This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Medgenics Reports Positive Meeting With NIH Recombinant DNA Advisory Committee

Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that it has received formal notification of recommendations from the National Institutes of Health (“NIH”) Recombinant DNA Advisory Committee (“RAC”) reflecting the Company’s successful presentation of study findings during a meeting held on March 8, 2012. Completion of the RAC process is an important step in advancing toward the Company’s proposed U.S. Phase II clinical study evaluating the safety and efficacy of sustained erythropoietin (“EPO”) therapy delivered via the Company’s EPODURE™ Biopump™ for the treatment of anemia in dialysis patients with end-stage renal disease (“ESRD”).

The RAC meeting was attended by an audience from the general public and was webcast live. An archive of this webcast is available at

EPODURE is an autologous dermal Biopump capable of the sustained secretion of therapeutic EPO in the body using a small tissue explant from the patient’s own skin. The EPODURE Biopump is subsequently implanted subcutaneously into the patient to provide continuous delivery of EPO.

“We are delighted that the RAC has given such positive responses regarding our proposed Phase II clinical protocol for EPODURE to treat ESRD and we have already addressed most of their recommendations in our study planning,” said Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics. “Clinical trials involving recombinant DNA products intended to be conducted in the U.S. generally need to satisfy review by the RAC, which is widely recognized as a most thorough scientific and clinical review by leading experts in relevant areas. Key to this positive response was the safety and sustained clinical activity we showed from the EPODURE Phase I/II trial conducted in Israel. We believe the RAC recommendations can be incorporated into our proposed protocol without difficulty and will not pose any significant delay or expense. Following a positive pre-Investigational New Drug (“IND”) application meeting with the U.S. Food and Drug Administration (“FDA”) last fall, completion of the RAC process clears an important hurdle toward the successful submission of our IND application and is a significant step in implementing our clinical strategy.

1 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $93.99 0.00%
FB $102.01 0.00%
GOOG $682.40 0.00%
TSLA $151.04 0.00%
YHOO $27.04 0.00%


Chart of I:DJI
DOW 15,973.84 +313.66 2.00%
S&P 500 1,864.78 +35.70 1.95%
NASDAQ 4,337.5120 +70.6750 1.66%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs