• AVEO Pharmaceuticals Inc., of Cambridge, Mass., said data from an expanded Phase I trial of the triple VEGF inhibitor AV-951 demonstrated that all nine patients with refractory renal cell carcinoma achieved a partial response or stable disease after treatment. The company initiated a 200-patient, placebo-controlled Phase II trial of the drug in metastatic renal cell carcinoma with co-primary endpoints of objective response rate and progression-free survival.

• Banyan Biomarkers Inc., of Gainesville, Fla., initiated a clinical trial to prove the effectiveness of its protein biomarkers in detecting traumatic brain injury. Banyan developed a panel of biomarkers that will be tested in blood and cerebrospinal fluid samples from more than 200 patients, and, if positive, those results will be submitted to the FDA as a feasibility study in preparation for a subsequent pivotal trial. The company is developing the biomarkers for use as in vitro diagnostic blood tests for detecting brain injury.

• CombinatoRx Inc., of Cambridge, Mass., initiated a Phase IIa trial of CRx-191 (nortriptyline-mometasone) in psoriasis. The trial will compare topical CRx-191 to each of its component ingredients and placebo. The primary endpoint is reduction from baseline in psoriatic infiltrate as measured by ultrasound.

• Cytori Therapeutics Inc., of San Diego, said an investigator-initiated study is being conducted in Japan with its Celution System. The 20-patient study will utilize adult stem cells derived from each patient's liposuctioned fat to augment fat transplanted to their breasts. Cytori anticipates commercializing the Celution System in Japan in 2008 and is sponsoring two postmarketing studies in breast reconstruction.

• MacroChem Corp., of Wellesley Hills, Mass., said interim data from an open-label Phase II study showed that EcoNail treatment caused an improvement in 54 percent of onychomycosis patients. The improvement was clinically significant in 32 percent of patients, and all patient cultures were negative for dermatophyte growth. The study will be completed next year. EcoNail is a topical antifungal containing econazole and MecroChem's SEPA enhancer.

• Metastatix Inc., of Atlanta, said the FDA accepted its investigational new drug application for MSX-122, a CXCR4 inhibitor, which the company anticipates moving into Phase I testing in solid tumors. In preclinical studies, MSX-122 displayed a favorable pharmacodynamic and safety profile, while inhibiting the function of the CXCR4 chemokine receptor, and might have potential in several indications including various cancers and inflammatory diseases.

• Neurotech Pharmaceuticals Inc., of Lincoln, R.I., completed enrollment in three ongoing trials of NT-501: a 60-patient Phase II/III trial in early stage retinitis pigmentosa, a 60-patient Phase II/III trial in late-stage retinitis pigmentosa; and a 48-patient Phase II trial in dry age-related macular degeneration. Data are expected by the end of 2008. NT-501 is an intraocular polymer implant containing Ciliary Neurotrophic Factor.

• Poniard Pharmaceuticals Inc., of South San Francisco, said preliminary Phase I data showed that oral picoplatin had 30 percent to 40 percent oral bioavailability in advanced cancer patients. Additional Phase I data will be presented in 2008. An intravenous formulation of the platinum chemotherapy agent is in Phase II trials.

• Sangamo BioSciences Inc., of San Diego, reported additional Phase Ib data from its ZFP Therapeutic program, showing statistically significant improvements in quantitative measurements of neurological health in subjects with diabetic neuropathy, which suggested an alteration of disease progression. Results showed that a single treatment with SB-509, a formulation of a zinc finger DNA-binding protein transcription factor (ZFP TF), might increase the mobilization of stem cells into a subject's blood and that those circulating stem cells might have implications for the nerve regeneration and nerve and blood vessel growth that have been reported from SB-509 treatment. Sangamo plans to move the product into a Phase II trial in the first quarter of 2008 in patients with mild to moderate diabetic neuropathy.

• Teva Pharmaceutical Industries Ltd. and Gamida-Cell Ltd., both of Jerusalem, treated the first patient in the pivotal trial of StemEx, a graft of expanded stem cells and progenitor cells derived from cord blood. The single-arm study is evaluating StemEx as a treatment for hematological malignancies, including leukemia and lymphoma, and received a special protocol assessment clearance last year. (See BioWorld Today, Nov. 3, 2006.)