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Dynavax Technologies Corp. has announced that recruitment for its Tolamba trial for allergic rhinitis has exceeded expectations for the speed and number of study subjects enrolled. More than 700 subjects were enrolled in the study in fewer than eight weeks, prompting the firm to close enrollment early. All 738 ragweed allergic subjects have been randomized into three arms for the 30-center, placebo-controlled study: a lower total dosing regimen consistent with a recently completed Phase II/III trial, a higher total dose regimen, and placebo. Subjects will receive six injections before the 2006 ragweed season starts, and their symptoms will be followed through the 2007 season.
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Avicena previously announced that the NINDS had awarded a grant for this Phase III trial to evaluate PD-02's potential to slow the progression of Parkinson's disease. As part of the Company's collaboration with the NINDS, Avicena will supply the drug PD-02 and placebo for use in the trial. In return, Avicena will have access to the study's data to file a New Drug Application with the Food and Drug Administration for the approval of PD-02 as a treatment for Parkinson's disease. Avicena ... holds intellectual property rights for the use of PD-02 in Parkinson's disease.
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Results from a Phase III trial evaluating the safety and efficacy of risedronate sodium tablets 35mg for male osteoporosis were presented in June at the International Osteoporosis Foundation World Congress on Osteoporosis. In the trial, patients treated with risedronate experienced a statistically significant 4.5 percent increase in lumbar spine bone mineral density, compared to patients receiving placebo after two years. The trial, sponsored by Procter & Gamble Pharmaceuticals and sanofi-aventis U.S. (The Alliance for Better Bone Health), was a double-blind, randomized, placebo-controlled, parallel group, multicenter study including 284 men who had osteoporosis.
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The clinical trial is a single-blind, placebo-controlled, repeat-dosing study designed to evaluate the clinical safety and clinical effects of repeat administration of SB-509 in diabetics with moderate to severe diabetic peripheral sensory motor neuropathy in the legs. The trial will be conducted at multiple sites. SB-509 is an injectable formulation of plasmid DNA that encodes a ZFP TF, designed to upregulate the VEGF-A gene.
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XIENCE V SPIRIT WOMEN clinical trial is the first large interventional study to study how cardiovascular disease differs in women from men. XIENCE V SPIRIT WOMEN will include approximately 2,000 women from about 100 sites throughout Europe, Asia-Pacific, Canada and Latin America.
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"The Avicena Group, as part of its ongoing collaboration with NINDS, will provide PD- 02 and placebo for the Phase III creatine trial and fund a related chronic toxicology study. In turn, Avicena has the right to utilize the study's findings for the NDA (New Drug Application) submission to the FDA for the approval of PD-02 as a treatment for Parkinson's disease."
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