On 6 May 2018, the researchers’ conference of Proxalutamide’s Phase III clinical trial, participated by more than 30 hospitals, was successfully held in Suzhou, marking an official start of the first Phase III clinical trial of Kintor Pharma.
Photo of all experts in the conference
The Phase III clinical trial of Proxalutamide was led by the Changhai Hospital of Shanghai, with academician Sun Yinghao being the Principal Investigator (PI) and R&G Pharma being the Contract Research Organization (CRO). The researchers’ conference, hosted by Kintor Pharma, invited nearly 100 experts from more than 30 hospitals across the nation to gather in the city of Suzhou to provide insights and advice for the clinical research of Proxalutamide.
Developed independently by Kintor Pharma, Proxalutamide is a new generation of androgen receptor (AR) antagonist targeting prostate and breast cancers, especially for metastatic castrate-resistant prostate cancer (“CRPC”) and AR-positive triple-negative breast cancer (” TNBC”). It has received pre-clinical approvals from China and the U.S. respectively in 2015 and 2016. Its preclinical and clinical studies were selected into the Technological Special Project for “Significant New Drugs Development” of the Nation’s 12th and 13th Five-year Plan.
Prostate cancer is one of the most common malignant tumors in men’s reproductive system. It is ranked fourth and second in the global incidence rates of major cancers and male cancers, respectively, and accounts for 15% of new male cancer cases. According to the Report on Public Healthcare and People’s Health of Beijing City published by the People’s Medical Publishing House in 2015, the incidence rate of prostate cancer among the urban residents registered in Beijing increased from 9.22/100,000 in 2005 to 20.58/100,000 in 2014. Androgen receptor antagonist (AR Antagonist) is one of the preferred drug therapies being adopted to control CRPC at this stage. Proxalutamide is an AR Antagonist featuring “Dual Action Mechanism” as it has a biological effect of inducing down-regulation of AR on more effective inhibition of AR. Considering that overexpression of AR is a major mechanism by which prostate cancer cells develop resistance to castration therapy, Proxalutamide is expected to become a more effective, less toxic second-generation AR antagonist, which will have a bright prospect once it receives approval for coming on the market.
Dr. Tong Youzhi, Chairman/CEO of Kintor Pharma
Dr. Tong Youzhi, Chairman of Kintor Pharma, said: “Phase III clinical trial is the most important step before the launch. We are very excited to announce the start of the first Phase III clinical trial of Proxalutamide tablets in Suzhou. Before the launch of the Phase III clinical trial, we had communicated effectively with the Center for Drug Evaluation (CDE) and received their consent. At the same time, the trial had also been passed in the ethics meeting of Changhai Hospital, the leader of the trial. Currently, the clinical trial of Proxalutamide in the U.S. is proceeding smoothly. The results of the clinical trials conducted simultaneously in China and the U.S. will provide key clinical data for the approval of the launch of Proxalutamide on the market. According to the company’s clinical development strategy, we will have more clinical trials around Proxalutamide in the future. This meaningful researchers’ conference marks the official start of Phase III clinical trial. It is an important milestone in the development history of Kintor Pharma. We will strive to accomplish our mission going forward!”