• Aspireo Pharmaceuticals Ltd., of Tel Aviv, Israel, reported results of a Phase II study in acromegaly patients showing that Somatoprim, its somatostatin analogue, demonstrated a dose-dependent effect on lowering excess growth hormone in treatment-naïve patients. No serious adverse events were reported, and the reported adverse events were mild to moderate and transient in nature. The trial was designed to test single-ascending doses of Somatoprim in up to 20 patients.

• Cellular Biomedicine Group, of Palo Alto, Calif., has started a Phase I study testing its HaMPC (human adipose-derived mesenchymal progenitor cells) therapy for knee osteoarthritis. The open-label study will test the safety and efficacy of intra-articular injections of the autologous treatment in order to reduce inflammation and regenerate damaged joint tissue.

• Erytech Pharma SA, of Lyon, France, said it received clearance of its investigational new drug application for a Phase I trial of Eryasp (L-asparagainase-loaded erythrocytes) in patients 40 years and older with newly diagnosed acute lymphoblastic leukemia. The company plans to start enrolling in the study in the second half of this year. Eryasp has orphan designation in both the U.S. and Europe.

• GlobeImmune Inc., of Louisville, Colo., said it started a Phase II trial at the National Cancer Institute (NCI) to evaluate Tarmogen candidate GI-6207 in subjects with medullary thyroid cancer. The trial is expected to enroll a total of 34 patients in a crossover design, with patients treated either with the drug for one year to be observed for six months and then treated with GI-6207 for one year. The primary endpoint is the effect of GI-6207 on changes in calcitonin levels after six months of treatment vs. observation. GI-6207 is being developed as part of a Collaborate Research and Development Agreement between NCI and GlobeImmune.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said it started a Phase I study of ISIS-APOARx, an antisense drug targeting apolipoprotein(a) for the treatment of atherosclerosis. The dose-escalation trial will enroll about 56 healthy volunteers and will assess safety, tolerability and pharmacokinetics of both single and multiple doses. ISIS-APOARx is designed to reduce lipoprotein(a), or Lp(a), by inhibiting the production of apolipoprotein(a). Isis plans to develop the drug to treat patients with high Lp(a) levels who are at high risk of experiencing cardiovascular events.

• Novavax Inc., of Rockville, Md., said top-line data from its Phase II dose-ranging study testing its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age hit its protocol-specified objectives, supporting progression to the next stage of advanced clinical testing. The study tested two dose levels of the RSV F protein nanoparticle vaccine candidate with and without aluminum phosphate as an adjuvant and enrolled 330 women to receive either one or two intramuscular injections of a single-dose of vaccine or placebo, at study day 0 and day 28. Data showed the vaccine was well tolerated and, overall, the immune responses observed were similar to or exceeded immune responses seen in Phase I testing. The trial is being conducted in collaboration with the nonprofit organization PATH, which committed about $2 million in support.

• Prana Biotechnology Ltd., of Melbourne, Australia, said about 37 percent of patients across two trials in Alzheimer's and Huntington's diseases have been dosed to six months or longer with PBT2, twice the duration of the previous Phase II Alzheimer's trial. The drug has been well tolerated and both trials are on schedule. Each independent data safety monitoring board recommended that each trial continue as planned.