Search Results for: Clinical Roundup
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Jennerex Plucks $21.6M Private Placement; Is IPO Up Next?
The primary endpoint is overall survival (OS) for patients receiving Pexa-Vec plus best supportive care compared to best supportive care alone...The company said proceeds will be used for general corporate purposes, including clinical trial expenses and additional regulatory efforts related to erectile dysfunction drug Vitaros (alprostadil 0.3 percent topical cream) and female sexual dysfunction candidate Femprox (alprostadil 0.4 percent topical creamBy Marie Powers | BioWorld Today | Friday, May 24, 2013 -
Clinic Roundup
The study is being sponsored by the Alliance for Clinical Trials in Oncology, a cooperative group of the National Cancer Institute (NCI...In the trial, aldoxorubicin showed prolonged clinical activity, including partial tumor response, in two subjects with small-cell lung cancer who had failed other therapies...Promedior Inc., of Lexington, Mass., presented data from a clinical study of PRM-151 at the American Thoracic Society Conference in PhiladelphiaBioWorld Today | Thursday, May 23, 2013 -
Clinic Roundup
Clinical improvements were seen in all patients with reductions in median stool frequency from 23 to 14 per week (p = 0.03) and an improvement in the median Bristol Stool Form Scale assessing stool type from 5.515 to 4.34 (p = 0.05...The trial design was supported by promising data from a Phase IIb study in patients receiving bavituximab plus docetaxelBioWorld Today | Tuesday, May 21, 2013 -
Clinic Roundup
The analyses included the description of new predictive biomarkers of clinical response to Vectibix, activating mutations in KRAS (beyond exon 2) and in NRAS, collectively referred to as RAS...Additional edata will be presented at the annual meeting of the American Society of Clinical Oncology in Chicago...ACT is currently enrolling patients in three clinical trials in the U.SBioWorld Today | Friday, May 17, 2013 -
Beyond Kalbitor: Dyax Adds $30M for HAE Prophylactic
is more than doubling its cash position with a $30 million registered direct offering, with proceeds to fund R&D activities, namely clinical development of DX-2930, a drug slated to start clinical development for prophylactic use in hereditary angioedema (HAE...He added that patients receiving C1 inhibitors have still shown a "40-plus percent breakthrough attack" rate in HAE attacksBy Jennifer Boggs | BioWorld Today | Tuesday, May 14, 2013 -
Clinic Roundup
The mean change in hemoglobin in ferumoxytol-treated AUB patients was 2.8 g/dL, compared to no increase (0 g/dL) in AUB patients receiving placebo (p < 0.0001...The NH004-3 clinical trial is a double-blind, placebo-controlled, randomized, crossover, multicenter study comparing NH004 and placebo thin films in Parkinson's disease patient complaining of sialorrheaBioWorld Today | Tuesday, May 7, 2013 -
Clinic Roundup
Secondary objectives of the trial include clinical activity by serum TTR levels...In a sub-study, mean saliva production in patients receiving Tolenix was restored to a level similar to that of placeboBioWorld Today | Tuesday, March 19, 2013 -
Clinic Roundup
Avaxia plans to enroll 24 patients in three dose groups, with six patients receiving the study drug and two patients receiving placebo in each dose group, for 28 days...The study also has exploratory endpoints for clinical efficacy and inflammation biomarkers...Ltd., of Taipei, Taiwan, added two additional Taiwanese clinical centers in Cel-Sci's Phase III head and neck cancer trial for Multikine (Leukocyte Interleukin, Injection), including the China Medical University Hospital, of Taichung, TaiwanBioWorld Today | Tuesday, February 26, 2013 -
Clinic Roundup
Two posters feature clinical data of PROSTVAC evaluated as monotherapy or in combination with a radiopharmaceutical...Patients receiving either 1,000-mg or 2,000-mg daily doses of GTx-758 demonstrated significant reductions in their serum-free (unbound) testosterone levels, with related reductions in their levels of serum prostatic specific antigenBioWorld Today | Thursday, February 14, 2013 -
Newlink Adds $42.5M in Public Offering for Immunotherapies
The company has an extensive pipeline of products in clinical development, including HyperAcute Pancreas (algenpantucel-L), HyperAcute Lung (tergenpumatucel-L), HyperAcute Melanoma, HyperAcute Renal and others...In patients receiving high-dose therapy, disease-free survival was 15.3 months, and one-year overall survival was 96 percentBy Catherine Shaffer | BioWorld Today | Thursday, January 31, 2013 -
Clinic Roundup
The incidence of grade 3 or 4 febrile neutropenia in patients receiving Neulasta across the first four cycles of chemotherapy was 2.4 percent compared to 5.7 percent in the placebo group (OR = 0.41, p = 0.014...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 -
Clinic Roundup
All patients receiving DPX-Survivac also demonstrated antigen-specific immune responses, as measured by at least one of the study's three immune monitoring assays...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
Durata said the secondary endpoint of clinical success at the end of treatment – the expected primary endpoint for regulatory review in Europe – also was met...iCo Therapeutics Inc., of Vancouver, British Columbia, said there have been no drug-related serious adverse events among patients receiving repeat doses of iCo-007 at the midpoint of its Phase II iDEAL study in diabetic macular edema...The results from the study suggested the 12-mg dose may provide clinical benefit to women suffering fromBioWorld Today | Monday, January 7, 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...Patients receiving Tolenix, a twice-daily combination of muscarinic antagonist tolterodine and muscarinic agonist pilocarpine, exhibited no safety issues and also demonstrated statistically significant and clinically meaningfulBioWorld Today | Friday, January 4, 2013 -
FANG Bites Off $24M Series B; Gradalis Ovarian Trial Advances
Funds from the Series B, which the firm was expected to disclose today, also will be used to progress clinical and preclinical development of its bifunctional short hairpin RNA (shRNA) platform, but it was FANG that loosened the purse strings in the round...Gradalis emerged from stealth mode this spring, shortly after data from a "very broad" Phase I trial were published in Molecular Therapy, showing "great activity in a number of tumor types," Haselwood said. (See BioWorld Today, March 12, 2012By Randy Osborne | BioWorld Today | Thursday, January 3, 2013 -
Clinic Roundup
Data showed that 82.3 percent of patients who received oritavancin met the early clinical endpoint of cessation of spread, absence of fever and no rescue antibiotics, compared to 78.9 percent of patients receiving vancomycin...About 79.6 achieved clinical cure, compared to 80 percent of the vancomycin groupBioWorld Today | Friday, December 21, 2012 -
Clinic Roundup
Data demonstrated that patients with established atrial fibrillation (AF) receiving Gencaro in the trial had improvements in heart failure clinical endpoints, and those receiving Gencaro were more likely to achieve ventricular rate control...The second Phase III trial resulted in a median two-year progression-free survival rate of 92 percent in patients with diffuse large B-cell lymphoma who received maintenance lenalidomide, compared with 83 percent for patients receiving lenalidomide plus RituxanBioWorld Today | Thursday, December 13, 2012 -
Clinic Roundup
AiCuris GmbH, of Wuppertal, Germany, said it started the second clinical efficacy trial testing pritelivir (AIC316), its herpes simplex virus (HSV) drug, after data from the first study showed a high degree of efficacy against genital herpes...All patients receiving sofosbuvir/RBV became HCV RNA negative on treatment and relapse accounted for all virologic failuresBioWorld Today | Wednesday, November 28, 2012 -
Clinic Roundup
Subcutaneous administration achieved efficient conversion to decitabine, resulting in an improved pharmacokinetic profile over the intravenous Dacogen (decitabine) formulation, and clinical responses were observed in the heavily pretreated population of patients with relapsed/refractory intermediate- or high-risk myelodysplastic syndromes or acute myelogenous leukemia...XBiotech Inc., of Austin, Texas, reported an interim analysis from a Phase II study, showing that patients receiving MABp1 toBioWorld Today | Wednesday, November 21, 2012 -
Clinic Roundup
Immunomedics Inc., of Morris Plains, N.J., said patients receiving epratuzumab reported clinically meaningful improvements in health-related quality of life (HRQoL) that were sustained over about four years of treatment...Opexa Therapeutics Inc., of The Woodlands, Texas, said Health Canada approved its clinical trial application, enabling the company to expand its ongoing trial in secondary progressive multiple sclerosis (SPMS) to include several sites in CanadaBioWorld Today | Wednesday, November 14, 2012
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