Idera Pharmaceuticals Inc., of Cambridge, Mass., reported that IMO-3100 was well tolerated at all dose levels evaluated in the 30 healthy subjects that received IMO-3100 in a single-dose, dose-escalation Phase I clinical trial, and that target engagement of TLR7 and TLR9 was observed through inhibition of TLR7- and TLR9-mediated immune responses...Protalex Inc., of Summit, N.J., said dose escalation and treatment for the first patients has started in the second cohort of its ongoing South African

Hybrigenics plans to proceed to a clinical efficacy Phase IIb study in the same therapeutic indication...ProNAi Therapeutics Inc., of Kalamazoo, Mich., said the first patient has been dosed in an open-label, single-arm Phase I dose-escalation study assessing the safety and tolerability of its PNT2258 in patients with advanced solid tumors, a disease for which no standard therapy exists...Sanofi and its partner, Zealand Pharma AS, of Copenhagen, Denmark, had reported top-line results in April

Ascendis Pharma A/S, of Copenhagen, Denmark, initiated a Phase II European trial of ACP-001, its once-weekly human growth hormone prodrug...The Phase I dose-escalation study will assess safety and immunogenicity associated with an IM formulation of LigoCyte's investigational vaccine in healthy adults...Clinical studies to date have shown a nasal formulation of a monovalent norovirus VLP vaccine to be immunogenic, having the ability to create an immune response, for example, and it is generally well

Action Pharma AS, of Aarhus, Denmark, has obtained positive safety, tolerability and efficacy results in the second Phase II trial (CS005) with its leading development candidate, AP214...Forward Pharma AS, of Copenhagen, through its wholly owned subsidiary Forward Pharma GmbH, of Leipzig, Germany, said that it has initiated its first Phase II trial investigating efficacy and safety of different doses and regimens of of FP187 in moderate to severe plaque psoriasis

Agensys Inc., of Santa Monica, Calif., an affiliate of Tokyo-based Astellas Pharma Inc., initiated a single-agent, open-label, dose-escalation Phase I trial to evaluate the safety and tolerability of AGS-16M8F, an antibody-drug conjugate, in patients with renal cancer and identify the maximum-tolerated dose

Horizon Pharma Inc., of Northbrook, Ill., reported interim results from a pilot clinical study showing that Lodotra (modified-release prednisone tablet) chronotherapy might improve asthma control and asthma-related quality of life when added to standard asthma therapy in patients with severe nocturnal asthma...The dose-escalation study will test three dose levels and cohorts of three to six patients to determine a maximum-tolerated dose

The first part of the trial is an open-label, dose-escalation trial that will enroll up to 80 patients and test Debio 0932 as a single agent to find the recommended dose for the second part of the trial...Icagen said it currently expects that the clinical studies at higher doses may be completed during the second half of this year, subject to available funding...Kiadis Pharma BV, of Amsterdam, the Netherlands, said a two-year follow up data from the Phase I/II study for mismatched bone marrow

AM-Pharma BV, of Bunnik, the Netherlands, disclosed positive results from its Phase II acute kidney injury trial with alkaline phosphatase at the International Symposium on Intensive Care and Emergency Medicine...Evotec AG, of Hamburg, Germany, completed the clinical part of the first Phase I trial of its NR2B-selective NMDA receptor antagonist EVT 103, showing that the compound was safe and well tolerated, with excellent bioavailability and only a minimal effect of food in the kinetic profile...Stem

The placebo-controlled, dose-escalation study will involve four cohorts of eight patients each...LEO Pharma A/S, of Ballerup, Denmark, reported findings from a Phase III study of PEP005 (ingenol mebutate) gel in actinic keratosis, showing that once-daily treatment for two consecutive days on nonhead locations resulted in significant clearance of AK lesions when compared to vehicle or placebo

The open-label, dose-escalation study will determine the safety, tolerability and pharmacokinetics of the drug...BioAlliance Pharma SA, of Paris, reported final positive results of its pivotal Phase III study in immunocompetent patients with recurrent herpes labialis (LIP Study) treated with acyclovir Lauriad...Secondary clinical endpoints showed the duration of episode from the first prodromal symptoms to healing to be significantly decreased (p=0.0062), the percentage of patients with abortive

There were no serious adverse events in the clinical trial...CytRx Corp., of Los Angeles, has begun a dose-escalation study with its oncology drug candidate tamibarotene combined with Trisenox (arsenic trioxide, Cephalon Inc.) in patients with relapsed acute promyelocytic leukemia...Nektar Therapeutics, of San Carlos, Calif., presented clinical study data demonstrating that the oral tablet formulation of NKTR-118 has favorable systemic bioavailability and a low risk for mediating significant drug-drug

The trial is a randomized, double-blind, placebo-controlled, sequential single to multiple dose escalation study, with a planned enrolment of 46 subjects to assess the safety and tolerability of two different doses in healthy subjects...Strativa Pharmaceuticals, of Woodcliff Lake, N.J., said partner BioAlliance Pharma SA, of Paris, presented Phase III study results for miconazole Lauriad mucoadhesive buccal tablets (MBT) that demonstrate noninferiority to clotrimazole troches for oropharyngeal

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...Initiation of the clinical trial has triggered an undisclosed milestone payment under the agreement...Merck also is reviewing clinical data for migraine compound MK-0974 (telcagepant), which is in Phase III trials in preparation for discussions with regulatory agencies later this year

The dose-escalation trial in 45 healthy volunteers is designed to expand the human safety database...Palau Pharma SA, of Barcelona, Spain, said the first patient has been enrolled in a Phase II trial of dersalazine sodium for the treatment of mild to moderate ulcerative colitis

Staff Writer While both the investment and clinical communities eagerly await detailed data expected next week from Dendreon Corp.'s confirmatory Phase III trial of cancer vaccine Provenge (sipuleucel-T) in late-stage prostate cancer, the company presented data from an ongoing Phase III trial in earlier-stage patients...In addition to tracking the gene expression and molecular pathway change through the preclinical and clinical development of a drug, the Erlotinib results open up the possibility

Novagali Pharma SA, of Evry, France, reported Phase II results showing that Cyclokat, its formulation of cyclosporine, demonstrated statistically significant improvement in signs and symptoms in patients suffering from moderate to severe dry eye syndrome...Pharmacyclics Inc., of Sunnyvale, Calif., has begun treating patients in a Phase I dose-escalation study to evaluate the safety and tolerability of PCI-32765, an orally available, selective inhibitor of Bruton's tyrosine kinase as a potential

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

It has completed a Phase I dose-escalation trial in healthy volunteers and is proceeding to a Phase IIa, multiple-ascending dose trial in treatment-naive HIV-infected individuals...Vivalis, of Nantes, France, and Innate Pharma, of Marseille, France, signed a collaboration and commercial license agreement related to the use of Vivalis EB66 cell line, for the setup of an industrial process and the manufacturing of clinical batches of Innate Pharma's IPH 4101, a cytotoxic monoclonal antibody for the