The primary objectives of the phase I study are to evaluate the safety and dosing of talabostat in combination with chemotherapy in the pediatric population.
The decision of the NCI and Point Therapeutics to collaborate on this study was based on positive preclinical data in a sarcoma cell line. Sarcomas are cancerous tumors of the bone or soft tissues and comprise approximately 7% of all cancers in children age 20 years or younger. It is anticipated that many of the patients to enroll in this study will have sarcomas.
Additionally anti-tumor effects have been observed in previous and ongoing clinical trials of talabostat in adult patients, particularly, when talabostat was given in combination with chemotherapy or monoclonal antibodies.
Talabostat is currently being studied in two phase III studies in adult patients who have advanced non-small cell lung cancer as well as several phase II studies in various tumor types.
“This collaboration is of great interest to us because it represents our first study in a pediatric population. In addition, there is a clear unmet clinical need since these patients have exhausted other treatment options,” said Don Kiepert, president and CEO of Point Therapeutics. “It also provides us greater insight in determining the efficacy of talabostat in additional patient populations and disease states.”