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Clinical Trials Translational Medicine Asthma > Rigel Pharmaceuticals (www.rigel. com) commenced a Phase II trial of R343, an inhaled SYK inhibitor that is being eval- uated as a potential treatment for allergic asthma. R343 is designed to bind to the SYK in mast cells to interrupt the signal from the IgE receptors. R343's ability to inhibit SYK potentially prevents or stops the immune response to the allergen and may be effective in the short- and long- term control of allergic asthma. Approxi- mately 270 adults with allergic asthma will be randomized into the three arms of the study for eight weeks of treatment with either of two different doses of the agent or placebo. The primary endpoint of this double-blind, multicenter study will be the measurement of each patient's change in FEV1 (the maximum amount of air a person can forcefully exhale in one second) from baseline to dosing comple- tion. Rigel will be using the 3M™ Taper Dry Powder Inhaler device for this trial. Cancer > TG Therapeutics (www.tgtherapeu- tics.com) initiated a Phase I/II trial to evalu- ate the safety, tolerability, and efficacy of ublituximab, its third-generation anti- CD20 monoclonal antibody, for patients with relapsed or refractory B-cell non- Hodgkin's lymphoma (NHL) who were pre- viously treated with rituximab (Rituxan). The trial will enroll up to 36 patients in the Phase I dose-escalation component. Once the optimal dose is determined, up to 77 patients total will be enrolled for the Phase II component and stratified by subtype of B-cell lymphoma, including follicular lymphoma, diffuse large B-cell lymphoma, marginal zone lymphoma, and other NHL subtypes. All enrolled patients will be relapsed or refractory to Rituxan or a Rituxan containing regimen, and, in most cases, multiple other lines of therapy. > Baxter International (www.baxter. com) began dosing patients with malignant solid tumors in a Phase I trial of a monoclonal antibody. The candidate is a fully human, re- combinant antimacrophage migration inhib- itory factor (anti-MIF) monoclonal antibody with potential to be a new therapeutic agent for cancer treatment. The anti-MIF antibody targets the MIF protein, a protein that induces inflamma- tory responses in the body and that has also been shown to influence the growth and spread of tumors. By inhibiting the cancer-promoting effects of MIF, the anti- MIF antibody may be capable of restrict- ing the growth of tumors. The Phase I, open-label study is de- signed to assess the safety, tolerability, and optimal dose of the antibody in up to 44 adult patients with malignant solid tumors. The ''all-comers'' design of the sin- gle-agent trial will allow for expedited ac- crual of patients and evaluation of safety and potential therapeutic activity in pa- tients with varied solid tumor types. The study will also investigate pharmacokinet- ics and changes in levels of markers that indicate antitumor activity. > ImmunoCellular Therapeutics (www.imuc.com) completed enrollment for its Phase II randomized, double-blinded, placebo-controlled, multicenter study of its dendritic cell-based cancer vaccine ICT-107 for treatment of glioblastoma. A total of 278 patients at 25 participating sites have been enrolled in this trial. This potential vaccine tested in patients with stage four glioblastoma is designed to leverage the ImmunoCellular Therapeutics' ICT-107 is a therapeutic cancer vaccine using patients' dendritic cells (DCs) engineered to target six tumor-associated antigens highly expressed on GBM tumors (IL13Rα2, Her2/neu, gp100, MAGE1, AIM2, Trp-2) and elicit immune responses against cancer stem cells and differentiated tumor cells. 62 | October 1, 2012 | genengnews.com | Genetic Engineering & Biotechnology News