Spectrum Pharmaceuticals Inc., of Henderson, Nev., presented clinical data at the recent American Society of Hematology meeting in Atlanta for cancer drug Zevalin (yttrium-90-ibritumomab tiuxetan), including results from a Phase II study showing that Zevalin plus BEAM chemotherapy (carmustine, etoposide, cytarabine and melphalan) prior to autologous stem cell transplantation in refractory non-Hodgkin's diffuse large B-cell lymphoma produced a two-year overall survival rate of 65 percent and a
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.
By Marie Powers | BioWorld Today | Friday, December 14, 2012
Data demonstrated that patients with established atrial fibrillation (AF) receiving Gencaro in the trial had improvements in heart failure clinical endpoints, and those receiving Gencaro were more likely to achieve ventricular rate control
The company plans to use proceeds to expand clinical development of its dismutase mimetics, small-molecule mimics of critical enzymes in the oxygen metabolic pathways designed to overcome limitations of prior approaches to controlling superoxide and its harmful roles in human disease
RedHill Biopharma Ltd., of Tel Aviv, Israel, said it completed a private placement of approximately $6.5 million, which will be used to advance the company's late clinical-stage programs...It also plans to start a Phase IIa trial with RHB-104 for the treatment of multiple sclerosis in January 2013.
By Catherine Shaffer | BioWorld Today | Friday, December 7, 2012
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
The Series D enables Zafgen to move clinical and regulatory activities forward without the distraction of additional fundraising, Hurwitz added...Proceeds will support a Phase III trial of Multikine (leukocyte interleukin, injection).
By Marie Powers | BioWorld Today | Wednesday, December 5, 2012
Because of the nature of the registry and vision testing variability, the company said, a clear comparison could not be drawn between registry data and clinical trial results
Net proceeds are expected to total about $44.7 million – or $51.5 million if underwriters exercise in full their overallotment option for 900,000 additional shares – and will be used for commercial launch activities and continued clinical development of the firm's pipeline of extended-release drugs
FDA Seeks Comments on Cellular, Gene Therapy The FDA made available a draft document relating to preclinical assessment of cellular and gene therapy products providing guidance on the substance and scope of information needed to support clinical trials...The brief was filed in connection with an antitrust action against Warner Chilcott, alleging that Warner Chilcott maintained a monopoly for its antibacterial drug Doryx by reformulating the drug three times.
By Staff Reports | BioWorld Today | Monday, December 3, 2012
delafloxacin showed an 88 percent clinical response rate dosed at 300 mg twice daily, compared to 82 percent for Tygacil (tigecyline, Pfizer Inc...A separate Phase II trial in community-acquired pneumonia showed an 87 percent clinical response rate at 200-mg and 400-mg doses of oral delafloxacin...Shares of Rexahn (NYSE:RNN) fell 14 cents, or 30.3 percent, to close Thursday at 33 cents.
By Catherine Shaffer | BioWorld Today | Friday, November 30, 2012
AiCuris GmbH, of Wuppertal, Germany, said it started the second clinical efficacy trial testing pritelivir (AIC316), its herpes simplex virus (HSV) drug, after data from the first study showed a high degree of efficacy against genital herpes...A Phase Ib study of ProHema achieved its primary objective of demonstrating safety and tolerability and established early clinical proof of concept, including trends of accelerated neutrophil recovery, improved 100-day survival and low rates of graft-vs.-host
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
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
Using Electronic Data in Clinical Trials The FDA also is requesting comments on a revised draft guidance on the use of electronic source data in clinical trials...The document is designed to help sponsors, contract research organizations, data management centers, clinical investigators and others involved in capturing, reviewing and archiving electronic source data in FDA-regulated clinical trials to ensure the reliability, quality, integrity and traceability of the data
By Staff Reports | BioWorld Today | Tuesday, November 20, 2012
The Patient-Centered Outcomes Research Institute (PCORI) will award $12 million in funding through 14 contracts for studies addressing knowledge gaps in comparative clinical effectiveness research
Trial data showed clinical benefit, defined as partial response and stable disease of more than four months following up to eight cycles of treatment, at the maximum tolerated dose in 10 of 13 evaluable patients
Bayer Inc., of Deerfield, Ill., and the Population Health Research Institute said they started the COMPASS trial, the largest clinical study to date of oral anticoagulant rivaroxaban
The primary endpoint of the study is clinical benefit of AEZS-108...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...Based on outcomes for safety and tolerability, and measures of absorption, distribution, metabolism and excretion, Path will proceed to the next Phase of clinical trials in 2013
The Phase III study met its primary endpoint and demonstrated statistically significant protection against clinical and severe malaria in infants...In the trial, infants (ages 6-12 weeks at first vaccination) receiving the RTS,S vaccine candidate experienced one-third fewer episodes of both clinical and severe malaria and experienced similar reactions to the injection when compared to those who received the control meningococcal C conjugate vaccine
Spectrum Pharmaceuticals Inc., of Henderson, Nev., presented clinical data at the recent American Society of Hematology meeting in Atlanta for cancer drug Zevalin (yttrium-90-ibritumomab tiuxetan), including results from a Phase II study showing that Zevalin plus BEAM chemotherapy (carmustine, etoposide, cytarabine and melphalan) prior to autologous stem cell transplantation in refractory non-Hodgkin's diffuse large B-cell lymphoma produced a two-year overall survival rate of 65 percent and a