KangLaiTe USA is a privately held biotechnology company developing a treatment for solid tumor cancers and for cancer-associated anorexia-cachexia syndrome. The parent company is the Zhejiang Kanglaite Group Ltd, located in Hangzhou, China.

The lead product under development, Kanglaite Injection (KLTi), was approved by the Chinese Ministry of Health for the treatment of patients with advanced non-small cell lung cancer (NSCLC) and hepatocellular cancer in 1995 and in Russia for treatment of patients with advanced NSCLC in 2003. It is likewise approved in China for palliative care of patients with advanced cancer of all kinds. KLTi is a sterile microemulsion for intravenous administration. The active pharmaceutical ingredient is a partially purified extract from coix seeds (Coix lacryma-jobi, family Cramineae), and as such is considered a botanical drug product under US FDA regulations (ref FDA Guidance for Industry, Botanical Drug Products, June, 2004). Additionally, the company is beginning this year a US clinical trial of the oral dose form, Kanglaite soft gelcap (KLTc), originally approved in China in 2004, and used primarily in palliative care of patients with advanced cancer.

The company holds an open IND for KLTi with the US FDA for all indications related to treatment of cancer. A Phase 1 PK/dosing study has been completed under this IND and a Phase IIb trial in patients with advanced pancreatic cancer is approximately 50% enrolled. Two large trials in palliative care (NSCLC and Pancreatic cancer) will begin in the second half of 2011. KLTc is likewise under IND and will be studied in patients with rising PSA after primary treatment of prostate cancer.

The company is collaborating with researchers at Johns Hopkins University to investigate the efficacy and mechanism of action of the product in animal and in vitro models. Data from these studies have confirmed that Kanglaite Injection has a cytostatic effect on tumor cells and blocks pathways in a manner previously shown to have a potential therapeutic effect in various types of cancer.

KangLaiTe USA is located in Redwood City, California, south of San Francisco.