Allachem LLC, of Hallandale Beach, Fla., said it initiated a phase Ib proof-of-concept study of AVR560, an orally bioavailable hepatitis C virus (HCV) entry inhibitor, to treat chronic HCV infection. The randomized, double-blind, placebo-controlled, multicenter study is examining safety, tolerability, pharmacokinetics and antiviral activity of AVR560 in treatment-naïve HCV-infected patients, who will be randomized to 100 mg or 150 mg of AVR560 or placebo for 14 days, with up to 10 subjects per cohort. The company expects to present results of the study at a scientific conference in the second half of the year.

Asterias Biotherapeutics Inc., of Menlo Park, Calif., presented results from its phase I trial assessing the safety of AST-OPC1 in patients with spinal cord injury. Asterias said the first-in-human trial of a cell therapy derived from human embryonic stem cells, first initiated in 2010 by Geron Corp., also of Menlo Park, supports the product's safety and provides a path for advanced studies of AST-OPC1. In the trial, five patients with neurologically complete, thoracic spinal cord injury were administered 2 million AST-OPC1 cells at the spinal cord injury site seven to 14 days post-injury. The patients received low-level immunosuppression for the next 60 days and were followed for two to three years through clinical visits, imaging studies and neurological assessments. Immune monitoring through one year post-transplantation showed no evidence of antibody-based or cellular immune responses to AST-OPC1. In four patients, serial MRI scans performed throughout follow-up suggested reduced spinal cord cavitation may have occurred and AST-OPC1 may have had some positive effects in reducing spinal cord tissue deterioration. Delivery of AST-OPC1 was successful in all patients, with no serious adverse events (AE) associated with intraoperative administration of the cells, AST-OPC1 or the immunosuppressive regimen. Three serious AEs occurred but were not associated with the treatment or delivery, including one each of pyelonephritis, urinary tract infection and dyspnea due to autonomic dysreflexia. No deaths occurred in the trial. The results were presented at the American Society for Gene and Cell Therapy annual meeting in Washington. (See BioWorld Today, April 5, 2013.)

Biogen Idec Inc., of Cambridge, Mass., plans to advance its program studying subcutaneous (SC) delivery of Tysabri (natalizumab) in relapsing/remitting multiple sclerosis (RRMS) into a phase II study. The 48-week study will test the approved, 300-mg dose of Tysabri, delivered monthly in two SC injections, to 113 Tysabri-naïve RRMS patients, with a goal of assessing immunogenicity and efficacy. The company also reported on clinicaltrials.gov that its phase II anti-LINGO study of BIIB-033 in optic neuritis completed enrollment. Thursday, the company's shares (NASDAQ:BIIB) gained $4.33, closing at $299.69.

Isis Pharmaceuticals Inc., of Carlsbad, Calif., reported top-line data from a phase II comparator-controlled study evaluating the incidence of venous thrombolic events (VTE) in patients treated with ISIS-FXIRx undergoing total knee arthroplasty (TKA). The global, multicenter, open-label, comparator-controlled study evaluated approximately 300 patients undergoing TKA, comparing the safety and activity of ISIS-FXIRx to enoxaparin. Patients in the ISIS-FXIRx-treated cohorts received either 200 mg or 300 mg of ISIS-FXIRx for six weeks prior to TKA surgery, then six hours and three days after surgery. Patients in the enoxaparin cohort received 40 mg of enoxaparin the evening before TKA surgery, six to eight hours after surgery and daily for at least eight days following surgery. In the study, with a data cutoff of May 7, patients treated with 300 mg of ISIS-FXIRx had a sevenfold (p < 0.0001) lower incidence of VTEs than patients treated with enoxaparin. Patients treated with 200 mg of ISIS-FXIRx had a comparable incidence of VTEs compared to those treated with enoxaparin. Across treatment arms, patients experienced low bleeding rates, although ISIS-FXIRx-treated patients had numerically fewer bleeding events. Isis plans to report full data at an upcoming undisclosed scientific meeting. On Thursday, the company's shares (NASDAQ:ISIS) gained $1.75 to close at $24.95.

Redhill Biopharma Ltd., of Tel Aviv, Israel, said the FDA cleared the firm to start the planned 320-subject phase III trial of a new, undisclosed indication with RHB-102, an extended-release oral pill formulation of antiemetic drug ondansetron. Patient enrollment is set to start in the third quarter.

Sotio AS, of Prague, said the first patient was enrolled in its global phase III VIABLE study of DCVAC/PCa, an active cellular immunotherapy to treat prostate cancer. The randomized, double-blind, multicenter, parallel-group study is evaluating the efficacy and safety of DCVAC/PCa as adjunctive therapy to first-line standard-of-care chemotherapy in patients with metastatic castration-resistant prostate cancer, compared to placebo with standard of care. The primary endpoint is overall survival. DCVAC/PCa is produced individually using a patient's dendritic cells to induce an immune reaction against presented tumor antigens. Sotio expects to enroll approximately 1,170 patients at sites across Europe, Russia and the U.S.

Stemcells Inc., of Newark, Calif., said it transplanted its purified human neural stem cells (HuCNS-SC) into the first five patients in the final cohort of its 16-patient phase I/II trial for geographic atrophy of age-related macular degeneration. Eight of the eight patients in the second cohort will receive a dose of 1 million stem cells into the most affected eye. Interim results from the study are expected next month, and the company anticipates starting a phase II proof-of-concept study later this year.

Telormedix SA, of Bioggio, Switzerland, said four of 10 evaluable patients with carcinoma in situ (CIS) of the bladder exhibited a response to Vesimune (TMX-101), a liquid formulation of the well-known toll-like receptor 7 (TLR-7) agonist imiquimod, in a phase II trial that recruited 12 patients in all. Three of the four were complete responders and achieved complete remission after just one cycle of therapy. The trial involved a total of six cycles of therapy, which was delivered intravesically. Imiquimod is widely used as a topical drug for treating pre-malignant and malignant conditions of the skin, but its toxicity profile prevents its systemic use. In the present study, which was performed in the U.S., Vesimune elicited mild-to-moderate side effects, including a burning sensation and an urge to void, which are also caused by other intravesical agents. The company is now seeking licensing partners to take the product further.

The Medicines Co., of Parsippany, N.J., said data reported at the late breaking clinical trial sessions at EuroPCR in Paris and published in the European Heart Journal showed that bivalirudin is superior to heparin alone without optional glycoprotein inhibitors (GPIs) in patients with ST-segment elevation myocardial infraction transported emergently for primary percutaneous coronary intervention. The study, dubbed EUROMAX, enrolled 2,198 patients with heart attacks during their transport to urgent heart procedures aimed at unblocking coronary arteries occluded by blood clots The study met all the pre-specified endpoints, comparing bivalirudin, branded Angiomax, to heparin or low-molecular-weight heparin given with optional GPIs.

TG Therapeutics Inc., of New York, saw its shares (NASDAQ:TGTX) jump 13.9 percent, or 65 cents, to close Thursday at $5.33 following the release of abstract data ahead of next month's European Hematology Association meeting in Milan, Italy. Among the data highlighted in the abstracts were phase II results showing that TG-1101, its anti-CD20 monoclonal antibody, in combination with Bruton's tyrosine kinase inhibitor Imbruvica (ibrutinib, Pharmacyclics Inc.) demonstrated clinical activity in patients with chronic lymphocytic leukemia. Additional early clinical data showed promising activity when testing TG-1101 in combination with antibody-conjugate drug Adcetris (brentuximab vedotin, Seattle Genetics Inc.) and in combination with Revlimid (lenalidomide, Celgene Corp.) In combination with TGR-1202, TG's own PI3K delta inhibitor, TG-1101 also showed early clinical activity in a phase I dose-escalation study.

Zalicus Inc., of Cambridge, Mass., reported data from phase I testing of multiple modified-release formulations of Z944, its oral, T-type calcium channel blocker in development for treating pain. The open-label, randomized crossover study compared three formulations the immediate-release capsule formulation of Z944, which previously demonstrated efficacy in a human clinical model of pain. Zalicus said the selected tablet formulation demonstrated a superior exposure and tolerability profile and warrants further clinical development.