• Addrenex Pharmaceuticals Inc., of Durham, N.C., initiated a double-blind, placebo-controlled, dose-ranging Phase II trial of ADX415 for hypertension. ADX415 is an alpha-2 adrenergic receptor agonist partnered with Sciele Pharma Inc., a division of Osaka, Japan-based Shionogi & Co. Ltd. (See BioWorld Today, Dec. 31, 2007.)

• Auspex Pharmaceuticals Inc., of Vista, Calif., reported positive results from its Phase I trial of SD-254, a selective serotonin-norepinephrine reuptake inhibitor. The product, a deuterium-substituted version of venlafaxine, is being developed for the treatment of major depressive disorder. In the study of 16 healthy volunteers, SD-254 exhibited a pharmacokinetic profile that appears to be superior to that of venlafaxine and consistent with that required for increasing safety and reducing side effects relative to existing therapies, while maintaining high patient response rates.

• Biogen Idec Inc., of Cambridge, Mass., said Phase IIb data showed that a 240-mg three-times-daily dosage of BG-12 (dimethyl fumarate) reduced the number of new gadolinium enhancing (Gd+) lesions by 69 percent in patients with relapsing-remitting multiple sclerosis compared with placebo. The firm said data also showed a 53 percent reduction in the mean number of T1-hypointense lesions and a 44 percent reduction in cumulative new Gd+ lesions in patients treated with BG-12 compared with placebo. The presence of Gd+ lesions is thought to indicate continuing inflammatory activity within the central nervous system. T1-hypointense lesions are associated with significant breakdown and loss of brain tissue. The Phase IIb results were published in the Oct. 25, 2008, issue of The Lancet.

• Columbia Laboratories Inc., of Livingston, N.J., said the Perinatology Research Branch of the National Institutes of Child Health and Human Development will combine its planned clinical trial of Prochieve 8 percent progesterone gel with the company's ongoing Phase III trial of the drug in the prevention of preterm birth. A previous Phase III study failed. Columbia's shares (NASDAQ:CBRX) fell 25 cents, or 18.4 percent, to close at $1.11 on Thursday. (See BioWorld Today, Feb. 6, 2007.)

• Cytochroma Inc., of Markham, Canada, initiated a Phase II trial of CTA018 Injection in secondary hyperparathyroidism (SHPT) patients with chronic kidney disease (CKD). The trial is an open-label, dose-escalating pharmacokinetic, pharmacodynamic, efficacy and safety study of CTA018 Injection in CKD patients with SHPT undergoing hemodialysis.

• DUSA Pharmaceuticals Inc., of Wilmington, Mass., said it is stopping development of Levulan PDT in combination with BLU-U light for moderate to severe acne, causing shares to fall Thursday. The study did not meet the company's goal to demonstrate a 20 percent difference between the Levulan and the control groups. DUSA will continue to support independent investigator-initiated studies in moderate to severe and cystic acne using Levulan with other various treatment regimens and will consider further clinical development if warranted. Dusa's stock (NASDAQ:DUSA) fell 42 cents, or 28.8 percent, to close Thursday at $1.04.

• Genzyme Corp., of Cambridge, Mass., and its partner, Bayer HealthCare Pharmaceuticals Inc., of Wayne, N.J., said Phase II results showed that patients with early relapsing-remitting multiple sclerosis taking once-yearly cycles of alemtuzumab reduced their risk of relapse by 74 percent and the risk of sustained accumulation of disability by 71 percent compared with patients treated with Rebif (high-dose interferon beta-1a), which is marketed by EMD Serono Inc., of Rockland, Mass. The firms noted that the mean disability of patients on alemtuzumab improved from baseline, whereas the mean disability of those on Rebif worsened. In addition, the companies said that the treatment benefits of alemtuzumab were sustained for at least three years, even though the majority of alemtuzumab-treated patients were last dosed two years earlier. The final three-year analysis results of the 334-patient Phase II study were reported in the Oct. 23, 2008, issue of the New England Journal of Medicine.

• HUYA Bioscience International LLC, of San Diego, and Chipscreen Biosciences Ltd., of Shenzhen, China, said a Phase I trial of Chidamide (HBI-8000) demonstrated best-in-class pharmacokinetics, biomarker and safety profiles, as well as activity against T-lymphoma and other tumor types. The compound is an orally bioavailable histone deacetylase inhibitor owned by Chipscreen in China and by HUYA elsewhere. A Phase II/III lymphoma trial in China and a Phase I cancer trial in the U.S. are scheduled to begin in early 2009.

• Mpex Pharmaceuticals Inc., of San Diego, presented clinical and preclinical data on MP-376, its aerosol formulation of levofloxacin for cystic fibrosis and chronic obstructive pulmonary disease. In a Phase Ib CF study, the drug was well tolerated at all doses and activity was indicated by a reduction in P. aeruginosa counts and improvements in lung function. A Phase II trial is under way. Data were presented at the North American Cystic Fibrosis Conference.

• Néovacs S/A, of Paris, a spin-off from the Pierre & Marie Curie University in Paris, started a Phase I/II study at three study centers in South Africa of its TNF-alpha-kinoid, a therapeutic vaccine for the treatment of TNF-alpha-dependent auto-immune diseases such as rheumatoid arthritis, Crohn's disease and psoriasis. It is the first administration in humans of a kinoid, with the first results expected in 2009.

• NeuroSearch AS, of Ballerup, Denmark, said results of a Phase II proof-of-concept study showed that its obesity compound tesofensine produced a weight loss twice that of currently approved obesity drugs. Tesofensine is designed to inhibit the presynaptic uptake of the neurotransmitters noradrenaline, dopamine and serotonin in the brain. Patients in the randomized, placebo-controlled Phase II study were prescribed a limited-energy diet and assigned to once-daily dosages of tesofensine 0.25 mg (52 patients), 0.5 mg (50 patients), 1 mg (49 patients) or placebo (52 patients) for 24 weeks. The primary outcome was percentage change in body weight. A total of 161 patients completed the study, and mean weight loss recorded for placebo and diet was 2.2 kg and for tesofensine 0.25 mg, 0.5 mg and 1 mg was 6.7 kg, 11.3 kg, and 12.8 kg, respectively.

• Newron Pharmaceuticals SpA, of Milan, Italy, reported positive results from its Phase II study of HF0220 in patients with mild to moderate Alzheimer's disease (AD). Data from the 28-day pilot study indicated that HF0220 in the dose range indicated was very well tolerated and could not be differentiated from placebo. Based on its mechanism of action and safety profile in AD patients, the company said, HF0220 may have synergistic effects in combination with currently marketed anti-dementia drugs.

• Novexel SA, of Paris, reported positive results from its Phase II trial of NXL103 in community-acquired pneumonia. The complete results from that trial will be published in the first half of 2009. NXL103 is an oral streptogramin antibiotic that has shown in vitro activity against certain Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus, as well as against respiratory pathogens including penicillin-, macrolide- and quinolone-resistant strains.

• Opexa Therapeutics Inc., of The Woodlands, Texas, provided additional data from the company's Phase IIb TERMS (Tovaxin for Early Relapsing Multiple Sclerosis) trial in multiple sclerosis, which missed its endpoint earlier this year. The additional data showed a statistically significant improvement in disability, as measured by the Expanded Disability Status Scale, in Tovaxin-treated patients compared to those receiving placebo. Opexa expects to conduct a Phase II close-out meeting with the FDA during the first half of 2009 to discuss next steps for the further clinical development of Tovaxin. The company also is actively engaged in discussions with potential strategic partners for the Tovaxin program. (See BioWorld Today, Sept. 23, 2008.)

• Oramed Pharmaceuticals Inc., of Jerusalem, said it received approval from the South Africa Medicines Control Council to begin Phase Ia trials on eight healthy human volunteers for ORMD 0802, the company's insulin suppository.

• SkyePharma plc, of London, said results of a Phase III study met the primary endpoint, showing statistically significant differences in the levels of improvement of forced expiratory volume in the first second in adolescent and adult patients with moderate to severe asthma who received Flutiform (fluticasone-formoterol) compared with two different formulations of fluticasone alone. The firm said the 438-patient, 12-week SKY2028-3-005 trial is the last Phase III clinical efficacy study the firm will conduct before seeking marketing approval.