CEB-01 / Cebiotex - LARVOL DELTA

CEB-01 membrane loaded with SN-38 for local post-resection control and metastasis reduction in preclinical pancreatic cancer models. (PubMed, Drug Deliv Transl Res) - "Implanted in the PC surgical bed, CEB-01 releases SN-38 in a prolonged manner for tumor growth control.Using in vivo pancreatic models, CEB-01 shows statistically significant reduction of postoperative tumor growth at local concentrations of SN-38 between 25 and 50 µg/cm2, both as monotherapy and in combination with chemotherapy (5-FU 30 mg/kg and 90 mg/kg leucovorin), in MIA PaCa-2 and metastatic Panc-1 pancreatic xenograft models...Overall, no systemic toxic effects or changes in body weight were observed, confirming that CEB-01 shows a tolerable profile after post-surgical resection in in vivo models of PC. In conclusion, CEB-01 is a feasible drug delivery strategy for the local release of SN-38 as an add-on adjuvant to current PC treatments, strategy that could potentially reduce systemic side effects compared to intravenous administration of irinotecan."

Journal • Preclinical • Oncology • Pancreatic Cancer • Solid Tumor

CEB-01 in Locally Resectable Pancreatic Cancer (clinicaltrials.gov) - P2 | N=39 | Recruiting | Sponsor: CEBIOTEX | N=21 ➔ 39

Enrollment change • Oncology • Pancreatic Cancer • Solid Tumor

CEB-01-RLP01-C: CEB-01 in Paediatrics With Locally Resectable Abdominal Tumours. (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: CEBIOTEX

New P2 trial • Pediatrics

CEB-01 in Locally Resectable Pancreatic Cancer (clinicaltrials.gov) - P2 | N=21 | Recruiting | Sponsor: CEBIOTEX

New P2 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

First-in-human CEB-01: Novel loco-regional SN-38 release membrane to prevent local recurrence in retroperitoneal sarcomas. (ASCO 2024) - P1 | "CEB-01 recommended phase II level is 18 mg. CEB-01 at 18 mg provides promising local disease control and a local steady and prolonged release of SN-38, with a much lower Cmax than irinotecan. An international phase 2 trial with CEB-01 at 18 mg to demonstrate local control is underway."

P1 data • Anemia • Cardiovascular • Hematological Disorders • Leiomyosarcoma • Liposarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

CEB-01-RLS01-CT: First-in-man Clinical Trial of CEB-01 PLGA Membrane in Recurrent or Locally Advanced Retroperitoneal Soft Tissue Sarcoma (clinicaltrials.gov) - P1 | N=21 | Active, not recruiting | Sponsor: CEBIOTEX | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2024 ➔ May 2025 | Trial primary completion date: Dec 2023 ➔ May 2025

Enrollment closed • Metastases • Surgery • Trial completion date • Trial primary completion date • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

FIRST IN HUMAN PHASE I TRIAL OF A NOVEL DRUG DELIVERY IMPLANT MATRIX WITH SN-38 (CEB-01) FOR RETROPERITONEAL SOFT TISSUE SARCOMA (CTOS 2023) - P1 | "CEB-01 is safe, well-tolerated and no dose-limiting toxicity has been observed at either dosage level. Adverse events are similar to those observed post RPS surgery. Local recurrence in the area of the membrane has occurred in 2 out of 10 patients (both treated with the lower dose)."

P1 data • Leiomyosarcoma • Liposarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

First in human trial of CEB-01 for retroperitoneal soft tissue sarcoma (ESMO 2023) - P1 | "Local recurrence occurred in 2 out of 10 pts at 5.5- and 8.6-months post-surgery. CEB-01 provides a local steady and prolonged release of SN-38, with a much lower Cmax than when SN-38 is administered as irinotecan."

P1 data • Leiomyosarcoma • Liposarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

CEB-01-RLS01-CT: First-in-man Clinical Trial of CEB-01 PLGA Membrane in Recurrent or Locally Advanced Retroperitoneal Soft Tissue Sarcoma (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: CEBIOTEX | Trial completion date: Apr 2023 ➔ Mar 2024 | Trial primary completion date: Mar 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

CEB-01-RLS01-CT: First-in-man Clinical Trial of CEB-01 PLGA Membrane in Recurrent or Locally Advanced Retroperitoneal Soft Tissue Sarcoma (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: CEBIOTEX | Trial completion date: Apr 2022 ➔ Apr 2023 | Trial primary completion date: Mar 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Surgical implantation of CEB-01, novel drug delivery matrix, in patients with recurrent or locally advanced retroperitoneal soft tissue sarcoma (RPS) (ESSO 2021) - No abstract available

Clinical • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

[VIRTUAL] First-in-human administration of CEB-01, a novel drug delivery implant matrix, in patients with recurrent or locally advanced retroperitoneal soft tissue sarcoma (RPS) after surgery: Preliminary safety and pharmacokinetics report. (ASCO 2021) - P1 | "CEB-01 biocompatible and resorbable implant matrix loaded with SN38 has proven to be safe upon first human administrations in RPS patients, with scarce low grade AEs and TRAE . Preliminary PK indicates low, prolonged, systemic SN-38 exposure as expected . Currently the second cohort of this trial is open for recruitment."

Clinical • P1 data • PK/PD data • Alopecia • Infectious Disease • Liposarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

[VIRTUAL] Cebiotex Biomedical Nanofibers (BIO 2021) - "Cebiotex current mission is to provide solutions to patients with cancer, both adult and paediatric through its CEBIOTEX® Technological Platform patented in USA, EU, China and Japan (last one in process) First drug, CEB-01, is the first effective local control system for Soft Tissue Sarcomas (STS) that covers an unmet oncological need by helping surgeons to obtain optimal results in their surgical interventions. Future perspective of CEBIOTEX® Technological Platform is to also provide solutions to patients who suffer from other cancer indications and other therapeutical applications as infections or advanced therapies for marrow and cartilage regeneration, marrow injuries, ... More information at www.cebiotex.com/en/"

Infectious Disease • Oncology • Pediatrics • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

First-in-man Clinical Trial of CEB-01 PLGA Membrane in Recurrent or Locally Advanced Retroperitoneal Soft Tissue Sarcoma (clinicaltrials.gov) - P1; N=21; Recruiting; Sponsor: CEBIOTEX

Clinical • New P1 trial • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor