• Aeolus Pharmaceuticals Inc., of Laguna Niguel, Calif., has begun a follow-on Phase I open-label compassionate use multiple-dose study of AEOL 10150 in a patient diagnosed with progressive and debilitating amyotrophic lateral sclerosis. The study is being conducted at UCLA and is designed to evaluate the safety and efficacy of AEOL 10150 in an ALS patient over an extended period of time. The patient will receive a subcutaneous injection of 75 mg AEOL 10150 two times each day for up to 24 weeks. Efficacy and safety data will be monitored in real-time for the duration of the study. The primary objective is to assess the clinical efficacy of AEOL 10150 with respect to the patient's baseline assessment of functional status.

• Antisoma plc, of London, started a Phase II trial evaluating the addition of AS1402 to the endocrine (hormonal) therapy letrozole in postmenopausal women receiving first-line treatment for advanced breast cancer. Approximately 110 patients will be assigned randomly to receive either letrozole plus AS1402 or standard treatment with letrozole alone. The safety of the AS1402-letrozole combination will be evaluated and its efficacy compared with that of letrozole alone. Final results are expected in 2010.

• ImClone Systems Inc., of New York, said the first patient has been treated in its Phase II trial of IMC-1121B in patients with advanced ovarian cancer. The compound is a fully human, IgG1 antivascular growth factor receptor-2 monoclonal antibody. The multicenter, open-label single-arm study is enrolling women with persistent or recurrent advanced ovarian, fallopian tube and primary peritoneal epithelial cancers following at least one platinum-containing chemotherapy regimen. Approximately 55 patients are expected to be enrolled.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., has begun a Phase III trial of its octreotide implant for acromegaly. The trial is designed to test the efficacy, safety and tolerability of the octreotide implant, which uses the company's Hydron Polymer Technology to deliver octreotide for six months. Octreotide is a synthetic peptide that mimics the natural hormone somatostatin to suppress release of growth hormone. Approximately 34 clinical sites in six countries are participating in the open-label Phase III trial of about 140 patients.

• PTC Therapeutics Inc., of South Plainfield, N.J., reported findings that demonstrated the utility of the six-minute walk test as a primary outcome measure in trials involving patients with Duchenne's muscular dystrophy (DMD). Results from an observational study showed that the six-minute walk test clearly differentiated boys with DMD from healthy boys and provided a reliable assessment of ambulatory function in boys as young as 5. Those data were reported at the International World Muscle Society Congress in Newcastle, UK. PTC said those results supported the design of the company's ongoing Phase IIb trial of PTC124 in DMD, which uses the walk test as the primary outcome measure. PTC124 also is being evaluated in a long-term extension study open to boys who participated in an earlier Phase IIa trial. The drug has orphan status in both the U.S. and Europe and is partnered with Cambridge, Mass.-based Genzyme Corp.

• VaxInnate Corp., of Cranbury, N.J., said its second influenza vaccine candidate entered the clinic. The Phase I study is designed to produce information about the safety and immunogenicity of the hemagglutinin-flagellin flu vaccine candidate. The study is taking place at the University of Rochester in New York. Results are expected in early 2009.