• AEterna Zentaris Inc., of Quebec City, and Spectrum Pharmaceuticals Inc., of Irvine, Calif., said Phase II results demonstrated that ozarelix, a luteinizing hormone-releasing hormone antagonist, achieved its primary goal of determining that a dose of 130 mg administered intramuscularly every four weeks during a three-month test period ensured continuous suppression of testosterone at castration level in patients with hormone-dependent, inoperable prostate cancer. Data showed the drug also achieved the time for onset of action, with all patients reaching those testosterone levels within two days of dosing. Those results were presented at the Societe Internationale d'Urologie meeting in Cape Town, South Africa.

• Alba Therapeutics Corp., of Baltimore, said a Phase Ib study of AT-1001, an oral zonulin receptor antagonist, met the primary endpoint of intestinal permeability in patients with celiac disease. The objective of the proof-of-concept study was to establish the safety, tolerability and effectiveness of single doses of the drug in CD patients in remission who are challenged with a large dose of gluten. Data also showed that symptoms of acute gluten toxicity were inhibited in the AT-1001 arm compared to placebo. Results were presented at the International Celiac Disease Symposium in New York.

• Altus Pharmaceuticals Inc., of Cambridge, Mass., said results from a Phase II study of ALTU-238 demonstrated a pharmacokinetic and pharmacodynamic profile that the company believes is supportive of a once-a-week dosing regimen for growth hormone-deficient adults. The study identified doses of ALTU-238 that maintained IGF-1 levels within the normal range for age and gender over the course of the study. Data were presented at the Growth Hormone Research Society and Insulin-like Growth Factor Research Society meeting in Kobe, Japan.

• Amgen Inc., of Thousand Oaks, Calif., said data from an ongoing Phase IV extension study showed that patients with ankylosing spondylitis who received Enbrel (etanercept) experienced sustained improvements in signs and symptoms, spinal mobility and physical function over 148 to 160 weeks of therapy. Those results are being presented at the American College of Rheumatology meeting in Washington. Amgen also reported that published data of Enbrel demonstrated improvements in multiple efficacy measures in rheumatoid arthritis patients completing up to nine years of therapy.

• Can-Fite BioPharma, of Petach Tikva, Israel, said data from an ongoing Phase IIa trial in the U.S., Europe and Israel of CF101 - its novel anti-inflammatory agent - for rheumatoid arthritis showed that patients with a high expression of the A3 adenosine receptor (70 percent of the patients) achieved a significant response to CF101, but patients with a low expression exhibited only a minor response. Those findings are being presented at the annual scientific meeting of the American College of Rheumatology in Washington. CF101 also is being developed for dry-eye syndrome and psoriasis.

• Centocor Inc., of Horsham, Pa., and Schering-Plough Corp., of Kenilworth, N.J., reported that nearly 75 percent of patients with moderate to severe active rheumatoid arthritis receiving golimumab (CNTO 148) and methotrexate experienced at least a 20 percent improvement in arthritis symptoms (ACR 20) at week 52, and that nearly one-third of patients receiving that combination achieved remission at one year. The Phase II study involved 172 patients with active rheumatoid arthritis for at least three months duration despite methotrexate therapy.

• Corcept Therapeutics Inc., of Menlo Park, Calif., completed patient enrollment of 441 patients in Study 06, the third of three Phase III trials in which Corlux (mifepristone) is being evaluated for treating the psychotic features of psychotic major depression. The company expects to announce the results in late February.

• Cytochroma Inc., of Markham, Ontario, started the recruitment of patients with chronic plaque psoriasis for a Phase II trial with CTA018 cream. CTA018 is a vitamin D analogue with a dual mechanism of action, designed to be both a strong activator of the vitamin D signaling pathway and a potent inhibitor of CYP24, the enzyme responsible for the catabolism of vitamin D.

• Dynavax Technologies Corp., of Berkeley, Calif., reported more data from a Phase IIb study showing Tolamba, its ragweed investigational therapy, reaped benefit for treated patients, regardless of the severity of their disease. The data were presented at the annual meeting of the American College of Allergy, Asthma and Immunology in Philadelphia.

• Genentech Inc., of South San Francisco, and Biogen Idec Inc., of Cambridge, Mass., revealed interim data from their ongoing open-label extension study of Rituxan (rituximab) in patients with rheumatoid arthritis who had an inadequate response to previous treatment with at least one tumor necrosis factor antagonist therapy. Those findings showed that a larger number of patients achieved American College of Rheumatology scores of 20, 50 or 70 after given an additional course of Rituxan in combination with methotrexate, compared to responses after their first course of Rituxan. Those findings, as well as other data from the study, are being presented at the annual scientific meeting of the American College of Rheumatology in Washington.

• MediQuest Therapeutics Inc., of Bothell, Wash., said Phase IIIa results reported at the American College of Rheumatology meeting in Washington showed that two different doses of Vascana produced a significant improvement in blood flow compared to placebo, which may have clinical benefits in patients with Raynaud's disease. In addition, the nonsystemic, topical product was well tolerated in patients with the disease, with minimal to no side effects.

• Neurogen Corp., of Branford, Conn., started Phase I trials with NGD-4715 for obesity. The drug works as an antagonist at the melanin-concentrating hormone receptor-1, and the obesity program is wholly owned by Neurogen.

• Ovation Pharmaceuticals Inc., of Deerfield, Ill., reported positive results from a 68-patient Phase II study of clobazam in patients with Lennox-Gastaut syndrome, a severe form of childhood epilepsy. Data showed a significant difference between the treatment groups in the percent reduction (85.3 percent in the high-dose group vs. 12 percent in the low-dose group) in weekly seizures from baseline to maintenance period, and more than 83 percent of patients in the high-dose group had a 50 percent or greater reduction in weekly drop seizures rate from baseline.

• Santhera Pharmaceuticals AG, of Liestal, Switzerland, said the U.S. National Institute of Neurological Disorders and Stroke at the National Institutes of Health presented results of a recently completed clinical trial with SNT-MC17/idebenone in Friedreich's ataxia, at the Third International Scientific Friedreich's Ataxia Conference in Bethesda, Md. The trial, carried out in collaboration with Santhera, enrolled 48 subjects between 9 and 18 years of age, and supported the safety and tolerability of the drug at doses up to 2,250 mg per day.

• Sepracor Inc., of Marlborough, Mass., said clinical data for Xopenex HFA (levalbuterol tartrate) inhalation aerosol demonstrated that both (R)-albuterol systemic exposure and consequent beta-mediated adverse events were reduced following cumulative dosing of the drug when compared to cumulative dosing with racemic albuterol HFA MDI. Data were presented at the American College of Allergy, Asthma and Immunology meeting in Philadelphia.

• Targeted Genetics Corp., of Seattle, said interim data from its ongoing Phase I/II trial of tgAAC94 in patients with inflammatory arthritis continued to support the safety and tolerability of intra-articular administration to affected joints in doses up to 1x10(13) DRP/mL of joint fluid and suggested that the drug might lead to a decrease in signs and symptoms of arthritis in infected joints. Data were presented at the American College of Rheumatology meeting in Washington.

• ThromboGenics NV, of Leuven, Belgium, said the FDA completed its review of the company's investigational new drug application for microplasmin for intraocular injection. The FDA considers the proposed MIVI III (Microplasmin for Vitreous Injection III) trial safe to initiate, and ThromboGenics will proceed with patient recruitment. Preliminary positive results of a Phase IIa clinical trial in Europe demonstrated that microplasmin could induce posterior vitreous detachment to ease vitrectomy surgical procedure.

• Transgene SA, of Strasbourg, France, said updated six-month data of its completed Phase II trial of TG 4001, a therapeutic HPV vaccine for high-grade cervical intraepithelial neoplasia (CIN2/3), showed that 10 of the 21 patients had no more CIN2/3 and none of those 10 patients had any human papillomavirus 16 (HPV16) mRNA detected. Of the six patients who had reached the month-12 evaluation, none showed any CIN2/3 relapse or any HPV16 persistence or re-infection. The company plans to initiate a Phase III trial in the fourth quarter of 2007 to test TG 4001 in 500 women with CIN2/3 caused by HVP16.

• Vion Pharmaceuticals Inc., of New Haven, Conn., accrued 210 patients in the Phase III trial of its lead anticancer agent, cloretazine, which is being evaluated in combination with cytarabine for the treatment of relapsed acute myelogenous leukemia. The protocol for the international Phase III randomized study includes a planned interim analysis on the first 210 patients.

• ZymoGenetics Inc., of Seattle, and Serono SA, of Geneva, reported positive results from a Phase Ib study of atacicept in systemic lupus erythematosus, which showed that the drug was well tolerated across all dose levels and was associated with clear biologic activity as shown by dose-dependent reductions in several biologic markers. Data were presented at the American College of Rheumatology meeting in Washington.