Project description:The study consists of three parts: 1) normal aging in liver and skin (cross-sectional); 2) treatment with rotenone in brain, liver and skin; 3) longitudinal study of 45 fish with different ages at their death measured at two different time points by fin clipping Jena Centre for Systems Biology of Ageing - JenAge (www.jenage.de)
Project description:Biopsy samples from 4 sites were collected for RNA-Seq and single-cell RNA-Seq from patients with HER2 positive tumors enrolled in a Phase 1 clinical trial of anti-HER2 CAR-macrophage cell therapy. Biopsies of solid tumors were aimed to be collected at screening, 8 days after treatment, and 4 weeks after treatment. Patients in Group 1 received dose escalation of intravenous administration of up to 500 million cells, 1.5 billion cells, and 3 billion cells, on Day 1, 3, and 5, respectively. Patients in Group 2 received their full dose of cells on Day 1. This trial aimed to determine the feasibility of manufacturing CAR-macrophages, as well as assess the safety and tolerability of CAR-macrophage therapy, and determine the severity of potential adverse events.
Project description:This is a Phase 1/2, multicenter, open label, first in human (FIH) study of DCC-3116 as monotherapy, and in combination with trametinib, binimetinib, or sotorasib in patients with advanced or metastatic solid tumors with RAS/MAPK pathway mutation. The study consists of 2 parts, a dose-escalation phase, and an expansion phase.
Project description:The study consists of 12 samples of 39-week-old N. furzeri (skin and brain). Jena Centre for Systems Biology of Ageing - JenAge (www.jenage.de)
Project description:Oncolytic viruses represent an emerging therapeutic approach for treating patients with solid tumours. One such virus, TILT-123 (Ad5/3-E2F-D24-hTNFα-IRES-hIL-2), is a serotype chimeric oncolytic adenovirus. TILT-123 is designed to encode tumour necrosis factor alpha and interleukin-2, aiming to induce T-cell infiltration and cytotoxicity within solid tumours. After several years of preclinical development, TILT-123 is now tested in phase I clinical trials either as a monotherapy, or in combination with other T-cell therapies across various solid tumour types. In a single-arm, multicentre phase I dose-escalation trial TUNIMO (NCT04695327), the safety of TILT-123 in patients with advanced solid cancers refractory to standard therapy was evaluated. During the intravenous phase of the study, researchers collected patient serum to identify potential predictive biomarkers associated with intravenous delivery of TILT-123.
Project description:To investigate the differential action between resistance and susceptible cultivars, we examined genome wide expression levels at five time points after Xag-inoculation using microarray. The soybean microarray was designed using the server-based eArray platform (http://earray.chem.agilent.com/earray/) from Agilent Technologies (Wolber et al., 2006). The current slide layout consists of four arrays of >44,000 features, including a set of Agilent's positive and negative control features.
Project description:The Sanaria® PfSPZ Vaccine can confer sterilizing protection against liver stage infection by Plasmodium falciparum (Pf) in malaria naïve individuals. The vaccine consists of aseptically purified irradiated Pf sporozoites. The PfSPZ Vaccine trial in Mali was the first to evaluate the safety and efficacy of this vaccine in a malaria endemic region. Vaccinees received five doses of 2.7 X 105 irradiated sporozoites and the efficacy was measured against naturally occurring Pf Infections in Malian adults during the malaria transmission season.
Project description:This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and expansion study intended to evaluate the safety, viral load kinetics and shedding, pharmacodynamic, and anti-tumor activity of PF-07263689, either alone or in combination with sasanlimab (an investigational anti-programmed cell death protein 1 [PD-1] antibody), in patients with selected locally advanced or metastatic solid tumors who have exhausted all available standard of care therapies available to them.
The study consists of 2 parts: Part 1 dose escalation for PF-07263689 monotherapy (Part 1A) and in combination with sasanlimab (Part 1B), followed by Part 2 dose expansion for the combination therapy.
Project description:The NEWEST (Neoadjuvant Endocrine Therapy for Women with Estrogen-Sensitive Tumours) trial compared the clinical and biological activity of fulvestrant 500 mg vs 250 mg in the neoadjuvant setting. In this multi-centre phase II study, post-menopausal women with operable, locally advanced (T2, 3, 4b; N0-3; M0) ER-positive breast tumours were randomised to receive neoadjuvant treatment with either dose of fulvestrant for 16 weeks before surgery. Tumour core biopsies were obtained at baseline, 4 weeks and at surgery for assessment of changes in biomarker expression. Tumour volumes were measured by 3-D ultrasound at the same timepoints. In this trial, the percentage of patients who showed a reduction in tumour volume or stabilisation of disease (using RECIST criteria) after treatment with fulvestrant 500 mg was 36% (26 out of 69 patients). Therefore, within a population of endocrine-therapy naive patients whose tumours were confirmed as being ER-positive at the time of study entry, there is a subgroup who gained particular clinical benefit from fulvestrant treatment. These clinical response data together with the availability of biological response information and frozen tumour tissue from participants makes the NEWEST trial an attractive setting in which to investigate the potential of new markers of response to fulvestrant. 42 samples
Project description:Innovative pro-regenerative treatment strategies for progressive multiple sclerosis (PMS), combining neuroprotection and immunomodulation, represents an unmet need. Neural precursor cells (NPCs) transplanted in animal models of multiple sclerosis promote neuroprotection and remyelination by releasing molecules sustaining trophic support and neural plasticity. We present the results of STEMS, a single dose escalation phase I clinical trial, evaluating the feasibility, safety, and tolerability of intrathecally transplanted human fetal NPCs (hfNPCs) in 12 PMS patients.