Kanglaite Injection (KLT), a drug that contains anti-cancer substances extracted from coix seed, has recently been cleared by the US Food and Drug Administration (FDA) to undergo phase III clinical trials.
KLT first underwent trials in 2001, making it the first traditional Chinese medicine (TCM) to go through the FDA approval process. During the second phase, the drug proved to prolong pancreatic, lung and liver patients’ lives by 1.9 months when used with chemotherapy, exceeding the success rate of existing Western cancer treatments.
On Saturday, Li Dapeng, the developer of the herbal remedy and a researcher at Zhejiang Chinese Medical University, announced that phase II was completed.
“After promising results from the phase II clinical trials, they are permitting us to move on to the third and final phase, where a larger number of volunteer cancer patients will be involved,” Li was quoted as saying in an ECNS report. “If everything goes smoothly, KLT will hit the U.S. market in three years.”
Li plans to enroll 750 patients for phase III, which is expected to take around three to four years to complete. Even though the trials require almost 16 years and millions of yuan, Li says it’s worth the effort and time.
KLT was approved in China in 1995 and has since become the most popular anti-cancer drug in the country. If KLT passes the third phase of clinical trials, it will become the third medicine derived from TCM to enter Western pharmacies, following Mahuang, or Ephedra sinica, for asthma and Qinghao, Artemisia annua, for malaria.
[Image via ChinaNews]
By Sharon Choi