Clinical Intelligence

Drug for Excessive Sleepiness Shows Promise in Phase II Study

Thursday, November 8, 2007

Vanda Pharmaceuticals reported positive results from a phase II trial of VSF-173, an orally administered stimulant, for the treatment of excessive sleepiness. This randomized, double-blind, placebo-controlled trial enrolled  fifty-five subjects who received three doses of VSF-173 administered at 50 mg, 100 mg and 200 mg and placebo administered at 25 mg, 50 mg and 100 mg at the usual bedtime and at four hours after the first dose.

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Centocor Psoriasis Drug Shows Impressive Results

Monday, October 29, 2007

Johnson & Johnson’s Centocor reported positive results from a phase III trial of CNTO1275 (ustekinumab) for the treatment of psoriasis. CNTO1275 is a monoclonal antibody (mAb) against the p40 subunit of interleukin 12 (IL-12) and IL-23. This randomized, double-blind, placebo-controlled study, dubbed PHOENIX 2, enrolled 1,230 subjects with chronic psoriasis.

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Gene Therapy Drug Shows Promise in MS Patients

Monday, October 15, 2007

Palo Alto, Calif.-based Bayhill Therapeutics reported positive results from a phase IIb trial of BHT-3009 for the treatment of multiple sclerosis. BHT-3009 is a gene therapy drug that delivers DNA that instructs cells to produce myelin basic protein (MBP). Myelin is the phospholipid sheath that surrounds neurons and is the target of many autoimmune diseases such as MS.

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Promising Results Seen in Lung Cancer Trials

Wednesday, September 26, 2007

Merck KGaA reported positive long-term results from a phase II trial of Stimuvax for the treatment of non-small cell lung cancer (NSCLC). The drug is a MUC-1 peptide-based liposomal vaccine, for the potential  treatment of cancers.

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ARISE Trials Shows Promising Results for Diabetes

Monday, September 17, 2007

Atherogenics reported positive results from a phase III trial of succinobucol (AGI-1067), an antioxidant oral vascular cell adhesion molecule-1 (VCAM-1) gene expression inhibitor, for the treatment of diabetes and coronary heart disease. This trial, dubbed ARISE (Aggressive Reduction of Inflammation Stops Events), enrolled over 6,000 subjects internationally. Results were reported at the European Society of Cardiology Congress 2007.

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Heart Drug Combo Reduces “Flushing”

Friday, September 7, 2007

Merck reported positive results from a phase III trial of Cordaptive for the treatment of dyslipidemia. Cordaptive was shown to lower LDL –or bad — cholesterol and raise HDL — or good — cholesterol, while lowering some of the side effects of such drugs.

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Cardium’s Heart Drug Shows Mixed Results

Monday, September 3, 2007

Cardium reported mixed results from two phase IIb/III trials of Generx (alferminogene tadenovec, Ad5FGF-4) for the treatment of chronic angina. These randomized, double-blind, placebo-controlled trials were dubbed AGENT (Angiogenic GENe Therapy -3 and -4 and enrolled a total of 532 subjects in the US and Europe.  Subjects received a low dose or high dose of Generx, administered via intracoronary infusion or placebo for 12 weeks. The primary endpoint was the change from baseline in exercise treadmill time (ETT) at 12 weeks and at secondary time points of 4 weeks and 6 months. Secondary endpoints included time to 1 mm ST-segment depression, time to onset of angina and change in Canadian Cardiovascular Society (CCS) class. Pooled data showed no significant difference in the active groups versus placebo in the primary endpoint.

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