On May 6, 2018, Proxalutamide Tablet Phase III Clinical Trials Investigator Meeting attracting participation of more than 30 hospitals was successfully held at Hyatt Hotel in Suzhou, symbolizing the official start of the first phase III clinical trials of Suzhou Kintor.
Group photo of all experts to the meeting
The proxalutamide tablet phase III clinical trials was led by Changhai Hospital of Shanghai（“Changhai Hospital”） as the group leader unit, in which, academician Yinghao Sun served as the principal investigator (PI) and R&G PharmaStudies was the clinical contract research organization. The investigator meeting sponsored by Kintor Pharmaceuticals invited nearly 100 experts from more than 30 hospitals across the country to Suzhou to escort and give advice to the clinical research of proxalutamide tablets.
Proxalutamide is a new-generation androgen receptor ("AR") antagonist independently developed by Suzhou Kintor to treat prostate cancer and breast cancer, especially castration resistant prostate cancer ("CRPC") and triple negative breast cancer ("TNBC") with positive AR expression. Receiving clinical approvals in China and the United States in 2015 and 2016, respectively, it is listed in National Scientific and Technological Major Special Projects of "Significant Novel Drugs Development" in the National 12th and 13th Five-Year Plans with its pre-clinical and clinical researches.
Prostate cancer is one of the most common malignant tumors in the male reproductive system, whose incidence ranks fourth among all major cancers in the world and second among male cancers, accounting for 15% of new cancer cases in men. According to the "2015 Beijing Health and Population Health Status Report" released by People's Medical Publishing House, the incidence of prostate cancer among Beijing residents recorded a rise from 92,200/100,000 in 2005 to 205,800/100,000 in 2014. AR Antagonist is one of the first choices of drug therapy for prostate cancer at the current stage to control castration failure. On the basis of more effective inhibition of AR, proxalutamide also has a biological effect of inducing the down-regulation of AR expression, which is an AR antagonist with "dual action mechanism". Considering that AR overexpression is a major mechanism for the development of resistance of prostate cancer cells to castration therapy, it is expected to become a more effective and low-toxicity second-generation AR antagonist, which will enjoy broad market prospects once approved for marketing.
Dr. Youzhi Tong, Chairman/CEO, Suzhou Kintor
Dr. Youzhi Tong, Chairman of Suzhou Kintor, said: "Phase III clinical trials represent the most important step before marketing of all novel drugs. We are very excited to announce the commencement of the first phase III clinical trials of proxalutamide tablets in the southern misty city, Suzhou. We have fully communicated with the Center for Drug Evaluation (CDE) of the National Medical Products Administration and obtained the CDE's consent before the start of the clinical trials. At the same time, we have also passed the ethics review by Changhai Hospital, the group leader unit. At present, proxalutamide’s clinical trials in the United States are progressing smoothly. The results of clinical trials conducted simultaneously by China and the United States will provide critical clinical data for the marketing approval of proxalutamide. According to the Group's clinical development strategy, we will carry out more clinical trials centered around proxalutamide. The successful holding of this investigator meeting symbolizes the official start of phase III clinical trials, which is an important milestone in the development history of Suzhou Kintor . We will stay true to the mission and keep on moving!"