Biotechnology Healthcare - June 2008 - (Page 9) DRUG TRACK preventing progression of joint damage at 6 and 12 months. … Roche’s tocilizumab (Actemra) plus conventional disease-modifying antirheumatic drugs is effective in patients with moderate to severe RA. At week 24, 61 percent of patients in the tocilizumab group achieved ACR20, compared with 25 percent in the placebo arm. Tocilizumab has enjoyed attention in numerous quarters of late. Two separate randomized, controlled, phase 3 trials published in the Lancet documented rapid symptom improvement in adults with moderate to severe active RA and significant improvement in ACR Pedi scores in children with juvenile idiopathic arthritis. Tocilizumab, which blocks interleukin-6, is already approved for use in Japan. Amgen expects big things from denosumab, which targets osteoclasts that break down bones. In a pivotal phase 3 trial published in the Journal of Endocrinology and Metabolism, twice-yearly subcutaneous injections of the osteoporosis drug significantly increased bone mineral density (BMD) over a twoyear period in women with earlyand late-stage postmenopausal osteoporosis. Separately, phase 3 data presented at the San Antonio Breast Cancer Symposium showed that denosumab increased BMD in breast cancer patients taking aromatase inhibitors. Other trials of note Three investigations of new uses of Genentech’s rituximab (Rituxan) yielded mixed results. In a phase 2, 48-week placebo-controlled trial published in the New England Journal of Medicine, a single dose reduced inflammatory brain lesions by 91 percent and relapses by 58 percent in patients with relapsingremitting multiple sclerosis (MS). A phase 2a/3 study of rituximab in patients with primary-progressive MS, however, disappointed when it did not meet its primary endpoint of time to progression. And, in yet another phase 2/3 study, rituximab did not meet its primary endpoint of major clinical response in patients with lupus. … The National Eye Institute has begun its long-anticipated trial comparing two Genentech drugs, ranibizumab (Lucentis) and bevacizumab, for the treatment of neovascular age-related macular degeneration. GlaxoSmithKline’s mepolizumab (Bosatria) was effective in treating hypereosinophilic syndrome (HES), a rare and potentially fatal disorder characterized by high levels of eosinophils, a type of white blood cell. Mepolizumab enabled patients to control their HES with lower levels of corticosteroids; in some instances, corticosteroids were not needed. The phase 3 results were published in the New England Journal of Medicine. … Cytos’s therapeutic hypertension vaccine CYT006-AngQb reduced blood pressure in hypertensive individuals, according to a phase 2a study published in the Lancet. CYT006AngQb prompts the immune system to produce antibodies that bind angiotensin II, the peptide that causes blood vessels to contract. … The FDA placed a clinical hold on Dynavax and Merck’s phase 3 trial of Heplisav, a vaccine for the treatment of hepatitis B in patients with end-stage renal disease. The FDA wants to review safety data after one enrollee was diagnosed with Wegener’s granulomatosis. Did you hear? Alnylam Pharmaceuticals claims to have achieved the first proof of concept for RNA interference in humans with its ALN-RSV01. In the phase 2 study, subjects were inoculated with respiratory syncytial virus. The group treated with ALN-RSV01 showed a 38.1 percent reduced infection rate compared to the placebo group. Fifty-six percent of the group treated with the RNAi drug remained uninfected, compared to 29 percent in the placebo group. … After determining that the death of a patient last year was unrelated to the therapy, the FDA permitted Targeted Genetics to resume its study of a gene therapy for RA. If Genitope is going to continue to seek regulatory approval of MyVax, Meeting highlights American Academy of Dermatology February 2008 Centocor presented results of a phase 3 study of an anti-IL-12p23, ustekinumab (CNTO 1275), suggesting high efficacy in patients with moderate to severe plaque psoriasis. Some 87 and 91 percent of patients receiving quarterly injections of 45 and 90 mg maintenance therapies, respectively, achieved PASI-75 after one year, with no increase in adverse events when therapy was stopped and restarted. Ustekinumab therapy is injected once every three months, compared to monthly infusions for infliximab (Remicade). … Two University of Alabama School of Medicine physicians reported a case study of off-label use of infliximab in combination with methotrexate. The pair said the combination controlled symptoms of severe intractable pustular psoriasis in a 44year-old patient. Etanercept (Enbrel) reduced C-reactive protein, a marker of inflammation, in patients with moderate to severe plaque psoriasis. After 12 weeks, mean CRP reductions were 10 times that of placebo. MAY/JUNE 2008 · BIOTECHNOLOGY HEALTHCARE 9
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