This Day On The Street
Continue to site
ADVERTISEMENT
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

Mesoblast Receives FDA Clearance For Phase 3 Bone Marrow Transplant Trial

MELBOURNE, Australia, July 7, 2011 /PRNewswire/ --

Key points:
  • Mesoblast's first Phase 3 trial submission cleared by United States Food and Drug Administration (FDA)
  • Rapid clearance (within 30 days) further validation of Mesoblast's clinical, regulatory, and manufacturing capabilities
  • Mesoblast's proprietary adult stem cells expand hematopoietic precursor cells in umbilical cord blood 40-fold, enabling rapid bone marrow reconstitution with lowered risk of life-threatening Graft Versus Host Disease (GVHD)
  • Mesoblast's novel clinical approach could make the use of bone marrow transplantation available to all those in need of the procedure but who currently cannot find a donor, without the need for full matching
  • Commercial opportunity based on potential to increase the total number of unrelated donor transplants performed globally by three- to four-fold
  • This product may be the first of Mesoblast's revenue generating biologic therapies in both the US and Europe

Global regenerative medicine company Mesoblast Limited (ASX:MSB; OTC ADR: MBLTY) today announced that it has received clearance from the United States Food and Drug Administration (FDA) to begin a Phase 3 clinical trial for bone marrow regeneration in patients with blood cancers. FDA clearance was obtained within the 30-day minimum time period after Mesoblast filed its Phase 3 Investigational New Drug (IND) submission.

The Phase 3 trial will aim to reproduce the positive pilot trial results seen at the University of Texas MD Anderson Cancer, where accelerated neutrophil and platelet recoveries, together with excellent 100-day patient survival and low GVHD rates, occurred in patients receiving partially mismatched hematopoietic cells from umbilical cord blood expanded by Mesoblast's proprietary allogeneic or 'off-the-shelf' mesenchymal precursor cells (MPCs).

Mesoblast's off-the-shelf MPCs are being developed under an Orphan Drug Designation granted for the condition of insufficient hematopoietic stem cell production in patients with hematologic malignancies who have failed treatment with conventional chemotherapy. Such patients are in need of bone marrow transplantation using hematopoietic stem cells that are of either autologous (patient's own) or allogeneic (unrelated donor, e.g. blood from other adults or umbilical cord) origin. Mesoblast's MPCs may potentially be used for expansion of both autologous and allogeneic hematopoietic stem cells for subsequent transplantation.

1 of 3

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
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG

Markets

DOW 17,776.91 +93.33 0.53%
S&P 500 2,081.34 +12.58 0.61%
NASDAQ 4,997.4590 +5.5190 0.11%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs