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Esperance Pharmaceuticals Announces Initiation of Clinical Studies of its Novel Membrane-disrupting Agent, EP-100, in Patients with Cancer
Date:9/10/2009

100 will be administered intravenously for three out of four weeks. Once the maximum tolerated dose (MTD) has been established, additional subjects with specific diagnoses of either breast, ovarian, endometrial, pancreatic or prostate cancer will be enrolled and dosed at the MTD. Additionally, patients with other types of cancer may be added based on activity observed in previous cohorts. More information on the trial can be found at www.clinicaltrials.gov.

Results from preclinical studies of EP-100 have shown that the drug regresses established tumors in breast, prostate, ovarian and endometrial cancer xenografts in mice. The results in ovarian cancer were presented at the 2009 American Association for Cancer Research (AACR) Annual Meeting. In in vivo studies, the efficacy of EP-100 in comparison to saline or untargeted membrane-disrupting peptide or cisplatinum was studied in an ovarian cancer xenograft model (OVCAR-3). EP-100 regressed established OVCAR-3 xenografts following weekly injections at doses as low as 0.2 mg/kg bodyweight (p<0.03 vs. baseline). In comparison, tumor growth was observed across the saline control, untargeted membrane-disrupting peptide and cisplatinum arms. In addition, in the EP-100 arm tumor volumes, weights and CA125 (a clinical biomarker for ovarian cancer) were reduced. LHRH receptor levels were also reduced and PET imaging revealed that EP-100 treated tumors became necrotic, lacking viable tumor cells after treatment. EP-100 was well tolerated in all treated groups.

Esperance is using its CLYP(TM) technology to develop a robust portfolio of novel tMDPs to selectively destroy cancer cells that express target receptors. In addition to EP-100, Esperance has other drug candidates in preclinical stages, all of which have a unique targeting mechanism of action whereby candidates bind specifically a
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SOURCE Esperance Pharmaceuticals, Inc.
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