A5022769933- Complement system in diseases
- Blood groups and transfusion
- Hemoglobinopathies and Related Disorders
- Coagulation, Bradykinin, Polyphosphates, and Angioedema
- Renal cell carcinoma treatment
- Liver Disease and Transplantation
- Renal Diseases and Glomerulopathies
- Cancer Genomics and Diagnostics
- Hepatitis C virus research
- Lung Cancer Treatments and Mutations
- Platelet Disorders and Treatments
- Radiopharmaceutical Chemistry and Applications
- Immune Response and Inflammation
- Colorectal Cancer Treatments and Studies
- Advanced Breast Cancer Therapies
- Immunotherapy and Immune Responses
- Erythropoietin and Anemia Treatment
- Cancer Treatment and Pharmacology
- Hepatitis B Virus Studies
- Prostate Cancer Treatment and Research
- Immunodeficiency and Autoimmune Disorders
- Lung Cancer Research Studies
- HER2/EGFR in Cancer Research
- Cancer Immunotherapy and Biomarkers
- Influenza Virus Research Studies
Apellis Pharmaceuticals (United States)
2021-2024
Pfizer (United States)
2018-2019
ImmunoGen (United States)
2015
Christian Medical College & Hospital
2009-2011
Cancer Institute (WIA)
2011
AVEO Oncology (United States)
2009-2011
Christian Medical College
2009-2011
Moffitt Cancer Center
2011
Nebraska Cancer Specialists
2011
Texas Oncology
2011
Purpose This study assessed the efficacy of combination standard taxane plus platinum chemotherapy with synthetic Toll-like receptor 9–activating oligodeoxynucleotide PF-3512676 in patients non–small-cell lung cancer (NSCLC). Patients and Methods Chemotherapy-naive stage IIIB to IV NSCLC were randomly assigned (one two ratio) receive four six cycles taxane/platinum alone or 0.2 mg/kg subcutaneous on days 8 15 each 3-week cycle. The primary end point was objective response rate (ORR). Results...
Abstract Paroxysmal nocturnal hemoglobinuria (PNH) is a rare disease characterized by complement-mediated hemolysis. Pegcetacoplan the first C3-targeted therapy approved for adults with PNH (United States), inadequate response or intolerance to C5 inhibitor (Australia), and anemia despite C5-targeted ≥3 months (European Union). PRINCE was phase 3, randomized, multicenter, open-label, controlled study evaluate efficacy safety of pegcetacoplan vs control (supportive care only; eg, blood...
CPG 10101, a synthetic oligodeoxynucleotide (ODN), is toll-like receptor 9 (TLR9) agonist with antiviral and immunomodulatory properties that could potentially influence chronic infection HCV. In this multicenter Phase 1b trial, 60 HCV-positive patients (50 genotype 1 HCV) were randomized received either placebo or 10101 at 0.25, 1, 4, 10, 20 mg subcutaneously (SC) twice weekly for 4 weeks 0.5 0.75 mg/kg SC once weeks. Dose-dependent cytokine induction was observed after administration of...
Abstract Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired hematologic disorder characterized by complement-mediated hemolysis. C5 inhibitors (eculizumab/ravulizumab) control intravascular hemolysis but do not prevent residual extravascular The newly approved complement inhibitor, pegcetacoplan, inhibits C3, upstream of C5, and has the potential to improve PADDOCK PALOMINO clinical trials assessed safety efficacy pegcetacoplan in inhibitor-naïve adults (≥ 18 years) diagnosed with...
Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired hematologic disease characterized by complement-mediated hemolysis and thrombosis. Complement component 5 (C5) inhibitors have decreased PNH-related thrombosis rates reduced mortality compared with those of age-matched controls. A small but significantly increased risk life-threatening
Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, life-threatening disease characterized by complement-mediated hemolysis and thrombosis. Pegcetacoplan, the first targeted complement component 3 (C3) PNH therapy, was safe efficacious in treatment-naive pre-treated patients with five clinical trials. The 307 open-label extension (OLE) study (NCT03531255) non-randomized, multicenter of long-term safety efficacy pegcetacoplan adult who completed parent study. All received pegcetacoplan....
Abstract Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, chronic, acquired, hematologic, life-threatening disease characterized by thrombosis, impaired bone marrow function, and complement-mediated hemolysis. The PEGASUS phase III clinical trial demonstrated superiority of pegcetacoplan over eculizumab regarding improvements in hemoglobin levels patients with suboptimal response to prior treatment. objective this post hoc analysis was compare the patient-reported outcome (PRO) rates...
CPG 10101 (ACTILON™) is a novel potent and selective unmethylated cytidine-phosphate-guanosine (CpG)-containing oligodeoxynucleotide agonist of Toll-like receptor 9 (TLR9) being developed for the treatment chronic infections such as HCV. Objectives Methods In this randomized, double-blind, placebo-controlled Phase I study in 48 normal volunteers, we investigated safety, pharmacokinetic parameters immune effects subcutaneous administration 10101. Five sequential escalating doses from 0.25 to...
For men with metastatic castration-resistant prostate cancer (mCRPC) whose condition is responding to enzalutamide, new unconfirmed bone lesions detected at posttreatment scinitigraphy may reflect an osteoblastic reaction that represents healing, known as pseudoprogression, which can lead premature discontinuation of therapy.To determine the association between on a follow-up scintigram (bone scan) and outcomes in enzalutamide-treated mCRPC.This post hoc, retrospective secondary analysis...
5032 Background: AV-951 is a potent inhibitor of VEGFR-1, 2 & 3 kinases (IC 50 0.21, 0.16 and 0.24 nM respectively), inhibits cKit PDGFR at 10-times higher concentrations 1.63 1.72 respectively). In phase II RDT (1.5 mg/day; wks on, 1 wk off) in RCC, preliminary ORR 16 was 28% (ASCO GU. 2008; abstract #283). Methods: Pts with locally advanced or metastatic RCC (any histology) no prior VEGF-targeted therapy received for wks, after which further treatment assigned based on response. ≥ 25%...
4599 Background: Tivozanib, a potent and selective inhibitor of VEGFR-1, 2, 3 kinases, was tested in phase II RDT that included patients (pts) with all histologies RCC, as well pts who had not undergone nephrectomy or received prior therapy cytokines chemotherapy. The median PFS 11.8 months [ASCO 2009; abstract #5032] Methods: A retrospective subgroup analysis conducted RCC clear cell component (CC), (N), both (CC+N). Subgroup also to explore the effect therapy. ORR were analyzed attained...
In the absence of head-to-head trials, this study compared treatment outcomes with C3 complement inhibitor pegcetacoplan versus C5 eculizumab or ravulizumab in inhibitor-naïve patients paroxysmal nocturnal hemoglobinuria (PNH). A matching-adjusted indirect comparison was conducted using individual patient data from arm PRINCE trial (NCT04085601; n = 34) and aggregate (n 125) 121) arms ALXN1210-PNH-301 (NCT03056040). Clinical quality life endpoints were evaluated after matching two trials on...
310 Background: Drugs that block vascular endothelial growth factor (VEGF) pathway signaling, such as the tyrosine kinase inhibitor sorafenib, have become standard treatment for pts with RCC. Tivozanib (AV-951) is a potent, selective small-molecule pan-VEGF receptor (VEGFR) inhibitor, activity against VEGFR-1, -2, and -3 kinases at subnanomolar concentrations. Preliminary results from phase II randomized discontinuation trial of tivozanib (1.5 mg/d; 3 wks on, 1 wk off) in RCC demonstrated an...
We determined normalization rates for hemoglobin, lactate dehydrogenase (LDH), and fatigue in patients with paroxysmal nocturnal hemoglobinuria (PNH) treated pegcetacoplan (PEG) the PEGASUS (NCT03500549) PRINCE (NCT04085601) phase III trials. Enrolled had PNH hemoglobin < 10.5 g/dL despite ≥ 3 months of eculizumab (ECU) [PEGASUS], or were complement component 5 (C5) inhibitor-naive, receiving supportive care only, less than lower limits normal (LLN) [PRINCE]. Hematologic endpoints greater...
Cold agglutinin disease (CAD) and warm antibody autoimmune hemolytic anemia (wAIHA) are rare anemias characterized by red blood cell destruction, largely attributable to complement activation resulting in intravascular extravascular hemolysis. Pegcetacoplan is a subcutaneously administered C3-targeted therapy, which may be suitable for treating CAD wAIHA. In this open-label phase 2 study, analyses were conducted two cohorts, one patients with the other each cohort, randomly assigned receive...
7039 Background: First line treatment for stage IIIb/IV NSCLC continues to be a combination of taxane + platinum with partial responses expected in only 20 - 30% patients. Multiple pre-clinical models have shown that tumor response and survival after chemotherapies are significantly improved by the addition CPG 7909. This new synthetic oligodeoxynucleotide acts through dendritic cells targeting Toll-like Receptor 9 subsequent immunomodulatory effects. Human dose ranging, safety biologic...
330 Background: Tivozanib, a potent and selective tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor receptors (VEGFR)-1, -2, -3, has demonstrated antitumor activity in phase II study RCC (Proceedings ASCO 2009, Abstract 5032). Temsirolimus, mammalian target rapamycin (mTOR) inhibitor, is approved for treatment advanced RCC. This Ib open-label examined combination tivozanib temsirolimus therapy pts with to determine the safety tolerability, maximum tolerated dose (MTD),...
7526 Background: Malignant melanoma is widely accepted as an immunologically responsive tumor. Expectations for major clinical benefit with treatment by interferons or from biochemotherapy trials have not been met, and the prognosis patients (pts) metastatic disease remains poor. A new synthetic chemical immunomodulator, CPG 7909 (ProMune), now being studied in a large randomized phase II trial based on single agent tumor activity pts. non-antisense oligodeoxynucleotide which activates...