Description of Kanglaite Injection

Kanglaite Injection is an aqueous microemulsion of an oil extracted from the seeds of Coix lacryma-jobi, or Job’s tears. The seeds of the coix plant are edible and resemble barley when cooked. The plant has a history of use in Traditional Chinese Medicine, including use as an anti-inflammatory agent.

The extract employed in Kanglaite Injection was developed by Dr. Dapeng Li, PhD, the founder of Zhejiang Kanglaite Group.  Preclinical and clinical research with this extract has shown it to have an anti-tumor effect, as well as to mitigate weight loss and other symptoms of cachexia and anorexia in cancer patients.

Preclinical Studies

Kanglaite Injection has been shown to cause a reduction in the size of tumors in animal models. In studies in China, nude mice were injected with a range of tumor cell lines, including lung, pancreatic, and breast cancer cells, and then treated with Kanglaite Injection. These mice typically showed a significant reduction in tumor size relative to untreated animals. Animals treated with Kanglaite Injection plus chemotherapy likewise had smaller tumor burdens than did animals treated with chemotherapy alone.

Recent studies in the US have confirmed that Kanglaite Injection is able to reduce the size of tumor xenografts in athymic nude mice compared to untreated controls. Array analyses and other studies have shed light on the cellular mechanism by which this occurs. These data have been accepted for publication.

Clinical Studies

A key Phase 3 licensing trial conducted in China as part of the approval process in that country compared tumor response rates in patients with advanced non-small cell lung cancer (NSCLC) who received a standard chemotherapy regimen with that of patients receiving the same chemotherapy regimen plus Kanglaite Injection. In this study, a tumor response rate of 45% was seen in the group receiving chemotherapy plus Kanglaite Injection, compared to a tumor response rate of 21% in the chemotherapy-only group. Response was defined according to World Health Organization (WHO) criteria.

A recent search of the Chinese literature revealed more than 300 publications of preclinical and clinical research on Kanglaite Injection in addition to the licensing studies conducted by Zhejiang Kanglaite Group. Although most of these publications are case descriptions by practicing oncologists, a number represent randomized, controlled trials.

The independent studies all reported an improvement in response rate when Kanglaite Injection was added to a chemotherapy regimen; this improvement reached statistical significance in half of the studies despite their modest size and variable dosing regimens.

In addition to tumor response, the studies looked at the clinical benefit of the treatment to patients as determined by multiple performance criteria. All of the studies that reported on the significance of the performance measure used found a statistically significant improvement in the Kanglaite Injection group. In most cases this was the Karnofsky score, supplemented by data on changes in weight in some studies. Many of the publications also document a decrease in other symptoms, including leucopenia, thrombocytopenia, pain, and nausea and vomiting. These data suggest that Kanglaite Injection may have multiple benefits for patients, influencing both the tumor itself and the patient’s overall health.