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Heavy! China's first "PEG small molecule anti-tumor drug" officially launched clinical

2019-01-01

   

On January 14, 2019, China's first "PEG small molecule anti-tumor drug" project kick-off meeting was successfully held, which marked the official launch of the first domestic PEG small molecule anti-tumor drug clinical trial. This project brings new hope for the treatment of solid tumors.


Clinical trial purpose


      MAIN OBJECTIVE: To evaluate the safety and tolerability of polyethylene glycol irinotecan for injection in patients with malignant solid tumors; and to determine its dose-limiting toxicity (DLT) and maximum tolerated dose (MTD).


       The secondary objective was to examine the pharmacokinetic properties of patients with malignant solid tumors and obtain pharmacokinetic parameters; to observe the initial efficacy of polyethylene glycol irinotecan for injection, and to recommend doses for subsequent clinical trials. The method of medicine provides the basis.


Drug Discovery


       Most small molecule anti-tumor drugs have poor water solubility, short half-life in vivo, and low bioavailability. Modified by polyethylene glycol (PEG) can significantly improve the water solubility of the drug, prolong the half-life in the body, and improve by enhanced penetration and retention effects. Passive targeting of tumor tissue.


       As a development company, Keykai Technology successfully completed the development of the first small molecule anti-tumor drug in China. After PEG bonding, it improved the efficacy, reduced the side effects, increased the anti-tumor spectrum and reduced the number of administrations.


Project management


       Guanqin Pharmaceutical, as a contract research organization specializing in drug development project management services, provides project management for pre-clinical registration and phase I clinical trials.



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