Opaxio (paclitaxel poliglumex) / SOBI - LARVOL DELTA

Phase III Randomized Trial of Maintenance Taxanes Versus Surveillance in Women With Advanced Ovarian/Tubal/Peritoneal Cancer: A Gynecologic Oncology Group 0212:NRG Oncology Study. (PubMed, J Clin Oncol) - "Maintenance therapy with P and PP did not improve OS among patients with newly diagnosed O/tubal/peritoneal cancer, but may modestly increase PFS. GI and neurologic toxicities were more frequent in the taxane treatment arms."

Journal • P3 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer

Synthesis of doxorubicin-loaded peptosomes hybridized with gold nanorod for targeted drug delivery and CT imaging of metastatic breast cancer. (PubMed, J Nanobiotechnology) - "In this regard, the synthesized theranostic peptosomes offer innovative hybrid multipurpose platform for fighting against breast cancer."

Journal • Breast Cancer • Oncology • Solid Tumor

Polyphosphazenes: Versatile backbone structures in branched polymeric architecture (ACS-Sp 2022) - "Polyglutamic acid (PGA) is a promising polymeric material for biomedical applications, already in late stage III clinical trials in the form of Opaxio®/Polyglumex, however suffers from a relatively low plasma half-life time limited by its relatively low synthetically achievable molecular weight and linear structure. Herein, we demonstrate the synthesis of novel high molecular weight, densely grafted PGA-g-PPz, overcoming the limits of its linear analogue through combination with poly(organo)phosphazenes. Furthermore, the pharmacokinetics, as well as the enhanced biodistribution profil of fluorophore-labelled bottlebrush polymers are reported."

A Phase I/II Study of Radiation Therapy, Paclitaxel Poliglumex and Cetuximab in Advanced Head and Neck Cancer (clinicaltrials.gov) - P1/2; N=53; Completed; Sponsor: State University of New York - Upstate Medical University; Recruiting ➔ Completed

Trial completion • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • CTSB • ER

CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mL (clinicaltrials.gov) - P3; N=0; Withdrawn; Sponsor: CTI BioPharma; N=43 ➔ 0; Terminated ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer (clinicaltrials.gov) - P3; N=350; Terminated; Sponsor: CTI BioPharma; Active, not recruiting ➔ Terminated

Clinical • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Cancer Nanomedicines Based on Synthetic Polypeptides. (PubMed, Biomacromolecules) - "A few polypeptide-based nanoformulations (e.g., NK105, NC6004, NK911, CT2103) are under phases I-III clinical investigation for treating patients with advanced solid tumors. Moreover, virus-mimicking vehicles have been devised from polypeptides for efficient non-viral delivery of highly potent peptides, proteins, and nucleic acids, greatly advancing biotherapy for cancers. In this perspective, we highlight the state-of-the-art design and fabrication of cancer nanomedicines based on synthetic polypeptides, and at the end give our viewpoints on their future development for targeted cancer therapy and potential challenges for clinical translation."

Journal • Oncology • Psychiatry • Solid Tumor

Carboplatin With Either Paclitaxel Poliglumex or Paclitaxel in Treating Women With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer (clinicaltrials.gov) - P3; N=450; Terminated; Sponsor: CTI BioPharma; Recruiting ➔ Terminated

Clinical • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer (clinicaltrials.gov) - P3; N=N/A; Terminated; Sponsor: CTI BioPharma; Active, not recruiting ➔ Terminated

Clinical • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer (clinicaltrials.gov) - P3; N=N/A; Terminated; Sponsor: CTI BioPharma; Active, not recruiting ➔ Terminated

Clinical • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mL (clinicaltrials.gov) - P3; N=43; Terminated; Sponsor: CTI BioPharma; N=450 ➔ 43; Active, not recruiting ➔ Terminated

Clinical • Enrollment change • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A randomized phase III trial of maintenance chemotherapy comparing 12 monthly cycles of single agent paclitaxel or CT-2103 (IND# 70177) versus no treatment until documented relapse in women with advanced ovarian, primary peritoneal or fallopian tube cancer who achieve a complete clinical response to primary platinum/taxane chemotherapy (NRG 2020) - No abstract available

Clinical • P3 data

A randomized phase III trial of maintenance chemotherapy comparing 12 monthly cycles of single agent paclitaxel or CT-2103 (IND# 70177) versus no treatment until documented relapse in women with advanced ovarian, primary peritoneal or fallopian tube cancer who achieve a complete clinical response to primary platinum/taxane chemotherapy (NRG 2020) - No abstract available

Clinical • P3 data