• Cell Genesys Inc., of South San Francisco, disclosed final data from its second multicenter Phase II trial of GVAX immunotherapy for prostate cancer, which evaluated escalating doses of the immunotherapy in 80 patients with metastatic hormone-refractory prostate cancer. Additional follow-up of the 22 patients who received the dose that is comparable to that being employed in the company's ongoing Phase III program indicated that the median survival is 35 months. Four patients withdrew consent to further follow-up and were censored in the analysis. The company's stock (NASDAQ:CEGE) jumped $1.39, or 32.3 percent, to close at $5.70.

• Genelabs Technologies Inc., of Redwood City, Calif., reached an agreement with the FDA on a special protocol assessment for a Phase III clinical trial of Prestara for the treatment of lupus. Prestara is an oral drug that contains as the active ingredient highly purified prasterone, the synthetic equivalent of dehydroepiandrosterone, or DHEA, a naturally occurring hormone and the most abundant adrenal hormone in humans.

• LigoCyte Pharmaceuticals Inc., of Bozeman, Mont., started a Phase I trial with its investigational Norovirus vaccine at the University of Maryland Medical Center. The study will assess safety and immunogenicity of the intranasally-delivered, dry powder vaccine in healthy adults.

• NanoBio Corp., of Ann Arbor, Mich., began enrolling patients in a Phase II trial of NB-002, a topical treatment for onychomycosis, a fungal infection of the fingernail and toenail. The randomized, double-blind, placebo-controlled study at 25 sites in North America is designed to enroll about 1,000 patients.

• NicOx SA, of Sophia Antipolis, France, initiated the second pivotal Phase III trial of naproxcinod, in patients with osteoarthritis of the knee. The 302 Study is expected to enroll 1,020 patients at 120 clinical centers in the U.S. The study is designed to measure pain, function and disease status vs. placebo. Secondary endpoints include an efficacy comparison vs. naproxen at 26 weeks, and patients' blood pressure measurements. The first trial in the Phase III program produced positive results. The third pivotal study in the program will assess naproxcinod's efficacy and safety in patients with osteoarthritis of the hip. It is expected to begin this quarter. The product is from the COX-inhibiting nitric oxide-donating class.

• Opexa Therapeutics Inc., of The Woodlands, Texas, disclosed positive top-line data from an open-label Phase I/II dose-escalation trial of the T-cell vaccine, Tovaxin, for multiple sclerosis. In the one-year, 10-subject trial, Tovaxin therapy was shown to be safe and produce a 90 percent reduction (p=0.0039) in annualized relapse rates. Enrollment is under way in the Phase IIb TERMS trial, a 150-patient, randomized, double-blind, placebo-controlled study to evaluate Tovaxin T-cell vaccination in patients with clinically isolated syndrome and relapsing-remitting MS. Enrollment is expected to be completed by midyear.

• Repros Therapeutics Inc., of The Woodlands, Texas, disclosed final data from a Phase II study with oral Proellex for symptoms of uterine fibroids. The study suggested that treatment with Proellex results in a statistically highly significant improvement in symptoms associated with uterine fibroids and is generally well tolerated. The 12-week, double-blind study compared two doses of Proellex, 12.5 mg and 25 mg, to placebo. The study's primary endpoint was reduction in excessive menstrual bleeding, a common symptom of uterine fibroids.

• Theravance Inc., of South San Francisco, and GlaxoSmithKline plc, of London, disclosed results of two studies in their Phase IIb program of the investigational bronchodilators GSK642444 and GSK159797, long-acting beta2 agonist compounds from their Beyond Advair collaboration. Both showed clinically significant increases in bronchodilation at least equivalent to salmeterol given twice daily. Both compounds exhibited a pharmacodynamic profile similar to other inhaled LABAs, with little impact on heart rate. The goal of the collaboration is to develop a once-a-day inhaled medicine comprised of a LABA and a corticosteroid for treating asthma and chronic obstructive pulmonary disease.

• Viventia Biotech Inc., of Toronto, began patient treatment in its open-label Phase II trial of the armed antibody Vicinium, administered using intravesical instillation for the treatment of locally persistent non-invasive bladder cancer. The trial will enroll about 30 patients with locally persistent, non-invasive Tis bladder cancer. The primary clinical endpoint will be overall response rate assessed using histology of biopsy samples and urinary cytology. A goal is to substantially reduce or eliminate the need for surgical resection or removal of the bladder. Enrollment is expected to be completed in the fourth quarter.

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