• Anacor Pharmaceuticals Inc., of Palo Alto, Calif., completed enrollment for its Phase IIb study of AN2728, a topical anti-inflammatory candidate for psoriasis. The 68-patient study is designed to inform the plans for two pivotal Phase III studies and is not designed itself to demonstrate statistical differentiation from vehicle. AN2728 is a boron-based small molecule designed to inhibit phosphodiesterase-4.
• Athersys Inc., of Cleveland, dosed the first patient in a Phase II trial of MultiStem, its allogeneic cell therapy product for treating ulcerative colitis. The trial, slated to enroll up to 126 patients, will test the safety and efficacy of the product in subjects with moderate to severe disease. Primary safety and efficacy endpoints will include endoscopic evaluation at baseline and at eight weeks, with a follow-up of all patients through 12 months. The study is part of a 2009 collaboration between Athersys and New York-based Pfizer Inc. to develop MultiStem in inflammatory bowel disease. (See BioWorld Today, Dec. 22, 2009.)
• Biodel Inc., of Danbury, Conn., plans to test its two new formulations of recombinant human insulin in a Phase I trial in Type I diabetes patients. The study is designed as a three-period crossover trial in which patients will receive one subcutaneous injection of BIOD-105, BIOD-107 and Humalog (lispro, Eli Lilly and Co.) each on separate occasions. The pharmacokinetic, pharmacodynamic and tolerability profiles of the experimental insulins relative to Humalog will be evaluated. The study is expected to be completed in the third quarter. Pending positive data, Biodel anticipates moving into Phase II testing in the fourth quarter.
• BioInvent International AB, of Lund, Sweden, dosed the first patient in a Phase II study of antibody BI-204, which will test the intravenously administered drug in patients on standard-of-care therapy for stable atherosclerotic cardiovascular disease. The study will enroll 120 patients and is designed to demonstrate a reduction in plaque inflammation following treatment as quantified by FDG-PET imaging. BioInvent, which is developing BI-204 in collaboration with South San Francisco-based Genentech Inc., a unit of the Roche Group, will receive a $15 million milestone payment under the firms' 2007 deal. (See BioWorld Today, Jan. 16, 2007.)
• Biothera, of Eagan, Minn., started treating patients with earlier-stage high-risk chronic lymphocytic leukemia in a Phase I/II trial testing its Imprime PGG in combination with Campath (alemtuzumab, Genzyme Corp.) and Rituxan (rituximab, Biogen Idec Inc. and Genentech Inc./Roche AG). Researchers will dose up to 16 patients in the Phase I open-label, dose-escalation portion. In the Phase II portion, an additional 39 patients will be enrolled, and the goal is to assess the complete response rate, as well as overall subject response, time to progression, time to next treatment, duration of response and safety. Imprime PGG is designed to work by binding to and directing neutrophils to kill cancer.
• Euthymics Bioscience Inc., of Cambridge, Mass., started a Phase IIb/IIIa trial of its triple reuptake inhibitor, EB-1010, in major depressive disorder. Designated TRIADE, the study will compare EB-1010 to placebo and a standard treatment over a 12-week period, with changes in the Montgomery-Asberg Depression Rating Scale as the primary endpoint. Secondary measures include sexual function, weight gain and cognition. About 300 patients will be enrolled, and top-line results are expected in mid-2012.
• Inovio Pharmaceuticals Inc., of Blue Bell, Pa., said partner ChronTech Pharma AB (formerly Tripep AB), of Stockholm, Sweden, started a Phase IIb study of its ChronVac-C DNA vaccine in hepatitis C virus delivered using Inovio's electroporation DNA vaccine delivery technology, in combination with standard of care. The trial will enroll 32 patients and is designed to assess the level of immune responses and the level of HCV viral load and to further assess the response to the delivery technology.
• KAI Pharmaceuticals Inc., of South San Francisco, enrolled the first patients in a Phase II study of peptide candidate KAI-4169 in secondary hyperparathyroidism (SHPT). The study will assess multiple intravenous doses of the drug administered during hemodialysis in SHPT patients. Results will be used to select the appropriate dosing regimen for further development.
• Marina Biotech Inc., of Bothell, Wash., enrolled the first patient in the dose-escalating portion of its Phase Ib/IIa trial of oral RNAi-based candidate CEQ508 in familial adenomatous polyposis (FAP). Following the dose-escalation phase, the trial calls for a stable-dose phase in which additional patients will receive the highest safe dose. CEQ508 previously received orphan designation in FAP.
• StemCells Inc., of Palo Alto, Calif., started a Phase I/II trial of its HuCNS-SC human neural stem cells in chronic spinal cord injury in patients with both complete and incomplete degrees of paralysis who are three months to 12 months post-injury. The study will enroll 12 patients in three cohorts with thoracic spinal cord injuries who have a neurological injury level of T2-T11. In addition to safety, the trial will measure defined clinical endpoints, such as changes in sensation, motor and bowel/bladder function. All patients will receive HuCNS-SC cells through direct transplantation into the spinal cord and will be temporarily immunosuppressed. After transplantation, they will be evaluated regulatory over a 12-month period. A separate four-year observational study will be initiated at the conclusion of the trial.
• Transcept Pharmaceuticals Inc., of Point Richmond, Calif., enrolled the first patient in a Phase II trial of TO-2061, a low-dose formulation of ondansetron, as an adjunctive treatment for obsessive compulsive disorder (OCD) in patients who have responded inadequately to existing treatment. The study will enroll about 150 OCD patients, randomized into three groups to test TO-2061 compared to placebo. The primary endpoint is the difference between active and placebo treatment arms as measured by the Yale-Brown Obsessive Compulsive Scale.