Higher Dose EPO Biopumps Working in Patients
Misgav, Israel and London, UK -22 June 2010 - Medgenics, Inc. (AIM: MEDG, MEDU), the company that has developed a novel technology for the manufacture and delivery of therapeutic proteins continuously in patients using their own tissue, is pleased to announce 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 (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, and 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.
Dr. Andrew Pearlman, CEO of Medgenics commented: "We are very pleased that the first patients in the new part of our study have now commenced their treatment. We are particularly impressed with the potency of the EPODURE biopumps from these patients, which has enabled them to receive the medium dose using only a few biopump units, and with their successful preparation at a remote site Biopump processing center, establishing a model for wider future implementation. We now look forward to monitoring the haemoglobin response in these patients, while recruiting additional patients to the trial in the coming months. We are optimistic that this higher dose will confirm that the middle dose biopumps work well and that the therapeutic response is dose dependent and without adverse effects. As this is an open trial, we look forward to keeping investors updated as we treat additional patients and review the ongoing trial data."
For further information, contact:
Andrew Pearlman +972 4 902 8900
Mike Wort / Anna Dunphy +44 207 861 3838
De Facto Communications (PR)
James Pinner / Derek Crowhurst +44 207 444 0800
Religare Capital Markets (Nomad)
Ian Callaway / Alex Mattey +44 207 638 5600
SVS Securities plc (Joint Broker)
Jonathan Senior +44 207 776 1219
Nomura Code (Joint Broker)
Notes to Editors:
Medgenics is a commercial-stage biopharmaceutical Company, developing its unique tissue-based Biopump platform technology to provide sustained-action protein therapy for the treatment of a range of chronic diseases. The first revenue generating commercial deal with a well known multinational pharmaceutical company was negotiated in late 2009.
Biopumps are made using needle biopsies taken from the lower layer of the patient's skin under local anaesthetic, and processed during 10-14 days to become 30 mm long tissue "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. The Company is developing the Biopump to provide substantially greater safety and reliability in protein treatment in a more cost effective manner than experienced with the existing injected protein therapies. Medgenics currently has three products in development based on this technology, addressing the indications of:
- Anaemia - using EPODURE, a Biopump producing erythropoietin (EPO)
- Hepatitis-C - using INFRADURE - a Biopump producing interferon-alpha (IFN-a)
- Haemophilia - using a Biopump to produce clotting Factor VIII
The Company's Phase I/II clinical trial using EPODURE to treat anaemia in patients with chronic kidney disease, has demonstrated proof of concept of the Biopump. Designed to produce and deliver a therapeutic dose of EPO steadily for six months or more, EPODURE Biopumps have already provided effective anaemia treatment in most of the longest participating patients for 6-12 months, even at the low administered dose.
Medgenics intends to develop its innovative products and bring them to market via multiple strategic partnerships with major pharmaceutical and/or medical device companies. In addition to treatments for Anaemia, Hepatitis-C and Haemophilia, Medgenics plans to develop and/or out-license a pipeline of future Biopump products targeting the large and rapidly growing global protein therapy market, which is forecast to reach US $87 billion by the end of 2010. Other potential applications of Biopumps producing various proteins include multiple sclerosis, arthritis, pediatric growth hormone deficiency, obesity, and diabetes.
This information is provided by RNS