Safety Studies

A Phase 1 study was completed in which patients with a variety of solid tumors were exposed to doses of Kanglaite Injection ranging from 10gm/day to 50gm/day for successive 21 day cycles. No maximum tolerated dose was identified in this study.

Anti-neoplastic Trials 

A series of Phase 2b studies are being carried out to evaluate the effect of Kanglaite Injection on newly diagnosed tumors, when given concurrently with chemotherapy. In each case, most KLTi doses are being administered at home by trained home infusion nurses. These studies are in the following disease indications:

Pancreatic cancer: A Phase 2b open label comparison of gemcitabine to gemcitabine + KLT in patients is ongoing in patients with metastatic or locally invasive pancreatic cancer that is not amenable to surgical resection. The study is designed to enroll at least 75 patients and is being performed in community based oncology centers. The primary endpoint is progression free survival, although a number of quality of life endpoints are also being evaluated.

Additionally, in patients with pancreatic cancer who have exhausted all other options but who do not wish to enter hospice, a palliative care protocol will open in late 2011, providing open label KLTi in association with the physician's choice of treatment.

NSCLC: A palliative care protocol for patients with advanced NSCLC is likewise opening in the second half of 2011, very similar in design to the pancreatic palliative care protocol.

Patients requesting more information about these trials are encouraged to contact KangLaiTe USA directly at clinicaltrials@kanglaite-usa.com.