Author: Jared Louis Wolff
Publisher: Datamonitor Healthcare
ADI-PEG 20 (PEG-arginine deiminase; Polaris Group) is a bacterial enzyme that degrades the amino acid, arginine. The active ingredient is arginine deiminase (ADI), which is formulated with polyethylene glycol (PEG) of 20,000 Dalton molecular weight (PEG 20). Human hepatocellular cancer (HCC) cell lines have been found to require an external arginine supply for growth. Elimination of arginine from the circulatory system inhibits the proliferation of HCC tumor cells and has been shown to reduce tumor size. Normal human cell types should remain unaffected as they are able to synthesize arginine using argininosuccinate synthase, an enzyme that is not present in HCC tumor cells. ADI is a bacterial enzyme that provokes an immune response in humans. However, formulation with PEG 20 decreases the immune response to ADI while increasing the length of time the drug stays in circulation.
It is difficult to assess the efficacy of ADI-PEG 20 (PEG-arginine deiminase; Polaris Group) in hepatocellular cancer (HCC). The only data available are from a small population of patients with varying treatment histories. Datamonitor Healthcare believes that Polaris Group’s lack of marketing experience combined with ADI-PEG 20’s unattractive intravenous formulation and anticipated high cost will severely restrict the drug’s commercial potential in the HCC market.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 ADI-PEG 20 : Hepatocellular cancer
LIST OF FIGURES
6 Figure 1: Phase II results for ADI-PEG 20 in hepatocellular cancer
8 Figure 2: ADI-PEG 20’s SWOT analysis for hepatocellular cancer
9 Figure 3: Datamonitor Healthcare’s drug assessment summary for ADI-PEG 20 in
10 Figure 4: Datamonitor Healthcare drug assessment summary for ADI-PEG 20 in hepatocellular
LIST OF TABLES
4 Table 1: ADI-PEG 20 – drug profile
5 Table 2: Clinical development of ADI-PEG 20 in hepatocellular cancer
7 Table 3: Summary of
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