• CorMedix Inc., of Bridgewater, N.J., completed patient enrollment in its Phase II CI-AKI (Contrast Induced Acute Kidney Injury) study of CRMD001. The trial is designed to test safety and efficacy of the drug on biomarkers of acute kidney injury and kidney function. CorMedix expects to report final results before year-end. CRMD001 is a formulation of oral iron chelator deferiprone.

• D-Pharm Ltd., of Rehovot, Israel, said the protocol for its ongoing Phase III study of neuroprotective candidate DP-b99, published in the International Journal of Stroke, calls for the evaluation of safety and therapeutic effects of intravenous 1 mg/kg/day DP-b99, initiated within nine hours of stroke onset in patients with moderately severe hemispheric acute ischemic stroke, as the primary objective. The primary efficacy outcome is the mRS score at day 90. The study, dubbed MASCI (Membrane Activated Chelator Stroke Intervention), will enroll 770 patients and is being conducted under a special protocol assessment with the FDA.

• ImmunoGen Inc., of Waltham, Mass., said Bayer HealthCare Pharmaceuticals, a unit of Berlin-based Bayer AG, filed an investigational new drug application for TAP (Targeted Antibody Payload) candidate BAY 94-9393, triggering a $2 million milestone payment to ImmunoGen. That compound emerged from the companies' collaboration involving ImmunoGen's TAP technology to develop cancer drugs targeting mesothelin. Under the terms, ImmunoGen could received milestones of up to $170.5 million for each program, plus royalties on sales.

• Neuralstem Inc., of Rockville, Md., said the safety monitoring board unanimously approved advancing the ongoing Phase I trial of the company's spinal cord stem cells in amyotrophic lateral sclerosis patients to transplantation in the cervical region. The next three patients, all of whom are ambulatory, will each receive five injections, unilaterally, in the cervical spinal cord. The FDA also must approve the trial's advancement to the next level of transplantations. Neuralstem said it anticipates presenting data from the first 12 patients who received injections in the lumbar region of the spine only to the FDA in the near future.

• Neurelis Inc., of San Diego, said results of a randomized, crossover pilot study in healthy volunteers showed a similar bioavailability of NRL-1, its intranasal diazepam, compared to intravenous administration. NRL-1 also was well tolerated, with only mild adverse events reported.

• Orexo AB, of Uppsala, Sweden, reported data from the first OX27 pharmacokinetic trial showing that three different doses, administered to healthy subjects, indicated that the active pharmaceutical ingredient in the sublingual tablet was rapidly absorbed and subsequently eliminated, rendering the product suitable for treating breakthrough cancer pain. Orexo plans to initiate and complete the next clinical study in healthy volunteers in the fourth quarter of this year.

• QRxPharma Ltd., of Sydney, Australia, completed Study 022, an exploratory Phase III study comparing the tolerability and safety profile of MoxDuo IR to equi-analgesic doses of either morphine or oxycodone alone, with data showing that MoxDuo effectively reduced pain with less respiratory depression.

• Sangart Inc., of San Diego, started a Phase IIb study of MP4OX, an oxygen therapeutic agent, plus standard of care in severely injured trauma patients with lactic acidosis due to hemorrhagic shock. About 360 patients will be enrolled, and the primary objective is to measure the proportion of patients discharged alive from the hospital, as well as a number of secondary endpoints, including lactic acidosis resolution.

• Tengion Inc., of East Norriton, Pa., said it is working to collect additional clinical data while modifying the surgical approach for future implants for the Phase I trial with its Neo-Urinary Conduit candidate in patients with bladder cancer who have had cystectomies. The firm expects to submit those data and changes to the FDA in the third quarter, prior to enrolling additional patients in the trial.

• TWi Biotechnology Inc., of Taipei, Taiwan, said the company enrolled more than 50 percent of the total 240 patients for its Phase IIb trial of AC-201 in Type II diabetes. The study is designed primarily to evaluate the HbA1c-lowering effects, while the cardiovascular safety profile will be monitored according to FDA guidance. AC-201 is an oral small molecule aimed at modulating the transcriptional cytokine synthesis of IL-1 beta and IL-1RA.