Acceleron Pharma Inc., of Cambridge, Mass., reported preliminary results from the ACE-031 Phase I single dose trial demonstrating that ACE-031 increased lean body mass and muscle volume...The open-label, multiple-dose study will examine the safety and effectiveness of TAK-700 in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer

BHR Pharma, of Herndon, Va., will initiate a global, Phase III, multicenter pivotal trial to evaluate the effectiveness of its BHR-100 intravenous progesterone infusion product as a neuroprotective agent for treating severe traumatic brain injury patients in early 2010...The primary objective of the multicenter, open-label study is to assess the overall tumor response to the regimen of bavituximab in combination with carboplatin/paclitaxel

Patients enrolled in the open-label, single-arm study will receive 200 mg of R788 twice a day and will be monitored to measure a variety of clinical responses as well as drug safety

BioCis Pharma Ltd., of Turku, Finland, said it started Phase I testing of ProtoCure intravesical instillation solution, a drug aimed at treating urinary bladder cancer...The open-label study will evaluate the locally administered drug in 22 patients with primary or recurrent nonmuscle invasive bladder cancer

Amarillo Biosciences Inc., of Amarillo, Tex., has selected Accelovance Inc., a clinical research organization based in Rockville, Md., to conduct a human clinical study of the company's oral interferon product during the upcoming 2009-2010 influenza season in the U.S. The new Phase II trial will be a follow-up to the ongoing study at the University of Western Australia, which is already under way...Sucampo Pharmaceuticals Inc., of Bethesda, Md., a unit of Sucampo Pharma Ltd., has begun enrollment

Antares Pharma Inc., of Ewing, N.J., and the Population Council announced preliminary positive results from the Phase II trial for a contraceptive gel containing the progestin Nestorone and the bio-identical estrogen estradiol (NES/E2) using the Antares advanced transdermal delivery gel system...The trial is a dose-finding, open-label, crossover study to evaluate the effect of NES/E2 transdermal gel delivery on ovulation suppression in normal ovulating women

Evoke Pharma Inc., of San Diego, said it started a Phase IIb trial of EVK-001 in adults with symptoms of diabetic gastroparesis...Novagali Pharma SA, of Evry, France, said that the FDA has cleared the company's investigational new drug application to proceed with a Phase III trial of Catioprost (Nova21027), for the treatment of glaucoma...Tranzyme Pharma Inc., of Research Triangle Park, N.C., said it started dosing in a Phase II study of TZP-102, a selective, second-generation oral ghrelin agonist, in

The trial was an open label, first-in-man, multicenter, single escalating dose study, and the primary safety endpoint was achieved and the drug was well tolerated by all subjects at all doses tested...Tranzyme Pharma Inc., of Research Triangle Park, N.C., said that it plans to present its successful Phase II study results of ghrelin agonist TZP-101 for the management of postoperative ileus (POI) at the upcoming 2009 Annual Meeting of the American Society of Colon and Rectal Surgeons in Hollywood

Antisense Pharma GmbH, of Regensburg, Germany, has enrolled the first patients with recurrent or refractory anaplastic astrocytoma in a pivotal Phase III trial called SAPPHIRE, a randomized, active-controlled study designed to confirm the efficacy and safety of trabedersen (AP 12009) as a monotherapy compared to current standard therapy with temozolomide (alternatively BCNU...The primary objective of the multicenter, open-label study is the overall response rate

He called the drug the "most desirable HCV polymerase inhibitor in the clinic" - given the recent acquisition of ViroChem Pharma Inc...The randomized, double-blind, placebo-controlled, 299-patient study showed that rifaximin reduced the risk of clinical HE breakthrough episodes by 58 percent during the six-month dosing period (p < 0.0001...IDX316, a preclinical protease inhibitor, showed potent activity without cytotoxicity in vitro and bioavailability in animals supportive of once- or twice-daily

The open-label, dose-escalation study will evaluate safety, tolerability and maximum tolerated dose, and is expected to conclude in the fourth quarter...Zosano Pharma Inc., of Fremont, Calif., presented positive results from its Phase II study of the ZP-PTH rapid delivery patch for the treatment of osteoporosis

Acacia Pharma, of Cambridge, UK, has started a Phase IIa study of APD209 to treat cachexia in cancer patients...The multicenter, open-label, dose-escalation study will explore the safety, tolerability, pharmacokinetics and radiologic assessment of intravenous administration of PEGPH20 as a single agent with repeat dosing

Enobia Pharma Inc., of Montreal, completed enrollment in its pilot trial in infants suffering from a severe form of hypophosphatasia...The trial is an open-label, six-month study evaluating safety, efficacy and pharmacokinetics of subcutaneous ENB-0040 in hypophosphatasia infants with severe rickets and respiratory compromise...EyeGate Pharma Inc., of Waltham, Mass., completed follow-up visits for all patients in its Phase II trial of EGP-437 (dexamethasone phosphate) for dry eye

One open-label Phase Ib trial will enroll up to 42 patients with locally advanced or metastatic solid tumors to evaluate the safety and efficacy of multiple doses of PTC299 alone and in combination with Taxotere (docetaxel) chemotherapy...Sucampo Pharma Ltd., of Japan, a wholly-owned subsidiary of Sucampo Pharmaceuticals Inc., of Bethesda, Md., said it initiated dosing in a first-in-human Phase I study of a prostone, SPL-017, as a potential treatment for peripheral arterial disease

The feasibility study is a prospective, open label, multicenter trial being performed in Germany...EyeGate Pharma, of Waltham, Mass., enrolled the first dry eye patient in a Phase II safety and efficacy study of EGP-437...Other data from preclinical and clinical studies demonstrated that HIF-PHI compounds are orally active, which also sets them apart from ESAs, which must be administered by injection

The trial is an open-label, dose-escalating pharmacokinetic, pharmacodynamic, efficacy and safety study of CTA018 Injection in CKD patients with SHPT undergoing hemodialysis...Mpex Pharmaceuticals Inc., of San Diego, presented clinical and preclinical data on MP-376, its aerosol formulation of levofloxacin for cystic fibrosis and chronic obstructive pulmonary disease

The open-label, two-treatment, two-period, randomized, crossover study will compare MetControl and immediate-release Metformin tablets in healthy volunteers...Tranzyme Pharma, of Research Triangle Park, N.C., announced positive proof-of-concept study results in cancer cachexia with its novel ghrelin agonist, TZP-101

The study was conducted by Novartis Pharma AG, of Basel, Switzerland, and Nordic Bioscience A/S, of Herlev, Denmark, and results were published in the Sept...Nile Therapeutics Inc., of San Francisco, said interim data from is multicenter, open-label Phase IIa study of CD-NP, a novel chimeric natriuretic peptide, in acute heart failure patients, showed that the compound elicited favorable hemodynamic effects with minimal changes in blood pressure relative to baseline, and no significant blood

GL1001, the first clinical-stage inhibitor of the ACE2 enzyme, was administered previously in a Phase I single ascending-dose clinical study completed in the UK, where it was well tolerated and exhibited favorable pharmacokinetics consistent with once-daily dosing...Tranzyme Pharma, of Research Triangle Park, N.C., announced positive Phase IIb results for its ghrelin agonist TZP-101 for the management of postoperative ileus (POI