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
Cramer's Action Alerts PLUS - See his portfolio and get alerts BEFORE every trade. Learn more NOW!

Sub-Group Analysis Of Data From Pediatric Patients With Hereditary Angioedema Published In The Journal Of Pediatrics

Data from the Open-Label Extension of the Routine Prophylaxis StudyTwenty-three children received open-label Cinryze for routine prophylaxis. Prior to enrollment, the median monthly attack rate was 3.0 and decreased to 0.39 while the patients were receiving Cinryze for routine prophylaxis. The majority of patients (20/23, 87 percent) experienced less than or equal to one attack per month, and 22 percent reported no attacks during the study period. 



Pre-procedural ProphylaxisEight children received Cinryze prior to 40 procedures; 90 percent of which were dental procedures. A single 1000 U dose of Cinryze was administered prior to 39 procedures, and two 1000 U doses were administered over a 48-hour period for one procedure per investigator's discretion. Across all procedures, only one HAE attack was reported within 72 hours after pre-procedural dosing; no attacks occurred during or within 2 days of the administration of Cinryze.   



Data from the Placebo-Controlled Study on Treating HAE AttacksTwelve pediatric patients were treated for an attack (7 Cinryze, 5 placebo) in the placebo-controlled acute-attack treatment study. Another 3 children received open-label Cinryze for treatment of laryngeal angioedema and/or prior to emergency surgical procedures. Unequivocal relief of the defining symptom began within 4 hours after initial treatment in 71 percent of patients (5 of 7) receiving Cinryze, consistent with the rate observed in the study population as a whole (60 percent), compared with 2 of 5 patients receiving placebo. For those children who achieved unequivocal relief, the median time to the beginning of unequivocal relief was 30 minutes with Cinryze compared with 2 hours with placebo.

Data from the Open-Label Study on Treating Acute Attacks In the open-label acute extension, 22 pediatric patients experienced 121 attacks.  Eighty-eight attacks were treated with one dose of Cinryze and 33 attacks with two doses. Unequivocal relief started within 1 hour after the initial dose of Cinryze in 79 percent of attacks and within 4 hours after the initial dose in 89 percent of attacks. In the majority of laryngeal attacks, unequivocal relief started within 1 hour, and no child receiving Cinryze required intubation or hospitalization for a laryngeal attack. Response rate within 4 hours and time to beginning of relief remained consistent irrespective of attack number or location. In addition, one hundred seventeen attacks were evaluated for clinical relief (discharged to home prior to obtaining all assessments required for unequivocal relief); 113 of 117 (97 percent) achieved clinical relief within 4 hours.

Safety DataIn the pivotal prophylaxis study, one patient experienced pyrexia that was considered by the investigator to be possibly related to study drug. In the open-label prophylaxis extension, 17 of 23 patients reported adverse events; two patients reported a total of three adverse events that were considered by the investigator to be related to Cinryze: One patient had headache and nausea, and the other had infusion-site erythema. All 3 of these events were mild in severity.

No adverse events were reported in the acute-attack treatment trial.  In the open-label treatment extension, 9 of 24 subjects reported adverse events. No adverse events in the open-label treatment extension were considered by the principal investigator to be related to Cinryze. 

2 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
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 18,132.70 -81.72 -0.45%
S&P 500 2,104.50 -6.24 -0.30%
NASDAQ 4,963.5270 -24.3630 -0.49%

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