• Clavis Pharma ASA, of Oslo, Norway, said it will expand its pivotal Phase III trial, dubbed CLAVELA, testing elacytarabine in patients with late-stage acute myeloid leukemia in order to improve the chances of success. The firm will increase the statistical power of the study from 80 percent to close to 90 percent and amend the inclusion criteria to allow patients older than 65 with disease of poor prognosis after only one previous treatment cycle. The primary endpoint of survival now will be evaluated after 300 events vs. 250 events, and the trial is expected to enroll about 400 patients. Clavis anticipates top-line data in the fourth quarter of 2012.

• Emergent BioSolutions Inc., of Rockville, Md., said results from a Phase Ia trial of BioThrax, its anthrax vaccine adsorbed, with CPG 7909 adjuvant mixed at bedside generated peak antibody responses that were sixfold higher than those generated by BioThrax alone. The 69-subject study demonstrated that BioThrax plus CPG 7909 also accelerated the time to reach the peak immune response seen following BioThrax vaccination by three weeks. Both of those findings were statistically significant (p < 0.001). Data were published in Vaccine.

• Medistem Inc., of San Diego, filed a response to the FDA's clinical hold for its Phase I trial application seeking to treat 10 patients with critical limb ischemia who have no options but amputation with the company's universal donor endometrial regenerative cells (ERCs). Since the agency placed the clinical hold in 2009, Medistem has published four peer-reviewed publications containing new data regarding endometrial-derived adult stem cells, while independent groups have published data on cells similar to Medistem's ERCs showing that they induced benefit in animal models of heart failure, Parkinson's disease, diabetes and stroke.