Hadasit Bio-Holdings Ltd., of Jerusalem, said portfolio company Enlivex completed a 13-patient clinical trial of cellular treatment ApoCell for graft-vs.-host disease (GvHD), with results indicating efficacy and safety in recipients of bone marrow transplants from foreign donors...The primary endpoint of the 33-patient study is to determine the clinical benefit rate, while secondary objectives include progression-free survival and safety and tolerability

The funds were raised from accredited investors and will be used to advance multiple clinical development programs

Derma Sciences Inc., of Princeton, N.J., said it plans to begin its Phase III program in December for DSC127, a clinical formulation of NorLeu3-A(1,7), in diabetic foot ulcers, to support the filing of a new drug application

Investigators said 47 percent of patients receiving Simponi 50 mg and 51 percent of patients receiving Simponi 100 mg maintained clinical response through week 54 compared with 31 percent of patients on placebo (p = 0.01 and p < 0.001, respectively...Investigators will report clinical response, clinical remission and mucosal healing results through one year at the American College of Gastroenterology meeting in Las Vegas

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

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

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