• MRA (tocilizumab) is a humanized monoclonal antibody against the human interleukin-6 receptor (IL-6R). MRA has been shown to compete for both the membrane-bound and soluble forms of the human IL-6R and to inhibit IL-6 function.

  MRA has been administered to humans in multiple trials in Japan and Europe. The development of MRA in the United States started with the filing of an IND for multiple myeloma and Castleman's disease, and later, for systemic lupus erythematosus.

  In a placebo-controlled phase II study conducted in the Europe, MRA alone or in combination with methotrexate was shown to have a positive effect in patients with rheumatoid arthritis (RA). Most adverse events were mild and self-limiting. The efficacy analyses, including the criteria of the American College of Rheumatology (ACR) 20, ACR 50 and Disease Activity Score (DAS) demonstrated superior improvement over the placebo.

  In February an exclusive license to jointly develop and promote MRA for all therapeutic indications in the world, except for Japan, South Korea and Taiwan, was granted to Roche. Back to Top.

• GM-611 (mitemcinal), a macrolide derivative that possesses motilin-agonist activity, has been shown in a phase II trial to accelerate gastric emptying in patients with diabetic and idiopathic gastroparesis. The results led to the initiation of a phase II trial designed to assess improvement in symptoms of gastroparesis. New therapies for treating symptoms of gastroparesis are urgently needed, as the last FDA approval of a new drug for this disease was granted more than 20 years ago. Back to Top.

• Nicorandil is a nicotinamide nitrate derivative which functions as both a nitrate and ATP-dependent potassium channel opener. It is marketed in Japan and Europe for treatment of angina and unstable angina. In a large clinical trial the cardioprotective effect of Nicorandil was confirmed. The product was shown to be safe and effective when administered to men and women with stable angina and other risk factors resulting in significant improvement in outcomes (CHD death, non-fatal MI or unplanned hospitalizations). Back to Top.

• CHS13340 is a humanized parathyroid hormone (hPTH 1-34, teriparatide) targeted for treatment of primary osteoporosis which will be delivered by intranasal absorption. CHS 13440 is expected to reduce bone resorption, increase bone density as well as quality of bone and thereby reduce the risk of vertebral and other fractures. In Phase I and II trials conducted in Japan, the nasal formulation of CHS13340 was safe and showed dose related increase in lumbar spine bone marrow density. The intranasal route of administration may provide a more convenient alternative to subcutaneous teriparatide. Back to Top.

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