• Clinical Data Inc., of Newton, Mass., reported Phase I data showing that Stedivaze (apadenoson), a selective agonist of the adenosine A2A receptor subtype, demonstrated overall safety and tolerability in patients with asthma and chronic obstructive pulmonary disease (COPD). In an asthma study, Stedivaze treatment did not have any effects on pulmonary function and did not induce bronchoconstriction. Data from the COPD study also showed no effects on pulmonary function, and there appeared to be no association between severity of disease and the overall incidence or severity of treatment- emergent adverse events. Findings were presented at the American Society of Nuclear Cardiology meeting in Philadelphia and published in the Journal of Nuclear Cardiology.

• Enobia Pharma Inc., of Montreal, reported that its investigational drug ENB-0040 (asfotase alfa) for hypophosphatasia (HPP) resulted in radiographic improvement of rickets, improvement in muscle strength and agility, and amelioration of pain in six out of seven patients. ENB-040 is an enzyme replacement therapy given by subcutaneous injection. In the trial, it was given to 13 children between 5 and 12 years of age with rickets and gross motor deficits resulting from HPP. ENB-040 has orphan drug and fast-track status.

• Genta Inc., of Berkeley Heights, N.J., started a Phase II trial of tesetaxel in patients with advanced bladder cancer who have developed progressive disease after treatment with a single first-line regimen. The primary endpoint is overall response rate, with secondary endpoints evaluating durable response, disease control, progression-free survival and safety.

• Intarcia Therapeutics Inc., of Hayward, Calif., said final results of its 24-week, 155-patient, Phase II study of ITCA 650 (DUROS continuous subcutaneous delivery of exenatide) in Type II diabetes showed substantial reductions in HbA1c and body weight at all doses. Data were presented at the European Association for the Study of Diabetes meeting in Stockholm, Sweden. A treatment regimen involving a 20 mcg/day starting dose with a transition to 60 mcg/day after week 12 was selected for the Phase III trial, anticipated to start enrollment in early 2011.

• Movetis NV, of Turnhout, Belgium, began Phase III trials to expand the label of prucalopride (Resolor) to include male patients with chronic constipation. Resolor is currently labeled for women with chronic constipation who have failed laxatives. The 12-week trial will include 348 patients from nine European countries.

• Top-line results of a noninferiority trial for a cutaneous T-cell lymphoma (CTCL) therapy from Radnor, Penn.-based Yaupon Therapeutics Inc. showed that 59 percent of patients responded to therapy, vs. a 48 percent response with an active comparator. The trial enrolled 260 patients at 13 U.S. cancer centers. The therapy, a topical mechlorethamine gel is intended for patients in stages I through IIa of CTCL.