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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

ImmunoCellular Provides Update On Phase II Clinical Trial Of ICT-107 For Treatment Of Glioblastoma

ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular” or the “Company”) (NYSE MKT: IMUC), a clinical stage biotechnology company that is focused on developing new immune-based products to treat cancer, announced today that it will expand its current Phase IIb trial of ICT-107 from 102 to up to 123 patients with glioblastoma multiforme (GBM) and who are HLA-A1/A2 positive. There are currently 231 patients enrolled in the study and more than 105 patients have either been treated or are scheduled to be randomized and treated over the next few weeks. The Company expects to complete the expanded enrollment within the next 60 days.

“We believe that the increase in the number of patients may further validate the study, and accelerate the path to data analysis,” said Manish Singh, Ph.D., President and CEO of ImmunoCellular Therapeutics. “The additional patients could also provide for a more robust and meaningful trial.”

The Phase IIb trial of ICT-107 is a double-blind, placebo-controlled, 2:1 randomized study designed to evaluate the safety and efficacy of ICT-107 in patients with newly diagnosed GBM. The study has been enrolling patients at medical institutions in collaboration with leading experts and opinion leaders in neuro-oncology at those sites. An interim analysis is expected when 32 events have been observed. As the final analysis will be event-driven, increasing the number of patients treated, the Company believes it may shorten the trial by a few months compared to treating only 102 patients. This should also provide more information for robust sub-group analysis of the trial results, as differences in age, degree of resection, and other factors can impact overall survival.

In the Phase I clinical study of ICT-107 in GBM, 16 newly diagnosed patients who received the vaccine in addition to standard of care treatment of surgery, radiation and chemotherapy demonstrated two-year overall survival of 80 percent and a three-year overall survival of 55 percent. These figures compare favorably to the current 26 percent two-year overall survival and 16 percent three-year overall survival based on the historical standard of care treatment alone. Updated data from the 16 patients in the Phase I trial shows that patients treated with ICT-107 reported overall survival (OS) of 50% after four years and 38% of the trial patients are progression free (PFS) for 48-66 months. This compares very favorably to historic mean OS of 12.1% after four years and 5.6 % PFS after 48 months with standard of care alone. The clinical centers currently recruiting for this clinical trial and enrollment criteria are listed at: http://clinicaltrials.gov/ct2/show/study/NCT01280552?term=ICt-107&rank=1.

About ImmunoCellular Therapeutics, Ltd.

IMUC is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. The Company is conducting a Phase II trial of its lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor associated antigens for glioblastoma. To learn more about IMUC, please visit www.imuc.com.

Forward-Looking Statements for ImmunoCellular Therapeutics

This press release contains certain forward-looking statements that are subject to a number of risks and uncertainties, including the risk that obtaining the additional capital that will now be necessary to fund the increased costs for expanding the current trial and other costs associated with development of ICT-107 and completion of that trial may not be available to IMUC on attractive terms or at all; and the risk prior safety and efficacy results for ICT-107 will not be confirmed in current or any subsequent trials in statistically significant larger patient populations; and the risks associated with adhering to clinical timeframes. Additional risks and uncertainties are described in IMUC’s most recently filed SEC documents, such as its most recent annual report on Form 10-K, all quarterly reports on Form 10-Q and any current reports on Form 8-K. IMUC undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

1 of 2

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.
Submit an article to us!
DOW 16,985.61 +78.99 0.47%
S&P 500 1,972.83 +9.12 0.46%
NASDAQ 4,419.0340 +27.5710 0.63%

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