Nerofe (84AA-API 14AA) / Immune System Key - LARVOL DELTA

Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced MDS and AML (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Immune System Key Ltd | Phase classification: P1b ➔ P1 | Trial completion date: Dec 2022 ➔ Aug 2025 | Trial primary completion date: Dec 2022 ➔ Jun 2025

Metastases • Phase classification • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • ST2

Transformation of immunosuppressive mtKRAS tumors into immunostimulatory tumors by Nerofe and Doxorubicin. (PubMed, Oncotarget) - "It was observed that the combination of Nerofe and DOX downregulated KRAS signaling via miR217 upregulation, resulting in enhanced apoptosis of tumor cells. In addition, the combination of Nerofe and DOX also resulted in activation of the immune system against tumor cells, manifested by an increase in the immunostimulatory cytokines IL-2 and IFN-γ as well as the recruitment of NK cells and M1 macrophages to the tumor site."

Journal • Colorectal Cancer • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • IFNG • IL2 • KRAS • MIR217

Phase I study of NEROFE and doxorubicin in KRAS-mutated ST2-positive solid tumors. (ASCO 2023) - P1 | "Recent advances targeting KRAS G12C with sotorasib and adagrasib are encouraging but limited to a small subset of patients. Enrollment to DL1 began in Q1 2023 (NCT05661201). Clinical trial information: NCT05661201."

P1 data • Gastrointestinal Cancer • Gastrointestinal Disorder • Immune Modulation • Oncology • Solid Tumor • IL33 • KRAS • MAPK1 • MIR217 • ST2

NEROFE and Doxorubicin in KRAS-mutated ST2-positive Solid Tumors (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Georgetown University | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • KRAS • ST2

NEROFE and Doxorubicin in KRAS-mutated ST2-positive Solid Tumors (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Georgetown University

New P1 trial • Oncology • Solid Tumor • KRAS • ST2

Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced MDS and AML (clinicaltrials.gov) - P1b | N=18 | Recruiting | Sponsor: Immune System Key Ltd | Trial completion date: May 2022 ➔ Dec 2022 | Trial primary completion date: May 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • ST2

Safety and Efficacy of IV Nerofe™ Followed by Doxorubicin, In Metastatic Ovarian Cancer and Triple Negative Breast Cancer (clinicaltrials.gov) - P1b; N=0; Withdrawn; Sponsor: Immune System Key Ltd; N=24 ➔ 0; Recruiting ➔ Withdrawn

Clinical • Combination therapy • Enrollment change • Trial withdrawal • Breast Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer

A Phase 2a, Open-Label, Two Stage Study of Nerofe or Nerofe With Doxorubicin in Subjects With AML or MDS (clinicaltrials.gov) - P2a; N=0; Withdrawn; Sponsor: Immune System Key Ltd; N=29 ➔ 0; Trial completion date: Dec 2020 ➔ Jul 2020; Recruiting ➔ Withdrawn

Clinical • Combination therapy • Enrollment change • Trial completion date • Trial withdrawal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced MDS and AML (clinicaltrials.gov) - P1b; N=18; Recruiting; Sponsor: Immune System Key Ltd; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced MDS and AML (clinicaltrials.gov) - P1b; N=18; Not yet recruiting; Sponsor: Immune System Key Ltd

Clinical • New P1 trial • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Improving college students sub-threshold depression by music neurofeedback (PubMed, Sheng Wu Yi Xue Gong Cheng Xue Za Zhi) - "In the experimental group, the scores of self-rating depression scale(SDS) decreased after the stimulation of musical nerofeedback, indicating that the depression was improved. The result of this study showed that music neurofeedback stimulation can improve sub-threshold depression and may provides an effective new way for college students to self-regulation of emotion."

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