Grifols SA, of Barcelona, Spain, presented results from a study demonstrating that a higher dose of Prolastin-C (alpha1-proteinase inhibitor [human]) increased levels of the alpha1 protein in patients with alpha1antitrypsin (AAT) deficiency to levels that are considered within the normal range for healthy individuals...Results of the PROLASTIN-C SPARK study, a multidose pharmacokinetic clinical trial, were presented at the annual meeting of the American Thoracic Society in Philadelphia

Mirna Therapeutics Inc., of Austin, Texas, has initiated a Phase I study of MRX34, the first miRNA to advance to a clinical trial for cancer...Prometheus Laboratories Inc., of San Diego, said PROCLIVITY 01, a multicenter study of Proleukin (High Dose Interleukin-2 [HD IL-2])1 plus vemurafenib therapy in patients with BRAF V600 mutation-positive metastatic melanoma (mM) is enrolling patients

The primary endpoint is clinical benefit, which will be assessed at six months...RepliCel Life Sciences Inc., of Vancouver, British Columbia, said it started clinical development of an autologous cell therapy for the treatment of a variety of chronic tendon injuries, including Achilles, patellar and elbow...Statistically significant mean body weight reduction relative to baseline occurred in the three highest dose groups, and a similar reduction in body weight also was observed in the obese

Array BioPharma Inc., of Boulder, Colo., reported clinical data at the International Myeloma Workshop in Kyoto, Japan, showing that ARRY-520, a selective KSP inhibitor, demonstrated single-agent activity in heavily pretreated patients with relapsed or refractory multiple myeloma, with 19 months median overall survival and a 16 percent overall response rate...The company said safety endpoints were met, with no significant toxicities observed at a higher dose

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...The ALS Therapy Development Institute, of Cambridge, Mass., received FDA approval to conduct a clinical trial of TDI-132, or fingolimod (Gilenya, Novartis AG) in amyotrophic lateral sclerosis (ALS...Following successful completion of the dose-escalation component of the study, an additional

30, will support clinical trials of KaloBios' Humaneered antibody pipeline, as well as general corporate purposes...In the meantime, Sanofi is in the middle of a Phase I study in healthy volunteers testing higher doses of the drug as part of its development plan for KB001-A in ventilator-associated pneumonia...The company plans to use the proceeds for R&D expenses, acceleration of clinical trials acquisitions of new technologies and other corporate purposes

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 percent

The primary efficacy endpoint will be clinical improvement in the Systemic Lupus Erythematosus Responder Index (SRI-8...The trial will enroll about 48 patients with IgA nephropathy to receive high-dose blisibimod or placebo for eight weeks, followed by a 24-week maintenance period of blisibimod or placebo

The proposed trail is intended to cut through the undergrowth of current clinical trial requirements by allowing for smaller, more targeted studies that wouldn't take as long to complete...Clinical trials represent an aggregate expense of about $31.3 billion, or nearly 40 percent of the R&D budget of major drug developers – much of that due to systemic inefficiency, according to the report...It's hoped that the results will help guide decisions in the future on whether a drug warrants further clinical

Data also indicated rapid onset of activity, with clinical activity reported for 16 of 19 responders occurring within the first two cycles of treatment...OncoSec plans to use the proceeds to fund clinical trials and research and development and for other corporate purposes...The company plans to use the proceeds to fund research and development, clinical trials and for other corporate purposes.

The study is being conducted at 76 clinical sites in the USA, Canada, Europe and Australia...with experience and expertise in stem cell clinical trials studying treatments for cardiovascular heart diseases...Dompe Group, of Milan, Italy, said it presented the status of a clinical trial to evaluate the safety and pharmacokinetic profile of Reparixin, administered orally in combination with paclitaxel in women with metastatic breast cancer at the San Antonio Breast Cancer Symposium

BCI-838 showed a favorable safety profile, with no treatment-related trends in clinical laboratory results, vital sign measurements, 12 lead ECG results or physical examination findings, and the drug was well tolerated up to the dose levels predicted for efficacy...Cotara, a targeted loco-regional therapy designed to deliver a high dose of radiation directly into the brain tumor while sparing radiation exposure to healthy brain tissue, has orphan and fast track status in the U.S

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...Cohorts two and three will enroll 18 subjects each, and an additional 50 patients with severe traumatic brain injury will be

At week 12, AMG 145 reduced LDL-C by up to 66 percent when dosed every two weeks and up to 50 percent when dosed every four weeks, compared to placebo (p < 0.001 for the highest dose vs. placebo...Moberg Derma AB, of Stockholm, Sweden, said it received the final results from a Phase II study of MOB-015 in patients with onychomycosis and, because the clinical efficacy was unsatisfactory, said it decided to initiate a new study with an improved formulation...Senesco Technologies Inc., of Bridgewater, N

Chelsea Therapeutics International Ltd., of Charlotte, N.C., reported results from a clinical study designed to determine the blood pressure effect of escalating doses (100 mg, 200 mg and 400 mg) of Northera (droxidopa) in hypotensive individuals with chronic spinal cord injuries ranging from cervical to low thoracic lesions...A completed Phase I trial in end-stage cancer showed a desirable safety profile, plus stable disease or clinical response in about 25 percent of patients...At the 2-mg dose, the

The trials, CARE-MS-I and CARE-MS II, showed that Lemtrada was significantly more effective at reducing annualized relapsed rates than Rebif (high dose subcutaneous interferone beta-1a, Merck Serono) and more patients receiving Lemtrada were relapse-free at two years...Study efficacy results demonstrated positive trends in slowing the rate of disease progression, ranging from 13 percent to 19 percent in multiple parameters of clinical benefit, although those pre-defined endpoints did not reach

Patients will be monitored for development of clinical symptoms and viral shedding...Initiation of the study followed a successful, dose-escalation Phase I study in which clinical activity was observed in five of seven patients receiving the two highest dose levels

Among the group that received the higher doses of ApoCell, no cases of GvHD grades 2-4 were observed, while 50 percent of similar patients who did not receive ApoCell did develop GvHD grades 2-4...The primary endpoint of the 33-patient study is to determine the clinical benefit rate, while secondary objectives include progression-free survival and safety and tolerability

The data showed that the vaccine was safe and well tolerated at the highest dose, and that there were HPV-E7-antigen-specific T-cell responses in a majority of vaccinated women...The study showed that the drug was safe and well tolerated at all dose levels, and that more patients in the higher-dose cohorts showed improvement in their clinical disease activity index than patients in the lower-dose or placebo cohorts