- |||||||||| Comirnaty (tozinameran) / Pfizer, Fosun Pharma, BioNTech, Vaxzevria (ChAdOx1-S recombinant) / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of Oxford
Clinical, Journal: Basophil reactivity to BNT162b2 is mediated by PEGylated lipid nanoparticles in PEG allergic patients. (Pubmed Central) - Jul 21, 2021
Recruiting --> Active, not recruiting Our findings implicate PEG, as covalently modified within the vaccine lipid nanoparticle, as a potential trigger of anaphylaxis to BNT162b2.
- |||||||||| Bavencio (avelumab) / EMD Serono, Trodelvy (sacituzumab govitecan-hziy) / Gilead, Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
Trial completion date, Trial primary completion date, Tumor mutational burden, Metastases: InCITe: Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer (clinicaltrials.gov) - Jul 15, 2021
P2, N=150, Recruiting,
However, these effects indicated variability depending on the cell lines and 2D or 3D model types. Trial completion date: Jul 2021 --> Jul 2023 | Trial primary completion date: Jul 2021 --> Jul 2023
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche, Imbruvica (ibrutinib) / AbbVie, J&J
Enrollment change: Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib,Rituximab (TEDDI-R) in Primary CNS Lymphoma (clinicaltrials.gov) - Jul 14, 2021
P1, N=93, Recruiting,
Trial completion date: Jul 2021 --> Jul 2023 | Trial primary completion date: Jul 2021 --> Jul 2023 N=68 --> 93
- |||||||||| pegylated liposomal doxorubicin / Generic mfg.
Journal: Iron-crosslinked Rososome with robust stability and high drug loading for synergistic cancer therapy. (Pubmed Central) - Jul 9, 2021
On the syngeneic mouse model of breast cancer, the iron-crosslinked Rososomes exhibit better anticancer efficacy than free rosmarinic acid, doxorubicin, non-crosslinked Rososome and commercial liposomal formulation of doxorubicin (DOXIL). This study introduces a novel strategy for the development of liposomes with robust stability, high drug loading and synergistic anti-cancer efficacy.
- |||||||||| Journal: From micro to nano: evolution and impact of drug delivery in treating disease. (Pubmed Central) - Jul 4, 2021
Very recently, the first siRNA lipid nanoparticle medicine, Patisiran (Onpattro®), was approved for treating hereditary transthyretin-mediated amyloidosis. In this inspirational note, we will highlight the technological evolution of drug delivery from micro- to nano-, citing some of the approved medicines demonstrating the significant impact of the drug delivery field in treating many diseases.
- |||||||||| pegylated liposomal doxorubicin / Generic mfg.
Journal: Computational and Experimental Approaches to Investigate Lipid Nanoparticles as Drug and Gene Delivery Systems. (Pubmed Central) - Jul 3, 2021
More than twenty years ago, Doxil was the first LNPs-based drug approved by the US Food and Drug Administration (FDA)...Here, we provide a review on recent advances in the development of efficient and robust LNPs for drug/gene delivery. We emphasize the importance of rationally combining experimental and computational approaches, especially those providing multiscale structural and functional information of LNPs, to the design of novel and powerful LNP-based delivery systems.
- |||||||||| Abraxane (albumin-bound paclitaxel) / BMS, Otsuka
Review, Journal: Novel Strategies for Disrupting Cancer-Cell Functions with Mitochondria-Targeted Antitumor Drug-Loaded Nanoformulations. (Pubmed Central) - Jul 2, 2021
The novel use of these NPs still faces tremendous challenges and an immense amount of research is needed to understand the proper mechanisms of cancer progression and control by these NPs. Here in this review, we summarize current advancements and novel strategies of delivering different anticancer therapeutic agents to mitochondria with the help of various nanoformulations.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Opdivo (nivolumab) / Ono Pharma, BMS, Nexavar (sorafenib) / Bayer, Amgen
Journal, Combination therapy: 223-Radium for metastatic osteosarcoma: combination therapy with other agents and external beam radiotherapy. (Pubmed Central) - Jul 1, 2021
Radiation therapy, including stereotactic body radiotherapy (SBRT), was also given to 11 patients concurrently with 223-radium (n=2), after 223-radium completion (n=3), or both concurrently and then sequentially for other sites (n=6). After 223-radium infusions, patients without RT had a median overall survival of 4.3 months compared with those with SBRT and/or RT, who had a median overall survival of 13.5 months.Conclusion Although only 1/15 of patients with osteoblastic osteosarcoma still remain alive after 223-radium, overall survival.
- |||||||||| pegylated liposomal doxorubicin / Generic mfg.
Journal: Effect of the ammonium salt anion on the structure of doxorubicin complex and PEGylated liposomal doxorubicin nanodrugs. (Pubmed Central) - Jul 1, 2021
After 223-radium infusions, patients without RT had a median overall survival of 4.3 months compared with those with SBRT and/or RT, who had a median overall survival of 13.5 months.Conclusion Although only 1/15 of patients with osteoblastic osteosarcoma still remain alive after 223-radium, overall survival. The structure, physical state, and pharmacokinetics of doxorubicin in PEGylated nanoliposomes, prepared by transmembrane remote loading using gradients of ammonium salts, strongly depend on the counteranions.
- |||||||||| Myocet (non-pegylated liopsomal doxorubicin) / Teva, Lubrizol
Journal: Microformulations and Nanoformulations of Doxorubicin for Improvement of Its Therapeutic Efficiency. (Pubmed Central) - Jun 30, 2021
Lack of a comprehensive related to drug-resistance cancer cells particularly in metastasis stages is an important hindrance to get acceptable results. Understanding of the drug resistance mechanisms in cancers cells particularly, in metastasis stages, is a critical factor to prepare efficient formulations.
- |||||||||| pegylated liposomal doxorubicin / Generic mfg.
Journal: Subtherapeutic Photodynamic Treatment Facilitates Tumor Nanomedicine Delivery and Overcomes Desmoplasia. (Pubmed Central) - Jun 26, 2021
Enhanced nanoparticle accumulation combined with the reduced extravascular barriers improved therapeutic efficacy in the absence of off-target toxicity, wherein 5 mg/kg of Doxil with PDP was equally effective in delaying tumor growth as 15 mg/kg of Doxil. Overall, this study demonstrates the potential of PDP to enhance tumor nanomedicine accumulation and alleviate tumor desmoplasia without causing cell death or vascular destruction, highlighting the utility of PDP as a minimally invasive priming strategy that can improve therapeutic outcomes in desmoplastic tumors.
- |||||||||| pegylated liposomal doxorubicin / Generic mfg.
Preclinical, Journal: Aptamers against mouse and human tumor-infiltrating myeloid cells as reagents for targeted chemotherapy. (Pubmed Central) - Jun 24, 2021
These RNA aptamers recognized tumor infiltrating myeloid cells in a variety of mouse tumors in vivo and from human HNSCC ex vivo. This work suggests the use of RNA aptamers for the detection of myeloid-derived suppressor cells in humans and for a targeted delivery of chemotherapy to the tumor microenvironment in multiple malignancies.
- |||||||||| pegylated liposomal doxorubicin / Generic mfg.
Journal: Physical characterization of liposomal drug formulations using multi-detector asymmetrical-flow field flow fractionation. (Pubmed Central) - Jun 22, 2021
This method meets a documented high priority need in regulatory science as applied to NEPs such as Doxil and can be adapted to the measurement of other NEP forms (such as lipid nanoparticle therapeutics) with some modifications...Additionally, the approach used in this work (based on international collaboration between leading non-regulatory institutions) can be replicated to address other identified gaps in the analytical characterization of various classes of NEPs. Finally, a plan exists to pursue more extended interlaboratory validation studies to advance this method to a consensus international standard.
- |||||||||| irinotecan / Generic mfg.
Journal: Design principles of drug combinations for chemotherapy. (Pubmed Central) - Jun 22, 2021
With liposomal encapsulation of each drug pair, we enabled uniform drug pharmacokinetics across the drug combinations, thus allowing us to study the inherent benefits of the drug pairs and compare them to DOX liposomes representative of DOXIL®...The GEM/DOX liposome-treated group had the longest median survival time, double that of the DOX liposome-treated group and 3.4-fold greater than that of the untreated controls. Our studies outline the development of a more efficacious formulation than clinically representative liposomal doxorubicin for breast cancer treatment and presents a novel strategy for designing cancer drug combinations.
- |||||||||| pegylated liposomal doxorubicin / Generic mfg., doxorubicin hydrochloride / Generic mfg.
Clinical, Journal: Ultrasound-mediated delivery enhances therapeutic efficacy of mmp sensitive liposomes. (Pubmed Central) - Jun 22, 2021
The MMP sensitive liposome showed better therapeutic efficacy than the non-MMP sensitive version indicating that cleaving the PEG-layer is important. However, the Doxil-like liposome outcompeted the MMP and non-MMP sensitive liposome, both with and without the use of ultrasound and microbubbles.
- |||||||||| pegylated liposomal doxorubicin / Generic mfg.
Review, Journal: Liposomal doxorubicin as targeted delivery platform: Current trends in surface functionalization. (Pubmed Central) - Jun 22, 2021
Pegylated liposomal doxorubicin clinically approved and, on the market, Doxil®, exemplifies the benefits offered upon the surface modification of liposome with polyethylene glycol...Small biomolecules such as peptides, fraction of antibodies and carbohydrates have the potential to target receptors present on the surface of the malignant cells. Hence, active targeting of malignant cells using functionalised nanocarrier (liposomes encapsulated with doxorubicin) have been attempted which is reviewed in this article.
- |||||||||| Yondelis (trabectedin) / Otsuka, PharmaMar, Valeo Pharma
Clinical, Observational data, Journal: A European, observational, prospective trial of trabectedin plus pegylated liposomal doxorubicin in patients with platinum-sensitive ovarian cancer. (Pubmed Central) - Jun 22, 2021
P=N/A
Although our study population represented a heterogeneous, older and more pretreated population than those in prospective clinical trials, the combination of trabectedin plus PLD induced comparable clinical benefits, with a similar and manageable safety profile. Overall, our findings support that trabectedin in combination with PLD maintains antitumor activity when administered to heavily pretreated patients in real-life clinical practice.
- |||||||||| dexamethasone / Generic mfg., pegylated liposomal doxorubicin / Generic mfg.
Clinical, Journal: Hypersensitivity reaction to pegylated liposomal doxorubicin administration for Mullerian carcinoma in Japanese women. (Pubmed Central) - Jun 22, 2021
Overall, our findings support that trabectedin in combination with PLD maintains antitumor activity when administered to heavily pretreated patients in real-life clinical practice. Clinicians should be aware of the potential for HSR in patients administered PLD, particularly those with allergic history and those receiving the first cycle of PLD, even following premedication.
- |||||||||| Abraxane (albumin-bound paclitaxel) / BMS, Otsuka
Journal: Development of Drug Delivery Technology and Nanomedicine by Using Gold Nanoparticles (Pubmed Central) - Jun 22, 2021
The combined therapeutic modality between therapeutics and diagnostics is called "theranostics" and is promising for future personalized cancer therapy. This review also introduces recent research from our laboratory involving the use of various kinds of molecules [polyethylene glycol (PEG), drug/cyclodextrin inclusion complexes, biosimilars and small interfering (siRNAs)] loaded onto and/or conjugated with gold nanoparticles.
- |||||||||| Lipusu (liposomal paclitaxel) / Luye Group, Cynviloq (paclitaxel polymeric micelle formulation) / Sorrento, Samyang Group, ImmunityBio, Abraxane (albumin-bound paclitaxel) / BMS, Otsuka
Review, Journal: A Review on Nano-Based Drug Delivery System for Cancer Chemoimmunotherapy. (Pubmed Central) - Jun 22, 2021
The applications of NDDS to chemoimmunotherapy would be a powerful strategy for future cancer treatment, which could greatly enhance the therapeutic efficacy, reduce the side effects and optimize the clinical outcomes of cancer patients. Herein, the current approaches of cancer immunotherapy and chemoimmunotherapy were discussed, and recent advances of NDDS applied for chemoimmunotherapy were further reviewed.
- |||||||||| Duomeisu (pegylated liposomal doxorubicin) / CSPC Pharma, Myocet (non-pegylated liposomal doxorubicin) / Teva, Sopherion
Trial completion date, Trial primary completion date, Surgery: Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer (clinicaltrials.gov) - Jun 16, 2021
P1, N=40, Active, not recruiting,
Herein, the current approaches of cancer immunotherapy and chemoimmunotherapy were discussed, and recent advances of NDDS applied for chemoimmunotherapy were further reviewed. Trial completion date: May 2021 --> Jul 2022 | Trial primary completion date: May 2021 --> Jul 2022
- |||||||||| Rituxan (rituximab) / Roche, Imbruvica (ibrutinib) / AbbVie, J&J
Enrollment change: 19-C-0103: Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, and Rituximab (TEDDI-R) in Aggressive B-cell Lymphomas With Secondary Involvement of the Central Nervous System (CNS) (clinicaltrials.gov) - Jun 9, 2021
P2, N=65, Recruiting,
Not yet recruiting --> Recruiting | Trial completion date: Apr 2021 --> Jul 2021 | Trial primary completion date: Apr 2021 --> Jul 2021 N=36 --> 65
- |||||||||| Imfinzi (durvalumab) / AstraZeneca
Trial completion date, Trial primary completion date, Combination therapy, Tumor mutational burden, IO biomarker, Metastases: Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, (DURVA+ Study) (clinicaltrials.gov) - Jun 3, 2021
P2, N=115, Recruiting,
Not yet recruiting --> Recruiting Trial completion date: Jun 2021 --> Jun 2022 | Trial primary completion date: Jun 2021 --> Jun 2022
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