The primary endpoint is clinical improvement at 24 weeks...The study will be conducted in two parts: Part A is a dose-escalation study, while Part B will use the dose levels identified in the first part to be safe and tolerable, testing those levels in up to 12 patients

The project, "Human genetics-driven discovery of memory-modulating drugs," will start in March and will include three clinical studies supported by a CTI grant for three years...The study will involve about 32 subjects who currently are not undergoing vaso-occlusive crisis and will comprise ascending dose levels in five groups of single-dose infusions followed by three groups of fractionated doses

The trial evaluated efficacy, safety and tolerability at two dose levels of a single application of DeOvo compared to placebo, with treatment success defined as subjects who were lice-free 14 days following a single 10-minute treatment with DeOvo...In addition to safety, the trial will measure preliminary efficacy based on defined clinical endpoints, including changes in sensation, motor function and bowel/bladder function

AMAG Pharmaceuticals Inc., of Lexington, Mass., presented new clinical data for Feraheme (ferumoxytol), which is approved for iron deficiency anemia in chronic kidney disease...In a separate presentation, Array reported Phase I and Phase II data showing that ARRY-520, its kinesin spindle protein inhibitor, produced clinical activity in heavily pretreated multiple myeloma patients...CytRx Corp., of Los Angeles, reported results from a Phase II trial demonstrating bafetinib's clinical activity and

Results showed that RTS,S provided young African children with significant protection against clinical and severe malaria, reducing the risk by 56 percent and 47 percent, respectively, for the 12-month period following vaccination...The primary endpoint is to evaluate the changes in the overall clinical status using the Golbe scale after 52 weeks of treatment with two different doses of the drug vs...The open-label, dose-escalation study, set to start by the end of the year, will test three dose

The trial (EASED) will evaluate the safety and effectiveness of the drug at three dose levels...Synageva BioPharma Corp., of Lexington, Mass., expanded its ongoing clinical trial of SBC-102 in infants with lysosomal acid lipase deficiency, also known as Wolman disease or cholesteryl ester storage disease, to the U.S. Since no treatments have been approved for the life-threatening deficiency, SBC-102, an enzyme replacement therapy, has been granted orphan designation by the European Medicines Agency

MolMed SpA, of Milan, Italy, presented results from four clinical trials of its cancer candidate, NGR-hTNF...Other Phase II results in ovarian and small-cell lung cancer showed long-term clinical benefit, and Phase I results established safety of a high dose level with two-hour infusion

Bionomics Ltd., of Adelaide, Australia, said the higher dose level of 16 mg/m2 was cleared for BNC105, a vascular-disrupting agent that is being tested in a clinical trial in combination with mTOR inhibitor Afinitor (everolimus, Novartis AG) in patients with metastatic renal cell cancer

Under the firms' 2010 deal, Otsuka will contract with Acucela for early clinical development in exchange for an opt-in right to co-develop and co-promote the compound in the U.S...Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, said data from a recently completed clinical trial of LX4211 , a dual inhibitor of the sodium glucose transporters 1 and 2, demonstrated a favorable safety profile and effects on multiple parameters of glycemic control and cardiovascular health in healthy subjects

The study will test two dose levels of a single application for efficacy, safety and tolerability compared to vehicle and will involve about 132 healthy subjects 2 years and older with head lice infestation...NexBio Inc., of San Diego, said an article in Clinical Infectious Diseases showed that a bone marrow transplant patient who had progressive and worsening parainfluenza virus Type 3 infection, given DAS181, experienced improved respiratory status within one day of initiating treatment

Senesco Technologies Inc., of Bridgewater, N.J., finalized a clinical trial agreement with the Mayo Clinic in Rochester, Minn., to study SNS01-T in relapsed or refractory multiple myeloma patients...The open-label, dose-escalation study, expected to begin in the third quarter, calls for twice-weekly dosing of patients for six weeks followed by a safety data review before escalating to a higher dose level in a new group of subjects

Endpoints include biochemical markers in muscle biopsies and clinical outcomes to measure muscle strength, function and degree of ambulation...The study will evaluate pharmacokinetics and safety of the drug in 24 for patients with HIBM at four single dose levels, with repeat dosing at three dose levels after seven days. (See BioWorld Today, June 21, 2011

Neovacs, of Paris, reported that its TFN-K-003 clinical study has recruited all patients...The treatment's safety and clinical efficacy are secondary endpoints...Novavax expects to initiate further clinical evaluations of both seasonal and H5N1 pandemic VLP vaccines within the next 12 months under the initial phase of a three-year, $97 million Biologics Advanced Research and Development Authority contract awarded earlier this year

The total number of patients to be enrolled will depend on how many ascending dose levels are needed to reach the maximum-tolerated dose...Threshold Pharmaceuticals Inc., of Redwood City, Calif., initiated a clinical trial of TH-302 in combination with bevacizumab (Avastin, Roche AG) in patients with recurrent high-grade astrocytoma including glioblastoma

The drug was well tolerated, and a dose-limiting toxicity of skin photosensitivity and ulceration occurred at the fourth dose level...Complete clinical regression of target tumors was seen in 14 of 16 patients completing the first assessment and eight of 11 patients completing the second assessment

The first dose level of 200 mg, one of four dose levels planned, was successfully completed and no dose-limiting toxicities were observed when 200 mg of resminostat and the standard dose of the FOLFIRI regimen were administered in combination

Infinity Pharmaceuticals Inc., of Cambridge, Mass., said it is expanding its clinical program for IPI-926, an oral, small molecule designed to inhibit Smoothened, a component of the Hedgehog pathway...Oxford BioMedica plc, of Oxford, UK, said the first dose level of RetinoStat was safe and well tolerated at one month following treatment

Adaptimmune Ltd., of Oxford, UK, opened a Phase I/II, dual site, two-cohort, open-label clinical trial in multiple myeloma at the University of Maryland and the University of Pennsylvania testing its enhanced T-cell receptor T-cell therapy...Argos Therapeutics, of Durham, N.C., announced that its Arcelis immunotherapy for the treatment of renal cell carcinoma (RCC), AGS-003, in combination with sunitinib demonstrated a strong immunologic response that correlated to improved clinical outcomes in a

Data will be presented at the 2011 American Society of Clinical Oncology annual meeting in Chicago...In previous clinical trials, bavituximab has shown antitumor activity in combination with taxane-based chemotherapies...Profectus BioSciences Inc., of Baltimore, reported that the AIDS Clinical Trials Group immunized the first subject in a U.S. Phase I trial of Profectus' multi-antigen HIV plasmid DNA vaccine administered with various doses of GENEVAX interleukin-12 (IL-12) pDNA adjuvant and delivered