News 2006

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December 2006

Week 52

• PSI reached an interim enrollment objective of 100 patients in a phase III study of a novel of a novel antibiotic in patients with complicated skin and skin structure infections. This milestone was reached 1 week ahead of schedule.
• PSI launched a phase III study of a novel anticancer agent in patients with metastatic hormone-resistant prostate cancer.

Week 51

• PSI initiated enrollment in a phase II study of a novel biological agent in patients with rheumatoid arthritis.
• PSI launched a phase II trial of a novel biological agent in patients with ulcerative colitis.

Week 50

• PSI initiated enrollment in a phase III study of a novel adjunct cancer therapy in patients with metastatic NSCLC.
• PSI initiated enrollment in a phase III study of a novel topical antiviral in immunocompromised patients with recurrent herpes simplex labialis.

November 2006

Week 49

• PSI completed the clinical part of a phase III trial of a novel biological agent in patients with breast cancer at high risk of febrile neutropenia.
• PSI initiated enrollment in a phase II trial of a novel antibiotic-resistance modifier in patients with acute respiratory tract infections.

Week 48

• PSI completed the active treatment period of a pharmacokinetic study in patients with metastatic breast cancer.
• PSI completed enrollment in a phase III trial of a novel anticancer agent in patients with metastatic breast cancer. In this study, 863 patients were enrolled 12 weeks ahead of schedule.

Week 47

• PSI initiated enrollment in a proof-of-concept study in patients with systemic lupus erythematosus.
• PSI completed a phase III trial of a novel antipsychotic in patients with schizophrenia.
• PSI launched a phase III study of a novel anticancer agent in patients with metastatic small-cell lung cancer.

Week 46

• PSI completed the active treatment period of a phase II study of a novel anticancer agent in patients with metastatic breast cancer.
• PSI completed enrollment in a proof-of-concept study of a novel biological agent in patients with relapsing-remitting multiple sclerosis. In this study, patient recruitment was completed 2 weeks ahead of schedule.

Week 45

• PSI completed the active treatment period of a phase III trial of a novel biological agent in patients with severe Crohn's disease.
• PSI completed a phase III study of a novel antimicrobial agent in patients with complicated skin and skin structure infections.

October 2006

Week 44

• PSI completed the active treatment period of a phase II trial of a novel biological agent in patients with cervical dystonia.
• PSI completed the active treatment period of a phase III trial of a novel biological agent in patients with moderate Crohn's disease.
• PSI launched a phase II study of a novel anticancer agent in patients with advanced small-cell lung cancer.

Week 43

• PSI initiated enrollment in a phase III study of a novel cancer vaccine in patients with metastatic renal cancer.
• PSI completed a phase II study of a novel memory enhancer in patients with dementia.

Week 42

• PSI initiated enrollment in phase III trial of a novel combination product in pediatric asthma.
• PSI completed enrollment in a phase II study of a novel agent for the treatment of intermittent claudication. In this trial, 126 patients were randomized 5 weeks ahead of schedule.
• PSI reached an interim enrollment target of 700 patients in phase III study of a novel anticancer agent in patients with metastatic breast cancer. This milestone was achieved 11 weeks ahead of schedule.
• PSI reached an interim enrollment objective of 200 patients in phase III study of a novel fixed-combination product for the treatment of COPD. This interim target was attained 4 weeks ahead of schedule.

Week 41

• PSI completed enrollment in a phase III trial in patients with hormone-sensitive prostate cancer. In this trial, 330 patients were recruited 10 weeks ahead of schedule.
• PSI completed the active treatment period of a phase III trial of a novel biologic agent in patients with breast cancer at high risk of febrile neutropenia.
• PSI completed the active treatment period of a proof-of-principle study of a novel anticancer agent in patients with metastatic NSCLC.

September 2006

Week 40

• PSI completed a phase III trial of a novel anticancer vaccine in patients with metastatic melanoma.
• PSI completed the active treatment period of a phase II study of a third-line anticancer agent in patients with advanced breast cancer.
• PSI completed the active treatment period of a phase III study of a novel enzymatic agent in patients with peripheral artery occlusion.
• PSI completed a phase II trial of a novel anticancer agent in patients with advanced NSCLC.

Week 39

• PSI completed the clinical part of a phase III study of a novel RSV vaccine in children with congenital heart disease.
• PSI launched a phase III study of a novel anticancer agent in patients with relapsed aggressive NHL.
• PSI launched a phase III study of a novel anticancer agent in elderly patients with diffuse large B-cell lymphoma.
• PSI reached an interim enrollment target of 600 patients in phase III study of a novel anticancer agent in patients with metastatic breast cancer. This milestone was achieved 9 weeks ahead of schedule.
• PSI initiated enrollment in a phase III study of a novel antithrombotic agent with patients with occluded central catheters.
• PSI reached an interim enrollment objective of 150 patients in phase III study of a novel fixed-combination product for the treatment of COPD. This interim target was attained 3 weeks ahead of schedule.

Week 38

• PSI completed a phase III study of an novel RSV vaccine in a pediatric population at high-risk of respiratory infections.
• PSI completed the active treatment period in a phase III study of a novel radiosensitizer in patients with advanced head and neck cancer.
• PSI completed a phase III study of a novel biological agent in patients with refractory follicular NHL.
• PSI completed the active treatment period in a phase II study of a novel agent for prevention of restenosis.
• PSI completed a phase II combined therapeutic modality study in patients in unresectable NSCLC.

Week 37

• PSI reached an interim enrollment objective of 250 patients in a phase III study in hormone-sensitive prostate cancer. This interim milestone was achieved 9 weeks ahead of schedule.
• PSI reached an interim enrollment target of 550 patients in a phase III study of a novel anticancer agent in patients with metastatic breast cancer. This interim objective was achieved 8 weeks ahead of schedule.

Week 36

• PSI reached an interim enrollment objective of 100 patients in a phase III study of a novel-fixed combination product for the treatment of COPD. This milestone was achieved 2 weeks ahead of schedule.
• PSI reached an interim enrollment objective of 100 patients in a phase II study of a novel agent for the treatment of intermittent claudication. This interim target was attained 4 weeks ahead of schedule.

August 2006

Week 35

• PSI completed the active treatment period of a phase III study of a novel antimicrobial product in patients with complicated skin and skin structure infections.
• PSI launched a phase II study of a novel anticancer agent in patients with advanced ovarian cancer.
• PSI launched a phase II study of a novel antipsychotic agent in patients with schizophrenia.

Week 34

• PSI launched a phase III study of a novel antimicrobial agent in patients with complicated skin and skin structure infections.
• PSI completed enrollment in a phase III study of a novel antithrombotic agent in patients with peripheral artery occlusion.

Week 33

• PSI completed a phase III study of a novel antipsychotic agent in patients with schizophrenia.
• PSI launched a phase III study of a novel antibiotic in patients with complicated skin and skin structure infections.

Week 32

• PSI completed enrollment in a phase III study of a novel bisphosphonate in osteoporosis. In this study, 197 patients were recruited 2 weeks ahead of schedule.
• PSI completed enrollment in a phase II study of a novel platinum agent in advanced small-cell lung cancer. In this study, 50 patients were enrolled 3 weeks ahead of schedule.
• PSI reached an interim enrollment objective of 200 patients in a phase III study in hormone-sensitive prostate cancer. This interim milestone was achieved 7 weeks ahead of schedule.

July 2006

Week 31

• PSI completed enrollment in a phase III study in patients with metastatic pancreatic cancer. In this study, 185 patients were recruited 3 weeks ahead of schedule.
• PSI completed a phase III study of a novel anti-inflammatory product in patients with ulcerative colitis.

Week 30

• PSI reached an interim enrollment target of 500 patients in a phase III study of a novel anticancer agent in patients with metastatic breast cancer. This interim objective was achieved 7 weeks ahead of schedule.
• PSI completed a phase III study in osteoporosis. In this study, 950 patients were enrolled 13 weeks ahead of schedule.

Week 29

• PSI completed enrollment in a phase III study of a novel growth factor in breast cancer patients at risk of developing severe neutropenia. In this study, 170 patients were accrued 4 weeks ahead of schedule.
• PSI initiated enrollment in phase III study of a novel fixed-combination product in patients with COPD.

Week 28

• PSI reached an interim enrollment objective of 150 randomized patients in a phase III study in hormone-sensitive prostate cancer. This interim milestone was achieved 6 weeks ahead of schedule.
• PSI launched a confirmatory study of a novel coagulation product in hemophiliac patients scheduled for knee replacement surgery.
• PSI launched an exploratory clinical pharmacology study of a novel antiarrhythmic in patients undergoing coronary angiography.
• PSI launched a phase III study of a novel topical antiviral in immunocompromised patients with recurrent herpes simplex labialis.

Week 27

• PSI completed a proof-of-principle study of a novel biological agent in patients with metastatic NSCLC.
• PSI launched a phase II/III study of a novel biological agent in patients with renal cell carcinoma.
• PSI initiated enrollment in a phase III study of a novel biological agent in patients with moderate to severe Crohn's disease. 

June 2006

Week 26

• PSI completed the active treatment period in a phase III study of a novel cognitive enhancer in patients with dementia secondary to Parkinson's disease.
• PSI completed the active treatment period in a phase III study of a novel anti-inflammatory agent in patients in ulcerative colitis.
• PSI launched a follow-on protocol of a novel biological agent in patients with cervical dystonia.

Week 25

• PSI initiated enrollment in a phase III study of novel enzymatic agent in patients with peripheral artery disease.
• PSI reached an interim enrollment objective of 100 randomized patients in a phase III study in hormone-sensitive prostate cancer. This interim milestone was achieved 5 weeks ahead of schedule.

Week 24

• PSI launched a phase III study of a novel chemotherapy combination in patients with metastatic NSCLC.
• PSI launched a proof-of-concept study of a novel biological agent in patients with asthma.
• PSI completed the active treatment period in a phase III study of a novel biological agent in patients with severe Crohn's disease.

Week 23

• PSI completed enrollment in a phase II dose-ranging study of a novel first-line agent in patients with stage IV breast cancer. In this study, 300 patients were recruited 5 weeks ahead of schedule.
• PSI launched a proof-of-concept study of a novel biological agent in patients with SLE.
• PSI reached an interim enrollment objective of 50 randomized patients in a phase III study in hormone-sensitive prostate cancer. This interim milestone was achieved 4 weeks ahead of schedule.
• PSI launched a phase III study of a novel anticancer agent in patients with metastatic melanoma.

May 2006

Week 22

• PSI completed enrollment in a phase III study of a novel biological agent in patients with cervical dystonia. Patient recruitment was completed 3 weeks ahead of schedule.
• PSI reached an interim enrollment target of 150 patients in a phase III study of a novel bisphosphonate in osteoporosis. This milestone was achieved 3 weeks ahead of schedule.
• PSI launched a phase III study of a novel fixed-combination product in pediatric asthma.

Week 21

• PSI reached an interim enrollment objective of 150 patients in a phase III study of a novel growth factor in breast cancer.
• PSI completed a phase III study of a novel extended-release loop diuretic in patients with mild to moderate hypertension.
• PSI completed the active treatment period in a Phase II study of a novel interferon in patients with genotype I hepatitis C. In this study, 90 patients were randomized 4 months ahead of schedule. 

Week 20

• PSI initiated enrollment in a phase II study of a novel platinum agent in patients with advanced hormone-resistant prostate cancer.
• PSI completed the active treatment period of a phase III study in osteoporosis. In this project, 950 patients were enrolled at a rate of 3.7 pts/site/month, 13 weeks ahead of schedule.

Week 19

• PSI launched a phase II study of a novel antihyperglycemic in patients with type II diabetes.
• PSI completed enrollment in a phase II chemotherapy combination study in patients with metastatic NSCLC. In this study, 250 patients were recruited 3.5 months ahead of schedule.
• PSI reached an interim enrollment objective of 100 patients in a phase III study in patients with metastatic pancreatic cancer. This interim target was achieved precisely on schedule.

April 2006

Week 18

• PSI completed the active treatment phase of a pivotal study in patients with metastatic melanoma.
• PSI reached an interim enrollment objective of 100 patients in a phase III study of a novel growth factor in breast cancer.
• PSI completed enrollment in a phase I pharmacokinetic study of a novel toxicity modulator in patients with advanced breast cancer.

Week 17

• PSI initiated enrollment in a phase III study of a novel antimicrobial agent in patients with complicated skin and skin structure infections.
• PSI initiated enrollment in a phase III study of a novel GnRH antagonist in patients with hormone-sensitive prostate cancer.
• PSI reached an interim enrollment target of 100 patients in a phase III study of a novel bisphosphonate in osteoporosis. This milestone was achieved 3 weeks ahead of schedule.

Week 16

• PSI reached an interim enrollment target of 400 patients in a phase III study of a novel anticancer agent in metastatic breast cancer. This interim objective was achieved 6 weeks ahead of schedule.
• PSI initiated enrollment in a phase II study of a novel platinum agent in patients with advanced small-cell lung cancer.
• PSI initiated enrollment in a phase II study of a novel platinum agent in patients with metastatic colorectal cancer.

Week 15

• PSI reached an interim enrollment objective of 50 patients in a phase III study of a novel growth factor in breast cancer.
• PSI reached an interim enrollment objective of 200 patients in a phase II dose-ranging study of a novel first-line breast cancer agent in stage IV breast cancer. This interim milestone was achieved 5 weeks ahead of schedule.
• PSI completed enrollment into a phase III rollover protocol in receptor-positive metastatic breast cancer. 340 patients were enrolled 4 weeks ahead of schedule.

 Week 14

• PSI launched a phase III study of a novel insulin-sensitizer in patients with type II diabetes.
• PSI completed enrollment in a phase III study of a novel aromatase inhibitor in receptor-positive metastatic breast cancer. Enrollment of 863 patients was achieved precisely on schedule.
• PSI reached an interim enrollment target of 50 patients in phase III study of a novel bisphosphonate in osteoporosis. This interim objective was attained 2 weeks ahead of schedule.

March 2006

Week 13

• PSI initiated enrollment in a phase II study of a novel humanized monoclonal antibody in patients with relapsing-remitting multiple sclerosis.
• PSI initiated enrollment in a phase III study of a novel biological agent in patients with cervical dystonia.
• PSI initiated enrollment in a phase I study of a novel anticancer agent in patients with solid tumors and hepatic dysfunction.
• PSI launched a phase III trial of a novel thrombolytic agent in patients with occluded central venous access devices.

Week 12

• PSI initiated enrollment in a phase III study of a novel bisphosphonate in patients with osteoporosis.
• PSI reached an interim enrollment objective of 300 patients in a phase III study of a novel anticancer agent in metastatic breast cancer. This interim target was achieved 5 weeks ahead of schedule.
• PSI initiated enrollment in a phase III study of a novel growth factor in breast cancer patients at risk of developing severe neutropenia.

Week 11

• PSI reached an interim enrollment objective of 350 patients in a phase III study of a novel antibiotic for the treatment of complicated skin and skin structure infections. This milestone was reached 2 weeks ahead of schedule.
• PSI initiated enrollment in a phase II study of a novel agent for the prevention of restenosis.
• PSI completed enrollment in a phase III rollover protocol in schizophrenia.

Week 10

• PSI reached an interim enrollment objective of 200 patients in a phase II combined therapeutic modality study in metastatic NSCLC. This recruitment target was reached 15 weeks ahead of schedule.
• PSI launched a phase III study of a novel bisphosphonate in patients with osteoporosis.

February 2006

Week 9

• PSI reached an interim enrollment target of 300 patients in a phase III study of a novel antibiotic for the treatment of complicated skin and skin structure infections. This milestone was reached precisely on schedule.
• PSI reached an interim enrollment target of 200 patients in a phase III study of a novel anticancer agent in metastatic breast cancer. This interim objective was achieved 4 weeks ahead of schedule.

Week 8

• PSI completed the active treatment period of a phase III study of a novel antipsychotic in patients with schizophrenia. In this study 373 patients were randomized at a rate of 3.8 pts/site/month.
• PSI reached an interim enrollment objective of 150 patients in a phase II dose-ranging study of a novel first-line anticancer agent in stage IV breast cancer. This milestone was attained 5 weeks ahead of schedule.

Week 7

• PSI completed the active treatment period of a pivotal Phase III study in metastatic breast cancer patients eligible to receive hormonal therapy. In this study 821 patients were randomized at a rate 0.7 pt/site/month.
• PSI initiated enrollment in a Phase II study in patients with intermittent claudication.
• PSI reached an interim enrollment objective of 35 patients in a follow-on Phase III study in patients with severe Crohn's disease. This interim target was attained precisely on schedule.
• PSI reached an interim enrollment target of 300 patients in a Phase III rollover protocol in receptor-positive metastatic breast cancer. This interim milestone was achieved 3 weeks ahead of schedule.

Week 6

• PSI reached an interim enrollment objective of 150 patients in a phase III schizophrenia study. This interim target was met 6 weeks ahead of schedule.
• PSI reached an interim enrollment target of 150 patients in a phase III study of a novel anticancer agent in metastatic breast cancer. This interim milestone was achieved 4 weeks ahead of schedule.
• PSI initiated enrollment into an extended-protocol Phase II combined therapeutic modality study in metastatic NSCLC.
• PSI completed the active treatment period of a phase III study of a novel extended-release loop diuretic in patients with mild to moderate hypertension.

Week 5

• PSI launched a proof-of-principle study of a novel hemostatic agent in patients with hemophilia.
• PSI reached an interim enrollment objective of 200 patients in a phase III rollover protocol in receptor-positive metastatic breast cancer. This interim milestone was reached 2 weeks ahead of schedule.

Week 4

• PSI reached an interim enrollment objective of 100 randomized patients in a phase II dose-ranging study of a novel first-line anticancer agent in stage IV breast cancer. This interim milestone was attained 4 weeks ahead of schedule.
• PSI reached an interim enrollment objective of 75 randomized patients in a phase III study of a novel anticancer agent in patients with metastatic breast cancer. This interim target was met 3 weeks ahead of schedule.
• PSI launched a phase II study of a novel disease-modifying agent in patients with rheumatoid arthritis.

Week 3

• PSI reached an interim enrollment objective of 200 patients in a phase III study of a novel antibiotic for the treatment of complicated skin and skin structure infections.
• PSI launched a phase III study of a novel fixed-combination product in patients with COPD.

Week 2

• PSI reached an interim enrollment objective of 175 patients in a phase II combined therapeutic modality study in metastatic NSCLC. This interim objective was attained 15 weeks ahead of schedule.
• PSI reached an interim enrollment objective of 100 patients in a phase III rollover protocol in patients with receptor-positive metastatic breast cancer. This interim milestone was reached 1 week ahead of schedule.
• PSI reached an interim enrollment objective of 125 patients in a phase III schizophrenia study. This interim target was met 5 weeks ahead of schedule.

Week 1

• PSI reached an interim enrollment objective of 75 randomized patients in a phase II dose-ranging study of a novel first-line anticancer agent in stage IV breast cancer. This interim milestone was attained 3 weeks ahead of schedule.
• PSI reached an interim enrollment objective of 50 randomized patients in a phase III study of a novel anticancer agent in patients with metastatic breast cancer. This interim target was met 2 weeks ahead of schedule.
• PSI completed enrollment in a phase III 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.