Cadi-05 is a novel Poly-TLR, poly-antigenic vaccine containing Mycobacterium W. It is a potent Th1 response enhancer as revealed by cytokine profile. In a phase I study of patients with advanced non small cell lung cancer Stage IIIb or more, it was used along with chemotherapy and radiotherapy. Twnenty patients recruited were randomized to receive chemo-radio therapy (Control group) or chemo-radio therapy along with Cadi-05 (Treatment group). All the patients received External beam radiation therapy of 60 Gy in fraction of 2Gy, 5 fractions per week for six weeks. Chemotherapy used was cisplatin+ Etoposide. Cadi-05 was administered systemically by way of intradermal injections once every month for four months to this group. One patient in treatment group died while on therapy due to unrelated disease. Of nine patient in treatment group six responded to therapy. Six month after completion in the treatment group six who responded to therapy were found to have stable disease while all in the control arm had progression of the disease. Four of the six patients available for follow-up at eighteen months following therapy and demonstrated stable disease. Three years after therapy three patients of six responders are alive attending hospital. Cadi-05 used along with chemo-radiotherapy seems to provide a durable response. A phase two study is planned.

[Proc Amer Assoc Cancer Res, Volume 47, 2006]