(By Balaseshan) Medgenics Inc. (NYSEAMEX:MDGN), a protein-therapeutics medical technology company, said it has initiated its first U.S. Biopump processing facility in Davis, California initially to supply Epodure for U.S. anemia clinical trials.
Epodure is an autologous dermal Biopump, a small tissue implant made from the patient's own dermal (skin) tissue. Epodure Biopumps are processed to enable the continuous production of erythropoietin, and are subsequently implanted subcutaneously.
Medgenics recently said it had received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to conduct a Phase 2b study of Epodure for the treatment of anemia in dialysis patients in the U.S.
Epodure Biopumps for the treatment of anemia in patients undergoing renal dialysis are now being processed by the company's contract manufacturing organization (CMO) in a good manufacturing practice (GMP) certified facility.
This marks the first Biopump processing site outside of Israel, and provides Medgenics with a significant ability to scale-up its clinical and commercial capabilities to address global therapeutic areas such as anemia and hemophilia.
The company said the initial processing of Biopumps in the GMP facility of U.S. CMO resulted in product that meets all quality requirements for use in human clinical trials. Medgenics plans to continue with processing additional lots of product to ensure consistency and reliability before the U.S. clinical trial begins.
In a key "dry run" test of the production system, tissue micro-organs were obtained and loaded into individual closed processing chambers in Israel, and then shipped to the U.S. CMO Biopump processing center in California.
There, the micro-organs were processed in their closed systems into fully functioning Epodure Biopumps, meeting the release criteria for use in human clinical trials in the U.S.
This demonstrates Medgenics' capability to support the treatment of patients at remote clinical sites, transporting their Biopumps to and from strategically located processing facilities, thereby allowing for multicenter clinical trials and practical commercial implementation.
MDGN is trading down 5.26% at $6.30 on Thursday. The stock has been trading between $2.08 and $8.60 for the past 52 weeks.