Aastrom Biosciences Inc., of Ann Arbor, Mich., enrolled its first patients in a Phase IIb trial of ixCELL-DCM to assess safety and efficacy of ixmyelocel-T in advanced heart failure that is caused by ischemic dilated cardiomyopathy. The randomized, double-blind, placebo-controlled trial will enroll 108 patients at about 30 sites in the U.S. to receive ixymyelocel-T through a catheter. The primary endpoint will be the average number of events per patient, over a 12-month period. Aragon

Aspireo Pharmaceuticals Ltd., of Tel Aviv, Israel, reported results of a Phase II study in acromegaly patients showing that Somatoprim, its somatostatin analogue, demonstrated a dose-dependent effect on lowering excess growth hormone in treatment-naïve patients. No serious adverse events were reported, and the reported adverse events were mild to moderate and transient in nature. The trial was designed to test single-ascending doses of Somatoprim in up to 20 patients. Cellular Biomedicine

Ampio Pharmaceuticals Inc., of Greenwood Village, Colo., said the FDA accepted its investigational new drug application and announced treatment of the first 15 patients in a trial using Ampion to treat osteoarthritis of the knee. The trial will proceed in two parts, with the first run-in portion to evaluate two doses of Ampion in 320 adults to determine the optimal dosage for the second portion of the pivotal study. The number of patients required in the second part will be determined based on

Advanced Cell Technology Inc., of Santa Monica, Calif., treated patients in a third cohort of each of its two Phase I trials of human embryonic stem cell-(hESC) derived retinal pigment epithelial cells for macular degeneration. The patients received 150,000 cells, compared with the 100,000-cell dose used in the second cohort. The trials will assess safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation in patients with Stargardt's macular dystrophy and dry age

Anaeropharma Science Inc., of Tokyo, initiated a Phase I trial of APS001F in U.S. patients with advanced or metastatic solid tumors whose disease is no longer responsive to available treatments. The dose-escalation trial is designed to evaluate the safety, tolerability and efficacy of APS001F, a living recombinant bifidobacterium designed to express the cytosine deaminase gene in tumors. The therapy is expected to limit the systemic toxicity of the antitumor agent 5-FU. Anthera Pharmaceuticals

BioCryst Pharmaceuticals Inc., of Research Triangle Park, N.C., said it started a Phase I trial in healthy volunteers to evaluate orally administered BCX4161 , a selective inhibitor of plasma kallikrein in development for the prevention of attacks in patients with hereditary angioedema. The study is expected to assess safety, characterize plasma drug levels and estimate the extent of kallikrein inhibition achieved. Data are expected later this year. Catabasis Pharmaceuticals Inc., of

Phosphagenics Ltd., of Melbourne, Australia, said it achieved all the endpoints of its Phase I trial of its oxymorphone patch by successfully delivering the opioid into the bloodstream via its TPM transdermal patch. The company will proceed with Phase II trials in the second half of 2013.

Auxilium Pharmaceuticals Inc., of Chesterbrook, Pa., reported positive top-line data from a Phase IIa trial of Xiaflex (collagenase clostridium histolyticum, or CCH) in adhesive capsulitis, commonly known as frozen shoulder syndrome (FSS). The open-label study assessed the safety and efficacy of CCH in Stage II unilateral idiopathic FSS in comparison to an exercise-only control group. Fifty patients at 11 U.S. sites were enrolled into five cohorts of 10 patients each. Four groups received up to

Benitec Biopharma Ltd., of Sydney, Australia, selected the Duke Clinical Research Unit in Durham, N.C., as a site for its upcoming Phase I/II first-in-human trial of TT-034 in hepatitis C virus (HCV). The open-label, dose escalation study will evaluate the safety and activity of single doses of TT-034 in patients with chronic HCV genotype 1 infection who failed previous treatments. The trial is expected to involve 14 patients in 5 sequential dose cohorts, although additional consolidation

LEO Pharma UK, of Princes Risborough, UK, reported that data published in the Journal of the American Medical Association Dermatology demonstrated the long-term effectiveness of Picato (ingenol mebutate) in treating actinic keratosis (AK), a leading cause of nonmelanoma skin cancer. The data showed that about 45 percent of patients who achieved clearance after the initial two- or three-day treatment experienced sustained clearance of AK lesions a year later. Patients in the overall study

Teva Pharmaceutical Industries Ltd., of Jerusalem, and H. Lundbeck A/S, of Copenhagen, Denmark, said the ANDANTE (Add oN to Dopamine AgoNists in the TrEatment of Parkinson's disease), testing Azilect (rasagiline tablets) as an add-on treatment to dopamine agonists compared to placebo met its primary endpoint. Results showed that the addition of Azilect 1 mg/day provided a statistically significant improvement in total Unified Parkinson's Disease Rating Scale score from baseline to week 18 in

Acorda Therapeutics Inc., of Ardsley, N.Y., said data from a Phase I study showed that a single dose of 20-mg Diazepam Nasal Spray had comparable plasma bioavailability to 20 mg of diazepam rectal gel. Diazepam Nasal Spray is being developed for treating people with epilepsy who experience cluster seizures, also known as acute repetitive seizures. Data were presented at the American Academy of Neurology meeting in San Diego. Acorda plans to submit a new drug application under the 505(b)(2

Acasti Pharma Inc., of Laval, Quebec, a subsidiary of Neptune Technologies & Bioressources Inc., reported preliminary data from a randomized, open-label, dose-ranging, multicenter trial assessing the safety and efficacy of NKPL66, or CaPre, in mild-to-high hypertriglyceridemia. Data from 157 patients who completed four weeks of treatment with 0.5, 1, 2 or 4 grams of CaPre per day were assessed, with CaPre achieving a statistically significant triglyceride reduction of up to 23 percent, compared

Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, and Eli Lilly and Co., of Indianapolis, started a Phase IIIb trial to evaluate the glycemic efficacy and safety of linagliptin in patients with Type II diabetes with prevalent albuminuria (defined as urinary albumin-to-creatinine ratio [UACR] 30-3000 mg/g creatinine), while remaining on current standard therapy for diabetic nephropathy.

Eli Lilly and Co., of Indianapolis, presented findings at the European Association of Urology Congress in Milan, Italy, showing that Cialis 5 mg once daily co-administered with finasteride (Proscar, Merck & Co. Inc.) significantly improved scores on the International Prostate Symptom Score (IPSS), compared to placebo/finasteride, in men with lower urinary tract symptoms of benign prostatic hyperplasia (LUTS/BPH) and enlarged prostates. On a pre-specified secondary measure, Cialis/finasteride

Alnylam Pharmaceuticals Inc., of Cambridge, Mass., began dosing patients in a Phase I trial of ALN-TTRsc for TTR-mediated amyloidosis. The randomized, double-blind, placebo-controlled trial will be carried out in the UK with a primary objective of safety and tolerability of single and multiple doses of subcutaneous ALN-TTRsc. Secondary objectives of the trial include clinical activity by serum TTR levels. The company expects to present data from the trial in mid-2013. Upon completion, it will

AMAG Pharmaceuticals Inc., of Lexington, Mass., reported preliminary data from the IDA-303 study showing that the 151 patients who received their first course of therapy with ferumoxytol achieved a statistically significant mean increase in hemoglobin from baseline to week five of 2.6 g/dL, a change consistent with the 2.7 g/dL increase in hemoglobin reported for ferumoxytol-treated patients in both pivotal IDA-301 and IDA-302 studies. The single-arm, open-label extension trial was designed to

Advanced Cell Technology Inc., of Santa Monica, Calif., said an independent data and safety monitoring board authorized the firm to move forward with enrollment and treatment of patients in the next cohort of each of its three ongoing trials of human embryonic stem cell-derived retinal pigment epithelial cells for eye diseases. The next cohort will receive 50 percent more cells than the previous cohort, and after six months another safety review will be conducted before continuing to treat

BioLineRx Ltd., of Jerusalem, said it received approval from French regulators to start a Phase I/II trial of BL-8020, an oral, interferon-free treatment for hepatitis C virus (HCV). The open-label trial will evaluate the efficacy, safety and tolerability of the drug in patients infected with HCV, of any genotype, who have previously failed or relapsed following standard-of-care treatment. Interim data are expected toward the end of this year. Biothera Inc., of Eagen, Minn., said it completed