Canyon Pharmaceuticals Inc., of Parsippany, N.J., said results from its open-label, single-arm study, dubbed DESIR-ABLE, showed that desirudin (Revasc, Iprivask) demonstrated clinical utility and safety for the prevention of dangerous blood clots in a broad population of surgical and medically ill patients...Results were published in Clinical and Applied Thrombosis and Hemostasis

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

Acorda Therapeutics Inc., of Ardsley, N.Y., reported safety data from more than 62,400 people with multiple sclerosis (MS) taking Ampyra (dalfampridine) extended-release tablets during the first two years of availability in the U.S., with results showing a similar safety profile as observed in clinical trials...Alexion Pharmaceuticals Inc., of Cheshire, Conn., said researchers presented data from an open-label Phase II study in 14 patients with severe, relapsing neuromyelitis optica (NMO), showing

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

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

Data were published in the Journal of Allergy and Clinical Immunology...Neuralstem Inc., of Rockville, Md., gained the go-ahead to start a clinical trial in motor deficits due to ischemic stroke with its spinal cord stem cells (NSI-566) at BaYi Brain Hospital in Beijing, through its subsidiary, Neuralstem China (Suzhou Neuralstem Biopharmaceutical Co. Ltd...The study evaluated Microcyn-based Atrapro antipruritic hydrogel in reducing the itch and clinical signs of atopic dermatitis when applied to

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.

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

The results were published online in the Journal of Clinical Oncology in September 2012...Cellceutix Corp., of Beverly, Mass., said that it expects to start clinical trials with its anti-cancer drug Kevetrin in about three weeks at Harvard Cancer Center's Dana-Farber Cancer Institute and the Beth Israel Deaconess Medical Center...Topotarget A/S, of Copenhagen, Denmark, reported preliminary clinical results for a trial of belinostat for relapsed and refractory peripheral T-cell lymphoma

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.)

The study is the first of two identical trials, and the endpoints of both will include vitamin D status, adverse events, physical and clinical laboratory assessments and changes in serum calcium, serum phosphorous and plasma intact parathyroid hormone

Imprimis Pharmaceuticals Inc., of Solana Beach, Calif., said it started a clinical trial testing Impracor, a topical cream designed to deliver ketoprofen

The findings were published in the Journal of Clinical Oncology

KG, which will enable it to take forward two mRNA-based therapeutic cancer vaccines, in clinical development for prostate cancer and non-small-cell lung cancer (NSCLC...The investment comes in the wake of positive clinical data from early stage trials of both CV9103 and NSCLC vaccine CV9201...The financing adds to more than $4 million in nondilutive funding the company has received from Small Business Innovation Research and other grants.