Metabolex Inc., of Hayward, Calif., said an open-label clinical pharmacology study showed that the higher dose of arhalofenate plus Osaka, Japan-based Takeda Pharmaceutical Co...Tranzyme Pharma Inc., of Research Triangle Park, N.C., and Norgine BV, of Amsterdam, the Netherlands, completed patient enrollment in ULISES 007, the first of two pivotal Phase III studies of ulimorelin, an intravenous ghrelin agonist, for the acceleration of gastrointestinal recovery in patients undergoing partial bowel

Acacia Pharma Ltd., of Cambridge, Mass., reported Phase IIa data for APD209 in cancer cachexia, given to 13 patients with an average weight loss of 11.4 percent in the previous six months...Aesrx LLC, of Newton, Mass., said it started a clinical trial to test Aes-103, its anti-sickling agent, in healthy volunteers...Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi SA, of Paris, reported top-line results from the Phase III GetGoal Duo 1 study, which showed that once-daily GLP-1 inhibitor

The open-label study is designed to test safety, tolerability and clinical response activity of the drug in patients, 60 and older, who have relapsed or primary refractory disease...Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi SA, of Paris, presented new results from a four-week Phase II study showing that GLP-1 agonist Lyxumia (lixisenatide) produced significantly greater postprandial glucose lowering than Victoza (liraglutide, Novo Nordisk A/S) in patients with Type II diabetes

But, if data for INX-189 continue to flow positive, the company could find itself in an enviable position for a lucrative big pharma partnership or even an acquisition, as biopharma races to create the first all-oral, interferon-free HCV regimen...Proceeds will be used to accelerate the firm's drug development pipeline, including generating clinical data from partnerships in Russia and India.

The compound demonstrated preliminary but encouraging single-agent clinical activity in both indications...Niiki Pharma Inc., of Hoboken, N.J., reported preclinical combination studies showing that its lead product, NKP-1339, demonstrated synergistic activity in both in vitro and in vivo models when given with a broad range of antitumor agents...In vitro studies tested the drug in combination with cisplatin, oxaliplatin, 5-FU, docetaxel, doxorubicin, gemcitabine, Tarceva (erlotinib, Astellas Pharma

The company said proceeds from the IPO would see the company through 2013 and allow it to advance the TVI-Brain-1 clinical program, though additional financing would be needed to complete clinical trials of the compound...Affiris is developing peptide vaccines, including a vaccine for Parkinson's disease set to start Phase I testing in early 2012.

Cardiome Pharma Corp., of Vancouver, British Columbia, said partner Merck & Co...Galena Biopharma Inc., of Lake Oswego, Ore., reported that data from Phase II clinical trials of its NeuVax vaccine showed that it may provide a meaningful clinical benefit in patients with less aggressive forms of breast cancer, and potentially keep them free of their disease...Rexahn said the firm plans to evaluate the Serdaxin clinical programs and possible paths forward

Auxilium Pharmaceuticals Inc., of Malvern, Pa., reported that clinical practice data from the TRiUS (Testim Registry in the United States) study showed that daily administration of Testim 1 percent (testosterone gel) resulted in significantly improved sexual function and increased total testosterone levels in men with hypogonadism...Clinical follow-up, completed three months after the administration of PLX-PAD cells, noted statistically significant improvements in several parameters, including

True, there has been only one pricing since the spring – specialty pharma firm's Horizon Pharma Inc.'s $49.5 million offering in July – but the fact that a couple of other platform biotechs have jumped in the queue – Merrimack Pharmaceuticals Inc...NanoViricides said it is moving toward an investigational new drug application filing for influenza candidate NV-INF-1.

Ampio Pharmaceuticals Inc., of Greenwood Village, Colo., reported positive results from the Ampion-In-Knee (AIK) clinical trial, showing the drug was well tolerated and reduced pain over and above steroids...The decision follows reports of laboratory abnormalities and adverse events in a subset of clinical trial participants...Solasia Pharma K.K., of Tokyo, reported that enrollment of a Phase I trial evaluating the safety and tolerability of darinaparsin injection (SP-02L) for the treatment of

Clavis Pharma ASA, of Oslo, Norway, established the cutoff level for defining hENT1 low vs...Low hENT1 levels have been correlated to poor clinical outcome with gemcitabine, the standard treatment for many solid tumors...PharmaGap Inc., of Ottawa, said it has chosen ovarian cancer as its target for clinical development of GAP-107B8

Add in large target markets and a cost-efficient clinical development path, and you've got a salve for many of the issues currently ailing other sectors of the drug industry...He previously headed Peplin Inc., which garnered positive data in its first pivotal trial of actinic keratosis drug PEP005 and was promptly acquired by LEO Pharma A/S for $287.5 million. (See BioWorld Today, Sept. 4, 2009.) So Wiggans teamed up with scientist Eugene Bauer, who'd had similar experiences...QLT eventually spun-out

Galderma Pharma SA, of Lausanne, Switzerland, reported top-line results from a Phase IIb trial showing that CD07805/47, a topical gel in development for moderate to severe facial erythema of rosacea, was rapidly effective at reducing facial redness...Data, which resulted from a pooled analysis of five trials in postsurgical pain management, were presented at the American College of Clinical Pharmacy meeting in Pittsburgh

Complete cure is the primary clinical endpoint for the conduct of pivotal clinical trials seeking FDA approval, Topica said...Net proceeds will be used for clinical trials activities related to completion of enrollment and ongoing patient dosing for the trial testing davunetide in progressive supranuclear palsy, as well as for general corporate purposes and working capital

Following a handful of IPO pricings earlier in the year, activity dropped off over the summer, with only one company going public: specialty pharma firm Horizon Pharma Inc...Amarantus is developing products based on MANF, a protein that corrects protein misfolding.

Dynavax will manage early clinical development, with AstraZeneca providing approximately $20 million to cover the cost of clinical development activities through Phase IIa...Tranzyme Pharma, of Research Triangle Park, N.C., dosed its first patient in a Phase IIb, 12-week trial of TZP-102, its oral gastrointestinal (GI) motility drug candidate

Action Pharma A/S, of Aarhus, Denmark, released top-line results for its Phase IIb AP214 trial in patients undergoing major cardiac surgery, indicating that AP214 is safe, reduces kidney injury and improves 90-day outcomes on a composite end point (death, dialysis and kidney function) in patients undergoing cardiac surgery with cardiopulmonary bypass who are at increased risk of developing acute kidney injury...The study will evaluate the safety and tolerability of ALN-PCS in subjects with elevated

Bionomics Ltd., of Adelaide, Australia, said the higher dose level of 16 mg/m2 was cleared for BNC105, a vascular-disrupting agent that is being tested in a clinical trial in combination with mTOR inhibitor Afinitor (everolimus, Novartis AG) in patients with metastatic renal cell cancer...Niiki Pharma Inc., of Hoboken, N.J., reported interim data from a Phase I study of NKP-1339 in patients with metastatic solid tumors resistant to standard therapies showing that six of the first 24 patients

Proceeds will be used to fund clinical trial activities relating to progressive supranuclear palsy drug davunetide, as well as for general administrative expenses, working capital and general corporate purposes...Proceeds are expected to help the specialty pharma firm expand its commercialization activities, prepare for the extension of its product line including Altrazeal Collagen and Altrazeal Silver and position it for negotiating with potential partners