Data will be used to support Phase II trial in U.S.
Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG) (the “Company”), the developer of Biopump?, a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today provided an update on results from the first four patients treated thus far in its ongoing Phase IIa clinical trial in Israel of EPODURE? Biopumps to treat anemia in patients on dialysis with end-stage renal disease (“ESRD”).
Each of the four patients had been receiving routine EPO injections with each dialysis session until his or her EPODURE Biopumps were administered by subcutaneous implantation. Initial and on-going experience to date in ESRD patients is in line with observations from the Company’s prior Phase I/II study in anemic pre-dialysis patients with chronic kidney disease (“CKD”). To date, there have not been any procedure or drug related serious adverse events. Thus far in this single treatment study, each patient has received a single administration of EPODURE Biopumps, measured to produce between 19 to 51 IU EPO per kg per day, in place of the serial injections of EPO or ESA the patient had been receiving with each dialysis session. Following the administration of EPODURE Biopumps, the hemoglobin in these patients remained in the desired 9-11 g/dl range for approximately 2-4 months, without needing any EPO or other ESA injections. Notably, at no point following EPODURE treatment did the concentration of EPO in the serum of the patients exceed the typical normal range and always remained under 100 mU/ml.
As the first study with EPODURE Biopumps in ESRD patients on dialysis, this Phase IIa study is testing administration techniques and dosing to determine how long a single treatment using EPODURE Biopumps can replace the periodic injections of EPO or other erythropoietic stimulating agents (“ESAs”) currently used in the standard care of such patients, while maintaining the patient’s hemoglobin within the desired range. The current standard of care for ESRD patients on dialysis involves EPO or ESA injections with each dialysis session, which is typically three times per week. Each injection is short-lived, typically causing an extreme transient elevation of EPO in the patient’s blood to levels of several thousand milliUnits/ml, typically 10-100 times the normal physiological levels, followed by a decline to ineffective levels within a few days, so the patient may not have sufficient EPO or ESA until the next injection. The high transient levels of EPO in the blood are a source of potential safety concern to many medical experts as well as to the U.S. Food and Drug Administration (“FDA”), and is in marked contrast with the normal EPO levels maintained with EPODURE, as reported above.
“These preliminary data are encouraging and we believe they will be valuable as we move forward with plans to implement a larger Phase II trial in the U.S. in the second half of 2013. When EPODURE reaches routine clinical use, we believe the ability to titrate the dose to reach the most effective dosing level based on the patient’s early hemoglobin response could further extend the duration of hemoglobin maintenance,” stated Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics.
“EPODURE Biopumps aim to provide a cost-effective way to maintain hemoglobin within a target range in anemic patients by providing sustained delivery of EPO within the normal physiological range, while avoiding the extreme elevations seen with repeat injections. We believe that EPODURE could improve the safety and efficacy of anemia treatments while enhancing patient quality of life by providing a more reliable treatment that reduces or eliminates the need for frequent EPO or ESA injections, and also could provide clear cost benefits to payers,” added Dr. Pearlman.
Medgenics is developing and commercializing Biopump?, a proprietary tissue-based platform technology for the sustained production and delivery of therapeutic proteins using the patient’s own tissue for the treatment of a range of chronic diseases including anemia, hepatitis and hemophilia, among others.
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company’s financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as “estimate,” “project,” “intend,” “forecast,” “anticipate,” “plan,” “planning, “expect,” “believe,” “will,” “will likely,” “should,” “could,” “would,” “may” or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.
Dr. Andrew L. Pearlman, +972 4 902 8900
Anne Marie Fields, 212-838-3777
Adam Michael/Joanne Shears/Jamie Hooper
+44 207 398 7719
Nomura Code Securities (NOMAD & Joint Broker)
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