Precision Biologics reports findings from Phase I/IIA study of NPC-1C at ASCO meeting

Precision Biologics, in collaboration with investigators from Duke University, has been selected to present an abstract of findings from its Phase 2 clinical trial at the Annual Meeting of the American Society of Clinical Oncology. The meeting will be held May 31 - June 4, 2013 at the McCormick Place Convention Center in Chicago, Illinois.

Precision Biologics is reporting findings from a Phase I/IIA study using NPC-1C. NPC-1C (NEO-101; Ensituximab) is a chimeric monoclonal antibody developed as a novel biological treatment for pancreatic and colorectal cancers. The study consists of patients, who are refractory to standard therapy, with advanced pancreatic and colorectal cancer. 20 subjects have enrolled in the study (3 non-evaluable, 10 colorectal, 7 pancreatic), and NPC-1C treatment was well tolerated. Of the patients treated, 29 percent demonstrated stable disease on scans after completing the first course of treatment (four doses). Overall survival was 6.3 months in pancreatic cancer patients and 8.1 months in colorectal cancer patients.

Safety of NPC- 1C has been established at the 1.5 mg/kg dose. A new lot of NPC-1C, produced with improved sterility and purification procedures and demonstrating no red cell agglutination, has been manufactured under GMP conditions. Precision Biologics is currently treating patients with this new lot at the 1.5 mg/kg dose level at Duke University, UT SouthWestern Medical Center, and the National Cancer Institute. If there are no dose limiting toxicities, Precision Biologics plans to dose escalate to a higher MTD at which they will re-evaluate clinical efficacy.