This Day On The Street
Continue to site right-arrow
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
TheStreet Open House

Pluristem Provides Update On Clinical Status Of IC Trials

HAIFA, Israel, June 19, 2013 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, provided an update today on the status of its clinical trials in Intermittent Claudication (IC):

  • As previously announced, on June 4, 2013 the company received notification from the U.S. Food & Drug Administration (FDA) that its U.S. phase II IC trial was put on hold following the hospitalization of a patient with an allergic reaction in the company's IC trial in the United States. The patient, who suffers from a number of severe background diseases (including oxygen-dependent chronic obstructive pulmonary disease) in addition to IC, experienced a rash and shortness of breath following the treatment. She was admitted to a local hospital and discharged the following day after resolution of her symptoms.
  • According to FDA regulations, within 30 days of the notification of the clinical hold, the FDA is to provide Pluristem with a letter detailing a list of questions and requests for information from the Company. Pluristem has not yet received this letter.
  • In order to accelerate the review of the relevant facts and resolution of the issues, Pluristem has already provided the FDA with additional information and aggregate safety analyses based on the database compiled by the company from its previous clinical studies.
  • Since the IC study is a multi-national trial being conducted under identical study designs in both the U.S. and Germany, Pluristem advised the Paul-Ehrlich-Institute (PEI) in Germany about the FDA clinical hold and provided relevant information. Following further communication with the PEI, and in order to maintain consistency among the study protocols, the company has issued an amendment to the protocol putting the IC study in Germany on hold in order to provide more comprehensive analysis, and a risk minimization proposed plan.

Zami Aberman, Pluristem's Chairman and CEO, stated, "We continue to work closely and transparently with the FDA and PEI to address all issues in the IC clinical study. Pluristem is committed to resolve this issue and to provide the regulatory agencies the information needed to ensure the maintenance of patient safety and wellbeing and to move forward with this clinical trial as soon as possible."

1 of 2

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
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

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
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 17,678.23 -40.31 -0.23%
S&P 500 2,056.15 -4.90 -0.24%
NASDAQ 4,863.3620 -13.1570 -0.27%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs