicines Agency (EMA).

ORYZON Announces Last Patient Last Visit in its Phase IIb PORTICO Study for Borderline Personality Disorder (BPD)

Retrieved on: 
Tuesday, November 7, 2023
ORY, Genomics, Aggression, DMC, ISIN, CNS, Data monitoring committee, EudraCT, Disease, ECNP, Safety, Agitation, BPD, Interim analysis, Patient, Borderline personality disorder, Pharmaceutical industry, Medical device

: 2020-003469-20, ClinicalTrials.gov Identifier NCT04932291) is a global double-blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial evaluating the efficacy and safety of vafidemstat in a BPD population.

Key Points: 
  • : 2020-003469-20, ClinicalTrials.gov Identifier NCT04932291) is a global double-blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial evaluating the efficacy and safety of vafidemstat in a BPD population.
  • The trial has two primary endpoints: reduction of agitation and aggression and overall disease improvement in BPD severity.
  • The independent Data Monitoring Committee (DMC) has met routinely and reviewed unblinded safety data throughout the PORTICO trial.
  • Our quest on the primary endpoints is replicated in a rich set of secondary endpoints, making PORTICO a very informative trial.

Neurocentrx Reports Positive Top-line Results from Phase 1 Clinical Study of its Lead Oral Ketamine Capsule Programme

Retrieved on: 
Tuesday, October 24, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, Wellcome Trust, Trust, Ketamine, MTD, Trial of the century, DSM-IV codes, Esketamine, EudraCT, Drug, Conference, SAD, Pharmacodynamics, Psychology, MHRA, Index, Marketing, Bipolar, Spectrum, Depression, Safety, International Society, Patient, Pharmaceutical industry, Vaccine

At several KET-IR dose levels, ketamine and ketamine metabolite blood concentrations were similar to those reported for intranasal esketamine, which is used to treat patients with treatment-resistant depression, and with intravenous ketamine.

Key Points: 
  • At several KET-IR dose levels, ketamine and ketamine metabolite blood concentrations were similar to those reported for intranasal esketamine, which is used to treat patients with treatment-resistant depression, and with intravenous ketamine.
  • Pharmacodynamic effects known to be associated with ketamine therapy, such as dissociation and mild sedation, were apparent at several doses.
  • “We are encouraged by the results of our phase 1 study of KET-IR.”, added Graeme Duncan, Head of Clinical Development at Neurocentrx.
  • Blood levels of ketamine and ketamine metabolites were similar to levels associated with therapeutic ketamine administration at several dose levels (Perez-Ruixo et al.

ORYZON presents blinded aggregate safety data from vafidemstat’s ongoing Phase IIb PORTICO trial in Borderline Personality Disorder

Retrieved on: 
Tuesday, October 10, 2023
Congress, Aggression, European College of Neuropsychopharmacology, BPD, ORY, Safety, Psychotherapy, Borderline personality disorder, Genomics, Agitation, Clinical trial, ISIN, CNS, EudraCT, ECNP, Patient, Pharmaceutical industry

Oryzon presented a poster communication entitled “PORTICO – Double-blind, randomized placebo-controlled, adaptive phase IIb trial with vafidemstat in borderline personality disorder – aggregated baseline characteristics, demographics and safety”, which was presented by Dr. Michael Ropacki, Oryzon’s CMO for CNS.

Key Points: 
  • Oryzon presented a poster communication entitled “PORTICO – Double-blind, randomized placebo-controlled, adaptive phase IIb trial with vafidemstat in borderline personality disorder – aggregated baseline characteristics, demographics and safety”, which was presented by Dr. Michael Ropacki, Oryzon’s CMO for CNS.
  • The data presented at ECNP-2023 correspond to the analysis of aggregated blinded safety data cut as of August 23, 2023.
  • As of September 2023, PORTICO randomized 210 participants, and 131 of the originally planned participants (N = 150) already completed the trial.
  • : 2020-003469-20, ClinicalTrials.gov Identifier NCT04932291) is a global double blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial evaluating the efficacy and safety of vafidemstat in a BPD population.

Almirall's Lebrikizumab Improves Signs and Symptoms of Moderate-to-Severe Atopic Dermatitis (AD) in Patients Inadequately Controlled With or Ineligible for Cyclosporine1

Retrieved on: 
Friday, October 13, 2023
Health, Managed Care, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Congress, EudraCT, Eli Lilly and Company, Knowledge, European Academies' Science Advisory Council, Advantage, CHMP, Abstract, Advocate, Ciclosporin, United Kingdom, BME, University, Week, Safety, ALM, Human, Disease, NRS, Psoriasis Area and Severity Index, Journal of the European Academy of Dermatology and Venereology, Almirall, Adolescence, Marketing, IGA, Adherence, AD, TCS, News, Overalls, EASI, Patient, Quality of life, Pharmaceutical industry, Dermatology, Venereology

Improvements in absolute skin response over 16 weeks for patients with moderate-to-severe AD treated with lebrikizumab or placebo were also shared.

Key Points: 
  • Improvements in absolute skin response over 16 weeks for patients with moderate-to-severe AD treated with lebrikizumab or placebo were also shared.
  • Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe.
  • Almirall expects regulatory decisions for lebrikizumab in moderate-to-severe AD in additional European markets, including the United Kingdom and Switzerland in 2024.
  • † More information about the Phase 3 studies: ADvocate 1: EudraCT Number 2019-002932-10; NCT04146363; ADvocate 2: EudraCT Number 2019-002933-12; NCT04178967; ADhere: EudraCT Number 2019-004300-34; NCT04250337

Amylyx Pharmaceuticals Receives Negative CHMP Opinion on its Marketing Authorisation Application for AMX0035 for the Treatment of ALS in the European Union Following Re-Examination Process

Retrieved on: 
Friday, October 13, 2023
Biotechnology, Neurology, Health, Pharmaceutical, Clinical Trials, European, ALS, EudraCT, Food, European Directive on Traditional Herbal Medicinal Products, CHMP, Eupales, Frustration, European Organization for Quality, Committee for Medicinal Products for Human Use, Health Canada, European Commission, Safety, European Medicines Agency, Survival, EMA, Marketing Authorisation Application, FDA, AMX0035, Marketing, Clinical trial, Committee, Patient, Medication, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Civil service commission, MAA, Pharmaceutical industry, Amylyx Pharmaceuticals, PHOENIX, EU

The decision follows the conclusion of the CHMP’s formal re-examination procedure of an initial negative opinion adopted in June 2023.

Key Points: 
  • The decision follows the conclusion of the CHMP’s formal re-examination procedure of an initial negative opinion adopted in June 2023.
  • Since the medication’s approval with conditions in Canada and full approval in the U.S., thousands of people have been prescribed AMX0035 in North America.
  • PHOENIX is a 48-week, randomized placebo-controlled global Phase 3 clinical trial further evaluating the safety and efficacy of AMX0035 for the treatment of ALS.
  • The CHMP opinion will be forwarded to the European Commission, who will adopt the final decision on this application.

SOTIO Announces First Patients Dosed in Two Combination Arms of CLAUDIO-01 Study Evaluating SOT102 in First-Line Gastric and Pancreatic Cancer

Retrieved on: 
Wednesday, October 11, 2023
Oncology, Health, Health Technology, General Health, Clinical Trials, Pharmaceutical, Biotechnology, PPF (company), EudraCT, Cancer, GEJ, Pancreatic cancer, NAB, Nivolumab, Safety, Patient, Pharmaceutical industry

CLAUDIO-01 is evaluating SOTIO’s potent antibody-drug conjugate SOT102 in patients with gastric and pancreatic cancer.

Key Points: 
  • CLAUDIO-01 is evaluating SOTIO’s potent antibody-drug conjugate SOT102 in patients with gastric and pancreatic cancer.
  • The combination arms will be the first clinical evaluation of SOT102’s potential as a first-line cancer treatment in combination with current standard of care.
  • In the gastric cancer arm, SOT102 will be combined with mFOLFOX plus nivolumab.
  • In the trial’s combination arm, by contrast, SOT102 will be dosed in combination with standard-of-care as a first-line treatment for patients with advanced/metastatic gastric/gastroesophageal junction (GEJ) or pancreatic cancers.