This Day On The Street
Continue to site
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

ImmunoGen, Inc. Attains Patient Enrollment Milestone In IMGN901 NORTH Trial

ImmunoGen, Inc . (NASDAQ: IMGN), a biotechnology company that develops targeted anticancer therapeutics, today announced that it has completed patient enrollment in the first stage of its NORTH two-stage Phase II trial. The NORTH trial is assessing the Company’s IMGN901 product candidate for first-line treatment of extensive disease small-cell lung cancer (SCLC). Attaining this milestone enables the findings from the planned interim analysis of PFS at 6 months to be available in 2H2013.

The NORTH trial is designed to assess whether IMGN901 provides a clinically meaningful benefit when used in conjunction with a standard-of-care for this cancer, etoposide plus carboplatin (E/C). Patients with newly diagnosed extensive disease SCLC enrolled in the trial are randomized, two-to-one, to treatment either with IMGN901 plus E/C or with E/C alone.

While the NORTH trial is designed to include a total of 120 patients, its two-stage design specifies that an analysis of PFS at six months is to be performed with the first 39 evaluable patients randomized to the IMGN901 plus E/C treatment arm. Patient enrollment of this cohort of patients – and the corresponding 20 patients in the E/C alone arm – has now been completed. These patients will now be followed for the interim analysis while patient enrollment continues.

“Achieving timely enrollment of patients with small-cell lung cancer is known to be challenging, and we believe our attainment of this milestone on schedule speaks to both the clinical need for new therapies for SCLC and our increasing strength as a development company,” commented James O’Leary, MD, Vice President and Chief Medical Officer. “When available, we intend to use the findings from the interim analysis to make decisions related to the development of IMGN901. We also plan to submit them for presentation at a medical conference.”

ImmunoGen’s NORTH Trial

The 120-patient NORTH trial is designed to evaluate the efficacy and safety of IMGN901 for first-line treatment of extensive disease SCLC. All patients enrolled are provided with up to six cycles of E/C, standard-of-care for this cancer. Two-thirds of the patients enrolled are randomized to also receive IMGN901. These patients can elect to remain on IMGN901, as monotherapy, after completion of the E/C cycles if benefiting from treatment.

1 of 3

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
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
SYM TRADE IT LAST %CHG

Markets

Chart of I:DJI
DOW 17,598.20 -91.66 -0.52%
S&P 500 2,098.04 -5.80 -0.28%
NASDAQ 5,115.3820 -12.8990 -0.25%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs