Calistoga Pharmaceuticals Inc., of Seattle, said it has initiated a Phase I clinical trial of CAL-101, an orally available small molecule that inhibits an important intracellular signaling component known as phosphoinositide-3 kinase (PI3K) delta...The primary endpoint is time to last unformed stool, and secondary endpoints include clinical cure based on relief of symptoms and microbiological eradication rates...UCB Pharma Canada Inc., of Burlington, Ontario, said early data from a Phase IIIb study of

LifeCycle Pharma A/S, of Horsholm, Denmark, announced positive top-line results from a Phase II clinical trial for LCP-Tacro in stable kidney transplant patients...NicOx SA, of Sophia Antipolis, France, has begun two large clinical pharmacology studies in the U.S

The study also will measure the effect of Soliris on other clinical manifestations of PNH, including blood transfusion requirements, thromboses and kidney function...market in February 2005, only a few months after gaining approval for multiple sclerosis, and ongoing trials in MS and CD were halted after two patients contracted progressive multifocal leukoencephalopathy, a potentially fatal brain infection...GTC's partner LEO Pharma A/S, of Ballerup, Denmark, has begun launching the product in Europe

LifeCycle Pharma A/S, of Horsholm, Denmark, said results from a Phase I head-to-head clinical trial comparing LCP-Tacro, its lead product candidate being developed as a once-daily tablet version of tacrolimus, showed that LCP-Tacro proved superior to Advagraf (tacrolimus prolonged release, Astellas Pharma Inc

Biopure expects to move on several fronts, emphasizing clinical development in Europe...Three Phase II clinical trials are proposed and being designed for 2008: one in heart attack patients, one to address anemia in chemotherapy patients instead of, or in addition to, erythropoietin-stimulating agents, and one to investigate possible improvement of quality of life in the terminally ill...MGI Pharma Inc., of Minneapolis, and its partner Helsinn Healthcare SA, of Lugano, Switzerland, presented results

DOR BioPharma Inc., of Miami, said a clinical review of orBec (oral beclomethasone dipropionate) in gastrointestinal graft-vs.-host disease, published in the Expert Review of Clinical Immunology, concluded that orBec fulfills a critical need in the allogeneic hematopoietic cell transplantation populations in mild to moderate GI GVHD...Syngis Pharma, of Heidelberg, Germany, said an analysis of results from its 44-patient Phase IIa study of AX200 in acute ischemic stroke showed the drug was safe and

Avigen Inc., of Alameda, Calif., initiated a Phase II trial of AV650 (tolperisone HCl) in the treatment of spasticity associated with multiple sclerosis...Zealand Pharma A/S, of Copenhagen, Denmark, said it is advancing ZP1846 into Phase I trials in the U.S. ZP1846, a peptide that incorporates Zealand's SIP technology, is being developed as a therapy for the prevention and treatment of chemotherapy-induced diarrhea

Akela Pharma Inc., of Montreal, reported positive results from the extension part of its 50-patient Phase IIb trial of Fentanyl Taifun, which showed statistically significant differences compared to placebo in the measured primary and secondary efficacy variables, resulting in faster and superior pain relief...LifeCycle Pharma A/S, of Horsholm, Denmark, started a head-to-head study of LCP-Tacro, its once-daily tacrolimus tablet, vs. Advagraf (tacrolimus prolonged release, Astellas Pharma Inc.) in

has the resources to begin moving forward with the pipeline of marketed and clinical-stage urea cycle disorder treatments it licensed last month...The first asset Rivera and team identified was a suite of products from Ucyclyd Pharma Inc., a subsidiary of Scottsdale, Ariz.-based Medicis Pharmaceutical Corp...The funding is earmarked specifically for the identification of new, selective potassium channel modulators for multiple sclerosis, and Wellcome retains the option to fund preclinical and clinical

BioLineRx Ltd., of Jerusalem, completed a study determining the clinical binding properties of BL-1020 to the dopamine receptors in the human brain...The trial has received a $5 million grant from the National Multiple Sclerosis Society in partnership with the National MS Society's Southern California chapter, with support from the National Institutes of Health...Trion Pharma GmbH, of Munich, Germany, and Fresenius Group, of Bad Homburg, Germany, said further secondary endpoint data from a Phase II

Advanced Viral Research Corp., of Yonkers, N.Y., said Health Canada's Therapeutic Products Division approved a clinical trial application to start studies of AVR118 in patients with histologically confirmed malignancies who present with clinically demonstrable anorexia or anorexia-cachexia syndrome...Inflazyme Pharmaceuticals Ltd., of Vancouver, British Columbia, said a review of study reports for IPL455,903, a PDE4 inhibitor, showed that data might support further clinical studies, as well as

Antisense Pharma GmbH, of Regensburg, Germany, said data from a Phase IIb trial in anaplastic astrocytoma showed its AP 12009 as a monotherapy was superior to temozolomide...LifeCycle Pharma, of Horsholm, Denmark, will initiate a Phase II clinical trial of LCP-Tacro for the prevention of organ rejection in kidney transplant patients following an update of its initial investigational new drug application to the FDA

pivotal Phase III trial of MBP8298, a synthetic peptide for the treatment of multiple sclerosis...NovaDel Pharma Inc., of Flemington, N.J., said data from two clinical studies comparing zolpidem oral spray with zolpidem tablets (Ambien, Sanofi-aventis Group) support a new drug application filing this year under the 505(b)(2) regulatory process

Intarcia has conducted two Phase II clinical trials with an injectible formulation of omega interferon, both as a monotherapy and in combination with ribavirin...In prostate cancer, Bayer Schering Pharma AG markets the FDA-approved, CMS-reimbursed Viadur (leuprolide acetate implant...Last week, Memory started a Phase IIa clinical trial of MEM 3454 in Alzheimer's disease

7TM Pharma A/S, of Horsholm, Denmark, began a Phase I/II trial of TM30339, an obesity agent derived from the company's discovery program on Y4 receptor selective agonists...The primary clinical endpoint is the cumulative number of new gadolinium-enhancing lesions, a marker of MS disease activity...Secondary objectives include additional MRI measurements, analysis of clinical relapses, measures of neurologic disability, immunologic evaluations and safety

of Tarrytown, N.Y., announced today that Novartis Pharma AG, of Basel, Switzerland, and its development partner Nordic Bioscience, of Herlev, Denmark, have initiated a Phase III trial of an oral form of salmon calcitonin, a new drug candidate that uses Emisphere's eligen-delivery technology to treat osteoporosis...In 2000, Emisphere and Novartis Pharma entered into a license agreement for the development of oral salmon calcitonin...The clinical trial is being conducted by Nordic Bioscience following a

The biopharmaceutical company plans to use the money for general business purposes, such as funding studies of its six clinical compounds for asthma, multiple sclerosis, status asthmaticus, interstitial cystitis, solid tumors, generalized anxiety disorder, preterm labor, urinary incontinence and thrombotic disorders

Data were presented at the American Society of Clinical Oncology 2007 Gastrointestinal Cancers Symposium held in Orlando, Fla...Droxidopa, on the market since 1989 in Japan, was licensed from Dainippon Sumitomo Pharma Co...Data were presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in Orlando, Fla

The hypercholesterolemia product will be the subject of Alnylam's second clinical development program...Funds will support clinical and preclinical work, discovery and general corporate purposes. (See BioWorld Today, Dec. 11, 2006...Tom Rolfs, of Red Top Capital and Carl Spalding.