scholarly journals Development, Optimization and Absorption Mechanism of DHP107, Oral Paclitaxel Formulation for Single-Agent Anticancer Therapy

Author(s):  
In-Hyun Lee ◽  
Jung Wan ◽  
Yura Jang ◽  
Yeong Taek ◽  
Hesson Chung
2011 ◽  
Vol 29 (31) ◽  
pp. 4129-4136 ◽  
Author(s):  
Purvish M. Parikh ◽  
Ashok Vaid ◽  
Suresh H. Advani ◽  
Raghunadharao Digumarti ◽  
Jayaprakash Madhavan ◽  
...  

Purpose To investigate the activity and safety of oral talactoferrin (TLF) in patients with stages IIIB to IV non–small-cell lung cancer (NSCLC) for whom one or two prior lines of systemic anticancer therapy had failed. Patients and Methods Patients (n = 100) were randomly assigned to receive either oral TLF (1.5 g in 15 mL phosphate-based buffer) or placebo (15 mL phosphate-based buffer) twice per day in addition to supportive care. Oral TLF or placebo was administered for a maximum of three 14-week cycles with dosing for 12 consecutive weeks followed by 2 weeks off. The primary objective was overall survival (OS) in the intent-to-treat (ITT) patient population. Secondary objectives included progression-free survival (PFS), disease control rate (DCR), and safety. Results TLF was associated with improvement in OS in the ITT patient population, meeting the protocol-specified level of significance of a one-tailed P = .05. Compared with the placebo group, median OS increased by 65% in the TLF group (3.7 to 6.1 months; hazard ratio, 0.68; 90% CI, 0.47 to 0.98; P = .04 with one-tailed log-rank test). Supportive trends were also observed for PFS and DCR. TLF was well tolerated and, generally, there were fewer adverse events (AEs) and grade ≥ 3 AEs reported in the TLF arm. AEs were consistent with those expected in late-stage NSCLC. Conclusion TLF demonstrated an apparent improvement in OS in patients with stages IIIB to IV NSCLC for whom one or two prior lines of systemic anticancer therapy had failed and was well tolerated. These results should be confirmed in a global phase III trial.


Author(s):  
Jian Sun ◽  
Edikan Archibong Ogunnaike ◽  
Xing Jiang ◽  
Zhaowei Chen

Nanotechnology-based combination anticancer therapy offers novel approaches to overcome the limitations of single-agent administration. The emerging siRNA technology combined with chemotherapy has shown considerable promise in anticancer therapy. There are...


2016 ◽  
Vol 38 (1) ◽  
pp. 133-145 ◽  
Author(s):  
Yura Jang ◽  
Hye Jin Chung ◽  
Jung Wan Hong ◽  
Cheol-Won Yun ◽  
Hesson Chung

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 4-4
Author(s):  
Suzanne Trudel ◽  
Randy Davis ◽  
Nicole M. Lewis ◽  
Kalpana K. Bakshi ◽  
Bikramjit Chopra ◽  
...  

Introduction: Belantamab mafodotin (belamaf; GSK2857916) is a B-cell maturation antigen (BCMA)-targeting antibody-drug conjugate. In the pivotal Phase II DREAMM-2 study, single-agent belamaf demonstrated deep and durable responses with a manageable safety profile in heavily pretreated patients with RRMM (Lonial et al. Lancet Oncol 2020). Responses were sustained at 13 months of follow-up; with belamaf (2.5 mg/kg administered intravenously [IV] every 3 weeks [Q3W]), overall response rate (ORR) was 32% and median duration of response (DoR) was 11.0 months (Lonial et al. ASCO 2020 Poster 436). Preclinical data suggest synergistic antimyeloma activity of belamaf in combination with pomalidomide/dexamethasone (Pd). Preliminary data from an ongoing Phase I/II study (NCT03715478) evaluating belamaf in combination with Pd (B-Pd) suggest an acceptable safety profile and early signs of clinical activity in patients with RRMM. The DREAMM-8 study (NCT04484623) will evaluate the efficacy and safety of B-Pd compared with pomalidomide, bortezomib, and dexamethasone (PVd). Methods: This Phase III, two-arm, randomized, open-label, multicenter study will include patients with measurable RRMM who have received ≥1 prior line of therapy (including lenalidomide), with documented disease progression during or after their most recent line of treatment. Patients aged ≥18 years with Eastern Cooperative Oncology Group Performance Status 0-2, adequate organ system function, and who provide informed consent will be eligible. Patients with prior exposure to BCMA-targeted therapies or pomalidomide and those intolerant/refractory to bortezomib will be excluded. Approximately 450 patients will be randomized (1:1) to Arm A (B-Pd) or Arm B (PVd), stratified by number of prior lines of treatment, prior exposure to bortezomib, and International Staging System status. No more than 50% of participants with two or more prior lines of treatment will be enrolled. In Arm A, patients will receive belamaf 2.5 mg/kg (IV) Q4W on Day 1 in Cycle 1 (28-day cycle) followed by belamaf 1.9 mg/kg (IV) Q4W on Day 1 in Cycle 2 onwards (28-day cycles); pomalidomide 4 mg (orally [PO]) will be administered on Days 1-21 and dexamethasone 40 mg (PO) on Days 1, 8, 15, and 22 in all cycles (28-day cycles). In Arm B, pomalidomide 4 mg (PO) will be administered Q3W on Days 1-14 in all cycles (21-day cycles); bortezomib 1.3 mg/m2 will be administered subcutaneously on Days 1, 4, 8, and 11 in Cycles 1-8, and Days 1 and 8 in Cycle 9+ (21-day cycles). Dexamethasone 20 mg (PO) will be administered on the day of and the day after bortezomib. The dose level of dexamethasone in each arm will be reduced by half in patients >75 years of age. Treatment in both arms will continue until progressive disease, unacceptable toxicity, withdrawal of consent, initiation of another anticancer therapy, or end of study or death. The primary endpoint is progression-free survival (PFS; time from randomization to the earliest date of documented disease progression or death [any cause]). Minimal residual disease negativity rate is a key secondary endpoint. Additional secondary endpoints include ORR, time to response, DoR, time to progression, overall survival, PFS2 (PFS after initiation of new anticancer therapy), safety, health-related quality of life, and pharmacokinetic and pharmacodynamic parameters. The study is planned to start in August 2020. Funding: GSK (Study 207499); drug linker technology licensed from Seattle Genetics; mAb produced using POTELLIGENT Technology licensed from BioWa. Disclosures Trudel: GSK, Celgene, Janssen, Amgen, Genentech: Research Funding; Celgene, Janssen, Takeda, Sanofi, Karyopharm, Amgen Canada: Honoraria; Celgene, Amgen, GSK: Consultancy, Research Funding. Davis:GSK: Current Employment, Current equity holder in publicly-traded company. Lewis:GSK: Current Employment, Current equity holder in publicly-traded company. Bakshi:GSK: Current Employment, Current equity holder in publicly-traded company. Chopra:GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Montes de Oca:GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Ferron-Brady:GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Eliason:GSK: Current Employment, Current equity holder in publicly-traded company. Kremer:GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Gupta:GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company; Novartis: Current equity holder in publicly-traded company. Wu:GSK: Current Employment, Current equity holder in publicly-traded company.


2013 ◽  
Vol 12 (8) ◽  
pp. 1442-1452 ◽  
Author(s):  
Amy D. Guertin ◽  
Jing Li ◽  
Yaping Liu ◽  
Melissa S. Hurd ◽  
Alwin G. Schuller ◽  
...  

2012 ◽  
Vol 42 (18) ◽  
pp. 6
Author(s):  
PATRICE WENDLING
Keyword(s):  

2020 ◽  
Vol 92 (2) ◽  
pp. 20101
Author(s):  
Behnam Kheyraddini Mousavi ◽  
Morteza Rezaei Talarposhti ◽  
Farshid Karbassian ◽  
Arash Kheyraddini Mousavi

Metal-assisted chemical etching (MACE) is applied for fabrication of silicon nanowires (SiNWs). We have shown the effect of amorphous sheath of SiNWs by treating the nanowires with SF6 and the resulting reduction of absorption bandwidth, i.e. making SiNWs semi-transparent in near-infrared (IR). For the first time, by treating the fabricated SiNWs with copper containing HF∕H2O2∕H2O solution, we have generated crystalline nanowires with broader light absorption spectrum, up to λ = 1 μm. Both the absorption and photo-luminescence (PL) of the SiNWs are observed from visible to IR wavelengths. It is found that the SiNWs have PL at visible and near Infrared wavelengths, which may infer presence of mechanisms such as forbidden gap transitions other can involvement of plasmonic resonances. Non-radiative recombination of excitons is one of the reasons behind absorption of SiNWs. Also, on the dielectric metal interface, the absorption mechanism can be due to plasmonic dissipation or plasmon-assisted generation of excitons in the indirect band-gap material. Comparison between nanowires with and without metallic nanoparticles has revealed the effect of nanoparticles on absorption enhancement. The broader near IR absorption, paves the way for applications like hyperthermia of cancer while the optical transition in near IR also facilitates harvesting electromagnetic energy at a broad spectrum from visible to IR.


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