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

Telik Announces Phase 1 Results Of A Multicenter Study Of Telintra® (Ezatiostat Hydrochloride, TLK199) In Combination With Revlimid® (Lenalidomide) In Patients With Myelodysplastic Syndrome

PALO ALTO, Calif., Dec. 13, 2011 /PRNewswire/ -- Telik, Inc. (Nasdaq: TELK) today announced positive results from a Phase 1 multicenter dose-ranging trial of the combination of Telintra and Revlimid in patients with International Prognostic System Score (IPSS) Low to Intermediate-1 Risk non-deletion (5q) myelodysplastic syndrome (MDS).  

The majority of MDS patients are Low to Intermediate-1 Risk non-deletion (5q) and represent an important unmet medical need.  Although Revlimid currently is not approved for the treatment of non-deletion (5q) MDS it is used in this setting because of limited alternatives.  The rationale for the combination of Telintra and Revlimid is based on Telintra's novel mechanism of action, lack of suppression of white blood cell levels and the efficacy seen in single-agent Phase 1 and Phase 2 studies in the Low to Intermediate-1 Risk non-deletion (5q) MDS patient population.

The primary objective of the study was to establish the safety of the combination and the optimal dosing for Telintra in combination with the standard dose of Revlimid.  The secondary objectives were to assess the efficacy as measured by rates of hematologic improvement in red blood cell, white blood cell and platelet levels, and decreases in blood transfusions, according to International Working Group criteria (IWG 2006).  

Nineteen patients were treated at 9 investigational centers.  Patients received Telintra at a starting dose of 2000 mg in combination with standard dose Revlimid (10 mg) on days 1-21 of a 28-day cycle.  In stage 1, 3-6 patients in a standard 3+3 design were treated before escalation to the 2500 mg Telintra and 10 mg Revlimid dose levels.  The optimal dose of the combination was 2000 mg Telintra and 10 mg of Revlimid.  This cohort was expanded by an additional 10 patients in stage 2.

The median age was 75 years, with 5 patients having IPSS Low Risk classification and 14 patients having Intermediate-1 Risk.  Thirteen of 19 patients (68%) were red blood cell transfusion-dependent and required a median of 6 units of blood (range 4-10) during an 8 week period.  Two patients were platelet transfusion-dependent and 4 additional patients (21%) had clinically-significant low platelet levels.  

1 of 4

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 $95.01 0.00%
FB $99.51 -0.24%
GOOG $677.65 -0.75%
TSLA $148.25 0.18%
YHOO $26.82 -0.85%


Chart of I:DJI
DOW 16,014.38 -12.67 -0.08%
S&P 500 1,852.21 -1.23 -0.07%
NASDAQ 4,268.7630 -14.99 -0.35%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs