Medgenics has released results from Phase I/II clinical trials evaluating Epodure Biopump for the treatment of anemia
Medgenics is a commercial-stage biopharmaceutical company, developing tissue-based Biopump platform technology to provide sustained-action protein therapy for the treatment of a range of chronic diseases.
Biopumps are made using 30 mm long tissue samples taken by needle biopsies from the lower layer of the patient’s skin under local anaesthetic, and processed during 10-14 days to become ‘biofactories’ producing the required protein. The requisite number of Biopumps are injected under the patient’s skin to provide sustained protein production and delivery for many months.
Medgenics said that two new patients have joined the Medgenics’ Phase I/II clinical trial, using Biopumps producing middle dose levels of erythropoietin (‘EPO’) (40 IU/kg/day).
Medgenics said that the added patients have shown a greater therapeutic response to the higher dose than was obtained in similar patients in the low dose group (20 IU/kg/day).
In the first part of the Phase I/II clinical trial, the focus was on (20 IU/kg/day) dose, equivalent to the lowest recommended dose for EPO, administered in 6 of the patients treated, with one patient treated with the middle recommended dose (40 IU/kg/day).
In the trial, the Biopumps produced EPO continuously in all the patients, elevating or maintaining the haemoglobin levels in most, even with the lowest EPO dose, with most continuing for the 6 month duration of the trial and one for more than 20 months.
The second part of the trial is aimed at treating new patients with the medium and higher Epodure doses to confirm that haemoglobin will be safely maintained or elevated over the period of the trial using these higher dosage levels of EPO delivery, and to show evidence of dose-dependence: greater administered Epodure dose should generally result in greater haemoglobin response.
Medgenics claimed that the results are a significant step towards demonstrating sustained dose-dependent haemoglobin response, and in the company’s development of Epodure Biopump.
Andrew Pearlman, CEO of Medgenics, said: “We are particularly gratified by the greater rise in haemoglobin in these patients compared to the lower dose counterparts, a finding that supports our belief that Epodure is a dosable treatment.
“We are confident that the coming weeks and months will confirm for the mid-dose what we have shown at lower dose: that a single administration of Biopumps can provide many months of effective anaemia therapy in these patients replacing scores of EPO injections. We now look forward to following these patients, while recruiting additional patients to the trial in the coming months.”