A Randomized, Placebo-controlled, Double-blind Phase 2b Trial to Assess the Efficacy and Safety of Ex Vivo Allograft Admin of ICM012 Solution 2 Mg/mL to Improve Allograft Function in Recipients of Donation After Circulatory Death Kidneys

Randomized (1:1), placebo controlled, double blind efficacy trial. 200 patients will be followed up for 12 months post transplantation. The primary endpoint will be Delayed Graft Function (DGF) defined as the requirement for dialysis within 7 days post transplantation.

Start Date01 Jan 2025

Sponsor / Collaborator

iCoat Medical ABStartup

NCT05246618 / CompletedPhase 1/2

Phase I FIH Phase I/IIa Randomized Placebocontrolled Doubleblind Trial Evaluating Safety and Tolerability of ExVivo Deceased Donor Kidney Allograft Treatment With TUM012 to Minimize Ischemic Reperfusion Injury After Kidney Transplantation

A first-in-human single center, randomized, double-blind, placebo-controlled trial, with primary objective to evaluate safety and tolerability of ex-vivo kidney allograft treatment with TUM012 to reduce ischemia-reperfusion injury in de novo kidney transplant recipients.

Start Date31 Mar 2022

Sponsor / Collaborator

iCoat Medical ABStartup

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100 Clinical Results associated with TUM-012

100 Translational Medicine associated with TUM-012

100 Patents (Medical) associated with TUM-012

Literatures (Medical) associated with TUM-012

International Journal of NanomedicineQ2 · MEDICINE

A novel application of maleimide for advanced drug delivery: in vitro and in vivo evaluation of maleimide-modified pH-sensitive liposomes

Q2 · MEDICINE

ArticleOA

Author: Shinji Takeoka ; Tianshu Li

Maleimide is a stable and easy-to-handle moiety that rapidly and covalently conjugates thiol groups of cysteine residues in proteins or peptides. Herein, we use maleimide to modify the surface of liposomes in order to obtain an advanced drug delivery system. Employing a small amount (0.3 mol%) of maleimide-polyethylene glycol (PEG) to modify the surface of the liposomes M-GGLG-liposomes, composed of 1,5-dihexadecyl N,N-diglutamyl-lysyl-L-glutamate (GGLG)/cholesterol/poly(ethylene glycol) 1,2-distearoyl-sn-glycero-3-phosphoethanolamine (PEG5000-DSPE)/maleimide-PEG5000-Glu2C18 at a molar ratio of 5:5:0.03:0.03, drug delivery efficiency was remarkably improved both in vitro and in vivo compared to unmodified liposomes (GGLG-liposomes, composed of GGLG/cholesterol/PEG5000-DSPE/PEG5000-Glu2C18 at a molar ratio of 5:5:0.03:0.03). Moreover, this modification did not elicit any detectable increase in cytotoxicity. The maleimide-modification did not alter the physical characteristics of the liposomes such as size, zeta potential, pH sensitivity, dispersibility and drug encapsulation efficiency. However, M-GGLG-liposomes were more rapidly (≥2-fold) internalized into HeLa, HCC1954, and MDA-MB-468 cells compared to GGLG-liposomes. In vivo, M-GGLG-liposomes encapsulating doxorubicin (M-GGLG-DOX-liposomes) also showed a more potent antitumor effect than GGLG-DOX-liposomes and the widely used 1,2-dipalmitoyl-sn-glycero-3-phosphocholine (DPPC)-DOX-liposomes after two subcutaneous injections around breast cancer tissue in mice. The biodistribution of liposomes in this model was observed using an in vivo imaging system, which showed that M-GGLG-liposomes were present for significantly longer at the injection site compared to GGLG-liposomes. The outstanding biological functions of the maleimide-modified liposomes as a novel drug delivery system make them ideally suited to a wide range of applications.

100 Deals associated with TUM-012

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Reperfusion Injury	Phase 3	-	iCoat Medical ABStartup	01 Jan 2025
Transplant complication	Phase 3	-	iCoat Medical ABStartup	01 Jan 2025
Oxygen radical damage	Phase 2	SE	iCoat Medical ABStartup	31 Mar 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05246618 (ATMIRe, Corporate Publications) Manual	Phase 1	Renal transplant rejection	18	TUM012	(yebjurigdj) = Adverse events were equally distributed between the two treatment groups. There were no serious adverse events related to iCM012 treatment. scmfdmbjjp (kxmopofnny ) Met	Positive	19 Sep 2023
				Placebo

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