The primary objective of this Phase I/II clinical trial was to determine the tolerability and safety profile of repeated administration of CTCE-9908. The secondary objective was to evaluate early signs of efficacy such as tumor stabilization and reduction of tumor growth and spread.
The final results demonstrate that repeat dosing of CTCE-9908 is well tolerated with no dose limiting toxicity observed up to the maximum dose of 5.0mg/kg/day.
Results also showed encouraging signs of efficacy. A total of 20 patients received the targeted efficacious dose of 1-5mg/kg/day based on preclinical studies and were evaluable for tumor response. From this number, six patients (30%) had overall stable disease after one cycle (one month).
One patient with ovarian cancer had a significant reduction in the tumor marker CA125 with a correlating reduction in target tumor size after less than one cycle of treatment.
Walter Korz, president and CEO of Chemokine, said: “Based on the safety data of this trial we are now preparing to move forward with our Phase II cancer study.”