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July 23, 2007
Fresenius issued positive results from a phase II/III trial of removab for the treatment of malignant ascites. This trial enrolled 258 subjects with end-stage cancer and recurrent symptomatic malignant ascites, who either no longer responded to or could no longer be treated with chemotherapy. Subjects were randomized to receive puncture therapy alone or removab administered intraperitoneally at ascending doses through infusions (10, 20, 50, and 150 microgram/g), following paracentesis on days 0, 3, 7, and 10. After the trial endpoint, half the subjects in the control arm crossed over to receive removab. The primary endpoint was puncture free survival. This was achieved, with subjects on removab showing a four-fold increase in puncture-free survival over puncture therapy alone (median 46 vs. 11 days (p less than 0.0001). Key secondary endpoints were met as well, including the median time to the first therapeutic puncture (77 days in the removab group versus 13 days in the control group (p less than 0.0001), time to progression (111 days for removab compared to 35 days for control (p less than 0.0001) and median overall survival (72 days in the removab arm compared to 68 days in the control arm (p=0.0846). Based on the results, Fresenius plans to file a MAA with the EMEA later in 2007.
July 21, 2003
Alteon reported negative results from a phase IIb trial investigating ALT-711, a crosslink breaker for the treatment of uncontrolled systolic hypertension. Results showed that ALT-711 did not demonstrate statistical significance as compared to placebo in the primary endpoint, the reduction of systolic blood pressure by ‘office cuff pressure’ measurement. The data showed a 6-10 mm Hg drop in systolic blood pressures in all groups during the first two weeks. The dose ranging, double-blind, placebo-controlled trials, called SAPPHIRE (Systolic And Pulse Pressure Hemodynamic Improvement by Restoring Elasticity) and SILVER (Systolic Hypertension Interaction with Left VEntricular Remodeling), enrolled 768 subjects having elevated systolic blood pressure at over 60 sites nationwide. Subjects were maintained on background hypertension medication during treatment.
EPIX Medical reported positive results from two phase III trials investigating MS-324, a blood pool contrasting agent for the use with magnetic resonance angiographs (MRA). The two trials were conducted on subjects with suspected vascular disease in the renal and pedal arteries. Results demonstrated that both studies met their primary clinical endpoint, demonstrating statistically significant improvement in accuracy for detecting renal and pedal vascular disease with MS-325 compared with non-contrast MRA. The renal study enrolled 145 subjects with suspected disease in the renal arteries and administered each a 0.03 mmol/kg dose of MS-325. Data showed that three individual MRA readers achieved an accuracy of 73%, 79% and 79%, with MS-324 enhancement compared with 45%, 56% and 51% for non-contrast MRAs. The pedal study enrolled 96 subjects with suspected pedal artery stenosis and administered each a 0.03 mmol/kg dose of MS-325. The three readers showed improved specificity of 21%, 34% and 34% with MS-325-enhanced MRA compared to non-contrast MRA. Results were announced at the 11th annual meeting of the International Society of Magnetic Resonance in Medicine (ISMRM) in Toronto.
Sanofi-Synthelabo reported positive results from a general surgery study investigating Arixtra (fondaparinux), a selective factor X inhibitor for the treatment of venous thromboembolism (VTE). Results showed that Arixtra was at least as effective and as safe as the low molecular weight heparin (LMWH) dalteparin for the prevention of VTE following major abdominal surgery. In abdominal cancer surgery subjects, fondaparinux was significantly more effective than the low molecular weight heparin. The randomized, double blind study, called PEGASUS (The PEntasaccharide in GenerAl SUrgery Study) enrolled 2,927 subjects who had undergone major abdominal surgery. Results were presented at the 19th Congress of the International Society on Thrombosis and Haemostasis.