In addition to pharmacokinetic and safety data, multiple efficacy endpoints will be measured...The primary efficacy endpoint for both studies is the mean change in hemoglobin from baseline

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...Efficacy endpoints include change from baseline in corneal staining, tear production and dry eye symptom scores

Interim analysis indicated the trial would not meet the pre-specified primary efficacy endpoint...On Friday, the Vetex's shares (NASDAQ:VRTX) gained $1.60, closing at $79.49.

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...Results of the pre-planned interim analysis showed that Lymphoseek met the primary efficacy endpoint of accurately identifying sentinel lymph

dosage form of either tedizolid or linezolid with the option to switch to the respective oral dosage forms at the discretion of the clinical investigator on or after the second day of treatment...Tedizolid also met all secondary efficacy endpoints measured at both the end of therapy and post-treatment evaluations

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 primary safety endpoints are dose-limiting adverse events, and primary efficacy endpoints are serum viral load reduction and degree of hepatocyte transduction, measured by liver biopsies

It is the first immune cell clinical trial of its kind in China...A follow-on Phase II trial will include clinical markers of muscle health, levels of utrophin expression and other biomarkers...CALM is investigating the clinical efficacy and safety of Cavatak in Stage IIIc or IV melanoma

Inc., of Whitehouse Station, N.J., said researchers from the Clinical Trial Service Unit at Oxford University presented results from the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study of Tredaptive (extended-release niacin/laropiprant) during the late-breaking clinical trial session at the American College of Cardiology 62nd Annual Scientific Session in San Francisco...Findings were presented during the late-breaking clinical trial session

The primary objectives include the evaluation of adverse events and the evaluation of six-month clinical response...Edison Pharmaceuticals Inc., of Mountain View, Calif., said it started a Phase II study, titled "Double-Blind, Placebo-Controlled Clinical Trial of EPI-743 in Patients with Cobalamin C Defect...Gilead Sciences Inc., of Foster City, Calif., said top-line results from a Phase III (FUSION) study of sofosbuvir plus ribavirin in genotype 2 or 3 chronic hepatitis C virus met its primary

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...Health authorities have agreed with the designation of cardiovascular mortality as a primary efficacy endpoint, and patient enrolment is already under way in the U.S

The trial will assess safety and clinical benefit of various dose levels of cells...In addition, the vaccine candidate failed to provide statistically significant protection in the secondary efficacy endpoint of preventing infection with Mycobacterium tuberculosis

Anthera's Phase IIb study, PEARL-SC, missed its primary efficacy endpoint of clinical improvement at 24 weeks in the Systemic Lupus Erythematosus Responder Index...The primary efficacy endpoint will be clinical improvement in the Systemic Lupus Erythematosus Responder Index (SRI-8

Ampio plans to start enrolling in a 450-patient clinical trial this quarter...Those data completed the pivotal pharmacokinetic and clinical program for BNX, which BDSI said will enable a new drug application submission in mid-2013...In November, Omeros said OMS302 met the co-primary efficacy endpoints in the second trial, demonstrating statistically significant (p < 0.00001) maintenance of intraoperative mydriasis and statistically significant (p = 0.0002) reduction in pain in the early postoperative

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...Primary efficacy endpoints will be derived from a combination of pain and disability assessments from standard tests along with sincerity of effort, measured by grip strength testing

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

The HCV program is on track for an investigational new drug application in the first quarter of 2013, and the company expects clinical proof-of-concept data by year-end 2013...The primary efficacy endpoint of the study was to evaluate the complete early viral response (cEVR) of four regimens of MK-5172 in combination with peginterferon/ribavirin (PR) compared to the control arm in which patients received a four-week lead-in of PR followed by the addition of Victrelis (boceprevir) 200-mg capsules

Eli Lilly and Co., of Indianapolis, said three Phase III studies of dulaglutide met their primary efficacy endpoints of reduction in hemoglobin A1c...Investigators will report clinical response, clinical remission and mucosal healing results through one year at the American College of Gastroenterology meeting in Las Vegas

The primary efficacy endpoint will be reduction in intraocular pressure...Data were published in the Journal of Allergy and Clinical Immunology