The biotechnology company reviewed both this study and additional preclinical data conducted with outside collaborators, before concluding the drug was ready for further investigation.
CTCE-9908 is designed to block CXCR4, a receptor found on the surface of cancer cells. CTCE-9908 inhibits the growth and spread of certain common cancers, with the potential for use with existing therapies (chemotherapy, surgery, and radiation) to improve treatment outcomes.
The company recently completed a phase I, dose-escalation clinical trial using CTCE-9908 in the UK to assess its safety in healthy volunteers. CTCE-9908 was shown to be well tolerated causing no serious or drug related adverse events in the 24 participants recruited.
The study consisted of three dose levels with four subjects receiving CTCE-9908 and two receiving a placebo. The first group of subjects received placebo or CTCE-9908 at a dose of 0.5mg/kg body weight with the subsequent groups receiving placebo or 2 and 5mg/kg body weight respectively. The fourth group consisted of healthy women of non-child bearing potential who were administered a dose of 5mg/kg or placebo, in the same manner as the first three groups. There were no serious adverse events noted in any subject during the study.
In a separate study conducted by the National Cancer Institute (NCI), CTCE-9908 was found to dramatically inhibit the spread of cancer to the lung in mice that had osteosarcoma, a form of bone cancer. The group treated with CTCE-9908 had a dramatic decrease (67%) in the number of visible lung nodules due to the cancer spreading when compared to the untreated group.