AMAG Pharmaceuticals Inc., of Cambridge, Mass., reported that deaths from its Phase III study of ferumoxytol as an intravenous treatment of iron deficiency anemia in patients with chronic kidney disease were lower for the treated group. Overall, 31 deaths occurred, and none were considered related to study treatment. The incidence of deaths following ferumoxytol treatment was lower (1.1 percent) than deaths following oral iron treatment (2.8 percent). For deaths that occurred within 30 days of the last study treatment, the incidence was also lower with ferumoxytol, and was 0.7 percent among ferumoxytol subjects compared to 1.4 percent among oral iron subjects.
AVEO Pharmaceuticals Inc., of Cambridge, Mass., has initiated a Phase Ib clinical trial for its lead product candidate, triple VEGF receptor inhibitor AV-951, in combination with the mTOR inhibitor temsirolimus (Torisel)). The open-label, sequential dose escalation study will evaluate the combination of AV-951 and temsirolimus in patients with metastatic renal cell carcinoma. It is the first of several combination trials to explore the potential use of AV-951 in in several different cancers, including colorectal, breast and lung cancers.
Kiadis Pharma, of Amsterdam, the Netherlands, successfully finalized its Rhitol Phase II clinical trial with the last patient completing its six-month treatment cycle. Rhitol is being evaluated as treatment for patients with extensive chronic graft-vs.-host disease intolerant or resistant to standard immunosuppressive treatment. Preliminary clinical results demonstrated an excellent safety profile and evidence of efficacy in the alleviation of symptoms, the company said, adding that it plans to file for a Phase III trial in the next few months.
Migenix Inc., of Vancouver, British Columbia, said it will add a 600-mg celgosivir combination therapy arm to its currently enrolling Phase II viral kinetics study in hepatitis C virus treatment-naïve patients. The purpose of that new arm is to assess that dosage of celgosivir, an oral alpha glucosidase I inhibitor, when combined with the standard of care (pegylated interferon plus ribavirin) vs. standard of care alone and to 400-mg celgosivir plus standard of care for up to 12 weeks of therapy. Results are expected in the third quarter.
Oncolytics Biotech Inc., of Calgary, Alberta, said it has met the initial criteria to proceed to full enrollment in its Phase II trial to evaluate the intravenous administration of Reolysin in patients with sarcomas that have metastasized to the lung. The trial protocol calls for a full enrollment of 52 patients, and Oncolytics had to demonstrate that at least one patient in the first 38 treated experienced a complete or partial response, or stable disease for greater than six months. The third patient treated in the study was demonstrated to have stable disease for more than six months as measured by CT scan. A PET scan taken at the same time showed that any residual mass was metabolically inert.
TargeGen Inc., of San Diego, started a Phase I/II trial of TG101348, an oral, selective inhibitor of JAK2, in patients with myeloproliferative diseases. The study is expected to enroll between 40 and 80 patients, with the primary goals to include identification of a maximum tolerated dose, accumulation of safety data, measurement of drug effect on surrogate markers, biomarkers and presumptive clinical endpoints. In preclinical models, TG101348 was shown to reduce cell populations expressing the V617F mutation in a dose-dependent manner without adversely affecting normal hematopoiesis.