TCM approved by FDA to go further clinical trials

A kind of traditional Chinese medicine has been cleared by the U.S. Food and Drug Administration (FDA) to enter phase III clinical trials.

Kanglaite, an anticancer drug with active ingredients extracted from coix seed, passed a phase II trial by FDA for efficacy in treating pancreatic cancer.

Prof. Dapeng Li, developer of the medicine and member of China Academy of Engineering, announced the phase II completion and launch of phase III at a press conference on Saturday.

Coix is a grass related to rice and maize and an important ingredient in traditional Chinese medicines (TCM).

Kanglaite has been proven to have significant effects on middle or late-stage malignancies of pancreatic, lung and liver cancers. Patients were found to have longer life expectancy when injected with it together with chemotherapy, according to Li.

After establishing that the benefits outweigh known risks, it can be approved for sale, according to Dr. John Paul Waymack, a Kanglaite research team member in charge of the medicine's FDA application.

Due to the low toxicity of Kanglaite and the serious nature of pancreatic cancer, it may be possible to enter the US market with only one phase III study instead of the normal two, he said.

The developer plans to enroll 750 patients in the phase III trial in China, the US and Europe. It will take three to four years to complete at a cost of some 50 million US dollars.

No increase in toxicity was found when treating pancreatic cancer with Kanglaite together with chemotherapy, said Dr. Waymack, nor significant racial differences in patients of different ethnicities.

Once the phase III trial is passed, Kanglaite could become the third medicine derived from TCM to enter the Western pharmacopeia following ephedrine, a stimulant and decongestant derived from Mahuang, and artemisinin, a malarial drug.

FDA reviewed the materials of proof of safety submitted by the company. It does not conduct tests regarding the drugs itself and is only able to provide information on approved drug product applications.

Kanglaite has been widely used by patients in China since it was certified in 1995. Intellectual property protection applies to Kanglaite in China, the USA and Russia.

Clinical trials of Kanglaite started in Russia in 2001. It received a medicine registration certificate in 2003 and has been sold in Russia since 2005. Endi