• AlphaCore Pharma Inc., of Ann Arbor, Mich., initiated a Phase I trial of ACP-501 in patients with stable coronary arterial disease. The trial, to be conducted by the National Institutes of Health, will assess the safety, tolerability, pharmacokinetics and lipid effects of ACP-501. The drug is being developed as a treatment for high-risk atherosclerosis and serious lipid metabolism disorders.

• ImmunoGen Inc., of Waltham, Mass., initiated Phase II testing of IMGN901 as a first-line treatment of small-cell lung cancer (SCLC). The NORTH trial will evaluate whether the addition of IMGN901, which targets CD56-expressing cancer cells, to standard first-line care for SCLC meaningfully impacts the duration of progression-free survival. The trial is expected to enroll 120 patients, all of whom will receive up to six cycles of carboplatin plus etoposide (C/E). Two-thirds of the patients will be randomized to also receive IMGN901. Those patients can elect to remain on IMGN901, as monotherapy, after completion of the C/E cycles. Trial findings will be compared with historic controls, with the control arm serving to verify consistency with historical results. ImmunoGen plans to use a six-month interim analysis to guide certain development decisions. IMGN901 has been granted orphan drug designation for SCLC in Europe and the U.S.

• The drug ibrutinib (PCI-32765), in development by Pharmacyclics Inc., of Sunnyvale, Calif., and Janssen Research and Development LLC, a unit of Johnson & Johnson, showed significant anti-cancer responses and modest side effects in a pilot trial in the activated B-cell form of diffuse large B-cell lymphoma. Subjects received 560 mg daily until progression of the disease. There were multiple responses and some complete remissions.

• Portola Pharmaceuticals Inc., of South San Francisco, started enrollment of patients in its pivotal Phase III APEX study, which is evaluating betrixaban, an oral, once-daily Factor Xa inhibitor, for hospital and post-discharge prevention of venous thromboembolism (VTE) in high-risk acute medically ill patients. The company recently raised $89 million to fund the trial. If betrixaban is approved, it will be Portola's first marketed product with an estimated patient population of 20 million. (See BioWorld Today, Nov. 22, 2011.)