Janssen Research & Development LLC, of Spring House, Pa., a unit of Johnson & Johnson, said a Phase IIb study testing Stelara (ustekinumab) in moderate to severe Crohn's disease showed that, among patients who had previously failed or were intolerant to at least one tumor necrosis factor antagonist, a significantly greater proportion receiving intravenous Stelara achieved the primary endpoint of clinical response at week six, defined as a 100-point reduction in Crohn's Disease Activity Index
The study showed that the drug was safe and well tolerated at all dose levels, and that more patients in the higher-dose cohorts showed improvement in their clinical disease activity index than patients in the lower-dose or placebo cohorts
The investors were very enthusiastic about the results from the Phase I/II clinical trial...APIM Therapeutics A/S, of Trondheim, Norway, closed a financing round to fund ATX-101, its lead compound, toward clinical trials...Proceeds would be used for R&D activities, clinical trials, investment in capital equipment and for working capital and other general corporate purposes
By Catherine Shaffer | BioWorld Today | Thursday, October 18, 2012
Biogen Idec Inc., of Weston, Mass., reported data from studies testing oral BG-12 (dimethyl fumarate) at the European Committee for the Treatment and Research of Multiple Sclerosis meeting in Lyon, France, supporting clinical and radiological effects of the drug in people with relapsing-remitting multiple sclerosis (MS
StemCells Inc., of Newark, Calif., said two papers reporting clinical and preclinical data demonstrating the therapeutic potential of the company's HuCNS-SC cells (purified human neural stem cells) for a range of myelination disorders were published in the Oct. 10, 2012, edition of Science Translational Medicine
Intercept estimated that remaining clinical development for OCA for PBC will take about $40 million, and that the current offering, plus $29.8 million from its recent Series C financing, plus its cash will be enough to put it over the top. (See BioWorld Today, Sept. 6, 2012.) That clinical development includes completion of the POISE trial and initiation of its long-term safety extension, initiation of a Phase III outcomes trial, carcinogenicity studies in animals, a Phase I safety trial in
By Catherine Shaffer | BioWorld Today | Friday, October 12, 2012
Guinea pigs showed a 45 percent reduction in duration, and a 55 percent reduction in severity, of clinical symptoms...A clinical program is slated to start next year, and GEN-004 "potentially can be taken in directions that cover new diseases," since the bug that causes pneumonia is responsible for other illnesses as well...LoneStar Heart Inc., of San Francisco, completed a milestone-based equity financing worth up to $20 million to support the clinical testing and regulatory clearance of its lead
By Randy Osborne | BioWorld Today | Thursday, October 11, 2012
Repros Therapeutics Inc., of The Woodlands, Texas, said the FDA agreed to a reclassification of the full clinical hold on further oral Proellex studies to a partial clinical hold to allow the firm to conduct a Phase II study of low-dose oral progesterone receptor blocker in endometriosis...The company said data generated from that 30-patient study should allow the remaining partial clinical hold to be lifted
KaloBios has three mAbs at the clinical development stage...Shares of Cell Therapeutics (NASDAQ:CTIC) dropped 51 cents, or 25 percent, to close Friday at $1.53.
By Marie Powers | BioWorld Today | Monday, October 8, 2012
Additional results from the PHOENIX-2 study showed that high levels of clinical responses were achieved and maintained with up to five years of ustekinumab treatment
The company said those findings supported the general safety of routine vaccine with HPV4 in a clinical care setting to prevent cervical and other genital and reproductive cancers
The trial will have two stages: The first stage will treat patients with escalating doses of SGI-100 and carboplatin to identify the maximum-tolerated dose and preliminary biological and clinical activity, while the second stage will randomize patients to receive SGI-100 plus carboplatin or one of three treatments of choice as determined by the clinical investigator – toptecan, pegylated liposomal doxorubicin or paclitaxel...Merrimack Pharmaceuticals Inc., of Cambridge, Mass., said Phase I data
By partnering with those organizations, which already see large populations of patients, NIH said it will be able to conduct large-scale and more cost-effective clinical research...As part of the collaboratory, eight awards are being funded, including seven pragmatic clinical trial demonstration products...Titled "Acute Bacterial Otitis Media: Developing Drugs for Treatment," the guidance addresses the agency's current thinking regarding the overall development program and clinical trial designs for
By Staff Reports | BioWorld Today | Tuesday, October 2, 2012
The company plans to use proceeds to fund continued clinical development of lead product candidate, obeticholic acid in primary biliary cirrhosis, including its Phase III POISE trial and work toward its anticipated regulatory filings
Clinical trials now represent an aggregate expense of approximately $31.3 billion, or nearly 40 percent of the R&D budget of major drug developers – much of that due to systemic inefficiency, according to the report...to analyze trial cost data and identify factors that delay or derail clinical studies...362, has been introduced in the Senate.
By Marie Powers | BioWorld Today | Thursday, September 27, 2012
Vertex Pharmaceuticals Inc., of Cambridge, Mass., and collaborator Alios BioPharma Inc., of South San Francisco, reported results from a viral kinetic study of adenosine nucleotide analogue prodrug ALS-2158 in hepatitis C, with data showing that seven days of dosing with up to 900 mg of the drug was well tolerated in people with genotype 1 chronic hepatitis C virus (HCV), but there was insufficient antiviral activity to warrant proceeding with further clinical development
Actinium Pharmaceuticals Inc., of New York, said it intends to raise up to $20 million in new funds to be used for further clinical development of immunotherapeutic candidates Actimab-A and lomab-B in hematologic malignancies and for continued preclinical development of additional drug candidates in solid cancer indications, as well as for general corporate purposes
ViroPharma Inc., of Exton, Pa., and Halozyme Therapeutics Inc., of San Diego, said the FDA provided guidance enabling ViroPharma to resume clinical trials testing the subcutaneous administration of hereditary angioedema drug Cinryze (C1 esterase inhibitor [human]) in combination with Halozyme's recombinant human hyaluronidase (rHuPH20...The FDA said, based upon its ongoing assessment, that it believes the potential safety signals regarding antibodies to rHuPH20 that were detected in the clinical
The network will consist of pediatric research consortia that receive awards to support basic, clinical, behavioral or translational research to meet unmet needs and to train researchers...FDASIA requires the inclusion of patient representatives in the drug development and review process. (See BioWorld Today, May 21, 2012.)
By Catherine Shaffer | BioWorld Today | Monday, September 24, 2012
Proceeds will be used to fund ACT's clinical activities, including its three ongoing Phase I/II trials for forms of macular degeneration, for development of its other clinical activities and for general corporate purposes
Janssen Research & Development LLC, of Spring House, Pa., a unit of Johnson & Johnson, said a Phase IIb study testing Stelara (ustekinumab) in moderate to severe Crohn's disease showed that, among patients who had previously failed or were intolerant to at least one tumor necrosis factor antagonist, a significantly greater proportion receiving intravenous Stelara achieved the primary endpoint of clinical response at week six, defined as a 100-point reduction in Crohn's Disease Activity Index