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
See Cramer's multi-million dollar portfolio for FREE and get his new book Get Rich Carefully! Learn More

Siltuximab Pivotal Trial Data Show Efficacy For Treatment Of Patients With Multicentric Castleman's Disease

RARITAN, N.J., Dec. 8, 2013 /PRNewswire/ -- Janssen Research & Development, LLC ("Janssen") today announced positive results from a pivotal Phase 2 global registration study (MCD2001) suggesting siltuximab, an investigational compound, along with best supportive care (BSC), exhibited statistically significant efficacy and a tolerable safety profile compared with placebo and BSC in treating patients with the rare disorder Multicentric Castleman's Disease (MCD) who are HIV-negative and human herpes virus-8 (HHV-8)-negative. 1 MCD is a disorder in which lymphocytes, a certain type of white blood cells, are over-produced and lead to enlargement of lymph nodes. 2 ,3

These data supported the recent regulatory filings of siltuximab in the United States and European Union. Interim findings from a separate Phase 2 study (MCD2002) reinforce the safety profile of siltuximab. 4 The studies were featured in an oral presentation (MCD2001) and poster presentation (MCD2002) at the 55 th American Society of Hematology (ASH) Annual Meeting in New Orleans, USA.

"MCD is a devastating disease that weakens the immune system and may lead to life-threatening infections," said Raymond S. Wong, MBChB, M.D., Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong and lead study investigator. "These results are encouraging and from my perspective support the potential for siltuximab as a new treatment for these patients who previously had no approved treatment options."  

Oral Presentation

The MCD2001 study found more than one-third of patients in the siltuximab arm had a durable tumor and symptomatic response to treatment, compared to none of the patients who received placebo plus BSC (34 percent versus 0 percent). The median time to treatment failure was not reached for patients who received siltuximab plus BSC versus 134 days for who received placebo plus BSC. In looking at the response rate to treat MCD-related symptoms, 25 percent of patients who received siltuximab plus BSC had durable complete symptom resolution, defined as 100 percent of reduction of baseline overall symptom scores for at least 18 weeks, compared to none of the patients who received placebo plus BSC. 1

The safety profile, defined by frequencies of treatment-emergent adverse events (AEs), Grade 3 or higher AEs and serious adverse events (SAEs), was similar between siltuximab and placebo even with the duration of treatment being twice as long for those in the siltuximab arm. The most frequently reported Grade 3 or higher AEs with siltuximab were fatigue (9 percent), night sweats (8 percent), hyperkalemia (high levels of potassium in blood), hyperuricemia (high levels of uric acid in blood), localized edema (swelling at a specific site in the body), hyperhidrosis (excessive sweating), neutropenia (an abnormally low number of neutrophils, a type of white blood cell), thrombocytopenia (a decrease of platelets in the blood), hypertension (high blood pressure), and weight increase (4 percent each). 1

Poster Presentation

In addition, an interim analysis of the Phase 2 study MCD2002 was presented on December 7 in a poster titled:

  • An Open-Label, Phase 2, Multicenter Study Of The Safety Of Long-Term Treatment With Siltuximab (an Anti-Interleukin-6 Monoclonal Antibody) In Patients With Multicentric Castleman's Disease (Abstract #1806)

This ongoing extension study assessed the safety of long-term treatment with siltuximab in 19 patients with MCD whose disease was controlled for an extended period of time in a Phase 1 study. At the time of study analysis ( January 2013), the patients had been treated with siltuximab for up to 7.2 years (median of 5.1 years) with no cumulative toxicity observed.  At the data cutoff for this interim analysis of the extension study, all patients were alive and maintaining disease control. Findings suggest prolonged siltuximab treatment exhibited a tolerable side effect profile. 4

During a median treatment duration of 5.1 (range 3.4-7.2) years, the most commonly reported AEs included upper respiratory tract infection (89 percent); nausea (63 percent); vomiting (58 percent); diarrhea (53 percent); hypercholesterolemia (high levels of cholesterol in blood) (47 percent); hypertriglyceridemia (high levels of triglycerides in blood), pain in arms and legs, headache, rash and abnormal liver function (each 42 percent). However, the majority of them were low grade. Two patients had at least one serious infection during the Phase 1 study, and none were reported during the Phase 2 extension study. 4

These abstracts were also published online in the December 6 supplemental volume of Blood.

MCD2001 Study Design 1

MCD2001 is a Phase 2 multi-national, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of siltuximab plus best supportive care (BSC) versus placebo plus BSC in 79 patients with MCD who are HIV-negative and HHV-8-negative. MCD2001 is the first randomized study in MCD. Patients were randomized 2:1 to receive either siltuximab plus BSC or placebo plus BSC until protocol-defined treatment failure, after which patients taking the placebo could cross over to un-blinded siltuximab. Half of the patients on placebo (13 out of 26) crossed over to siltuximab.

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

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

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
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.
DOW 16,408.54 -16.31 -0.10%
S&P 500 1,864.85 +2.54 0.14%
NASDAQ 4,095.5160 +9.2910 0.23%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto
Advertising Partners

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