A traditional Chinese medicine (TCM)-based candidate, Kanglaite, won U.S. FDA approval for a multiregion Phase III trial in pancreatic cancer treatment that uses a derivative of the coix seed, the state-run Xinhua news agency reports.
Zhejiang Kanglaite Pharmaceutical makes the candidate, which is described on the website as an injection listed by the Chinese government as a "State Basic Drug" that can be used in combination therapies to treat symptoms from cancer and kill cells. The coix seed comes from a grass related to rice and maize, Xinhua said.
The company could not immediately be contacted.
Xinhua said the candidate passed a Phase II trial for efficacy in treating pancreatic cancer. But a ClinicalTrials.gov search shows a study that was terminated by the sponsor as well as one completed by KangLaiTe USA.
Xinhua said the trial would enroll 750 patients in China, the U.S. and Europe over a four-year period with costs estimated at $50 million.
The news agency cited John Paul Waymack as a Kanglaite research team member in charge of the medicine's FDA application. No increase in toxicity was found when treating pancreatic cancer with Kanglaite together with chemotherapy, Waymack was quoted as saying by Xinhua, nor were there significant racial differences in patients of different ethnicities.
China has brought TCM candidates into Western pharmacopeia, including the stimulant ephedrine, and artemisinin, a malarial drug.
- here's the story from Xinhua
- get more about the NCT00733850 and NCT01483586 trials