Yonsei University Severance Hospital

SEOUL, South Korea I August 21, 2024 I Innovo Therapeutics Inc. has announced the results of its Phase 2 clinical trial demonstrating the innovative efficacy of INV-001 in scar treatment. The trial involved 77 Korean patients with wounds larger than 3 cm following thyroidectomy, conducted at four general hospitals including Severance Hospital in Seoul. Patients were randomly assigned within 14 days post-surgery to apply INV-001 twice daily for 12 weeks, with efficacy assessed at week 12 using the POSAS (Patient and Observer Scar Assessment Scale). The trial confirmed both the safety and tolerability of INV-001 at both low (0.2%) and high (2%) doses, with no serious adverse events (SAEs) reported. In the group that received the clinical drug at a high (2%) dose for 12 weeks without major protocol violations, a statistically significant difference (p<0.05, ANCOVA; Analysis of Covariance) was observed compared to the placebo, with a 24.5% reduction in scars at week 12, as confirmed through per-protocol set. Key Findings: Professor Won-Jae Lee, the Coordinating Investigator and a plastic surgeon at Yonsei University Severance Hospital, mentioned that this clinical trial is the first globally to confirm the scar suppression effects of HSP47 inhibition. He emphasized that the proven scar reduction effects of INV-001 are highly encouraging. Additionally, he noted that, given the current lack of specialized topical medications for scar suppression, the development of a specialized ointment based on this clinical trial would be welcomed by both clinicians and patients. Dr. Hee Dong Park, a founder and CEO of Innovo Therapeutics, stated that this clinical trial confirmed the safety and efficacy of INV-001, highlighting its potential as a scar treatment. He also noted that its innovative mechanism promises to deliver real value to patients in the scar treatment market. About INV-001: INV-001 inhibits HSP47, a key protein in collagen formation, transport, and extracellular secretion, thereby preventing and treating post-surgical and trauma-induced scars. Results from disease animal models have confirmed that INV-001 effectively inhibits trauma-induced scars without affecting wound healing. About Innovo Therapeutics: Innovo Therapeutics, Inc., headquartered in South Korea, is a biotechnology company primarily focused on developing small molecules for metabolic, inflammatory, and cancer diseases. The company is actively discovering new drug candidates and optimizing research through its AI platform, DeepZema®. SOURCE: Innovo Therapeutics

The Personal Information Protection Committee, South Korea's national data protection authority, has probed 17 university hospitals that allegedly allowed nearly 200,000 patient information to get exposed in a leak. WHAT IT'S ABOUT The PIPC acted on alleged reports of university hospitals leaking patient information to pharmaceutical companies. The case was later confirmed by the police following a search and seizure operation on the involved pharmaceutical companies. It was found that hospital staff took pictures or downloaded patient information needed for prescriptions, which were then sent via e-mail or flash drives to pharmaceutical companies. Based on the investigation, approximately 185,271 patient information, including sensitive ones, was leaked between April 2018 and January 2020. About half came from Yonsei University Severance Hospital (57,912) and St. Mary's Hospitals in Uijeongbu (20,027) and Yeouido (17,115). All but one of the 17 hospitals were found to have violated the Personal Information Protection Act for failing to ensure the safety of patient information. They were subjected to fines totalling KRW 64.8 million ($50,500). According to PIPC, for more than two years, 16 hospitals have not kept records of people who have accessed their system. They also have not amply confirmed their reasons for accessing and downloading information. Of those hospitals, Hallym University Sacred Heart Hospital, Dongtan Sacred Hospital, Kangnam Sacred Hospital and Hangang Sacred Hospital have not kept access records for over three years. These four hospitals, along with Soon Chun Hyang University Hospital Seoul and Konkuk University Chungju Hospital, also did not have security measures in place for exporting and importing data via auxiliary storage devices like hard and flash drives. Additionally, Kangbuk Samsung Hospital and Korea University Guro Hospital were found to have poor security, allowing unauthorised persons to access data physically. Aside from getting fines, all 17 hospitals were also told to make the following improvements: Regularly inspect respective personal information processing systems and enforce measures to prevent future data leaks Reinforce regular training for staff involved in protecting personal information Meanwhile, the South Korean police are still conducting investigations for possible criminal liability of involved hospital and pharmaceutical company staff in the data leak. THE LARGER TREND Cybersecurity authorities in South Korea were most recently alarmed by a large-scale data breach at Seoul National University Hospital. According to the hospital, the personal information of over 800,000 people, including patients and hospital employees, has been leaked following an attack on its IT servers between May and June last year. The local police said they have traced the source of the attacks from alleged servers of North Korean hackers. ON THE RECORD "Through this investigation, we hope university hospitals are now more aware of their role in protecting patients' highly sensitive personal data. This also serves as an opportunity for them to realise the importance of training staff on managing their personal information protection systems, as well as conducting regular checks of the system to prevent future data leaks from happening," the PIPC said in a statement.

SEOUL, South Korea, June 13, 2023 /PRNewswire/ -- Gencurix, a leading cancer molecular diagnostics company, has obtained approval from the Korean Ministry of Food and Drug Safety for its Droplex EGFR Mutation Test v2. This product is a companion diagnostic test designed to detect EGFR mutations commonly found in NSCLC patients and guide the selection of appropriate targeted anticancer therapies based on the test results. It is an IVD product that can be used with Bio-Rad's Droplet Digital PCR instrument and has also obtained CE certification in Europe last year. Compared to existing EGFR mutation tests using RT-PCR, this product demonstrates significantly higher sensitivity. This makes it capable of accurately detecting mutations even when plasma samples are used as the specimen. Additionally, while most existing products detect fewer than 50 mutations, this test can detect up to 107 mutations, further enhancing its accuracy. Notably, this product has an additional strength in its ability to detect Exon 20 Insertion, a mutation that has recently garnered significant attention in the oncologist community following the launches of Janssen's Rybrevant and Takeda's Exkivity. Among the existing single gene tests, there were no tests available to properly detect this mutation, necessitating the use of costly and time-consuming NGS tests. This is the second EGFR mutation test for which Gencurix has obtained approval. In addition, Gencurix has obtained European CE registration for a total of nine products, including KRAS, BRAF, C-MET, PIK3CA, ESR1, and POLE tests, making it the company with the highest number of digital PCR-based IVD tests in its portfolio. Hyun Park, VP of Strategy & Business Development at Gencurix, stated, "Gencurix has been developing diagnostic products that utilize Droplet Digital PCR technology, which has primarily been used for research purposes, in the field of cancer diagnostics. Through years of research and development, we are proud to have achieved world-class technological capabilities and a product portfolio." Gencurix is also developing solutions for early cancer detection and minimal residual disease (MRD) screening using digital PCR technology. The company also introduced new technology detecting colorectal cancer recurrence at AACR last April. Gencurix has been supplying diagnostic kits to major hospitals in Korea, such as Samsung Medical Center and Yonsei Severance Hospital, and has been actively expanding its global sales network, securing distributorship agreements in Europe, Asia, and other continents. In addition to collaborating with Bio-Rad, a leading manufacturer of digital PCR instruments, on marketing efforts, Gencurix is also pursuing the acquisition of new distributors. About Gencurix: Gencurix is a leading provider of molecular cancer diagnostics, dedicated to developing innovative solutions that improve patient outcomes. Committed to research and development, Gencurix strives to address unmet needs in cancer diagnosis and treatment, ultimately revolutionizing the field of precision medicine. For more information, visit . SOURCE Gencurix