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

Pluristem Receives Regulatory Approval To Extend Its Phase II Study Of PLX-PAD Cells In The Treatment Of Intermittent Claudication To South Korea

HAIFA, Israel, Nov. 13, 2013 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today that the South Korean Ministry of Food and Drug Safety (MFDS), formerly the Korea Food & Drug Administration (KFDA), has approved Pluristem's Investigational New Drug (IND) Application to conduct a Phase II study using PLX-PAD cells for the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD).

The IND approved by the MFDS mirrors INDs already approved by regulators in the USA, Germany and Israel. South Korea will be the fourth country participating in this multi-national trial involving the use of PLX-PAD in IC. CHA Bio&Diostech Co., Ltd. (KOSDAQ:KS), Pluristem's South Korean partner, will fund the trial and conduct it in its healthcare facilities.

"Pluristem's ability to extend our Phase II study of IC into South Korea is important for several reasons," commented Zami Aberman, Pluristem's Chairman and CEO. "Partnering with CHA Bio to conduct the clinical trial in their hospitals will accelerate the enrollment and strengthen our relationship with our South Korean partner. Additionally, Pluristem is proud of the fact that our PLX-PAD cells are the first placental-derived allogeneic cells allowed to be imported into South Korea. We at Pluristem believe this is a validation of Pluristem's expertise in cell therapy in general and PLX potential cell therapy in particular."

About the Study

Pluristem's Phase II study of IC is a randomized, placebo-controlled trial that will evaluate the safety and efficacy of two courses of PLX-PAD cells versus placebo, administered via intramuscular injections. The study protocol targets enrollment of 150 patients with IC: Fontaine class IIb, Rutherford category 2-3.

The primary efficacy end point of the trial is the change in the maximal walking distance from baseline during an exercise treadmill test. Secondary endpoints are hemodynamic and quality of life measurements. Safety parameters are also being assessed.

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

Chart of I:DJI
DOW 17,745.98 -5.41 -0.03%
S&P 500 2,108.63 +0.06 0.00%
NASDAQ 5,128.7850 +17.0520 0.33%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs