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

Sucampo Announces Completion Of Patient Enrollment In A Phase 3 Clinical Study Of Unoprostone Isopropyl For Retinitis Pigmentosa

BETHESDA, Md., Oct. 21, 2013 (GLOBE NEWSWIRE) -- Sucampo AG, a subsidiary of Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP) ("Sucampo"), today announced that its development partner, R-Tech Ueno, Ltd. (R-Tech), completed the enrollment on-time for a Phase 3 study of unoprostone isopropyl ophthalmic solution 0.15% for the treatment of retinitis pigmentosa (RP). R-Tech is conducting the clinical trial at 38 medical institutions in Japan.

The randomized, double-blind, placebo-controlled study will evaluate whether unoprostone isopropyl ophthalmic solution improves central retinal sensitivity as determined by Humphrey Field Analyzer (HFA) in patients with RP. The study's primary endpoint is the value of mean retinal sensitivity at four central points at one year, and the target sample size is 180 patients.

"There are no drugs currently approved for the treatment of RP anywhere in the world, and we believe that unoprostone isopropyl may be a promising candidate for this indication," said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Executive Officer and Chief Scientific Officer of Sucampo. "With the completion of the Phase 3 trial enrollment, R-Tech expects to complete this study by the end of 2014 with top-line results available in early 2015. Upon successful results, Sucampo intends to work with regulatory authorities in the United States and the European Union to determine the incremental data that will be necessary to form application packages for each region, and we look forward to the possibility of helping to meet the unmet needs of patients suffering from RP in these countries."

This study is being funded through an agreement established in February 2013 between R-Tech and the Japan Science and Technology Agency (JST), the governmental agency responsible for the implementation of science and technology policy in Japan ( News Release - Feb. 4, 2013). Sucampo licensed from R-Tech the exclusive development and commercialization rights to unoprostone isopropyl globally except for Japan, Peoples Republic of China, Taiwan, and Korea. Both the U.S. Food and Drug Administration and the European Medicines Agency have granted orphan drug designation to unoprostone isopropyl for treatment of RP. Sucampo is not responsible for any development costs for the Phase 3 RP trial in Japan.

Retinitis pigmentosa is a genetic disease characterized by progressive, irreversible vision loss and decreasing visual acuity. As RP progresses, daily life becomes increasingly difficult. Blindness from all causes is among the most significant injuries to a patient's qualify of life and is a major driver of patient-based cost of care and lifestyle maintenance.

1 of 5

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 $93.24 -0.41%
FB $117.81 -0.21%
GOOG $701.43 0.82%
TSLA $211.53 -4.96%
YHOO $36.94 2.61%


Chart of I:DJI
DOW 17,660.71 +9.45 0.05%
S&P 500 2,050.63 -0.49 -0.02%
NASDAQ 4,717.0940 -8.5450 -0.18%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs