Point Therapeutics Announces Interim Analysis to be Performed on Its Phase 3 Talabostat with Alimta Study

  
    
  
  
    
      Point Therapeutics, Inc. (NASDAQ: POTP) today announced that the Company’s 
      Board of Directors approved an unscheduled interim analysis on the Phase 
      3 non-small cell lung cancer (NSCLC) study of talabostat in combination 
      with pemetrexed (Alimta®: 
      Eli Lilly). The study was designed to enroll 400 NSCLC patients who have 
      already failed either one or two prior drug regimens. To date, 
      approximately 360 patients have enrolled in the study. The interim 
      analysis will examine approximately 150 events that have already been 
      recorded in this study, with events being defined as either disease 
      progression or death. The Company expects results from the interim 
      analysis by the end of this month.
    
    
      “This analysis will produce the first clinical 
      information on the effects of talabostat in a controlled, randomized 
      trial,” said Don Kiepert, President and CEO. “We 
      felt that it was important to have controlled data at this time in order 
      to properly assist us in our on going strategic and business initiatives.”
    
    
      Talabostat’s NSCLC program consists of two 
      randomized, placebo-controlled, double-blind Phase 3 studies in the 
      second-line and third-line setting. One of the Phase 3 studies is 
      evaluating talabostat and pemetrexed versus placebo and pemetrexed. In 
      the interim analysis, median progression-free survival (PFS) and overall 
      survival data and the statistical analyses of these data for the 
      talabostat treatment arm will be compared with the control arm by an 
      independent data monitoring committee. The Company expects to report on 
      the committee’s recommendation to continue the 
      trial or stop the trial either due to reaching statistical significance 
      (p< 0.005) or futility. The Company may 
      also perform an unscheduled interim analysis on its Phase 3 study 
      evaluating talabostat in combination with docetaxal (Taxotere® 
      : sanofi-aventis), although a final decision has not been made.
    
    
      Originally the pemetrexed study was powered at 80% to detect a 1.4 month 
      improvement (p=0.05) in PFS over the placebo arm with a positive trend 
      in overall survival upon final analysis. The addition of the interim 
      analysis has only slightly modified the final statistical plans. The 
      trial remains powered at 80% to demonstrate a 1.4 month improvement in 
      PFS with an adjusted statistical level of p=0.048.
    
    
      About Point Therapeutics, Inc.:
    
    
      Point is a Boston-based biopharmaceutical company which is currently 
      studying its lead product candidate, talabostat, in two Phase 3 double 
      blind placebo-controlled trials in metastatic non-small cell lung 
      cancer. Point is also currently studying talabostat in a Phase 2 trial 
      in combination with gemcitabine in Stage IV pancreatic cancer. In 
      addition, Point has studied talabostat in several Phase 2 trials, 
      including as a single-agent in metastatic melanoma, in combination with 
      cisplatin in metastatic melanoma and in combination with rituximab in 
      advanced chronic lymphocytic leukemia.
    
    
      Certain statements contained herein are not strictly historical and 
      are "forward-looking" statements as defined in the Private Securities 
      Litigation Reform Act of 1995, including the Company’s 
      expectation that results from the Company’s 
      interim analysis are expected by the end of this month, that these 
      results will assist the Company in making on going strategic and 
      business decisions, and that the Company may also perform an unscheduled 
      interim analysis on its Phase 3 study evaluating talabostat in 
      combination with docetaxal. Forward-looking statements are 
      statements that are not historical facts, and can be identified by, 
      among other things, the use of forward-looking language, such as 
      "believes," "feels," "expects," "may," "will," "projects," "should," 
      "seeks," "plans," "schedules to," "anticipates" or "intends" or the 
      negative of those terms, or other variations of those terms of 
      comparable language, or by discussions of strategy or intentions. A 
      number of important factors could cause actual results to differ 
      materially from those projected or suggested in the forward-looking 
      statements due to risks and uncertainties to which the Company is 
      subject, and other factors that are described in Form 10-Q filed with 
      the Securities and Exchange Commission on May 10, 2007, and from time to 
      time in Point's other reports filed with the Securities and Exchange 
      Commission.