• Ambrilia Biopharma Inc., of Toronto, said it completed patient recruitment in a pivotal Phase III trial of its prolonged-release formulation of octreotide (C2L) in acromegaly patients. The open-label, randomized, parallel-group study is comparing the efficacy of C2L 30mg and Sandostatin LAR 30mg (octreotide acetate for injectable suspension, Novartis AG), based on changes in the mean insulin-like growth factor 1 and growth hormone plasma levels in acromegalic patients. Additional open-label safety studies will follow completion of the efficacy study. Regulatory filings by Ambrilia's licensing partners are then expected to start in mid-2008, first in Europe followed by North America, it said.

• Anesiva Inc., of South San Francisco, completed enrollment of its Phase III study of Zingo (lidocaine hydrochloride monohydrate) powder intradermal injection system to reduce pain associated with peripheral venous access procedures in adults. Results from the study are expected in October. Zingo, a fast-acting topical, needle-free system for local analgesia, was approved in August to reduce the pain associated with venous access procedures in children ages three to 18. (See BioWorld Today, Aug. 20, 2007.)

• Biomira Inc., of Edmonton, Alberta, enrolled the first patient in its Phase I trial of PX-478, a small molecule designed to inhibit the activity of hypoxia inducible factor (HIF)-1 alpha, in patients with advanced metastatic cancer. HIF-1 is a transcription factor that controls the expression of a number of genes needed for growth and survival of cancer cells. The trial is expected to involve up to 36 patients with advanced solid tumors or lymphoma who have failed or are intolerant of standard therapy to receive PX-478 orally on days one through five of a 21-day cycle. Primary objectives include establishment of a maximum-tolerated dose and safety, and other objectives are designed to evaluate the drug's effects on tumor blood flow and vascular permeability.

• Cardium Therapeutics, of San Diego, reported that a prespecified analysis of pooled data from Phase IIb and Phase III clinical trials showed significant improvements in multiple clinical measures of heart disease among women who received Generx (alferminogene tadenovec, Ad5FGF-4) as compared with women who received a placebo. Generx, which recently received FDA fast-track status, is being developed as a potential treatment for men and women with myocardial ischemia and associated angina due to coronary heart disease and represents a new therapeutic class of cardiovascular biologics.

• Cobalis Corp., of Irvine, Calif., reported additional data from two randomized, placebo-controlled, Phase III clinical trials of PreHistin (cyanocobalamin) in 1,551 patients with moderate to moderately severe seasonal allergic rhinitis, or hay fever. The trials did not achieve their primary endpoint of a statistically significant reduction in total nasal symptom score, as previously reported, but patients treated with PreHistin had less of in increase in ragweed IgE. Average IgE levels for PreHistin patients increased from 6.27 to 7.68 kU/mL, while those for placebo patients increased from 6.34 to 9.20 kU/mL.

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., said results of a Phase II study for Col-118 in the treatment of erythema demonstrated a highly statistically significant dose-response relationship in the reduction of erythema, with a side effect profile similar to the vehicle control. The double-blinded, placebo-controlled study involved 110 patients in four arms, and patients were treated with one of three concentrations of Col-118 or a control. The study demonstrated a strong dose response relationship and achieved its primary endpoint. The average reductions in CEA in patients who had received the mid and the high doses of Col-118 were substantially greater across all visits than that of patients receiving the control. At the Day 28 visit, the average reduction in CEA in patients who had received the high dose was 1.6 at peak efficacy compared to an average peak reduction in the vehicle of 0.7, with a p-value of <0.001. At peak efficacy on Day 28, the average reduction in CEA in patients who had received the mid dose was 1.3 (p<0.05), and the average reduction in CEA in patients who had received the low dose was 1.0 (p=0.2).

• CuraGen Corp., of Branford, Conn., and TopoTarget, of Denmark, said the firms have initiated patient dosing in a Phase I/II clinical trial evaluating belinostat (PXD101), a histone deacetylase inhibitor, in combination with the anthracycline idarubicin for the treatment of Acute Myeloid Leukemia. The trial, which is enrolling up to 40 patients, is being conducted at multiple sites in the European Union. In preclinical studies, belinostat has shown potent growth-inhibitory activity on leukemic cell lines, and there is evidence that belinostat has an additive effect when combined with anthracyclines.

• ExonHit Therapeutics SA, of Paris, said a Phase I trial will begin later this year for the first new chemical entity to emerge from its drug discovery collaboration with Allergan Inc., of Irvine, Calif. Responsibility for clinical development and commercialization of the compound, dubbed EHT/AGN001, lies with Allergan. The collaboration, signed in 2003 and twice extended, focuses on discovering and developing drugs for neurodegenerative diseases, pain and ophthalmology.

• Human Genome Sciences Inc., of Rockville, Md., completed enrollment of a target 1,331 patients in the ACHIEVE 1 Phase III trial of the long-acting interferon Albuferon (albinterferon alfa-2b) plus ribavirin in treatment-naive patients with chronic hepatitis C. Data are expected in spring 2009, with potential regulatory applications to follow in fall 2009. While ACHIEVE 1 completed enrollment ahead of schedule, the ACHIEVE 2/3 Phase III trial is still on target to be fully enrolled by the end of the year. Separately, HGSI also said it will receive a $40 million milestone payment in September from partner Novartis AG due to the previously reported successful completion of a Phase IIb trial with Albuferon. (See BioWorld Today, Oct. 5, 2006.)

• ImaRx Therapeutics Inc., of Tucson, Ariz., said a Data and Safety Monitoring Board granted the company permission to proceed to the second dose cohort in its Phase I/II trial combining SonoLysis therapy with the thrombolytic drug tPA in ischemic stroke patients. The dose-escalation trial was initiated in January and is expected to complete enrollment of its target 72 patients in the first half of 2008. SonoLysis therapy combines ImaRx's MRX-801 microbubbles with ultrasound to break up blood clots and restore blood flow to tissues.

• Kythera Biopharmaceuticals Inc., of Los Angeles, initiated a Phase II study of ATX-101, for the reduction of unwanted submental (under chin) fat. It's the first of a series of planned studies of the drug in aesthetic applications aimed at proving the product's safety and effectiveness as a liposculpting agent. The trial will enroll 72 patients.

• Meridian Bioscience Inc., of Cincinnati, began a Phase I/II trial of a parvovirus B19 vaccine, in collaboration with two branches of the National Institutes of Health. The trial will evaluate the safety and immunogenicity of the vaccine in healthy adult human volunteers. Meridian in October 2003 was awarded a contract to manufacture a recombinant DNA parvovirus B19 vaccine from the NIH, and in 2005 was awarded the exclusive global license for technology related to the product.

• Valeant Pharmaceuticals International, of Aliso Viejo, Calif., has completed enrollment in the first retigabine pivotal study called RESTORE1. It is the first of two large pivotal Phase III trials to evaluate the safety and efficacy of retigabine, a first-in-class neuronal potassium channel opener, in patients with refractory partial-onset seizures who are receiving one, two or three concomitant antiepileptic drugs. The second trial, RESTORE2, is expected to achieve full enrollment this fall. RESTORE1 will have 306 patients and is being conducted at 49 sites across the U.S., Argentina, Mexico, Brazil and Canada. RESTORE2, which is targeted to enroll 510 patients, is being conducted in 72 sites across Europe, Israel, Australia, South Africa and the U.S.

• Vical Inc., of San Diego, said it has initiated the enrollment of the first subject in its Phase 1 trial of the company's Vaxfectin(TM)-formulated plasmid DNA (pDNA) pandemic influenza vaccine. The double-blind, placebo-controlled trial will evaluate safety, tolerability and immune responses in up to 60 healthy volunteers age 18-45 at two U.S. clinical sites. The pDNA vaccine, which includes nucleoprotein, ion channel protein, and a hemagglutinin surface protein from the H5N1 influenza virus strain A/Vietnam/1203/04, is designed to provide T-cell and antibody immune responses for broad cross-strain protection.