Higher Dose EPO Biopumps Working in Patients
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Medgenics, Inc. announces that the first new patients have now successfully commenced their treatment using biopumps producing middle dose levels of EPO in the Company’s ongoing Phase I/II clinical trials with EPODURE.
The new patients, were also the first to have their Biopumps prepared at a remote site, at the GMP processing center in Jerusalem, transported in a sealed chamber and subsequently administered locally at a major teaching hospital in Tel Aviv - thus successfully demonstrating the concept of a regional Biopump processing center serving a local treatment center, which is important for the wider implementation planned in the future.
In the first part of the Company’s Phase I/II clinical trial, completed in 2009 at the Hadassah Medical Center in Jerusalem, the equivalent of the lowest recommended dose for EPO (20 IU/kg/day) was prepared at the local GMP center and administered in 6 of the patients treated and one patient was treated with the middle recommended dose (40 IU/kg/day).
The biopumps produced EPO continuously in all the patients, elevating or maintaining the haemoglobin levels in many, even with the lowest EPO dose, with most continuing for the 6 month duration of the trial and one for more than 20 months.
This second part of the trial is being conducted at the Tel Aviv Medical Center, a is aimed at treating new patients with the medium and higher continuous doses, to confirm that haemoglobin will be maintained or elevated over the period of the trial at higher dosage levels of EPO delivery. Demonstrating elevation of the haemoglobin level and its maintenance within the normal therapeutic range are primary objectives of this trial.
In this new stage of the continuing Phase I/II clinical trial, sufficient EPODURE biopumps will be administered to each patient to provide 40 IU/kg/day. Two weeks ago, the team conducting the trial at Tel Aviv Medical Center successfully harvested micro-organs from the first two new patients entering the study and processed them to become EPODURE biopumps. These biopumps produced sufficient EPO per day that only 3 or 4 biopumps were necessary in each patient, and these were administered to them on June 17.
The treatment of these new patients is possible as a result of the recently announced, successful fundraising rounds. The Company is now delivering on its plan to move forward with these trials, which have already demonstrated safety and proof of concept of the EPODURE biopump, and now aim to show a trend of greater haemoglobin responses with the higher doses administered.
Following the implantation, the EPO measurements from the post-implant blood samples have confirmed a significant rise in serum EPO levels, demonstrating that the biopumps are efficiently delivering the protein in these patients.
In the previous part of this trial, confirmed EPO production in situ was followed by an elevation of haemoglobin levels within the ensuing months and the Company is confident that this will also happen in this higher dose stage of the trial.
The new patients, were also the first to have their Biopumps prepared at a remote site, at the GMP processing center in Jerusalem, transported in a sealed chamber and subsequently administered locally at a major teaching hospital in Tel Aviv - thus successfully demonstrating the concept of a regional Biopump processing center serving a local treatment center, which is important for the wider implementation planned in the future.
In the first part of the Company’s Phase I/II clinical trial, completed in 2009 at the Hadassah Medical Center in Jerusalem, the equivalent of the lowest recommended dose for EPO (20 IU/kg/day) was prepared at the local GMP center and administered in 6 of the patients treated and one patient was treated with the middle recommended dose (40 IU/kg/day).
The biopumps produced EPO continuously in all the patients, elevating or maintaining the haemoglobin levels in many, even with the lowest EPO dose, with most continuing for the 6 month duration of the trial and one for more than 20 months.
This second part of the trial is being conducted at the Tel Aviv Medical Center, a is aimed at treating new patients with the medium and higher continuous doses, to confirm that haemoglobin will be maintained or elevated over the period of the trial at higher dosage levels of EPO delivery. Demonstrating elevation of the haemoglobin level and its maintenance within the normal therapeutic range are primary objectives of this trial.
In this new stage of the continuing Phase I/II clinical trial, sufficient EPODURE biopumps will be administered to each patient to provide 40 IU/kg/day. Two weeks ago, the team conducting the trial at Tel Aviv Medical Center successfully harvested micro-organs from the first two new patients entering the study and processed them to become EPODURE biopumps. These biopumps produced sufficient EPO per day that only 3 or 4 biopumps were necessary in each patient, and these were administered to them on June 17.
The treatment of these new patients is possible as a result of the recently announced, successful fundraising rounds. The Company is now delivering on its plan to move forward with these trials, which have already demonstrated safety and proof of concept of the EPODURE biopump, and now aim to show a trend of greater haemoglobin responses with the higher doses administered.
Following the implantation, the EPO measurements from the post-implant blood samples have confirmed a significant rise in serum EPO levels, demonstrating that the biopumps are efficiently delivering the protein in these patients.
In the previous part of this trial, confirmed EPO production in situ was followed by an elevation of haemoglobin levels within the ensuing months and the Company is confident that this will also happen in this higher dose stage of the trial.
