• Apogenix GmbH, of Heidelberg, Germany, said it completed patient recruitment for a Phase II trial of APG101, an inhibitor of CD95 ligand, in glioblastoma. The 83-patient study is designed to test APG101 plus reirradiation vs. reirradiation alone, with a primary endpoint of progression-free survival at six months. Final results are expected in the first quarter of 2012.

• Bionomics Ltd., of Adelaide, Australia, said the higher dose level of 16 mg/m2 was cleared for BNC105, a vascular-disrupting agent that is being tested in a clinical trial in combination with mTOR inhibitor Afinitor (everolimus, Novartis AG) in patients with metastatic renal cell cancer. Patients in the trial now have received up to 14 cycles of combination treatment.

• Niiki Pharma Inc., of Hoboken, N.J., reported interim data from a Phase I study of NKP-1339 in patients with metastatic solid tumors resistant to standard therapies showing that six of the first 24 patients enrolled (25 percent) exhibited antitumor activity demonstrated by disease stability and/or tumor regression for at least 12 weeks. Of the responding six patients, one patient with carcinoid tumor has tumor regression and has continued on therapy for more than 70 weeks. NKP-1339 is a transferrin-targeted small molecule designed to down-regulate GRP78, a regulator of misfolded protein processing and a tumor survival factor.

• SanBio Inc., of Mountain View, Calif., opened a Phase I/IIa trial of SB623, a regenerative cell therapy consisting of cells derived from genetically engineered bone marrow stromal cells obtained from healthy donors, in patients suffering from disability following ischemic stroke. The study will enroll 18 patients who have suffered ischemic stroke within the past six months to 24 months and have motor neurological defects. It will measure safety and efficacy parameters, including improvements in motor function and cognitive status.

• Santarus Inc., of San Diego, said analysis of top-line safety data from a 12-month extended-use study in patients treated daily with either budesonide MMX 6 mg or placebo showed a similar frequency of treatment-related adverse events for both groups (21 percent to 21.3 percent) and no clinically meaningful differences in the numbers of patients with abnormal bone mineral density scans at baseline and end of the study between the budesonide and placebo groups. With those safety data, plus results from two Phase III studies, Santarus is planning a new drug application submission for budesonide for the induction of remission of mild or moderate active ulcerative colitis.

• TheraVasc Inc., of Cleveland, said it completed a Phase I trial testing TV1001 in two oral formulations – an enteric-coated and a nonenteric-coated capsule – with data showing few adverse events and no significant increase in methemoglobin levels. TV1001, an oral formulation of sodium nitrate, initially is in development as a treatment for diabetic patients with peripheral arterial disease. TheraVasc expects to complete Phase IIa trials in mid-2012.