• Astex Pharmaceuticals Inc., of Dublin, Calif., said it started the Phase II dose-expansion segment of its trial testing SGI-110, a hypomethylating agent, in patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML), enrolling treatment-native MDS and elderly AML patients (65 or older). The trial segment includes expansion of the total number of patients to about 90, and they will be treated on the five-day subcutaneous dosing schedule to evaluate the drug's safety and efficacy.

• Cellceutix Corp., of Beverly, Mass., said the FDA completed the review of its investigational new drug application for small-molecule cancer drug Kevetrin and cleared the drug to begin Phase I trials.

• Genentech Inc., of South San Francisco, part of the Roche Group, said patients with HER2-positive metastatic breast cancer lived significantly longer when treated with the combination of Perjeta (pertuzumab), Herceptin (trastuzumab) and docetaxel chemotherapy, compared to Herceptin and docetaxel chemotherapy alone in the Phase III CLEOPATRA study. Overall survival was a secondary endpoint in the study, which previously met its progression-free survival primary endpoint. Perjeta gained approval for use in combination with Herceptin and docetaxel in patients with HER2-positive metastatic breast cancer earlier this month in the U.S. and is under review in Europe. (See BioWorld Today, June 12, 2012.)

• Genkyotex SA, of Geneva, said it completed a Phase Ia study showing that GKT137831 , an inhibitor of NOX1 and NOX4 enzymes, is safe and well tolerated following oral administration of single doses in 36 healthy subjects. Pharmacokinetic analysis demonstrated good dose-proportional exposure to the drug and confirmed that once-daily or twice-daily dosing is a suitable regimen for further studies. A multiple-dose Phase Ib study is under way.