BOSTON--(BUSINESS WIRE)--Point Therapeutics, Inc. (NASDAQ: POTP - News) today provided preliminary results from the Company's open-label Phase 2 trial of talabostat plus gemcitabine in patients with metastatic pancreatic cancer (Stage IV) who have not received prior chemotherapy.
Of the 21 evaluable patients who entered the study at least six months ago, ten (48%) have survived more than six months. In addition, 31 patients are currently evaluable for tumor response. To date, three patients (9.7%) have demonstrated a clinical response to treatment, including one complete response and two partial responses. One patient with metastatic disease to the liver experienced a complete response to treatment--defined as the complete disappearance of tumor. Thus far, no unexpected toxicities have been seen in the trial that would prevent the Company from continuing to study talabostat in combination with gemcitabine.
The Phase 2 study is a single-arm, two-stage study in up to 60 evaluable patients with metastatic pancreatic cancer. The primary clinical endpoint is six-month survival. Secondary study endpoints include overall survival, progression-free survival, quality of life, and performance status. The Phase 2 study protocol called for an interim assessment before advancing the study to completion. Based on the preliminary six-month survival results and the responses seen to date, the Company has decided to advance the study to completion. Final results from the study are expected mid-year 2007.
"Metastatic pancreatic cancer represents a significant unmet medical need as there are limited treatment options available for patients. I am pleased with the activity seen to date in this trial, especially with an oral agent, and look forward to evaluating further data as it becomes available," said Dr. Yagnesh Oza, MD, Medical Director at the Center for Comprehensive Cancer Care in Mt. Vernon, IL and an investigator in the study.
"It's encouraging to see Point's preclinical work potentially translating into clinical benefits for patients," said Dr. George Demetri, a member of Point's Clinical Advisory Board and Director of the Ludwig Center at Dana-Farber/Harvard. "Point has demonstrated preclinically that talabostat is a potent inhibitor of fibroblast activation protein (FAP), an enzyme that is highly expressed in pancreatic cancer and is believed to promote tumor growth. In addition, preclinical work combining talabostat with gemcitabine has also demonstrated encouraging results. I believe these factors make pancreatic cancer a promising target for the study of talabostat," concluded Dr. Demetri. |
