Search Results for: Clinical Roundup
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Clinic Roundup
clinical trials where a single dose of NX-1207 has been found to produce on average symptomatic improvements about double that reported for currently approved BPH drugs without causing the sexual or cardiovascular side effects associated with those drugsBioWorld Today | Monday, May 6, 2013 -
Epizyme Files for IPO, Aims for $69M for Epigenetics Platform
The funding allowed ReXceptor to enter a formal partnership with C2N Diagnostics, which will assist the company with the initiation and coordination of the clinical trial of an AD program licensed from Case Western's Technology Transfer Office and based on discoveries that bexarotene, a medication sold at Targretin for cutaneous T-cell lymphomas, reversed AD symptoms in mice within 72 hours of a single dose of treatment.By Jennifer Boggs | BioWorld Today | Monday, April 29, 2013 -
Clinic Roundup
RP5063 also showed efficacy in the Clinical Global Impression Severity Scale and was well tolerated...Viralytics Ltd., of Sydney, Australia, said it finalized the clinical study report on the Phase I evaluation of Cavatak, administered intravenously to late-stage melanoma, prostate, breast or colorectal cancer patients, with results showing that the oncolytic virus-based drug candidate was well tolerated, with some evidence of stable disease despite most patients only receiving a single doseBioWorld Today | Wednesday, April 10, 2013 -
Clinic Roundup
Novavax Inc., of Rockville, Md., said top-line data from its Phase II dose-ranging study testing its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age hit its protocol-specified objectives, supporting progression to the next stage of advanced clinical testing...The study tested two dose levels of the RSV F protein nanoparticle vaccine candidate with and without aluminum phosphate as an adjuvant and enrolled 330 women to receive either one or two intramuscularBioWorld Today | Thursday, April 4, 2013 -
Clinic Roundup
Idera completed the escalating single dose and multiple dose parts of the Phase I trial...Tengion Inc., of Winston-Salem, N.C., said the firm's clinical trial application was accepted in Sweden to start a Phase I trial testing its Neo-Kidney Augment in up to five patients with advanced chronic kidney diseaseBioWorld Today | Tuesday, April 2, 2013 -
Clinic Roundup
Benitec Biopharma Ltd., of Sydney, Australia, selected the Duke Clinical Research Unit in Durham, N.C., as a site for its upcoming Phase I/II first-in-human trial of TT-034 in hepatitis C virus (HCV...The open-label, dose escalation study will evaluate the safety and activity of single doses of TT-034 in patients with chronic HCV genotype 1 infection who failed previous treatmentsBioWorld Today | Monday, March 25, 2013 -
AAN Roundup
The Phase I/II trial showed a significantly slower decline in overall clinical and respiratory function, as measured by the ALS functional rating score (ALSFRS-R) and forced vital capacity (FVC) score, respectively, in the six patients who received an intrathecal injection of the cells in the six months following treatment, as compared to the three months preceding treatment...In the single-dose, open-label study, ISIS-SMNRx was well tolerated in children with SMA at all dose levels tested andBioWorld Today | Friday, March 22, 2013 -
Clinic Roundup
Acorda Therapeutics Inc., of Ardsley, N.Y., said data from a Phase I study showed that a single dose of 20-mg Diazepam Nasal Spray had comparable plasma bioavailability to 20 mg of diazepam rectal gel...The company also is preparing a clinical program for marketing in Europe and the U.SBioWorld Today | Thursday, March 21, 2013 -
Clinic Roundup
The NX03-0040 prostate cancer clinical study of 150 men is testing low (2.5 mg) and high (15 mg) single doses of NX-1207 for the effect to eradicate or shrink low-grade localized prostate cancer tumorsBioWorld Today | Wednesday, March 20, 2013 -
Clinic Roundup
Secondary objectives of the trial include clinical activity by serum TTR levels...The company has found in studies to date that a single dose of NX-1207 produces symptomatic improvements about double those of currently approved BPH therapies without sexual or cardiovascular side effectsBioWorld Today | Tuesday, March 19, 2013 -
Clinic Roundup
Advanced Cell Technology Inc. (ACT), of Marlborough, Mass., said its clinical partner, the University of California, Los Angeles (UCLA), received FDA approval for its investigational new drug application...Biomarkers at both the gene and protein level showed that a single dose of CAT-1004 produced a 70 percent reduction in nuclear p65, a marker of NF-kB activationBioWorld Today | Tuesday, February 12, 2013 -
Clinic Roundup
The trial will assess safety and clinical benefit of various dose levels of cells...Data from a Phase IIb trial evaluating the safety and efficacy of tuberculosis (TB) vaccine MVA85A showed that a single dose of the vaccine was not sufficient to confer statistically significant protection against TB or infection in infants vaccinated at birth with the Bacille Calmette-Guérin (BCG) vaccineBioWorld Today | Tuesday, February 5, 2013 -
Clinic Roundup
Boosting with a single dose of licensed inactivated H5N1 gave significantly higher rates of seroprotection than in placebo recipients only receiving a single dose of H5N1 vaccine (p < 0.001BioWorld Today | Friday, February 1, 2013 -
Clinic Roundup
The open-label study is enrolling patients with Stage IIIb and Stage IV disease, and the primary objectives include evaluating the safety of a single dose and repeat doses...Repros Therapeutics Inc., of The Woodlands, Texas, provided a revised date for expected clinical results from the first pivotal trial, ZA-301, of Androxel (enclomiphene) in secondary hypogonadism, with data expected in the third quarter rather than the second quarterBioWorld Today | Tuesday, January 29, 2013 -
House Vote Has Makers of MCMs Breathing a Little Easier
The trial, which included 112 healthy volunteers, tested a single dose of each of four versions of the live-attenuated vaccine...While all the versions induced antibody responses against four dengue viruses, a single dose of TV003 resulted in an antibody response to all four viruses in 45 percent of participants and against three of the four viruses in an additional 45 percentBy Mari Serebrov | BioWorld Today | Thursday, January 24, 2013 -
Versartis' $25M Series C to Fund HGH Trial in Children
Results showed that a single dose of VRS-317 was well tolerated, and could be administered at or below the average-equivalent daily rHGH dose over 30 days to sustain normal serum IGF-1 levels in adults...Proceeds will be used for general corporate purposes, ultimately focused on advancing the firm's clinical pipelineBy Catherine Shaffer | BioWorld Today | Wednesday, January 16, 2013 -
Clinic Roundup
Secondary endpoints also were met, including the clinical cure rate at end of treatment day 10 to day 14 (88.9 percent) and test of cure at day 21 to day 28 (100 percent...That allows Lorus to initiate a biomarker clinical investigation to further explore the effects of the drug at relevant doses determined in the trial...The complete clinical study report for the interim analysis would be supplied to the FDA during the review within 60 days of the resubmissionBioWorld Today | Tuesday, January 8, 2013 -
Clinic Roundup
Alnylam Pharmaceuticals Inc., of Cambridge, Mass., filed a clinical trial application with the U.K. Medicines and Healthcare Products Regulatory Agency to initiate a Phase I study of ALN-TTRsc, an RNAi therapeutic targeting transthyretin (TTR), in TTR-mediated amyloidosis...Zogenix Inc., of San Diego, reported single-dose pharmacokinetic results from a Phase I trial testing Relday, a once-monthly subcutaneous formulation of risperidone for treating schizophrenia, showing that adverse events wereBioWorld Today | Friday, January 4, 2013 -
Clinic Roundup
NovaDigm Therapeutics Inc., of Grand Forks, N.D., published data from a Phase I study of its NDV-3 vaccine in Vaccine that showed a single dose of NDV-3 with alum adjuvant was safe, well tolerated and induced strong antibody and T-cell responses...Spectrum Pharmaceuticals Inc., of Henderson, Nev., presented clinical data at the recent American Society of Hematology meeting in Atlanta for cancer drug Zevalin (yttrium-90-ibritumomab tiuxetan), including results from a Phase II study showing thatBioWorld Today | Friday, December 14, 2012 -
Pharma: Clinic Roundup
Because of the nature of the registry and vision testing variability, the company said, a clear comparison could not be drawn between registry data and clinical trial results...Single doses up to 7.5 mg were generally well tolerated, with no significant adverse eventsBioWorld Today | Tuesday, December 4, 2012
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