Intravascular hemolysis

NovelMed Commences Phase II Trial for Anti-Bb Antibody (NM8074) in Treatment-Naïve PNH Patients: A Glimpse into the PNH Study Progress

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星期一, 十月 30, 2023
FDA, CP, PNH, Hemolysis, C3b, LDH, Intravascular hemolysis, Phase, Phase II, EVH, Lactate dehydrogenase, RBC, Risk, Paroxysmal nocturnal hemoglobinuria, AP, Safety, IVH, Therapy, Patient, Infection, PRBC, Pharmaceutical industry, Haptoglobin, Hemoglobin, Reticulocyte

Regulatory approval for the Phase II trial in treatment-naïve PNH patients was granted based on the safety and tolerance demonstrated in the previous Phase I clinical trial involving healthy subjects.

Key Points: 
  • Regulatory approval for the Phase II trial in treatment-naïve PNH patients was granted based on the safety and tolerance demonstrated in the previous Phase I clinical trial involving healthy subjects.
  • CLEVELAND, Oct. 30, 2023 (GLOBE NEWSWIRE) -- NovelMed Therapeutics is excited to announce the commencement of its Phase II clinical trial targeting treatment-naïve Paroxysmal Nocturnal Hemoglobinuria (PNH) patients with its groundbreaking anti-Bb antibody, NM8074.
  • This open-label, multi-dose, and multi-center study aims to assess the safety and efficacy of NM8074 in PNH patient population.
  • The Phase II study is divided into two cohorts, featuring a biweekly dosing schedule spanning a 3-month assessment period.

NovelMed Phase I Clinical Trial Shows Inhibition of the Alternative Pathway and Preservation of the Classical Pathway – A Long-Acting Anti-Properdin Monoclonal Antibody NM3086 for PNH Patients

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星期一, 六月 5, 2023
C3b, PD, C5a, Serum, Receptor (biochemistry), IVH, Pathology, CP, Pharmacokinetics, AP, Intravascular hemolysis, EVH, C3a, Disorder, Trial of the century, MAC, Clinical trial, Paroxysmal nocturnal hemoglobinuria, Patient, Anemia, PNH, Complement factor B, FDA, Therapy, ADA, Safety, Vaccine, News, Hydraulic machinery, Pharmaceutical industry

Total AP inhibition was achieved through all cohorts and the duration of alternative pathway (AP) inhibition occurred in a dose-dependent manner.

Key Points: 
  • Total AP inhibition was achieved through all cohorts and the duration of alternative pathway (AP) inhibition occurred in a dose-dependent manner.
  • Correspondingly, the classical pathway (CP) remained unaffected, suggesting that NM3086 selectively blocks the AP while maintaining the host defense.
  • The duration of AP-C3b inhibition followed the AP inhibition profile very closely in a dose dependent manner.
  • CLEVELAND, June 05, 2023 (GLOBE NEWSWIRE) -- NovelMed Therapeutics, Inc. announced today topline results from First-in-Human Phase I clinical trial of its complement blocker monoclonal anti-Properdin antibody, known as NM3086.

Forma Therapeutics Announces Four Presentations on Etavopivat and Olutasidenib at Upcoming 2021 ASH Annual Meeting

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星期四, 十一月 4, 2021
Biotechnology, FDA, Other Health, Health, General Health, Pharmaceutical, Oncology, Research, Infectious Diseases, Science, Clinical Trials, Well, Safety, Sickle cell disease, Cancer, Hemolysis, Thrombophilia, Puberty, 2021 Essex County Council election, Glioma, Research, LinkedIn, Prognosis, Anemia, Intravascular hemolysis, Survival, Inflammation, European Medicines Agency, IDH1, Private Securities Litigation Reform Act, Forma, FDA, Polymerization, Food, Pyruvic acid, ASH, SEC, European Commission, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Royal commission, Committee, PKR, NDA, Cell, Activation, Allosteric regulation, Health, Nasdaq, AML, ATP, Degenerative disease, Therapy, Prostate cancer, Society, SCD, RBC, Enzyme, Pharmaceutical industry, Medical imaging

Were pleased that these abstracts were selected for oral and poster presentation at the ASH annual meeting, said Patrick Kelly, M.D., chief medical officer of Forma Therapeutics.

Key Points: 
  • Were pleased that these abstracts were selected for oral and poster presentation at the ASH annual meeting, said Patrick Kelly, M.D., chief medical officer of Forma Therapeutics.
  • Etavopivat-mediated PKR activation also increases ATP levels, the fuel that provides energy to cells, to improve RBC health and survival.
  • In preclinical safety studies, etavopivat did not inhibit aromatase activity or affect steroidogenesis, important biological processes responsible for sexual development.
  • Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers.