Kintor launches Phase III clinical trial for Proxalutamide
Recently, nearly 100 experts from more than 30 hospitals across China gathered in Suzhou for the Clinical Trial Researcher Meeting to offer suggestions for Phase III clinical trial of Proxalutamide - an important new drug discovery program of Kintor Pharmaceuticals identified in the 12th and the 13th Five-Year Plans.
The Phase III clinical trial of Proxalutamide was led by Shanghai Changhai Hospital, with Academician Sun Yinghao as the Principal Investigator (PI), and R&G PharmaStudies Co. Ltd. as the contracted clinical study organization.
Group photo of all experts at the meeting
Proxalutamide is a new generation AR antagonist, independently developed by Kintor for prostate and breast cancers, especially Castration Resistant Prostate Cancer (CRPC) and Triple-Negative Breast Cancer (TNBC) with positive AR expression. It received the clinical trial approval from the drug administrations of China and the United States in 2015 and 2016 respectively, and the pre-clinical and clinical trials were recognized as one of the “Important New Drug Discovery” scientific and technological projects in the 12th and the 13th Five-Year Plan periods.
The prostate cancer is one of the most common types of malignant tumors in the male genital system. Its incidence ranks fourth of all types of cancers worldwide, and second in the male cancer incidence, accounting for 15% of the new male cancer cases. According to the 2015 Beijing Annual Health and Population Health Status Report, the prostate cancer incidence among the permanent residents registered in Beijing increased from 9.22/100,000 cases in 2005 to 20.58/100,000 in 2014. The AR Antagonist is one of the preferred pharmacotherapies for the treatment of castration prostate cancer at the current stage. In addition to a better AR inhibiting performance, Proxalutamide also has the biological effect of inducing down-regulation of AR expression as an AR antagonist with a “dual function mechanism”. Considering that AR over-expression is a major mechanism that causes drug tolerance of prostate cancer cells to the castration therapy, it is expected to become a more effective second generation AR antagonist with low toxicity. It will enjoy a broad market prospect once it's released to the market.
Dr. Tong Youzhi, chairman and CEO of Kintor Pharmaceuticals
Dr. Tong Youzhi, chairman of Kintor, said, “Phase III clinical trial is the most important step for a new drug before being approved to the market. We are very excited to announce Proxalutamide’s first Phase III clinical trial in Suzhou. Prior to this launch, we made sufficient communications with the Center for Drug Evaluation (CDE) of China Food and Drug Administration (CFDA) and obtained approval from CDE. Meanwhile it has passed the ethnic review of Changhai Hospital. Currently, the clinical trial of Proxalutamide has been processed smoothly in the United States. The results of the clinical trials conducted in both China and the United States will provide critical clinical data for the approval of Proxalutamide. According to Kintor’s clinical development strategy, more clinical trials centering on the new drug will be conducted in the future. The successful convening of the researcher meeting marked the official launch of Phase III clinical trial, and an important milestone in Kintor’s development history. We will surely continue to move forwards while bearing in mind the reason why we started.”