GenSpera, Inc. (OTCBB:GNSZ) announced that Devalingam Mahalingam, MD, PhD, principal investigator of the G-202 Phase II trial in hepatocellular carcinoma, presented final data from the G-202 Phase I clinical trial yesterday at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Boston, MA (http://www.aacr.org/home/scientists/meetings--workshops/molecular-targets-and-cancer-therapeutics.aspx). In presenting a poster called, "A First-in-Human, Phase I Clinical Study of G-202, a Thapsigargin-Based Prostate-Specific Membrane Antigen (PSMA)-Activated Prodrug, in Patients with Advanced Solid Tumors," Dr. Mahalingam reported that 27% of the patients exhibited stable disease and two of the five patients with hepatocellular carcinoma had a prolonged stable disease of more than nine months (nine cycles of treatment). The trial treated a total of 44 patients, with solid-tumor cancers who had failed on earlier therapies, with increasing dose levels. A subset of 16 patients received the recommended Phase II dosing regimen, which appeared to be well-tolerated. Dr. Mahalingam is an oncologist at the Cancer Therapy & Research Center at The University of Texas Health Science Center at San Antonio.
"This final data from the Phase I G-202 study included 16 patients treated at the recommended Phase II dose, five of whom had hepatocellular cancer (HCC)," said Dr. Mahalingam. "That two of them experienced a prolonged period of stable disease is a remarkable improvement in survival, given that median survival in this heavily pre-treated group is usually measured in weeks or months. These encouraging results form the basis of our ongoing Phase II study of G-202 in patients with advanced HCC who have failed standard therapy with Nexavar."
"This represents the first communication of our complete G-202 Phase I data, which illustrate the safety and tolerability of G-202 in advanced cancer patients," said Craig Dionne, PhD, GenSpera CEO and President. "Based on the strength of this data, particularly in the group of liver cancer patients, we initiated the G-202 Phase II trial in HCC, which is now open at five clinical centers. We are excited to develop what we believe may constitute a truly innovative treatment for this group of underserved patients."
Source: The University of Texas Health Science Center