ANSM

Affimed Announces Approval of Clinical Trial Application in France for a Phase 1 Study of AFM28 in Relapsed/Refractory Acute Myeloid Leukemia

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목요일, 12월 22, 2022
Disease, Cancer, AML, Patient, Affimer, CTA, ANSM, Pharmaceutical industry

HEIDELBERG, Germany, Dec. 22, 2022 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that the ANSM has authorized a CTA for the phase 1 study of AFM28 (AFM28-101) in relapsed/refractory acute myeloid leukemia (AML).

Key Points: 
  • HEIDELBERG, Germany, Dec. 22, 2022 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that the ANSM has authorized a CTA for the phase 1 study of AFM28 (AFM28-101) in relapsed/refractory acute myeloid leukemia (AML).
  • “The CTA approval in France is an important milestone in our strategy to develop AFM28 as quickly as possible,” said Dr. Wolfgang Fischer, Chief Operating Officer at Affimed.
  • “AML is one of the worst blood cancers with poor patient prognosis, especially in the relapsed or refractory setting, with no standard-of-care salvage regimen currently available.
  • Additionally, Affimed plans to investigate AFM28 in combination with allogenic natural killer (NK) cell therapy.

Transgene Receives Approval to Start a Phase I Trial of TG6050, a Novel IL-12-Armed Oncolytic Virus Given by Intravenous Administration

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금요일, 1월 6, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Cancer, ICIS, Euronext Paris, International Cancer Genome Consortium, ANSM, Neoplasm, Patient, Tumor microenvironment, CTA, Disseminated disease, Medication, Lysis, Large-cell lung carcinoma, IL-12, IV, National Agency for Food and Drug Administration and Control, Safety, NSCLC, Pharmaceutical industry, Vaccine

It has been engineered to express human IL-12, a cytokine that triggers a powerful antitumor immune response, and a full length anti-CTLA4 antibody.

Key Points: 
  • It has been engineered to express human IL-12, a cytokine that triggers a powerful antitumor immune response, and a full length anti-CTLA4 antibody.
  • TG6050 has been designed to be administered intravenously, a route of administration that has been demonstrated to be safe and feasible with an Invir.IO™ based OV.
  • Intratumoral injection, where the drug is injected directly into the tumor, is currently the only approved route of administration for an oncolytic virus.
  • Intravenous administration addresses a broader range of patients with solid tumors who are not suitable for intratumoral administration.

MaaT Pharma Presents Compelling Consolidated MaaT013 Clinical Data at the 64th ASH Annual Meeting

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토요일, 12월 10, 2022
Research, Infectious Diseases, Hospitals, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Phase, Infection, Immune system, GI, ORR, Food, Sorbonne University, Acceleration, Skin, ARES, Orphan, EMA, Patient, Cancer, Steroid, Graft-versus-host disease, MET, DSMB, Liver, FDA, Classification, US Foods, Survival, Biomarker, Authorization, European Medicines Agency, MAGIC, Clinical trial, ANSM, Safety, Hospital, Degenerative disease, Mortality, Euronext Paris, EAP, ASH, CGMP, CST, Pharmaceutical industry, Dietary supplement

In patients responding to MaaT013 therapy, the overall survival (OS) rate at 12 months was 59% (compared to 14% for non-responders) indicating a significant clinical benefit with MaaT013.

Key Points: 
  • In patients responding to MaaT013 therapy, the overall survival (OS) rate at 12 months was 59% (compared to 14% for non-responders) indicating a significant clinical benefit with MaaT013.
  • This patient population resembles the ongoing Phase 3 ARES clinical trial ( NCT04769895 ) being conducted in Europe.
  • MaaT Pharma, a clinical stage biotechnology company, has established a complete approach to restoring patient-microbiome symbiosis in oncology.
  • MaaT Pharma is the first company developing microbiome-based therapies listed on Euronext Paris (ticker: MAAT).

SparingVision’s lead asset SPVN06 clears IND application in the US for the treatment of retinitis pigmentosa

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목요일, 12월 1, 2022
Science, FIH, Professor, DSMB, RCD, Natural history, ANSM, Food, University, DNA, Epistasis, Gene, IND, University of Pittsburgh Medical Center, Safety, PDE6B, Toys "R" Us, Inc. v. Step Two, S.A, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PDE6A, Retina, Retinitis pigmentosa, Disease, RHO, CTA, IRD, AMD, Research, Quality of life, Severe cognitive impairment, Data monitoring committee, Oxidative stress, AAV, FDA, IRDS, Pharmaceutical industry, Vaccine, RP

SparingVision has also submitted a clinical trial authorisation (CTA) application to the French regulator (ANSM), which is currently under review.

Key Points: 
  • SparingVision has also submitted a clinical trial authorisation (CTA) application to the French regulator (ANSM), which is currently under review.
  • First safety data are anticipated in 2023 and the primary endpoint is expected to be reached in 2025.
  • With over 80 genes involved in RP, each with numerous causative mutations, we need to go beyond the gene-by-gene treatment approach.
  • SPVN06 has the potential to become the universal therapeutic solution that patients need, and we are excited for the next phase of development.

UroMems Initiates First-in-Human Study of Its Smart Implant to Treat Stress Urinary Incontinence

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화요일, 11월 29, 2022
Pressure, Urinary incontinence, National Agency for Food and Drug Administration and Control, Urethra, Perception, AUS, Partner, Pelvic floor, Anatomy, ANSM, Food, Disorder, SUI, Safety, Physician, AP-HP, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, MEMS, The Chartered Institute of Ergonomics and Human Factors, Social stigma, Teaching hospital, Investment, Urology, Depression, Male, Wellington Partners, Quality of life, La, Medication, Woman, Trial of the century, Sorbonne University, Mayo Clinic, Medical device, Pharmaceutical industry

GRENOBLE, France, Nov. 29, 2022 /PRNewswire/ -- UroMems, a global company developing breakthrough, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-in-human implant of the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) investigational device to treat SUI. This initial clinical study is a key milestone in the development of UroActive.

Key Points: 
  • GRENOBLE, France, Nov. 29, 2022 /PRNewswire/ -- UroMems , a global company developing breakthrough, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-in-human implant of the UroActive System, the first smart automated artificial urinary sphincter (AUS) investigational device to treat SUI.
  • This initial clinical study is a key milestone in the development of UroActive.
  • "This is a historic milestone for UroMems, patients, physicians and the industry as this is a first-of-its-kind fully automated AUS implant designed to treat SUI in both men and women," said Hamid Lamraoui, UroMems chief executive officer and co-founder.
  • UroActive is the first smart active implant that treats SUI, powered by a MyoElectroMechanical System (MEMS).

ContraFect Announces ANSM Approval of Clinical Trial Application for Exebacase in Prosthetic Joint Infections

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월요일, 11월 28, 2022
National Agency for Food and Drug Administration and Control, SOC, S. aureus, Peptide, Infection, PK, Cons, ANSM, Campaign, Pneumonia, Part, Lysin, Safety, Bacteria, Pseudomonas aeruginosa, Patient, Enterobacter, Endocarditis, Staphylococcus, State, Acinetobacter baumannii, Maintenance, Staphylococcus aureus, Death, Osteomyelitis, DLA, Security (finance), Breakthrough therapy, CTA, Subclinical infection, Knee, Biofilm, Medication, Clinical trial, MRSA, FDA, Pharmaceutical industry, MD

PJIs are a completely underserved area of medicine, where no randomized clinical trials have been completed.

Key Points: 
  • PJIs are a completely underserved area of medicine, where no randomized clinical trials have been completed.
  • As the population of the developed world ages, we must find a safe, effective and minimally-invasive way to treat these infections or millions of patients will continue to suffer.
  • Part 1 will evaluate the safety, PK, clinical outcomes, and microbiologic response in patients through Day 42.
  • Up to 2 dose levels of intra-articularly administered exebacase in addition to systemic antibiotics will be studied in up to 2 patient cohorts.

AB Science receives U.S. Food and Drug Administration (FDA) authorization to initiate confirmatory Phase 3 clinical study with masitinib in the treatment of Alzheimer’s Disease

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월요일, 11월 21, 2022
Marketing, ADAS, Inflammation, ANSM, Cell, Cognition, ADAS-Cog, Donanemab, Amyotrophic lateral sclerosis, B cell, AMF, Incidence, III, Degenerative disease, Patient, Cholinesterase, Veterinary medicine, Medicine, MMSE, ALS, Alzheimer's disease, Organic, Mini–Mental State Examination, Scientific Committee on Antarctic Research, AB, University, AD, Disease, Multiple sclerosis, Research, Science, Memantine, Safety, PKI, Reno 1868 FC, Communication, Euronext Paris, Macrophage, Tyrosine kinase inhibitor, European Medicines Agency, Microglia, Central nervous system, AE, INT, Mast cell, Memory, Survival, Pharmaceutical industry, Dietary supplement, Vaccine, Copper, Neurodegeneration

The primary endpoint of study AB21004 will be to evaluate the effect of masitinib on absolute change from baseline in ADCS-ADL score and in ADAS-Cog-11.

Key Points: 
  • The primary endpoint of study AB21004 will be to evaluate the effect of masitinib on absolute change from baseline in ADCS-ADL score and in ADAS-Cog-11.
  • Furthermore, masitinib is an orally administered tyrosine kinase whereas the aforementioned anti-amyloid antibody drugs are administered via injection.
  • The trial (AB21004) aims to confirm the outcomes observed in the previous masitinib phase 2B/3 study (AB09004) supporting the efficacy and safety of masitinib.
  • Study AB09004 was the first successful phase 2B/3 randomized trial in mild-to-moderate Alzheimers disease of a drug targeting innate immune cells of the neuroimmune system.

MaaT Pharma Reports Cash and Revenues for Third Quarter 2022

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화요일, 11월 8, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Kepler, Euronext Paris, Achievement, ANSM, Company, Digital, Society, IHMC, Maat, ARES, Agence nationale de sécurité du médicament et des produits de santé, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Salvage therapy, EUR, Drug design, IPO, Congress, EST, CGMP, Graft-versus-host disease, Survival, Forward-looking statement, Conference, Special access program, LSX, Annual general meeting, PICASSO, FDA, Biomarker, CIMON, Communication, Drug, ASH, R, Safety, CEO, Food, Showcase, EAP, Patient, Cancer, MET, Lymphatic system, CIC, UCSD Student-Run Free Clinic Project, Acute myeloid leukemia, International, Pharmaceutical industry, Film, Fine chemical

MaaT Pharma (EURONEXT: MAAT the Company), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, today reported its cash position as of September 30, 2022, and its revenues for the third quarter of 2022.

Key Points: 
  • MaaT Pharma (EURONEXT: MAAT the Company), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, today reported its cash position as of September 30, 2022, and its revenues for the third quarter of 2022.
  • The net increase in cash over the third quarter of 2022 was EUR 1.9 million.
  • November 15-17, 2022 13th Annual Jefferies London Healthcare Conference London, UK: Sin Crouzet, Chief Financial Officer of MaaT Pharma and Dr. Carole Schwintner, Chief Technology Officer of MaaT Pharma will attend the conference.
  • November 29, 2022 Investir day Paris, France: Sin Crouzet, Chief Financial Officer of MaaT Pharma and Dr. Savita Bernal, Chief Business Officer of MaaT Pharma will attend the investor event.

Domain Therapeutics to progress into clinical trials with its EP4R antagonist DT-9081 in solid tumors

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수요일, 10월 19, 2022
News, Neoplasm, Agence nationale de sécurité du médicament et des produits de santé, Patient, Gq alpha subunit, IO, G protein-coupled receptor, Standard of care, Cancer, ANSM, Immune system, Drug discovery, EP4, Pharmaceuticals and Medical Devices Agency, CEO, Immunosuppression, CTA, PGE2, Clinical trial, Pharmaceutical industry

The first-in-human clinical trial is on track to initiate by the end of the year.

Key Points: 
  • The first-in-human clinical trial is on track to initiate by the end of the year.
  • Given the high concentrations of PGE2 exhibited by a range of different solid tumors, Domain Therapeutics has developed an extensive biomarker strategy, enabling optimal selection of tumor types and patient subpopulations and monitoring the target engagement in future clinical trials.
  • Dr. Pascal Neuville, CEO of Domain Therapeutics, commented: Todays news marks a pivotal moment for Domain as we progress our first fully-owned immuno-oncology drug candidate towards the clinic.
  • Dr. Asmaa Boudribila,Medical Director at Domain Therapeutics, commented: DT-9081 is a promising new candidate with the potential to treat a wide range of cancers.

AB Science today reports its revenues for the first half of 2022 and provides an update on its activities

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금요일, 9월 30, 2022
Science, Disability, Data, Safety, COVID-19, Policy, Condition, DSMB, European Medicines Agency, THE, MRI, Review, Calendar, PPMS, European Investment Bank, Survival, FIRST, Patient, Riluzole, Committee for Medicinal Products for Human Use, AND, EDSS, Health Canada, Compliance, European Directive on Traditional Herbal Medicinal Products, Diagnosis, Magnetic resonance imaging, CHMP, Amyotrophic lateral sclerosis, WHO, ANSM, ALS, Research, Committee, NOC, EMA, Euronext, Toxicity, NSPM, Medical device, Online gambling, Pharmaceutical industry, Vaccine, Dietary supplement, Medical imaging

Under the NOC/c policy, Health Canada has a target of 200 calendar days maximum to review the application.

Key Points: 
  • Under the NOC/c policy, Health Canada has a target of 200 calendar days maximum to review the application.
  • AB Science filed an application for conditional Marketing Authorization to the European Medicines Agency (EMA) for Alsitek (masitinib) in the treatment of amyotrophic lateral sclerosis (ALS).
  • In line with this recommendation, AB Science has made the decision to continue the study only in moderate patients.
  • The following table summarizes the consolidated financial statements for the first half of 2022 prepared in accordance with IFRS, and comparative information with the first half of 2021: