News 2007

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December 2007

Week 52

• PSI reached an interim recruitment target of 50 patients in a phase II study of a novel antipsychotic in schizophrenia.
• PSI reached an interim enrollment objective of 150 randomized patients in a phase II/III study of a novel biological agent in renal cell carcinoma.

Week 51

• PSI launched a phase II study of a novel supportive care product in patients with multiple myeloma.
• PSI reached an interim enrollment target of 300 randomized patients in a phase III study of a novel adjunct cancer therapy in metastatic NSCLC.

Week 50

• PSI launched a phase II study of a novel anticancer agent in patients with chronic lymphocytic leukemia.
• PSI completed a phase III study of a novel combination product in pediatric asthma.
• PSI reached an interim recruitment milestone of 50 patients in a phase II study of a novel anticancer agent in renal cell carcinoma.

Week 49

• PSI completed enrollment in a phase III study of a novel antihyperglycemic in patients with type II diabetes mellitus.
• PSI launched a phase II study of a novel biological agent in patients with breast cancer at high risk of  febrile neutropenia.

Week 48

• PSI completed the active treatment period in a phase II study of a novel immunomodulator in patients with mild to moderate asthma.
• PSI completed a phase II study of a novel therapeutic agent in patients with intermittent claudication.

November 2007

Week 47

• PSI reached an interim enrollment objective of 100 randomized patients in a phase III study of a novel antibiotic in community-acquired pneumonia.
• PSI completed a phase III study of a novel antibiotic in patients with complicated skin and skin structure infections.

Week 46

• PSI initiated enrollment in a phase II study of a novel antibiotic in patients with hospital acquired pneumonia.
• PSI completed a phase II study of a novel antibiotic resistance modifier in patients with acute respiratory tract infections.

Week 45

• PSI launched a phase II study of a novel antibiotic in patients with uncomplicated skin and skin structure infections.
• PSI launched a phase III study of a novel hormonal agent in patients with hormone-sensitive prostate cancer.
• PSI reached an interim enrollment objective of 400 randomized patients in a phase III study of a novel cancer vaccine in patients with renal cell carcinoma.

Week 44

• PSI initiated enrollment in a phase II study of a novel biological agent in patients with acute myeloid leukemia.
• PSI initiated enrollment in a phase II study of a novel antithrombotic agent in patients with acute myocardial infarction.
• PSI completed a phase III study of a novel anticancer agent in patients with metastatic pancreatic cancer.

October 2007

Week 43

• PSI completed an exploratory study of a novel antiarrhythmic in patients undergoing invasive diagnostic procedures.
• PSI completed a phase III study of a novel enzymatic agent in patients with peripheral artery occlusion.

Week 42

• PSI initiated a phase III study of a novel biological agent in patients with relapsing-remitting multiple sclerosis.
• PSI completed a phase III study of a novel antithrombotic agent in patients with occluded central catheters.

Week 41

• PSI initiated enrollment in a phase II study of a novel anticancer agent in patients with renal cell carcinoma.
• PSI completed enrollment in a proof-of principle study of a novel anticancer agent in patients with small-cell lung cancer.

Week 40

• PSI launched a phase II study of a novel biological agent in patients with moderately severe ulcerative colitis.
• PSI reached an interim recruitment target of 200 randomized patients in a phase III study of a novel adjunct cancer therapy in patients with metastatic NSCLC.

September 2007

Week 39

• PSI initiated enrollment in a phase II study of a novel anticancer agent in patients with advanced NSCLC.
• PSI completed the active treatment period in a phase II study of a novel anticancer agent in patients with metastatic breast cancer.
• PSI reached an interim enrollment objective of 100 randomized patients in a phase III study of a novel biological agent in patients with metastatic renal cell carcinoma.

Week 38

• PSI completed enrollment in a phase III study of a novel biological agent in patients with chronic lymphocytic leukemia.
• PSI completed a proof-of-concept study of a novel recombinant coagulation factor in patients with hemophilia A.
• PSI reached an interim enrollment objective of 150 patients in a phase III study of a novel endocrine agent in patients with hormone-sensitive prostate cancer.

Week 37

• PSI reached an interim enrollment objective of 150 patients in a phase III study of a novel antihyperglycemic in patients with type II diabetes mellitus.
• PSI completed the clinical phase of a phase II study of a novel biological agent in patients with relapsing-remitting multiple sclerosis.
• PSI completed enrollment in a phase II study of a novel biological agent in patients with ulcerative colitis. In this study, 35 patients were recruited one week ahead of schedule.

Week 36

• PSI completed enrollment in a phase II study of a novel antibiotic in patients with complicated skin and skin structure infections. In this study, 280 patients were randomized 13 weeks ahead of schedule.
• PSI launched a phase II study of a novel anticancer agent in patients with metastatic pancreatic cancer.

Week 35

• PSI completed a phase III study of a novel anticancer agent in patients with hormone-resistant prostate cancer.
• PSI launched a phase III study of a novel opioid antagonist in patients with substance abuse.

August 2007

Week 34

• PSI completed enrollment in a phase II study of a novel immunomodulator in patients with mild to moderate asthma.
• PSI launched a phase II study of a novel antiviral agent in patients with chronic hepatitis B.
• PSI reached an interim enrollment objective of 100 patients in a phase III study of a novel endocrine agent in patients with hormone-sensitive prostate cancer.

Week 33

• PSI reached an interim enrollment objective of 300 randomized patients in a phase III study of a novel cancer vaccine in patients with renal cell carcinoma.
• PSI launched a phase III study of a novel anticancer agent in patients with metastatic breast cancer.
• PSI completed the active therapy period in a phase II study of a novel agent for the treatment of intermittent claudication.

Week 32

• PSI completed the clinical phase of a phase III study of a novel combination product in pediatric asthma.
• PSI launched a phase II study of a novel antiemetic in postoperative nausea and vomiting.
• PSI launched a phase III study of a novel anticancer agent in patients with indolent NHL.

Week 31

• PSI completed the clinical phase of a phase II study of a novel antibiotic resistance modifier in patients with acute respiratory tract infections.
• PSI launched a phase III study of a novel anticancer agent in patients with metastatic NSCLC.
• PSI reached an interim enrollment objective of 200 randomized patients in a phase III study of a novel antibiotic in patients with complicated skin and skin structure infections.

July 2007

Week 30

• PSI launched a phase II study of a novel immunological product in patients with moderate to severe asthma.
• PSI launched a phase III study of a novel antibiotic in patients with community-acquired pneumonia.

Week 29

• PSI completed enrollment in a phase III study of a novel antiviral product in recurrent herpes labialis. In this study, 240 adolescent patients were recruited 4 weeks ahead of schedule.
• PSI initiated enrollment in a phase II study of a novel disease-modifying agent in patients with rheumatoid arthritis.

Week 28

• PSI initiated enrollment in a phase III study of a novel anticancer agent in patients with hormone-sensitive prostate cancer.
• PSI reached an interim enrollment target of 100 randomized patients in a phase III study of a novel antimicrobial agent in patients with complicated skin and skin structure infections.

Week 27

• PSI launched a phase II study of a novel hematopoietic factor in patients with anemia due to chronic kidney disease.
• PSI initiated enrollment in a phase III study of a novel antimicrobial agent in patients with community-acquired pneumonia.

June 2007

Week 26

• PSI initiated enrollment in a phase II study of a novel antipsychotic in patients with schizophrenia.
• PSI reached an interim enrollment objective of 100 adolescent patients in a phase III study of a novel antiviral product.
• PSI completed enrollment in a phase II trial of a novel antibiotic-resistance modifier in patients with acute respiratory tract infections.

Week 25

• PSI initiated enrollment in a phase II study of a novel biological agent in patients with ulcerative colitis.
• PSI launched a phase III study of a novel insulin formulation in patients with type I diabetes mellitus.

Week 24

• PSI reached an interim recruitment target of 100 randomized patients in a phase III study of a novel adjunct cancer therapy in patients with metastatic NSCLC. This milestone was achieved precisely on schedule.
• PSI reached an interim enrollment objective of 200 randomized patients in a phase III study of a novel cancer vaccine in patients with renal cell carcinoma.

Week 23

• PSI initiated enrollment in a phase III study of a novel antiviral product in adolescent patients with recurrent herpes labialis.
• PSI completed the active treatment period in a phase II dose-ranging study of a novel anticancer agent in patients with metastatic NSCLC.

May 2007

Week 22

• PSI completed enrollment in phase III study of a novel combination product in patients with COPD. In this study, 355 patients were enrolled 3 weeks ahead of schedule.
• PSI reached an interim enrollment objective of 100 randomized patients in a phase III study of a novel antibiotic in patients with complicated skin and skin structure infections.
• PSI completed enrollment in a proof-of-principle study of a novel immunological agent in patients with allergic rhinitis.

Week 21

• PSI launched a phase III study of a novel chemotherapy regimen in patients with metastatic breast cancer.
• PSI launched a proof of principal study of a novel biological agent in patients with idiopathic thrombocytopenic purpura.

Week 20

• PSI reached an interim enrollment target of 50 randomized patients in a phase III study of a novel antimicrobial agent in patients with complicated skin and skin structure infections.
• PSI launched a phase II study of a novel antiemetic in patients with chemotherapy-induced nausea and vomiting.

Week 19

• PSI initiated enrollment in a phase III study of a novel anticancer agent in patients with small-cell lung cancer.
• PSI reached an interim enrollment objective of 50 randomized patients in a phase III study of a novel antibiotic in patients with complicated skin and skin structure infections.

Week 18

• PSI completed enrollment in a phase III study of a novel combination product in pediatric asthma. In this study, 640 patients were enrolled 4 weeks ahead of schedule.
• PSI initiated enrollment in a phase II/III study of a novel anticancer agent in patients with renal cell carcinoma.

April 2007

Week 17

• PSI initiated enrollment in a phase III study of a novel hormonal treatment in patients with hormone-sensitive prostate cancer.
• PSI reached an interim enrollment objective of 150 randomized patients in a phase III study of a novel cancer vaccine in patients with renal cell carcinoma.

Week 16

• PSI launched a proof of principle study of a novel anticancer agent in patients with hormone-resistant prostate cancer.
• PSI completed the active treatment period in a phase II study of a novel anticancer agent in patients with hormone-resistant prostate cancer.

Week 15

• PSI launched a phase II study of a novel anticancer agent in patients with metastatic NSCLC.
• PSI reached an interim enrollment target of 450 patients in a phase III study of a novel combination product in pediatric asthma. This milestone was completed 5 weeks ahead of schedule.
• PSI reached an interim enrollment objective of 300 patients in a phase III study of a novel combination product in patients with COPD. This milestone was achieved 3 weeks ahead of schedule.
• PSI completed the active treatment period in a phase III study of a novel antimicrobial agent in patients with complicated skin and skin structure infections.

Week 14

• PSI initiated enrollment in an exploratory study of a novel antiarrhythmic in patients undergoing invasive diagnostic procedures.
• PSI launched a phase III study of a novel anticancer agent in patients with metastatic ovarian cancer.
• PSI launched a phase II study of a novel antibiotic in patients with hospital-acquired pneumonia.
• PSI launched a phase II study of a novel biological agent in patients with acute myeloid leukemia.

Week 13

• PSI reached an interim enrollment objective of 100 patients in a phase III study of a novel antihyperglycemic in patients with type II diabetes mellitus. This milestone was completed 2 weeks ahead of schedule.
• PSI initiated enrollment in a phase IV study of a novel antihemophilic product in patients with severe hemophilia A scheduled for surgery.
• PSI reached an interim recruitment target of 50 randomized patients in a phase III study of a novel adjunct cancer therapy in patients with metastatic NSCLC. This milestone was achieved precisely on schedule.
• PSI launched a phase III study of a novel biological agent in patients with relapsing-remitting multiple sclerosis.

March 2007

Week 12

• PSI initiated enrollment in a phase III study of a novel antibacterial product in patients with complicated skin and skin structure infections.
• PSI reached an interim enrollment target of 350 patients in a phase III study of a novel combination product in pediatric asthma. This milestone was completed 4 weeks ahead of schedule.
• PSI initiated enrollment in a phase III study of a novel anticancer agent in patients with relapsed aggressive NHL.
• PSI completed the active treatment period in a phase III study of a novel antithrombotic agent in patients with occluded central catheters.

Week 11

• PSI completed enrollment in a phase III study of a novel antimicrobial agent in patients with complicated skin and skin structure infections. In this study, 176 patients were enrolled precisely on schedule.
• PSI initiated enrollment in a phase III study of a novel antibiotic in patients with complicated skin and skin structure infections.
• PSI completed enrollment in a phase III study of a novel topical antiviral in immunocompromised patients with recurrent herpes simplex labialis. In this study, 166 patients were enrolled 3 weeks ahead of schedule.
• PSI initiated enrollment in a proof-of-principle study of a novel immunological agent in patients with allergic rhinitis.

Week 10

• PSI launched a phase III study of a novel topical antiviral in adolescents with recurrent herpes simplex labialis.
• PSI launched a proof-of-concept study of a novel anti-inflammatory agent in patients with rheumatoid arthritis.
• PSI initiated enrollment in a proof-of-principle study of a novel recombinant coagulation factor in patients with hemophilia A.
• PSI completed a phase III study of a novel fixed-combination product in patients with COPD.

February 2007

Week 9

• PSI initiated enrollment in a phase II study of an antihyperglycemic agent in patients with type II diabetes mellitus.
• PSI launched a phase II study of a novel anticancer agent in patients with metastatic renal cancer.

Week 8

• PSI completed the clinical phase of a phase II study of a novel anticancer agent in patients with metastatic small-cell lung cancer.
• PSI reached an interim enrollment objective of 100 patients in a phase III study of a novel topical antiviral in immunocompromised patients with recurrent herpes simplex labialis. This milestone was attained precisely on schedule.

Week 7

• PSI reached an interim enrollment objective of 150 patients in a phase III study of a novel antibiotic in patients with complicated skin and skin structure infections. This milestone was achieved 1 week ahead of schedule.
• PSI reached an interim enrollment objective of 50 patients in a phase III study of a novel antihyperglycemic in patients with type II diabetes mellitus. This milestone was completed 2 weeks ahead of schedule.

Week 6

• PSI reached an interim enrollment target of 250 patients in a phase III study of a novel combination product in pediatric asthma. This milestone was completed 3 weeks ahead of schedule.
• PSI reached an interim enrollment objective of 50 patients in a phase II study of a novel prostaglandin antagonist in patients with mild to moderate asthma. This interim target was met precisely on schedule.

Week 5

• PSI reached final database lock in a phase II study of a novel antiviral agent in patients with chronic hepatitis C. This milestone was achieved precisely on schedule.
• PSI completed a phase III study of a novel neuroleptic in patients with schizophrenia.

January 2007

Week 4

• PSI completed the clinical phase of a phase III study of a novel bisphosphonate in patients with osteoporotic hip fractures.
• PSI completed the clinical phase of a phase III study of a novel anticancer agent in patients with metastatic pancreatic cancer.

Week 3

• PSI reached final database lock in a phase II study of a novel anticancer agent in patients with metastatic breast cancer. This milestone was achieved precisely on schedule.
• PSI reached an interim enrollment target of 150 patients in a phase III study of a novel combination product in pediatric asthma. This milestone was attained 2 weeks ahead of schedule.

Week 2

• PSI initiated enrollment in a phase III study of a novel antihyperglycemic in patients with type II diabetes mellitus.
• PSI completed the clinical part of a phase I/II study of a novel anticancer agent in patients with advanced solid tumors.

Week 1

• PSI initiated enrollment in a phase II study of a novel prostaglandin antagonist in patients with mild to moderate asthma.
• PSI completed a phase II study of a novel anticancer agent in patients with metastatic NSCLC.