progerinin (SLC-D011) / PRG S&Tech - LARVOL DELTA

PRG-PRO-005: Study to Determine Optimal Dose and Evaluate Safety, Tolerability, and Pharmacokinetics of Progerinin in Patients With Hutchinson-Gilford Progeria Syndrome (HGPS) (clinicaltrials.gov) - P2 | N=10 | Active, not recruiting | Sponsor: PRG Science & Technology Co., Ltd. | Recruiting ➔ Active, not recruiting | N=16 ➔ 10 | Trial completion date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Dec 2025 ➔ Mar 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • LMNA

Phase 2, Open-Label Study to Evaluate the Safety and Tolerability of Progerinin in Werner Syndrome (clinicaltrials.gov) - P2 | N=5 | Not yet recruiting | Sponsor: PRG Science & Technology Co., Ltd. | Trial completion date: Jan 2027 ➔ Dec 2027 | Trial primary completion date: Jan 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • Metabolic Disorders

Study to Determine Optimal Dose and Evaluate Safety, Tolerability, and Pharmacokinetics of Progerinin in Patients with Hutchinson-Gilford Progeria Syndrome (HGPS) (clinicaltrials.gov) - P2 | N=16 | Recruiting | Sponsor: PRG Science & Technology Co., Ltd.

New P2 trial

Outcome of patients with peritoneal metastasis from ovarian cancer treated with Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC). (PubMed, Pleura Peritoneum) - "There are few data on Pressurized IntraPeritoneal Aerosol Chemotherapy with cisplatin and doxorubicin (PIPAC C/D) in women with primary unresectable or recurrent platinum-resistant peritoneal metastasis (PM) from ovarian cancer (OC)...PIPAC C/D was feasible and induced histological regression in a substantial proportion of patients with platinum-resistant PM from OC. Larger studies are needed to evaluate impact on survival."

Journal • Cardiovascular • Oncology • Ovarian Cancer • Pulmonary Embolism • Respiratory Diseases • Solid Tumor

CRS-HIPEC following neo-adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC) with systemic chemotherapy in primarily advanced inoperable epithelial ovarian cancer: An ISPSM collaborative study. (ASCO 2024) - "PIPAC was given with Cisplatin 15mg/m2 and doxorubicin 3mg/m2...Out of 45 patients nearly 60% showed PRGS 1, 25% PRGS 2 and 15% PRGS 3... Neo-adjuvant PIPAC with Intravenous chemotherapy might be a promising combination for inducing good response rates in advanced epithelial ovarian carcinoma. CRS-HIPEC following neo-adjuvant PIPAC + IV chemotherapy is safe, feasible and tolerable. PIPAC repeated every 4-5 weeks along with systemic chemotherapy provides a ideal scenario to monitor & assess response to loco regional and systemic chemotherapy."

Clinical • Metastases • Hematological Disorders • Oncology • Ovarian Cancer • Solid Tumor

Development of a video-based deep learning model for differentiation of malignant and benign lesions during staging laparoscopy: Is the machine better than the expert? (ASCO 2024) - "The Peritoneal Regression Grading Score (PRGS) offers an objective histologic evaluation of the biopsied lesion by assessing the complete or partial presence of malignant cells (PRGS 2-3-4) and fibrous or benign lesion (PRGS 1)... While the accuracy of computer vision models may not be clinically acceptable as a substitute for biopsies, they outperform surgeons in differentiating PM from benign lesions. Computer vision models might be of aid for the surgeon in the recognition of these lesions."

Video • Breast Cancer • Gallbladder Cancer • Oncology • Peritoneal Cancer • Solid Tumor

Second annual report from the ISSPP PIPAC database. (PubMed, Pleura Peritoneum) - "Median overall survival from first PIPAC directed treatment varied from 10.7 months (CI 8.7-12.5) in gastric cancer to 27.1 months (16.4-50.5) in mesothelioma. The ISSPP PIPAC database provides substantial real-world data supporting the use of PIPAC directed therapy in patients with PM from different primary tumors."

Journal • Gastric Cancer • Gastrointestinal Cancer • Mesothelioma • Oncology • Solid Tumor

Peritoneal regression grading score (PRGS): first evidence for independent predictive and prognostic significance. (PubMed, Pleura Peritoneum) - P=N/A | "This is the first evidence for the independent predictive and prognostic significance of PRGS in PM. These encouraging results need validation in an adequately powered, prospective study."

Journal • Oncology

First clinical study reporting safety and outcomes of high dose oxaliplatin use in PIPAC for colorectal peritoneal carcinomatosis. (ASCO 2023) - "Of the 15 patients, 3 had complete response (PRGS 1) and 8 had major (PRGS 2), 3 had minor response (PRGS 3). PIPAC can be performed safely at dose of oxaliplatin 120mg/m2. There is better objective & pathological response with this dose with no major complications or side effects to the patients. There is also improvement in quality of life."

Clinical • Colorectal Cancer • Fatigue • Hematological Disorders • Oncology • Pain • Peritoneal Cancer

Progerinin, an Inhibitor of Progerin, Alleviates Cardiac Abnormalities in a Model Mouse of Hutchinson-Gilford Progeria Syndrome. (PubMed, Cells) - "From these data, we suggest that the administration of Progerinin in the HGPS model mouse can restore cardiac function and correct arterial abnormalities. These observations provide encouraging evidence for the efficacy of Progerinin for cardiac dysfunction in HGPS."

Journal • Preclinical • Cardiovascular • Fibrosis • Heart Failure • Immunology • LMNA

Phase 2, Open-Label Study to Evaluate the Safety and Tolerability of Progerinin in Werner Syndrome (clinicaltrials.gov) - P2 | N=5 | Not yet recruiting | Sponsor: PRG Science & Technology Co., Ltd.

New P2 trial • Metabolic Disorders