• Arrowhead Research Corp., of Pasadena, Calif., said the FDA approved the investigational new drug application submitted by its majority-owned subsidiary Insert Therapeutics Inc. Under the IND, Insert will conduct a Phase I study for IT-101, its first anticancer therapeutic, at the City of Hope in Duarte, California. IT-101 is a nanotechnology-based therapeutic that combines Insert’s patented Cyclosert technology and the anticancer compound camptothecin.

• Avicena Group Inc., of Palo Alto, Calif., disclosed results from a Phase II study designed to evaluate whether further study is warranted for PD-02 and the antibiotic minocycline as potential treatments for Parkinson’s disease. Data showed neither PD-02 nor minocycline was found to be futile as compared to predetermined thresholds, suggesting both agents may be worthy of further consideration. Results were published in Neurology.

• Cerexa Inc., of Alameda, Calif., said the FDA granted fast-track designation to PPI-0903, a next-generation, broad-spectrum, cephalosporin antibiotic, for complicated skin and skin-structure infections caused by methicillin-resistant Staphylococcus aureus. Cerexa started a Phase II trial in October.

• Dynogen Pharmaceuticals Inc., of Waltham, Mass., started a Phase II trial of DDP225 in patients with chronic functional vomiting, and the first patients have been dosed. This Phase II trial is a randomized, double-blinded, placebo controlled study that is assessing multiple symptom-based endpoints at multiple U.S. sites. CFV is the second clinical indication for DDP225, an orally active compound that targets two key pathways that control the gastrointestinal system. Dynogen started a Phase II trial with the compound in patients with diarrhea-predominant irritable bowel syndrome in October.

• Enzo Biochem Inc., of Farmingdale, N.Y., said its wholly owned subsidiary Enzo Therapeutics started a Phase II trial to evaluate its immunomodulatory candidate drug EGS21 as a therapeutic for managing Crohn’s disease. The study is being conducted at Hebrew University Hadassah Medical Center where subject enrollment is proceeding.

• GeoVax Inc., of Atlanta, said the FDA approved its investigational new drug application to begin clinical testing of its AIDS vaccines. The trials will be designed to administer two doses of the company’s DNA vaccine to prime the immune response, followed by two doses of its recombinant MVA vaccine to boost immune response. Trials are expected to begin in April.

• Neurotech, of Lincoln, R.I., said findings from its Phase I study of NT-501 for the treatment of retinitis pigmentosa showed that the product is well tolerated and demonstrated an improvement in visual acuity for three of the seven patients involved in the trial. Results were published in the Proceedings of the National Academy of Sciences. NT-501 is based on Neurotech’s Encapsulated Cell Technology and is designed as an intraocular, polymer implant containing human retinal pigment epithelial cells genetically modified to secrete ciliary neurotrophic factor.

• NitroMed Inc., of Lexington, Mass., reported that a post-approval analysis of the African-American Heart Failure Trial by gender demonstrated that taking BiDil (isosorbide dinitrate/hydralazine hydrochloride) produced similar positive clinical outcomes in both black men and black women who also were on standard heart failure therapy. Those results were presented at the 2006 American College of Cardiology meeting in Atlanta.

• Renovis Inc., of South San Francisco, said preliminary results from the Phase IIb CHANT trial of NXY-059 in acute intracerebral hemorrhage (ICH) showed that the safety and tolerability of the drug was similar to placebo, and both groups had a comparable, 20 percent mortality rate and no difference in stroke outcomes after ICH, a secondary endpoint. CHANT involved 603 patients who were randomized to receive 72 hours of intravenous infusion of NXY-059 or placebo within six hours of ICH onset. NXY-059 also is in two Phase III trials, called SAINT I and SAINT II, and Renovis’ partner, London-based AstraZeneca plc, plans to file regulatory submissions in the U.S. and Europe in the first half of 2007.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., filed with the FDA an investigational new drug application for EOquin for use in superficial bladder cancer. The product has undergone several studies in Europe, including a Phase II trial that demonstrated it had good tolerance and a durable, high complete response rate of 67 percent. The U.S. clinical study program will begin with a small pilot study of EOquin given in an adjuvant setting, after transurethral resection, and will continue with a randomized, controlled Phase III study.

• SuperGen Inc., of Dublin, Calif., said researchers at the Cleveland Clinic and Memorial Sloan Kettering Cancer Center demonstrated higher response rates and similar or less toxicity using a three-drug combination therapy of pentostatin, cyclophosphamide and rituximab for previously treated patients with chronic lymphocytic leukemia or other low-grade B-cell neoplasms. The data were published in an online article that also will appear in the April 2006 issue of Journal of Clinical Oncology. SuperGen’s product Nipent (pentostatin for injection) is approved as a single-agent treatment for patients with hairy-cell leukemia.

• Surface Logix Inc., of Boston, started a company-sponsored Phase I trial for SLx-4090, a novel microsomal triglyceride transfer protein inhibitor targeting dyslipidemia.

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