• Advanced Magnetics Inc., of Cambridge, Mass., said the independent data monitoring committee providing oversight for the ferumoxytol Phase III iron replacement therapy program reviewed the cumulative safety data from the ferumoxytol Phase III studies and identified no safety concerns. The panel recommended the continuation of the ferumoxytol Phase III studies, testing the lead product for use as an intravenous therapeutic in chronic kidney disease patients, whether or not on dialysis. The company’s stock (AMEX:AVM) closed Tuesday at $24.69, up 18 cents.

• Advaxis Inc., of North Brunswick, N.J., said it was authorized to begin Phase I/II testing with its lead compound, Lovaxin C, a Listeria-based cancer vaccine designed to target cervical cancer caused by HPV infection. The first regulatory approval was received for Belgrade, Serbia, with approvals for Israel and Mexico anticipated shortly. Advaxis expects to announce data from those trials during the second half of the year.

• Aldagen Inc., of Durham, N.C., said the FDA cleared a study at the Texas Heart Institute at St. Luke’s Episcopal Hospital in Houston to test the company’s Aldesort, a product designed to isolate a stem cell population for therapy in advanced heart failure patients. During the study, doctors will use a special catheter to identify areas of the heart that have sustained mechanical and electrical damage, and then, with the same catheter, inject bone marrow cells directly into the muscle of the left ventricle along the periphery of the damaged area to restore blood flow to damaged tissues. The first pilot phase of the study will test the product’s safety in 10 patients.

• DeCode Genetics Inc., of Reykjavik, Iceland, said top-line results from Phase I studies of DG041, its developmental compound for treating peripheral artery disease, demonstrate safety and tolerability in a total of 196 healthy subjects, and showed a dose-dependent reduction in platelet aggregation after stimulation with collagen and sulprostone. The company said it is on track with plans to begin Phase II trials with DG041, a small molecule that has shown activity as an antagonist of the EP3 receptor for PGE2.

• Introgen Therapeutics Inc., of Austin, Texas, said data from a Phase I/II study of INGN 225 in patients with advanced lung cancer showed that 62 percent of evaluable patients demonstrated objective tumor response following treatment with INGN 225, a p53-based immunotherapy, and chemotherapy. Results were published in Clinical Cancer Research. INGN 225 also is being testing in a Phase I/II trial in breast cancer patients.

• ISTA Pharmaceuticals Inc., of Irvine, Calif., reported positive preliminary results from its Phase IIb trial of ecabet sodium, an eye drop designed to treat dry eye syndrome. Results showed a strong trend in efficacy with the low 3 percent dose in addressing corneal staining and blink rate, and also demonstrated trends in reducing symptomatology as measured by ocular surface disease index. Further analyses of the 162-patient study are ongoing.

• Memory Pharmaceuticals Corp., of Montvale, N.J., said preliminary cognitive data from the multiple-ascending dose study of its Phase I program of MEM 3454, a nicotinic alpha-7 agonist, demonstrated that a 15 mg dose, given once daily over 13 days, showed a statistically significant effect of the Quality of Episodic Secondary Memory, one of the primary efficacy variables. Memory anticipates evaluating MEM 3454 in central nervous system diseases, such as schizophrenia and Alzheimer’s disease, and plans to start a Phase IIa trial during the first half of this year.

• OSI Pharmaceuticals Inc., of Melville, N.Y., started a Phase IIa clinical trial with its glycogen phosphorylase inhibitor, PSN357, which the company is developing for Type 2 diabetes. PSN357 will be administered to up to 30 patients as daily doses over an initial period of 14 days providing safety, pharmacokinetic and pharmacodynamic endpoints in a placebo-controlled, dose-escalation design. The study is expected to last about six months.

• PSivida Ltd., of Perth, Australia, said three-year follow-up data from a trial of Retisert in diabetic macular edema concluded that significantly more patients receiving a Retisert implant had improved visual acuity of three or more lines compared to those receiving standard of care. Retisert, an implant that releases a constant amount of fluocinolone acetonide, is approved for the treatment of posterior uveitis, and is licensed to Rochester, N.Y.-based Bausch & Lomb and co-promoted by Basel, Switzerland-based Novartis AG. PSivida also is developing Medidur, a next-generation product designed as an injectable device to release the same drug as Retisert. Medidur is in Phase III trials in diabetic macular edema in collaboration with Alimera Sciences Inc., of Atlanta. In separate news, PSivida reported three-year follow-up data from its trial of Retisert in chronic, non-infectious posterior segment uveitis showing that the recurrence rate was significantly lower in eyes receiving the implant, compared to non-implanted eyes.

• Synthetic Blood International Inc., of Costa Mesa, Calif., said it expects to initiate its Oxycyte Phase II sickle-cell anemia trial during the second quarter of 2006, allowing time for the company to revise its clinical protocol at the request of the FDA. Synthetic Blood said it will work with FDA officials to satisfy all necessary requirements.

• Vical Inc., of San Diego, reported that an Ebola vaccine candidate administered using Vical’s DNA delivery technology was safe and well tolerated and produced both antibody and T-cell Ebola-specific responses in all healthy volunteers who received the full three vaccine doses during a Phase I study. The trial was sponsored by the National Institutes of Health, which nonexclusively licensed gene sequences used in Vical’s product. Results were presented at the American Society for Microbiology 2006 Biodefense Research meeting in Washington.

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