• Athersys Inc., of Cleveland, said the FDA cleared its investigational new drug application for MultiStem adult stem cells derived from bone marrow. The company plans to begin an open-label, Phase I, dose-escalation trial testing the drug following a bone marrow transplant conditioning regimen and hematopoietic stem cell transplantation in acute leukemia, chronic myeloid leukemia, or myelodysplasia.

• BiPar Sciences Inc., of Brisbane, Calif., said it has initiated a Phase II study with its lead PARP inhibitor, BSI-201, in patients with triple-negative breast cancer that do not express the estrogen, progesterone or HER2 receptors. The trial will enroll 120 women in a multicenter, randomized, open-label trial that will compare standard chemotherapy with and without the addition of BSI-201.

• Genta Inc., of Berkeley Heights, N.J., said that results of a Phase I study of G4544 in healthy volunteers has demonstrated that the compound was well tolerated and with oral bioavailability of the active ingredient, and an excellent safety profile without serious adverse reactions. G4544 is a new tablet formulation using delivery technology developed by Emisphere Technologies Inc., of Tarrytown, N.Y., that enables oral absorption of the active ingredient contained in Ganite (gallium nitrate) for injection, which is marketed by Genta and approved in the U.S. for treatment of cancer-related hypercalcemia that is resistant to hydration. Low doses of the active ingredient in Ganite administered by intravenous or subcutaneous injections have shown clinical activity in a range of skeletal diseases, including hypercalcemia, bone metastasis, Paget's disease and osteoporosis.

• ImClone Systems Inc., of New York, and Bristol-Myers Squibb Co., also of New York, said Erbitux (cetuximab) administered as a single-agent increased survival in a 572-patient, open-label, randomized Phase III trial of metastatic colorectal cancer patients refractory to chemotherapy. The results were published in the New England Journal of Medicine and showed median survival of 6.1 months with Erbitux compared to 4.6 months on best supportive care (p=0.005). Erbitux already is approved in that setting, but ImClone said it is the first time an antibody used as a single agent has improved survival in those patients, and the drug's label has been updated accordingly.

• Innovive Pharmaceuticals Inc., of New York, said the first patient has been treated in a pivotal Phase II clinical trial evaluating oral tamibarotene for refractory acute promyelocytic leukemia (APL), a type of acute myeloid leukemia. The trial will be conducted under a special protocol assessment granted by the FDA in August. In conjunction with data from Japanese studies, data from the pivotal study of tamibarotene are expected to form the basis of a new drug application, the firm said. The drug was approved in Japan in 2005 for treatment of recurrent APL. The trial, known as STAR-1, is an open-label, non-randomized, single-arm, multinational study of 50 adult patients with relapsed or refractory APL following treatment with ATRA and arsenic trioxide (Trisenox, Cephalon Inc.). Tamibarotene will be self-administered orally via tablets on an outpatient basis at a dose of 6 mg/m2 per day. The primary objective of the study is to determine the rate of durable complete response for tamibarotene therapy when administered as a single agent to adults.

• Introgen Therapeutics Inc., of Austin, Texas, said that summary data from clinical studies of Advexin confirmed and extended previous biomarker data correlating the abnormal p53 biomarker with increased tumor responses following treatment of the agent and supported its use as a biomarker to predict efficacy.

• Oramed Pharmaceuticals Inc., of Jerusalem, said it successfully completed animal studies as part of Phase Ib clinical trials for its oral insulin capsule. Those positive results follow the successful completion of a Phase Ia study in eight healthy volunteers. The Phase Ib study was intended to assess the optimization of dosage for the formulation of Oramed's proprietary oral insulin delivery technology. Oramed said it plans to move ahead with additional trials on human volunteers for the final formulation in the upcoming weeks.

• Sosei Group Corp., of Tokyo, said partner Novartis AG, of Basel, Switzerland, has started a Phase II safety study of QVA149, a combination of NVA237, a once-daily long-acting muscarinic antagonist and indacaterol, a beta-2 agonist, for the treatment of chronic obstructive pulmonary disease (COPD). The randomized, double-blind, placebo-controlled, multicenter study will determine the effect of QVA149 and indacaterol on mean 24-hour heart rate in patients with moderate to severe COPD.