Drug discovery and development company Esperance Pharmaceuticals today announced that it has begun enrollment and dosing of patients in a Phase 1 study of EP-100 in patients with advanced solid tumors. EP-100, the lead candidate from Esperance's Cationic Lytic Peptide (CLYP(TM)) 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, skin and testicular cancers.
"We are pleased to have begun human clinical trials of EP-100 as a novel cancer therapeutic candidate with the potential to offer an improved safety and efficacy profile over existing therapies such as radiation or chemotherapy," said Hector Alila, Ph.D., President of Esperance. "Preclinical studies of EP-100 demonstrated this candidate's efficacy across multiple indications in oncology, including aggressive cancers known to be resistant to the current standards of care and, importantly, studies of EP-100's mechanism-of-action support that it targets and selectively kills cancer cells without harming normal cells."
The Phase 1 study is a multi-center, open-label, dose escalating study designed to evaluate the safety, pharmacodynamic and pharmacokinetic properties of EP-100. This study will enroll adult patients with solid tumors that over-express LHRH receptors as determined by tumor biopsy. Up to a total of 36 patients that are either refractory to the standard of care or for which no standard of care exists may be enrolled in the study. EP-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.