AMAG Pharmaceuticals Inc., of Lexington, Mass., presented new clinical data for Feraheme (ferumoxytol), which is approved for iron deficiency anemia in chronic kidney disease...Celator Pharmaceuticals Inc., of Princeton, N.J., presented findings from a Phase IIb study of CPX-351 (cytarabine:daunorubicin) liposome injection, which showed a statistically significant benefit in overall survival favoring the drug in first relapse patients with acute myeloid leukemia who had an unfavorable risk profile
Metabolex Inc., of Hayward, Calif., said an open-label clinical pharmacology study showed that the higher dose of arhalofenate plus Osaka, Japan-based Takeda Pharmaceutical Co...Arhalofenate is a uricosuric agent currently in Phase IIb trials
The FDA isn't convinced the REMS is strong enough to sufficiently mitigate the serious pulmonary events it said were seen in clinical trials among patients with asthma or COPD...A Phase IIb trial with Staccato loxapine for migraine trended toward statistical significance, but didn't meet its primary endpoint of pain relief
By Mari Serebrov | BioWorld Today | Friday, December 9, 2011
aureus, with a combined clinical cure rate of 92 percent...The clinical benefit rate, including complete response, partial response and stable disease exceeding six months, was 25.5 percent in the placebo group, and 50 percent in the everolimus group...Clinical response rates of 93 percent, 96 percent and 88 percent for the 100 U/kg, 50 U/kg and 2100 U Rhucin doses, respectively, were observed compared with 41 percent in the placebo group
EnVivo Pharmaceuticals Inc., of Watertown, Mass., said results of a Phase IIb study of EVP-6124, an oral nicotinic alpha-7 agonist, showed statistically significant and clinically meaningful effects on both cognition and functional symptoms including global cognitive function, in schizophrenic patients...A Phase IIb study will test the product as a treatment for negative symptoms and cognitive dysfunction in schizophrenia
Anthera Pharmaceuticals Inc., of Hayward, Calif., reported interim biomarker data from the Phase IIb PEARL-SC study in systemic lupus erythematosus, which showed that weekly and monthly subcutaneous doses of blisibimod resulted in statistically significant reductions of B cells...Ceregene Inc., of San Diego, completed enrollment in a Phase IIb trial of CERE-120, a gene therapy product in development for Parkinson's disease
Resverlogix Corp., of Calgary, Alberta, said its Phase IIb SUSTAIN study is fully enrolled with 176 subjects who have established atherosclerotic cardiovascular disease and low high-density cholesterol (HDL-C...Supernus Pharmaceuticals Inc., of Rockville, Md., initiated a Phase IIbclinical trial of its SPN-810 to treat impulsive aggression associated with attention deficit hyperactivity disorder in children ages 6 to 12
ChanRx plans to launch the Phase IIb in early January and complete the study by the end of 2012, according to Brown, adding that the multicenter trial "will have more than enough patients to power it at the appropriate level...acting as co-managers.
By Marie Powers | BioWorld Today | Wednesday, November 23, 2011
IDX184, whose progress has risen and fallen like a roller coaster and remains under a partial clinical hold, will report interim results from a Phase IIb study early next year on the first 30 patients to complete one month of therapy. (See BioWorld Today, Feb. 11, 2011.) "We hope these data will confirm the efficacy and safety of IDX184 and will provide the basis for the release of the partial clinical hold," he said
By Marie Powers | BioWorld Today | Thursday, November 17, 2011
The compound demonstrated preliminary but encouraging single-agent clinical activity in both indications...A Phase IIb/III trial in non-small-cell lung cancer is under way
FibroGen Inc., of San Francisco, reported data from an ongoing Phase IIb dose-finding study of FG-4592, a hypoxia-inducible factor prolyl hydroxylase inhibitor for anemia correction and hemoglobin (Hb) maintenance in patients with Stage III or Stage IV chronic kidney disease who are not on dialysis...Substudy analyses of the company's Phase IIb RADAR trial of lead program REG1 suggested that the anticoagulant system provided nearly complete Factor IXa inhibition with a dose of 1 mg/kg of
It has produced a number of recent clinical trial failures, including GenVec Inc.'s Phase III trial of TNFerade and AmpiMed Corp.'s Phase II trial of Amplimexon (imexon), as well as established cancer blockbusters like Avastin (bevacizumab, Genentech Inc./Roche AG) and Erbitux (cetuxumab, Eli Lilly and Co...NewLink expects to begin a Phase IIb/III trial in NSCLC in the first half of 2012, with the first interim analysis in 2013
By Catherine Shaffer | BioWorld Today | Monday, November 14, 2011
Daily oral dosing in a model of collagen-induced arthritis in mice showed a significant reduction in clinical arthritis score, as well as reduction in inflammation, pannus formation in the joint and damage to cartilage and bone...BioCryst Pharmaceuticals Inc., of Research Triangle Park, N.C., presented new Phase IIb results showing that BCX4208 in patients with gout who have failed to reach serum uric acid level (sUA) of < 6 mg/dL on allopurinol alone met the primary endpoint, defined as the
The second analysis, CGI-I, looked at patients rated as "much improved" or "very much improved" on the Clinical Global Impression – Improvement scale...NephroGenex just completed a Phase IIb trial that studied the safety and efficacy of Pyridorin in a similar patient population
4SC AG, of Planegg-Martinsried, Germany, presented final results from its Phase IIb COMPONENT study that demonstrated substantial anti-inflammatory activity of vidofludimus in rheumatoid arthritis...A Phase IIb trial is expected to begin early next year
Jennerex, Inc., of San Francisco, initiated the Phase IIb TRAVERSE trial evaluating the use of JX-594 to treat patients with advanced liver cancer, also known as hepatocellular carcinoma (HCC), who failed prior therapy with sorafenib (Nexavar), the only approved drug for advanced HCC...Rexahn said the firm plans to evaluate the Serdaxin clinical programs and possible paths forward
15 million, will be used to fund costs associated with ongoing clinical trials and for general corporate purposes and are expected to provide operating capital through the middle of 2013...Catalyst is working on CPP-109 (vigabatrin), which is in Phase IIb testing for cocaine addiction, and Phase I-stage CPP-115, a next-generation GABA-AT inhibitor in development for cocaine addiction and infantile spasms
Anthera Pharmaceuticals Inc., of Hayward, Calif., completed enrollment in its Phase IIb PEARL-SC study...The decision follows reports of laboratory abnormalities and adverse events in a subset of clinical trial participants
Alvine said it is preparing for a Phase IIb trial of the drug, an oral mixture of recombinant gluten-specific proteases cysteine protease and prolyl endopeptidase, to start in 2012...Low hENT1 levels have been correlated to poor clinical outcome with gemcitabine, the standard treatment for many solid tumors
Galderma Pharma SA, of Lausanne, Switzerland, reported top-line results from a Phase IIb trial showing that CD07805/47, a topical gel in development for moderate to severe facial erythema of rosacea, was rapidly effective at reducing facial redness...Inc., of Whitehouse Station, N.J., said results from a 24-week interim analysis of a 48-week Phase IIb study showed that 70.5 percent of patients (43/61) receiving its protease inhibitor Victrelis (boceprevir) in combination with peginterferon alfa and
AMAG Pharmaceuticals Inc., of Lexington, Mass., presented new clinical data for Feraheme (ferumoxytol), which is approved for iron deficiency anemia in chronic kidney disease...Celator Pharmaceuticals Inc., of Princeton, N.J., presented findings from a Phase IIb study of CPX-351 (cytarabine:daunorubicin) liposome injection, which showed a statistically significant benefit in overall survival favoring the drug in first relapse patients with acute myeloid leukemia who had an unfavorable risk profile