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Sunday, March 29, 2015 2:19:10 PM
"Another approach aims to make pancreatic cancer an operable disease. Using “Cell in a Box” technology developed by Austrianova, in Singapore, this cell therapy delivers ifosfamide locally to the cancer. Ifosfamide has previously shown promise as a chemotherapy against pancreatic cancer, but its effective dose was too toxic to give patients systemically. Instead, in the “Cell in the Box” approach, patients receive one-third of the usual dose of ifosfamide. “Cell in a Box” contains genetically modified cells that express the drug-metabolizing cytochrome P450 and converts the ifosfamide to its active form at the site of the tumor, according to CEO Brian Salmons, Ph.D. A catheter delivers the “Cell in a Box” capsule containing these cells to capillaries feeding the pancreas. This system of local delivery and activation greatly reduces side effects.
The European Medicines Agency fast-tracked this treatment, which is licensed to Nuvilex (Silver Spring, Md.). Nuvilex plans at least two new trials based on earlier phase I/II and phase II trials with a total of 27 patients with advanced pancreatic cancer. In the first, patients received two courses of ifosfamide at one-third the regular dose plus a urological protectant after transplantation of 300 capsules. Median survival after diagnosis rose to 40 weeks, compared with historical control of 28 weeks with gemcitabine, and 1-year survival increased to 36%, compared with 18% for gemcitabine. Four patients also reported improved pain, six were unchanged, and three had slightly more pain (The Lancet, May 19, 2001). However, in a second trial doubling the dosof ifosfamide, patients did not tolerate the drug well. Median survival was only 33 weeks, and 1-year survival was only 23%, suggesting that the lower dose previously used was better (Pharmaceutics, August 15, 2014, online).
“However, nine of the 27 patients were alive after 1 year, and two of these nine patients were alive for 2 years or more,” Salmons said.
An Australian phase IIb trial will test for median survival time and 1-year survival in advanced disease compared with best current treatment, and researchers plan a phase I/II trial for ascites (fluid in the abdomen) in metastatic cancer."
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