Delving into the Latest Updates on CEB-01 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

N-38 loaded biodegradable nanofiber, SN 38 loaded biodegradable nanofiber

+ [1]

Target

TOP1

Mechanism

TOP1 inhibitors(DNA topoisomerase I inhibitors)

Therapeutic Areas

NeoplasmsOther DiseasesDigestive System Disorders+ [1]

Active Indication

Pancreatic CarcinomaLocally Advanced Soft Tissue SarcomaNeuroblastoma

Inactive Indication

Ewing Sarcoma

Originator Organization

Polytechnic University of Catalonia

Active Organization

Cebiotex SL

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

RegulationOrphan Drug (EU)

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The CEB-01 implant is a membrane containing SN-38, the active metabolite of irinotecan, an already authorized chemotherapeutic agent. After surgical removal of the pancreatic cancer tumor, CEB 01 will be placed in the surgical bed for a local and sustained release of the chemotherapy. This is expected to delay or prevent local recurrence of pancreatic cancer after surgery, while keeping a tolerable toxicity profile.
The study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of CEB-01 in patients with locally resectable pancreatic cancer

Start Date09 Aug 2024

Sponsor / Collaborator

Cebiotex SL

[+1]

NCT04619056 / Active, not recruitingPhase 1

First-in-man Clinical Trial to Assess Safety and Tolerability of CEB-01 PLGA Membrane in Patients With Recurrent or Locally Advanced Retroperitoneal Soft Tissue Sarcoma After Surgery

This is an open label, first-in-man clinical trial to assess safety and tolerability of CEB-01 PLGA membrane in patients with recurrent or locally advanced retroperitoneal soft tissue sarcoma after surgery.
The trial will be conducted in 3 dose-escalation cohorts (3 patients each, enrolling patients one by one, after 4 weeks of observation and agreement of Scientific Committee and DMC) and in an expansion cohort, using the highest safe and tolerable dose. The study will follow a 3+3 modified design; dose escalation will follow a modified Fibonacci method. CEB-01 carrying a SN-38 dose between 9 and 36 mg will be placed in the surgical bed at the time of tumor resection.

Start Date03 Jun 2020

Sponsor / Collaborator

Cebiotex SL

100 Clinical Results associated with CEB-01

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100 Translational Medicine associated with CEB-01

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100 Patents (Medical) associated with CEB-01

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100 Deals associated with CEB-01

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pancreatic Carcinoma	Phase 2	ES	Cebiotex SL	09 Aug 2024
Locally Advanced Soft Tissue Sarcoma	Phase 1	ES	Cebiotex SL	03 Jun 2020
Neuroblastoma	Phase 1	-	Cebiotex SL	-
Ewing Sarcoma	Discovery	ES	Cebiotex SL	03 Jun 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04619056 (ASCO2021) Manual	Phase 1	Sarcoma	-	CEB-01	(ycsmifubrc) = AEs consisted of one catheter infection and one hypomagnesemia, both grade 3. repqposwiq (pxmebiavgb )	Positive	20 May 2021