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Liver Metastases

April 11, 2011

Jennerex and Transgene reported results from combined phase I and II trials of JX-594 for the treatment of liver cancer. Data are from 35 subjects with either hepatocellular carcinoma or cancer metastases to the liver (including colorectal cancer, melanoma and renal cancer). All subjects received up to eight intratumoral injections of JX-594 therapy. Twenty-three subjects (66%) exhibited significant tumor necrosis and responses by modified Choi criteria (decreased tumor density). Seven subjects (20% of evaluable) also exhibited objective response by Response Evaluation Criteria in Solid Tumor (RECIST) criteria, including two complete responses upon long-term follow-up. Twenty subjects (57%) had stable disease as defined by RECIST criteria. The most common adverse events was transient flu-like symptoms.

August 23, 2010

Positive results were reported from a phase II trial evaluating Sirtexs SIR-Spheres for the treatment of colorectal cancer liver metastases. This single arm trial enrolled 52 subjects with metastatic colorectal cancer who had failed prior chemotherapy regimens containing oxaliplatin and irinotecan. The SIR-Spheres were injected into the artery supplying blood to the tumors where they delivered radiation for approximately 14 days. Liver tumors completely disappeared in one subject, and 11 subjects had a partial response involving at least a 30% reduction in tumor size (p≡0.05). An additional 12 subjects had stable disease. The median overall survival for the entire population was 12.6 months, with significantly longer survival in the 24 (48%) subjects that responded to SIR-Spheres or who had stable disease compared to non-responders (median 16 months versus 8 months; p≡0.0006). In addition, 40% of the responders remain alive at two years compared to none of the non-responders. The most commonly reported side effects were fever and pain.

January 24, 2002

Phase III trial results indicate that a combination therapy consisting of histamine and interleukin-2 (IL-2) is well tolerated and improves the survival of advanced malignant melanoma subjects. In the multicenter trial, 305 subjects with stage IV melanoma were randomly assigned to receive IL-2, or IL-2 plus histamine. The IL-2/histamine combination resulted in a median survival of 283 days in subjects with metastases to their livers, compared to 154 days with IL-2 alone. For all randomized subjects entering the trial, the combination produced a median survival of 272 days, compared to 245 days for the IL-2-treated group. At 24 months follow-up, 25% of subjects receiving the histamine/IL-2 combination were alive, versus 17% of subjects receiving IL-2 alone. The trial was sponsored by Maxim Pharmaceuticals.