Medgenics, Inc. Announces Patient Nearing Unprecedented 11 Months of Anemia Relief in Clinical Trial From Single Treatment of Biopump Tissue Technology; News Follows Significant Interest of Strategic Partner for New Application
LONDON--(BUSINESS WIRE)--Aug 27, 2009 - Medgenics (AIM:MEDG) (AIM:MEDU) is pleased to announce that one of the patients, who was treated with the Company's EPODURE tissue Biopumps almost 11 months ago, continues to be effectively treated for anemia without a single erythropoietin (EPO) injection. This patient (#2) was dependent on frequent injections of the therapeutic protein (EPO) for the 18 months prior to receiving a single administration of 3 tiny EPODURE tissue Biopumps in the Company's phase I/II anemia trial in Israel. He has now gone a full year since his last EPO injection, while his hemoglobin level has been continuously maintained within the target range of 10-12 g/dl for this period. By contrast, conventional anemia treatment by EPO injections must be repeated up to 3 times every week to provide sustained treatment. To the best of the Directors' knowledge, nothing approaching EPODURE's length of sustained anemia relief in patients has been shown from a single treatment of any other kind.
The patient (#2), stated:
“For me the treatment has been and continues to be successful, without complications or discomfort. At 72 years old, I continue to do physical work in the citrus groves several hours a day, but unlike in the previous year, I have not needed injections. The treatment has improved my quality of life.”
Medgenics' unique tissue-based EPODURE Biopump platform technology is proving to be effective in maintaining hemoglobin levels within the target range for many months in most of the patients treated so far, even at lowest dose of treatment, according to internationally renowned nephrologist, Dr. Anatole Besarab, who is a member of Medgenics' Scientific Advisory Board. The Company plans to present the study findings at the upcoming American Society of Nephrology meeting in October.
Dr. Besarab has said:
"With a patient now nearing 12 months without EPO injections and others for more than 6 months, it is becoming clearer that the EPODURE Biopump is able to produce sufficient erythropoietin to effectively elevate and then sustain hemoglobin levels in patients with sufficient administered dose. I am not aware of any other technology that can achieve such prolonged and sustained therapy from a single treatment. Additional studies are needed in a broader range of patients, and we look forward to them to further confirm these very positive results.”
Medgenics has also recently moved significantly ahead in discussions with major pharmaceutical companies and with institutional investment funds.
Advanced discussions are now underway towards potential partnership in the coming months to co-develop a Biopump producing Factor VIII protein for the treatment of hemophilia, a market greater than $3.5b/year (La Marie 2007). In addition, the Company has recently entered advanced discussions with institutional investors interested in multimillion dollar investment in Medgenics in the coming months. Medgenics is also in active due diligence with an Asian biopharma company that has conveyed its written interest in a combined investment in the Company and licensing agreement for collaboration in certain Biopump applications in selected Asian markets to be agreed. The Board is also pleased by recent serious interest by companies in other new applications of the Biopump platform, and believes that such interest demonstrates the attractiveness of the Biopump platform for strategic partners.
The Directors believe that these discussions could lead to concrete steps in the coming months.
In addition to the closing and commitment of additional funds announced last week, which brought the total to $520,000, Medgenics notes that it was awarded a government grant in Q2/09 of $1.3 million from the Office of the Chief Scientist (OCS) at the Ministry of Industry, Trade and Labor of Israel. These funds will be received as government participation in approved R & D expenses incurred during the period April 2009 to March 2010. The OCS awards grants to industry in Israel to advance technological innovations. This is the fourth consecutive year that Medgenics has received this respected grant.
Dr. Andrew Pearlman, CEO of Medgenics said:
"We are excited that we have a patient who is now reaching a full year of effective anemia treatment without any EPO injections and with only a single treatment of EPODURE. In this period a typical patient in the U.S. being treated per the FDA guidelines for EPO administration would receive up to 150 injections. Month by month we have drawn growing encouragement from the continuing positive results of the Biopump anemia study. We are pleased by the significant progress with potential partners and institutional investors which gives us great hope that this will yield concrete results in the coming months. Meanwhile, the Company continues its focused efforts to raise several million US$ in the coming months to enable it to continue and expand the clinical trial and our other operations and to realize the potential of the great opportunities it now has."
The Company would also like to clarify that, further to the announcement made on 20 August 2009, included within the $55,000 debenture investment by “shareholders who are physicians with expertise in the clinical field addressed by Medgenics' lead product, EPODURE” was an investment of US $5,000 from Stephen McMurray, a director of the Company.
Contact: Medgenics, Inc.
Dr. Andrew L. Pearlman, +972 4 902 8900
Blomfield Corporate Finance (Nominated adviser)
James Pinner or Alan MacKenzie, +44 207 489 4500
SVS Securities plc (Broker)
Ian Callaway, +44 207 638 5600
Grayling Global (Financial PR)
Jonathan Shillington, +44 7900 053 536
Posted: August 2009