The clinical development program will include the treatment of hospital- and community-acquired Gram-positive infections...Enobia Pharma Inc., of Montreal, said preclinical data demonstrated that its enzyme replacement therapy (ERT) for hypophosphatasia appeared to heal bones that have been severely weakened by the disease...Sinovac Biotech Ltd., of Beijing, China, has begun clinical trials in Ukraine for its inactivated hepatitis A vaccine, Healive

Axentis Pharma AG, of Zurich, Switzerland, has initiated a Phase IIa trial to assess the safety and tolerability of a new therapeutic formulation for the treatment of severe pulmonary infection in cystic fibrosis patients...No evidence of clinical efficacy, a secondary objective, was observed in psoriasis patients with the doses and duration of administration tested...Human Genome Sciences Inc., of Rockville, Md., reported initial topline results from an ongoing randomized, multicenter, open-label

7TM Pharma, of Hørsholm, Denmark, has initiated a Phase I/IIa trial with the drug candidate TM30339 for treatment of obesity and related metabolic disorders...The trial is a single arm, two-stage, open-label study of Reolysin given intravenously with paclitaxel and carboplatin every three weeks...Each of those Phase III clinical trials met their primary endpoint

The company received FDA and Health Canada approval for the clinical trial earlier this year...The Phase II trial will be an international, multicenter, randomized, controlled, open-label study assessing the efficacy and safety of CTCE-9908 that will include up to 132 patients with liver cancer

Enobia Pharma Inc., of Montreal, said it dosed the first patient in its clinical program testing its enzyme replacement therapy with ENB-0040 in hypophosphatasia, a rare, genetic bone disorder...The first is examining one month of ENB-0040 dosing in adults, while the second trial will involve a six-month, open-label study in infants

The open-label, multidose, dose-escalation Phase I trial is expected to enroll up to 46 patients with selected advanced or recurrent solid tumors...The four clinical trials represent the basis for Xanodyne's planned filing of a new drug application with the FDA

The written response letter, received last week, addressed preclinical, manufacturing, microbiologic, immunologic and clinical questions concerning Lovaxin C and its therapeutic use in CIN and cervical cancer caused by the sexually transmitted human papilloma virus, the company said...Nutra Pharma Corp., of Boca Raton, Fla., said its wholly owned subsidiary, ReceptoPharm Inc., successfully completed the Phase IIb/IIIa trial of RPI-78M, in adrenomyeloneuropathy, a rare, inherited metabolic disorder

Hyperion Therapeutics Inc., of South San Francisco, said it has completed patient enrollment in its Phase I/II clinical trial to evaluate the safety, tolerability and ammonia scavenging effects of HPN-100 (formally called GT4P) vs. Buphenyl (sodium phenylbutyrate), co-marketed by Hyperion and Ucyclyd Pharma Inc., of Scottsdale, Ariz., in patients with urea cycle disorders...A Phase II clinical trial is now under way for JX-594 in liver cancer...Living Cell Technologies Ltd., of Auburn, Australia

This open label trial will explore the safety and clinical activity of CAL-101 in patients with chronic lymphocytic leukemia, selected B-cell non-Hodgkin lymphoma and acute myeloid leukemia

These open-label, randomized Phase III trials include two trials in non-dialysis patients (PEARL 1 and 2) and two trials in patients on dialysis (EMERALD 1 and 2...AM-Pharma BV, of Bunnik, Netherlands, announced the start of a second double-blind, placebo-controlled Phase II trial of bovine-derived alkaline phosphatase to treat acute renal failure

Agennix Inc., of Houston, said the final results from an open-label, single-arm Phase II monotherapy trial with talactoferrin alfa, a novel dendritic cell recruiter and activator, in patients who had failed previous treatment for advanced or metastatic renal cell carcinoma (RCC) were published in the July 1 issue of Cancer...SCOLR Pharma Inc., of Bellevue, Wash., said it initiated the third of three pivotal trials to evaluate the safety and efficacy of its formulation of 12-hour extended-release

The results confirmed previous clinical findings that DG041 inhibits platelet aggregation without increasing bleeding time as monotherapy, and demonstrated that in combination with clopidogrel alone, as well as with clopidogrel and aspirin, DG041 provided additional antiplatelet effect without prolonging bleeding time...EUSA Pharma, of Oxford, UK, said new data show that use of Caphosol, an advanced oral electrolyte solution, resulted in both favorable impact on rates and severity of oral mucositis

AP Pharma Inc., of Redwood City, Calif., completed enrollment in a Phase III trial comparing APF530 (sustained-release granisetron) to Aloxi (palonosetron hydrochloride, Eisai Co. Ltd.) in chemotherapy-induced nausea and vomiting...In the randomized, open-label, placebo-controlled trial, 15 to 25 patients will receive MN-221 at doses of up to 1,125 mcg or placebo in a continuous intravenous infusion for up to two hours...Tranzyme Pharma Inc., of Durham, N.C., announced positive results from its QT/QTc

Genzyme Corp., of Cambridge, Mass., said a preliminary analysis of data from an ongoing open-label Phase II trial of its investigational oral therapy Genz-112638 showed it produced a meaningful impact on key clinical manifestations of Gaucher disease...LifeCycle Pharma A/S, of Hørsholm, Denmark, announced positive results from its Phase II clinical program with LCP-AtorFen, a fixed-dose combination product of atorvastatin (the active ingredient of Lipitor from Pfizer) and fenofibrate for the

Roxro Pharma Inc., of Menlo Park, Calif., announced positive top-line data from the placebo-controlled proof-of-concept study evaluating the efficacy and safety of ROX-828, an intranasal formulation of the nonsteroidal anti-inflammatory pain reliever ketorolac, in the treatment of migraine and related symptoms...Titan Pharmaceuticals Inc., of South San Francisco, said four-year follow-up data from an open-label pilot study of Spheramine, a cell therapy product in development with Leverkusen

EyeGate Pharma, of Waltham, Mass., has begun a Phase I clinical study to assess the safety and tolerability of the noninvasive EyeGate II Ocular Drug Delivery System in up to 95 healthy adult volunteers...The first component of the trial is an open-label, dose-escalating, nonrandomized study of reolysin given intravenously with paclitaxel and carboplatin every three weeks

The open-label study overenrolled a total of 29 patients, the company said, adding that the patients will be treated with Soliris at clinical sites throughout Japan for 12 weeks...IDM Pharma Inc., of Irvine, Calif., said it has initiated enrollment in a clinical protocol finalized with the FDA for mifamurtide (L-MTP-PE

The 35-patient, open-label, dose-escalation study will assess safety and tolerability as well as clinical measures such as urine flow rate, sodium excretion rate and plasma cGMP levels...RFS Pharma LLC, of Atlanta, said the combination of Amdoxovir (DAPD) and Retrovir (zidovudine, GlaxoSmithKline plc) produced a synergistic decline in viral load in a Phase II trial

Akela Pharma Inc., of Montreal, said that, due to GLP deviations, the six-month inhalation preclinical toxicology studies for Fentanyl Taifun were deemed invalid by the FDA...The trial was an open-label, six-week study designed to determine the safety and maximum tolerated dose of BL-1020 in schizophrenic patients