Esperance Pharmaceuticals Initiates Phase 2 Clinical Trial of EP-100
- Results from Phase 1 clinical trial of EP-100 to be presented at ASCO
Esperance Pharmaceuticals announced that it has begun enrollment in a Phase 2, randomized, multi-center trial of EP-100 in combination with paclitaxel for the potential treatment of advanced ovarian cancer. EP-100 is a targeted membrane-disrupting peptide (tMDP) designed to seek and destroy cancer cells that over-express luteinizing hormone releasing hormone (LHRH) receptors on their surfaces. LHRH receptors are over-expressed in a wide range of cancers including ovarian cancer. The Phase 2 study design is based on the recent successful completion of a Phase 1 study of EP-100 in advanced solid tumors, the results of which will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June this year.
“Based on our successful Phase 1 study and results of preclinical studies, we believe there is a compelling rationale for the study of EP-100 in ovarian cancer — which is known to over-express LHRH receptors,” said Hector Alila, Ph.D., Chief Executive Officer of Esperance. “We are hopeful EP-100 may hold promise for this patient population with very few treatment options.”
The EP-100 Phase 2 study is enrolling five to eight patients in a run-in to confirm the maximum safe dose of EP-100 to be combined with paclitaxel. The randomized study then will enroll 40 patients randomized in a 1:1 ratio to receive either the standard weekly dose of 80 mg/m(2) paclitaxel or the same regimen of paclitaxel plus twice weekly EP-100 for three of four weeks during each of six cycles. The primary outcome of the study will be objective response rate, and secondary outcome measures include quality and duration of response, time to progression and follow-up for survival, as well as the safety of this new doublet regimen. Details of the trial are provided on ClinicalTrials.gov, NCT 01485848.
Abstract #3060/Poster Board 15B, “A phase I study of EP-100, a luteinizing hormone releasing hormone (LHRH) ligand conjugated to a synthetic cytolytic peptide in patients with advanced refractory LHRH- receptor (R)-expressing tumors” will presented by Ramesh K. Ramanathan, M.D., from the Virginia G. Piper Cancer Center/TGen, (Scottsdale, Az.), on Monday, June 4, 2012, at 8 a.m. CT in S Hall A2 at McCormick Place in Chicago, IL.
EP-100, the lead candidate from Esperance’s Cationic Lytic Peptide (CLYP™) platform technology, is a targeted membrane-disrupting peptide (tMDP) designed to seek and destroy cancer cells that over-express luteinizing hormone releasing hormone (LHRH) receptors on their surfaces. LHRH receptors are over-expressed in a wide range of cancers including breast, prostate, endometrial, pancreatic, ovarian, blood, skin and testicular cancers. Results from pre-clinical studies of EP-100 have shown that the drug regresses established tumors in breast, prostate, ovarian and endometrial cancer xenografts in mice. Preclinical 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 or 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.
About Esperance Pharmaceuticals
Esperance Pharmaceuticals, Inc., is a clinical stage company developing a new class of targeted anticancer drugs using its Cationic Lytic Peptide (CLYP™) platform technology. These drug candidates, called targeted membrane-disrupting peptides (tMDPs) and antibody drug conjugates (ADCs) selectively seek and destroy cancer cells, including cells known to be resistant to chemotherapeutic drugs, without harming normal cells. Targeting occurs through binding to specific receptors and antigens on the cell’s surface. The Company was founded on patented technology discovered by scientists at the Pennington Biomedical Research Center, the Louisiana State (LSU) Ag Center and LSU main campus. Founding investors include the Louisiana Fund I, Themelios Ventures and Research Corporation Technologies. Additional investors include Sanofi, Advantage Capital Partners, Louisiana Technology Fund and private investors. More information can be found at EsperancePharma.com.