Eighty percent of hepatocellular carcinoma (HCC) patients enrolled in San Antonio, Texas-based GenSpera, Inc.‘s Phase 1b/2 clinical trial of G-202 showed signs of tumor stabilization without growth after two months of treatment. The announcement was presented by principal investigator Dr. Devalingam Mahalingam, MD, PhD, at the Asia-Pacific Primary Liver Cancer Expert Association (APPLE) Congress held July 11-13 in Taipei, Taiwan.
“The efficacy and safety analyses on patients enrolled to date on this study continue to demonstrate that G-202 holds promise for patients with advanced HCC, with half the patients showing disease stability at 4 months and the majority of patients tolerating G-202 with minimal toxicities,” described Dr. Mahalingam in a news report.
Although the percentage of patients exhibiting disease stabilization at four months dropped to 50%, the results are nonetheless encouraging, as the enrolled patients’ cancers previously progressed when they were taking the agent sorafenib. What’s more, the median time to progression of the HCC patient population is only two months when entering subsequent clinical trials.
“These positive results enable management to remain optimistic about our ambitious G-202 clinical development program which is expanding into glioblastoma, prostate cancer and renal cell carcinoma trials,” said Dr. Craig Dionne, CEO of GenSpera. “Although still in early stages, we believe this clinical strategy will continue to build significant value in G-202 and in the company. We are particularly excited by the potential that G-202 is showing as a treatment for patients with liver cancer, a market which is expected to be at $1.5 billion by 2019.”
News of the trial first broke in March, when it was expected up to 34 patients would be enrolled in the trial. Patients are being evaluated using DCE-MRI, which “is a sophisticated imaging technique that allows us to assess effects of G-202 on tumor blood flow characteristics,” explained Dr. Dionne. “The DCE-MRI data in the single patient evaluated to date provide strong evidence that G-202 is significantly decreasing tumor blood flow in a fashion for which it was designed. We will extend this diagnostic procedure in future patients to confirm this important proof of concept observation.”
As described previously on BioNews Texas, G-202 is a modified form of the plant-derivide cytotoxin thapsigargin. As a prodrug, G-202 is specifically activated in the presence of prostate specific membrane antigen, an enzyme abundant in nearly all tumor cells. This makes G-202 a strong candidate for treating cancers such as HCC without creating excessive harm to patients.