Soo Young Hur

A phase 1/2a, dose-escalation, safety, and preliminary efficacy study of the RKP00156 vaginal tablet in healthy women and patients with cervical intraepithelial neoplasia 2

This study aimed to determine the safety and efficacy of the RKP00156 vaginal tablet, a CDK9 inhibitor, in healthy women and patients with cervical intraepithelial neoplasia grade 2 (CIN2). We conducted a phase 1/2a clinical trial of RKP00156. In step 1, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered transvaginally to 24 healthy women. In step 2, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered once daily for 4 weeks in 62 patients with CIN2. The primary endpoints of this trial were the safety of RKP00156 and the change in the human papillomavirus (HPV) viral load. A total of 86 patients were enrolled and randomized. RKP00156 administration did not cause serious drug-associated adverse events (AEs). Although no significant difference in the HPV viral load was found between the experimental and placebo groups, a reduction in the HPV viral load was observed in the 25 mg-dose group (-98.61%; 95% confidence interval=-99.83%, 4.52%; p=0.046) after treatment completion in patients with a high HPV viral load, despite a lack of statistical power. No differences in histologic regression and HPV clearance were observed. The safety of RKP00156 was proved with no serious AEs. Although the study did not show any significance in histologic regression and HPV clearance, our findings indicate that RKP00156 may have a possibility of short-term inhibitory effect on HPV replication in patients with higher viral loads. ClinicalTrials.gov Identifier: NCT02139267.

HPV vaccination status and effectiveness in Korean women with HPV16/18 infection (2010–2021): a retrospective study

To evaluate human papillomavirus (HPV) vaccine effectiveness in a cohort of Korean women infected with HPV. From 2010 to 2021, Korean women aged 20-60 years who diagnosed HPV-positive atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion were recruited from 6 hospitals. HPV vaccine effectiveness was estimated by observing the differences in pathological and clinical information and experimental results-prevalence, viral load (VL), physical state (PS), and HPV16/18 infection duration-between the vaccinated and unvaccinated groups. HPV16/18 prevalence declined from 18.5% to 11.8% as vaccination rates increased from 14.3% to 60.7% in the 1,757 registered cohort women. DNA analysis from 96 samples collected from the participants, indicated that HPV vaccination reduced HPV16 VL by 6 times and increased E2/E6 ratio for both HPV16 and HPV18 by 1.4 and 5 times, respectively. The HPV16 infection rate-lasting more than 18 months from 31.0% to 21.6%-and the HPV18 infection rate-lasting more than 12 and less than 24 months from 35.5% to 21.1%-were reduced by vaccination. We found VL and the infection duration to be directly proportional. Moreover, HPV vaccination reduced not only the VL to 1/4 in both the persistence and clearance groups but also the persistence rate from 90% (27/30) to 70.6% (12/17) in HPV16. HPV vaccination reduced the prevalence and duration of infection and kept the PS in an episomal form for both HPV16 and HPV18. The tendency of persistence VL to be higher than clearance in the unvaccinated group implies that the vaccine's effect of reducing VL in HPV16 may lower the risk of progression to cervical cancer by shortening the infection duration.

Peripheral bloodBRCA1methylation profiling to predict familial ovarian cancer

Familial cancer appears at a young age and its incidence is increasing. About 12% of familial ovarian cancer cases are associated with Using peripheral blood DNA from 55 subjects without a history of cancer [cancer(-)] and 52 ovarian cancer patients, we examined Our data suggest a predictive role of