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Last update 08 May 2025

bFGF x M-CSF

Last update 08 May 2025

Basic Info

Related Targets

bFGFM-CSF

Drugs associated with bFGF x M-CSF

AUP1602-C

Target

M-CSF x bFGF

Mechanism

M-CSF agonists [+1]

Active Org.

Aurealis Oy [+2]

Originator Org.

Aurealis Oy

Active Indication

Diabetic foot ulcer [+3]

Inactive Indication-

Drug Highest PhasePhase 2

First Approval Ctry. / Loc.-

First Approval Date20 Jan 1800

Clinical Trials associated with bFGF x M-CSF

NCT06111183

/ RecruitingPhase 2

Phase-2, Multi-centre, Prospective, Randomized, Standard-of-care Plus Placebo-controlled, Patient and Central Evaluator Blinded, Parallel Arm, Clinical Study to Evaluate Safety, Tolerability and Efficacy of the AUP1602-C as Treatment for Non-healing Neuro-ischemic DFU

This is a phase 2 study performed in diabetic foot ulcer (DFU) patients with chronic non-healing, neuro-ischemic wounds to investigate the safety, tolerability and efficacy of AUP1602-C.

Start Date21 Jul 2023

Sponsor / Collaborator

Aurealis Oy

CTIS2022-502048-10-00

/ Not yet recruitingPhase 2

A phase-2, multi-centre, prospective, randomized, standard-of-care plus placebo-controlled, patient and central evaluator blinded, parallel arm, clinical study to evaluate safety, tolerability and efficacy of the recommended phase-2 dose of AUP1602-C in two dosing frequencies as a topical treatment for non-healing neuro-ischemic diabetic foot ulcers - AT-W-CLI-2022-04

Start Date21 Jul 2023

Sponsor / Collaborator

Aurealis Oy

NCT04281992

/ CompletedPhase 1/2

A Phase 1/2A Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Single and Repeated Doses of AUP1602-C as Topical Treatment of Diabetic Foot Ulcers

This is a two-part phase 1/2A study performed in diabetic foot ulcer (DFU) patients with chronic non-healing wounds to investigate the safety and efficacy of AUP1602-C.

Start Date28 Jan 2020

Sponsor / Collaborator

Aurealis Oy

100 Clinical Results associated with bFGF x M-CSF

100 Translational Medicine associated with bFGF x M-CSF

0 Patents (Medical) associated with bFGF x M-CSF

Literatures (Medical) associated with bFGF x M-CSF

01 Jun 2025·Cryobiology

Effect of vitrification on in vitro developmental competence of rat testicular tissue

Article

Author: Ebrahimi, Bita ; Deheshkar Gooneh Farahani, Nafiseh Sadat ; Hajiaghalou, Samira ; Aghajanpour, Samaneh ; Shahverdi, Abdolhossein ; Rezazadeh Valojerdi, Mojtaba ; Sharbatoghli, Mina

Cryopreservation of testicular tissue has been proposed as a potential technique for preserving fertility in pre-pubertal boys with various malignancies. The present study aimed to compare the effects of two vitrification techniques-solid surface vitrification (SSV) and needle-immersed vitrification (NIV)-on the integrity, development, cell viability, and apoptosis of rat testicular tissue. Testes from 4-week-old Wistar rats underwent a two-step vitrification process. Tissue pieces were allocated to either the SSV or NIV group. Equilibration involved a solution containing 7.5 % dimethyl sulfoxide (DMSO) and 7.5 % ethylene glycol (EG), followed by a vitrification solution with 0.07 mol/L sucrose, 15 % DMSO, and 15 % EG. The optimal protocol was determined after vitrification using either the NIV or SSV technique. Samples from the control and selected vitrification (SSV) groups were cultured for 3 weeks. Tissue integrity, cell viability, apoptosis, and gene expression were evaluated using hematoxylin and eosin staining, trypan blue staining, annexin V-PI staining, and real-time PCR. Morphological changes were more pronounced in the NIV group compared to the SSV group (P < 0.05). Although the percentage of viable cells did not significantly differ between the NIV and SSV groups, it was slightly higher in the SSV group. Thus, SSV was identified as the optimum vitrification method. Real-time PCR analysis revealed altered gene expression: spermatogonial-related genes (Lrp4, Egr3, Nanos, Gfra1, C-kit, and Sohlh1) were significantly decreased in the SSV group, while somatic-cells-related genes (Gdnf, Csf1, and Fgf2) were higher. Overall, SSV appears suitable for rat testis tissue vitrification, although it induces some molecular changes. Optimization of the culture medium is essential to support successful spermatogenesis.

01 Apr 2025·Immunity, Inflammation and Disease

Altered Circulating Cytokine Profile Among mRNA‐Vaccinated Young Adults: A Year‐Long Follow‐Up Study

Article

Author: Hussain, Syed Danish ; Alnaami, Abdullah M. ; Alghamdi, Amani ; Wani, Kaiser ; Al‐Daghri, Nasser M. ; Amer, Osama Emam ; Sabico, Shaun

ABSTRACTObjectivesThis longitudinal study aimed to assess the impact of COVID‐19 vaccination on cytokine profile.MethodsA total of 84 Saudi subjects (57.1% females) with mean age of 27.2 ± 12.3 participated in this longitudinal study. Anthropometric data and fasting blood samples were obtained at baseline and after final vaccination, with an average follow‐up duration of 14.1 ± 3.6 months for adolescents and 13.3 ± 3.0 months for adults, calculated from the first dose of vaccination. Assessment of cytokine profiles was done using commercially available assays.ResultsAfter follow‐up, a significant increase in weight and body mass index was observed overall (p = 0.003 and p = 0.002, respectively). Postvaccination, significant increases were observed in several cytokines, including basic fibroblast growth factor 2 (p < 0.001), interferon gamma (IFNγ) (p = 0.005), interleukin‐1 beta (IL1β) (p < 0.001), IL4 (p < 0.001), IL6 (p = 0.003), IL7 (p = 0.001), IL17E (p < 0.001), monocyte chemoattractant protein‐1 (MCP1) (p = 0.03), MCP3 (p = 0.001), tumor necrosis factor alpha (TNFα) (p < 0.001), and VEGFA (p < 0.001). A significant reduction was observed only in macrophage colony‐stimulating factor (p < 0.001). When adjusted for age, epidermal growth factor (EGF), IL4, IL6, MCP3, TNFα, and vascular endothelial growth factor (VEGFA) remained statistically significant. Gender‐based analysis revealed that men experienced greater increases in IL6 (p = 0.008), IL4 (p = 0.04), and TNFα (p = 0.015) compared to women. Age‐based analysis showed that older participants had more pronounced increases in EGF (p = 0.011), IL6 (p = 0.029), MCP1 (p = 0.042), and TNFα (p = 0.017), while younger participants had a greater increase in VEGFA (p = 0.025).ConclusionsThe findings of this study indicated that COVID‐19 vaccination resulted in an increase in cytokine levels, which signifies the persistence of the humoral immune response to messenger RNA (mRNA) vaccines. This effect may be attributed to the persistent production of spike protein and highly inflammatory nature of mRNA–lipid nanoparticle. Additionally, the results suggested differences in cytokine levels based on gender and age. Notably, the cytokine profile remains favorably altered in young adults who received mRNA vaccinations, even after 1 year.

01 May 2024·Therapeutic Advances in Endocrinology and Metabolism

Multi-target gene therapy AUP1602-C to improve healing and quality of life for diabetic foot ulcer patients: a phase I, open-label, dose-finding study

Article

Author: Sanio, Mirka ; Wirth, Thomas ; Schellong, Sebastian ; Weber, Dirk ; Samaranayake, Haritha ; Mikosiński, Pawel ; Mierau, Igor ; Décory, Laurent ; Kärkkäinen, Hanna-Riikka ; Mikosiński, Jacek ; Kurkipuro, Jere ; Yrjänheikki, Juha ; Vartiainen, Aki ; Schindler, Christoph ; Smith, Wesley

Background: Diabetic foot ulcer (DFU) is a common and highly morbid complication of diabetes with high unmet medical needs. AUP1602-C, a topical four-in-one gene therapy medicinal product (GTMP), consisting of a Lactococcus cremoris strain that produces fibroblast growth factor-2, interleukin-4, and colony-stimulating factor-1, is a promising novel treatment for DFU. Objectives: The aim of this first-in-human study was to investigate whether AUP1602-C is safe and effective in improving wound healing and quality of life (QoL) in patients with non-healing DFU (nhDFU), and to determine the recommended phase II dose. Design: Phase I, single-arm, open-label, uncontrolled, dose escalation study. Methods: The study consisted of four cohorts of patients receiving AUP1602-C as a single dose of 2.5 × 105 colony-forming units (CFU)/cm2 ulcer size or as repeated doses between 2.5 × 106 and 2.5 × 108 CFU/cm2 administered 3 times per week for 6 weeks. Within each cohort, a 3 + 3 scheme for monitoring safety, tolerability, and efficacy was applied. Results: In total, 16 patients aged 53–80 years were included, 3 each in the safety and low dose, 4 in the medium dose, and 6 in the high-dose cohort. AUP1602-C demonstrated a favorable safety profile with almost 100% dosing compliance. The most frequently reported side effect related to treatment was skin maceration. No serious adverse reactions, systemic toxicity, deaths, or side effects suggestive of immunogenicity, hypersensitivity, allergic reaction, or dose-limiting toxicities related to treatment were reported. No biodistribution events were observed and shedding-related events were rare and did neither show accumulation nor dose dependency. The recommended phase II dose of 2.5 × 108 CFU/cm2 demonstrated complete healing in 83% of patients without recurrence of ulcers during follow-up. Conclusion: AUP1602-C was safe and well tolerated and demonstrated dose-dependent efficacy in patients with nhDFU. Data supports further clinical development of AUP1602-C. Trial registration: The study was registered in ClinicalTrials.gov (NCT04281992) and ClinicalTrialsRegister.eu (2018-003415-22).

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