FDA Approves Test of Traditional Chinese Medicine for Cancer

Pictured Above: Coix Plant

The US Food and Drug Administration (FDA) has approved a clinical trial of Kanglaite, a drug derived from an herb used in Traditional Chinese Medicine (TCM). The source of the drug is a tropical Asian grass called Coix lacryma-jobi (pronounced "coy"). Lacrima-jobi means Job's tears. The plant is related to corn, millet and other grains (maize). The stalks of the coix plant contain white beadlike grains that, in addition to being eaten, are sometimes used to make necklaces.

About 20 years ago, a young physician named Dr. Da-Peng Li observed that people in China who ate coix seed as a dietary staple had a surprisingly low incidence of cancer. He eventually derived a drug from the seed's oil. Kanglaite, which is given by injection, was approved by the Chinese authorities in 1996. Since then, more than 200,000 cancer patients in 2,000 Chinese hospitals have received the Kanglaite injection, either as a stand-alone agent or along with chemotherapy and radiation. According to the manufacturer, the Zhejiang Kanglaite Pharmaceutical Company, it is now the number one anti-cancer drug in China.

The company's brochures contain reports of its extensive research in test tubes, animals and humans. The drug has been shown to induce apoptosis, or programmed cell death, in various kinds of human tumors, and has a powerful effect on angiogenesis (the formation of new blood vessels to feed a tumor). In research using "nude" (immune-deficient) mice that had been grafted with human cancer cells, the drug significantly inhibited the growth of many kinds of cancer.

More recent clinical trials of cancer patients have also been promising. In one study, Kanglaite injection was compared to chemotherapy in the treatment of primary lung cancer. Out of 214 patients in the Kanglaite group, there were 26 partial responses (12.15 percent) and stabilization of disease in 165 patients (77.1 percent). This was about the same response as seen with chemotherapy alone. However, Kanglaite had none of the typical side effects of chemotherapy. In a trial of liver cancer patients, there was a response rate of 11.43 percent and disease stabilization in an additional 39 percent when Kanglaite was used alone.

Even more dramatic results have been achieved by the combination of Kanglaite and chemotherapy. In a small study of lung cancer patients, chemotherapy alone yielded a partial response rate of 22 percent. This response rate more than doubled, to 45 percent, when Kanglaite and chemotherapy were used together.

Kanglaite has also been used in combination with surgery. In one study, administering Kanglaite injection before surgery caused tumor destruction (necrosis) in more than 50 percent of the cases. Other research has shown that Kanglaite enhances the sensitivity of tumor cells to radiation therapy.

Particularly promising are studies demonstrating Kanglaite's ability to reduce cancer pain. One study found that Kanglaite's efficacy was 62 percent for severe pain and 100 percent for slight pain, for an overall effectiveness of 80 percent. Kanglaite's greatest success in pain reduction was in lung, breast, stomach, esophageal, colon and thyroid cancers. It was least successful with pancreatic cancer and bone sarcomas. The pain relief lasted about 7 days after the withdrawal of the drug. According to the manufacturer, Kanglaite can take the place of morphine or morphine-like analgesics. Its only side effect, as reported by the company, is an occasional allergy to the lipids, with mild flu-like symptoms (low fevers, shivering and nausea).

In 2001, the company received permission from the FDA to launch a phase I trial of Kanglaite at the Huntsman Cancer Institute in Salt Lake City. This small four-month trial demonstrated the drug's safety, clearing the way for a larger phase II trial of the drug's effectiveness to be conducted in China during the next year. I met John L. Harmer, the company's president and CEO, at the American Society of Clinical Oncology (ASCO) meeting, where Kanglaite USA had taken a booth to inform oncologists about the drug and the impending clinical trials.

Everything about Kanglaite sounds promising. Although Kanglaite by itself is not a "cancer cure," it is particularly promising when used together with radiation or chemotherapy. Its effect on pain and cachexia, if confirmed, could make it a major weapon in the fight against cancer.

However, be aware that the drug is presently only approved in China and is not yet available in the U.S. At best, some patients might be able to participate in a phase III clinical trial to be conducted at various sites in the U.S. in the future. Also, all of the data cited above is from the drug's manufacturer, and there is very little in the Western medical literature about Kanglaite or coix. While the Chinese science appears reliable, it needs to be confirmed in the West before Kanglaite can be approved for sale here.

To find out the current status of clinical trials you can visit the company's website, kanglaiteusa.com, or contact them at:

Kanglaite USA
Phone: 801-364-8904
Fax: 801-531-6558
Email: info@kanglaiteusa.com

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