Medgenics reports positive data from Phase I/II anemia study

In the company’s ongoing Phase I/II clinical trial, a one-time administration of Epodure, producing and delivering the low dose of 18-25IU/kg/day of the protein erythropoietin (EPO), was sufficient to sustain therapeutic elevation of hemoglobin in most patients. The earliest patients to receive treatment have shown sustained hemoglobin within the target range for four months without receiving any EPO injections, the company said.

The Phase I/II clinical trial was approved for three escalating dose groups, beginning with six patients at the lowest dose, and called for a safety review after treatment of these first six patients prior to treatment using higher doses.

The institutional review board of Hadassah Hebrew University Hospital in Jerusalem, Israel, where the study is being conducted, has now reviewed the results for this first group of patients and has confirmed the safety and efficacy of Epodure at the low dose and approved the continued recruitment and treatment of patients in the trial using higher Epodure doses.

Even with the low dose, the hemoglobin levels of most of the patients have remained within 10-12 grams per deciliter, the target range indicated by FDA guidelines for chronic kidney disease patients, with no adverse effects reported or observed, the company said. The results from the patients to date indicate that Epodure is safe and well tolerated and suggests that it can provide effective treatment of chronic anemia, the company added.

Medgenics intends to develop its technology for a variety of chronic conditions, initially focusing on anemia and hepatitis C, with the intent to bring it to market via multiple strategic alliances in the relevant therapeutic space. The company is in active discussions with major potential strategic partners for one or more applications.