Those results were presented at the New Clinical Drug Evaluation Unit meeting in Hollywood, Fla...Omeros Corp., of Seattle, said it filed a clinical trial application with European regulators to initiate clinical trials of OMS721, its lead human monoclonal antibody from its mannan-binding lectin-associated serine protease-2, or MASP-2, program...Zealand Pharma A/S, of Copenhagen, Denmark, and partner Helsinn Group, of Lugano, Switzerland, reported that Helsinn concluded a Phase IIa study with

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 Philadelphia

Bluebird's treatment approach involves the use of stem cells harvested from a patient's bone marrow...Proceeds would be used to fund clinical trials, R&D for additional alpha-1 antitrypsin (AAT) indications, expanding distribution capabilities for additional territories

clinical trials, for SMD and dry age-related macular degeneration (dry AMD...BHR Pharma LLC, of Herndon, Va., said the 1,000th patient has been enrolled in its SyNAPSe clinical trial, a global Phase III study evaluating the effectiveness of its intravenous progesterone infusion agent, BHR-100, to treat severe traumatic brain injury (TBI...BHR Pharma is sponsoring SyNAPSe with the intent to bring the first-ever approved TBI treatment to market

Stem Cell Therapeutics Corp., of Toronto, said it intends to file a prospectus supplement in certain Canadian provinces for its previously announced offering, consisting of up to 14 million units – each comprising one common share and one common share purchase warrant – priced at C25 cents (US24 cents) apiece...at the same unit price.

Targeted Medical Pharma Inc., of Los Angeles, said results from an open-label study of oral amino acid-based erythrocyte stimulating system (ESS) for the treatment of chronic anemia showed that hemoglobin increased an average of 11.39 percent from baseline measurement to 45 days...The ESS system is designed to stimulate progenitor stem cells in the bone marrow

Antisense Pharma GmbH, of Regensburg, Germany, revised its business objectives related to the advancement of its next-generation TGF-beta inhibitor oligonucleotide program...Kiadis Pharma BV, of Amsterdam, the Netherlands, said it received a No Objection Letter from Canadian regulators to proceed with a Phase II study testing ATIR, a cell-based product designed to enable stem cell transplantation from mismatched family donors

Amicus Therapeutics Inc., of Cranbury, N.J., reported positive results from clinical and preclinical studies of the pharmacological chaperone AT2220 (duvoglustat HCl) in combination with ERT for Pompe disease at the Lysosomal Disease Network World Symposium...Based on those results, the company plans to initiate a repeat-dose clinical study in the third quarter of 2013 to evaluate an intravenous formulation of AT2220 co-administered with Myozyme/Lumizyme...BioAlliance Pharma SA, of Paris, said the FDA

Acceleron Pharma Inc., of Cambridge, Mass., said it started a Phase II study testing dalantercept (ACE-041), an angiogenesis inhibitor designed to target the activin receptor-like kinase pathway, in combination with Inlyta (axitinib, Pfizer Inc.), a vascular endothelial growth factor receptor tyrosine kinase inhibitor, in patients with metastatic renal cell carcinoma...Portola Pharmaceuticals Inc., of South San Francisco, inked a clinical collaboration with Janssen Pharmaceuticals Inc., a unit of

Cerulean Pharma Inc., of Cambridge, Mass., said CRLX101 achieved the predefined gating criterion for advancement into the second stage of a Phase II trial in advanced ovarian cancer...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 resubmission

Acasti Pharma Inc., of Laval, Quebec, said it achieved significant progress in two ongoing clinical studies with CaPre for lipid management...The registrational Phase II double-blind, placebo-controlled clinical study has completed the first of two interim analyses

with experience and expertise in stem cell clinical trials studying treatments for cardiovascular heart diseases...A further nine patients are expected to be enrolled at three oncological centers in the U.S. Based on the results, the company will implement a clinical study aimed at evaluating the effects of Reparixin, an inhibitor of the CXCR1 receptor activated by chemokine interleukin 8, in oral monotherapy on cancer stem cells and on tumor microenvironment for the treatment of women with early

Accera Inc., of Broomfield, Colo., started a clinical efficacy trial examining the effects of AC-1204 in patients with mild-to-moderate Alzheimer's disease (AD...The Belgian Federal Agency for Medicines and Health Products gave authorization to Cardio3 BioSciences, of Mont-Saint-Guibert, Belgium, to begin a Phase III trial of C3BS-CQR-1, an autologous stem cell therapy, for congestive heart failure...The FDA gave permission to Isotechnika Pharma Inc., of Edmonton, Alberta, to begin two Phase III

The primary endpoint of the study is clinical benefit of AEZS-108...CellAct Pharma GmbH, of Dortmund, Germany, said its topoisomerase inhibitor CAP7...The study, conducted in 20 Asian patients at seven clinical trial sites, compared the outcome of a single intravenous dose of Zybrestat (15, 25, 35 or 45 mg/kg) with placebo

It keeps progenitor stem cells healthy and undifferentiated, "ready and waiting, if you will, until they get the signal that the body needs red or white cells," Martino said...The net proceeds will be used for working capital and general corporate purposes, including the continued conduct of the Abili-T clinical study, Opexa's recently initiated Phase IIb trial of personalized T-cell therapy Tcelna in patients with secondary progressive multiple sclerosis.

Bioheart Inc., of Sunrise, Fla., said it will start its ANGEL trial in Mexico and said NorthStart Biotech LLC, a consortium of Bioheart directors and shareholders, agreed to fund the study, which will test the safety and efficacy of LipiCell (adipose-derived stem cells) in congestive heart failure patients...Cellceutix Corp., of Beverly, Mass., said it has recruited the first patients with advanced solid tumors for clinical studies of cancer candidate Kevetrin...TransTech Pharma Inc., of High Point, N

About a year earlier, Dutch firm AM-Pharma BV banked €29.2 million (then US$39.8 million) in a Series D round, apparently the largest venture capital financing in Dutch biotechnology thus far...The company planned to switch from a bovine to a recombinant form of its AKI treatment, alkaline phosphatase. (See BioWorld Today, Sept. 14, 2011.) Bunnik, the Netherlands-based AM-Pharma had then gained only preliminary data from two small-scale clinical trials suggesting that bovine alkaline phosphatase

AlphaCore Pharma Inc., of Ann Arbor, Mich., said its Phase I trial met the primary endpoint by demonstrating the safety and tolerability of ACP-501 (recombinant human LCAT...The positive clinical effects of the twice-daily dose of the drug relative to placebo were observed in a variety of standard psoriasis assessment parameters, with the responses accumulating over the 24 weeks...Neuralstem Inc., of Rockville, Md., updated data from the Phase I trial to test its NSI-566 spinal cord stem cells in the

Athersys Inc., of Cleveland, completed enrollment of the first patient cohorts in its Phase II study of MultiStem, its adult stem cell therapy for administration to patients within approximately one to two days following an ischemic stroke...Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi SA, of Paris, reported data at the European Association for the Study of Diabetes meeting in Berlin supporting the use of once-daily glucagon-like peptide-1 receptor agonist lixisenatide in