Regulatory press release
Correction MAR label -Prostatype[®] shows strong data in Asian pilot study
-Selected for presentation at the Chinese Urology Association’s national congress
With the second independent pilot study in the East Asia region showing strong clinical performance, Prostatype Genomics is now reviewing commercialization opportunities in the region.
The recent study was conducted in China in collaboration with the Nanjing Drum Tower University Hospital, Jiangsu, and Prostatype Genomics’ partner GloriousMed based in Shanghai. The study indicates that the clinical performance of Prostatype® in East Asian population is in line with the results previously communicated results in several studies in Caucasian populations.
Strong predictive performance
In total 108 patients were included in the pilot study. All patients who either died from prostate cancer or developed metastasis were identified as “high-risk patients” according to the Prostatype® risk score (P-score) algorithm. The algorithm developed by Prostatype Genomics where the patients genetic information from genes closest associated with aggressive prostate cancer is added together with other relevant clinical parameters to form the P-score.. In addition, more than 26% of the patients (28 patients in total) were downgraded from a higher risk group to a lower risk group which is clinically important as it often results in different treatment options. The median follow-up time was 5.3 years from diagnosis.
Fredrik Persson, CEO of Prostatype Genomics comments: “This study is unique as it is the largest ever published study for a predictive biomarker used in prostate cancer a in an East Asian population and the first one with complete follow-up data. Prostatype® fills a large unmet need also for East Asian patients looking for optimal treatment of their prostate cancer. We are happy to once again conclude that Prostatype® is performing very well with strong predictive power. These results reinforce the scientific foundation for the continued journey of Prostatype Genomics in the East Asia region as the data from the study is well in line with the data we already have seen and communicated from the ongoing study in Taiwan, obviously also performed in an East Asian population. We expect to be able to present additional data from the ongoing validation study in Taiwan before the year end”.
We have now finalized two independent pilot studies in the East Asia region showing robust clinical performance by Prostatype®. Based on the previous strong results from the ongoing more comprehensive validation study in Taiwan, we are encouraged by the opportunities these results give Prostatype Genomics in the large and commercially interesting market of East Asia. We are currently reviewing the specific commercialization opportunities in the region. The ongoing challenges with Covid-19 in China and other countries in East Asia, including difficulties to travel due to Covid-restrictions, will decide how quickly we will be able to move forward in this specific market.
The results of the study will be presented at the Chinese Urology Association’s national congress on September 21-25, by Dr. Zhang Shun from the Nanjing Drum Tower Hospital.
This disclosure contains information that Prostatype Genomics AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 15-09-2022 10:26 CET.