• AnaMar Medical AB, of Stockholm, Sweden, received approval from the UK Medicines and Healthcare products Regulatory Agency to initiate clinical trials of AMAP102, a new oral drug candidate for rheumatoid arthritis. AMAP102 inhibits interleukin-6 and tumor necrosis factor alpha, two key cytokines associated with inflammation. AMAP102 also has shown an effect on pain. The aim of the study is to examine safety, tolerability and pharmacokinetics.

• Antisense Pharma GmbH, of Regensburg, Germany, has enrolled the first patients with recurrent or refractory anaplastic astrocytoma in a pivotal Phase III trial called SAPPHIRE, a randomized, active-controlled study designed to confirm the efficacy and safety of trabedersen (AP 12009) as a monotherapy compared to current standard therapy with temozolomide (alternatively BCNU). The study will be carried out in Europe, America and Asia and will include two treatment arms: Trabedersen in a dose of 10 micrometers compared to current standard therapy with either temozolomide or BCNU. Trabedersen will be administered intratumorally via one single catheter using convection-enhanced delivery on an outpatient treatment basis. The treatment period lasts up to six months consisting of seven-day cycles every other week. Trabedersen is a first-in-class targeted therapy that acts multimodally via inhibition of transforming growth factor-beta 2.

• Chelsea Therapeutics International Ltd., of Charlotte, N.C., reported findings from a Phase I trial of CH-4051, the L-isomer of CH-1504 and second drug candidate from its bioavailable, non-metabolized antifolate portfolio, showing that the drug was safe and well tolerated up to a maximally tolerated dose of 7.5 mg. The trial tested the CH-4051 in healthy male volunteers. Consistent with preclinical findings to date, a comparison of data from the study and prior Phase I evaluations of CH-1504 suggested that CH-4051 has improved absorption with about a twofold improvement in bioavailability compared to CH-1504, yet is better tolerated on the basis of both its dose to side effect profile and plasma concentrations to side effect profile.

• Discovery Laboratories Inc., of Warrington, Pa., said data analysis from its SELECT and STAR Phase III trials of Surfaxin (lucinactant) for the prevention of respiratory distress syndrome in premature infants showed that in-hospital costs are higher for infants who require reintubation after surfactant administration and successful extubation when compared with infants who do not require reintubation. Previously reported data demonstrated that infants treated with Surfaxin in both trials required less reintubation compared to infants treated with existing animal-derived surfactants. Data were presented at the International Congress on Clinical Pharmacy meeting in Orlando, Fla.

• GTx Inc., of Memphis, Tenn., said a Phase III trial of advanced prostate cancer patients being treated with androgen deprivation therapy (ADT) showed nearly one in four placebo group subjects developed bone fractures or critical bone loss (> 7 percent loss) within two years. That analysis of placebo group data from the Phase III trial evaluating toremifene 80 mg for the prevention of bone fractures in men with prostate cancer on ADT was presented at the American Urological Association meeting in Chicago.

• Juvaris BioTherapeutics Inc., of Burlingame, Calif., reported Phase I results demonstrating that its vaccine adjuvant, JVRS-100, generated T-cell mediated immune responses and antibody responses when combined with a trivalent inactivated seasonal flu vaccine. The 128-subject study showed that those receiving the adjuvanted vaccine had antibody responses to influenza A that were about twofold higher than recipients of unadjuvanted vaccine, and significant T-cell responses, including polyfunctional T cells secreting multiple cytokines, were observed in subjects in the JVRS-100 group. Data were presented at the National Foundation for Infectious Diseases conference on vaccine research in Baltimore.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said updated preliminary data from its Phase II trial evaluating bavituximab in combination with carboplatin and paclitaxel in advanced breast cancer showed that nine of 14 evaluable patients in the initial cohort achieved an objective tumor response after a maximum of six treatment cycles according to RECIST criteria. The primary objective of the multicenter, open-label study is the overall response rate. Patients may continue to receive bavituximab as monotherapy after completion of chemotherapy as long as the cancer does not progress and side effects are acceptable. The company said patient dosing is under way in the expansion stage of the trial, which will enroll an additional 31 patients for a total of 46 advanced breast cancer patients overall. Peregrine's stock (NASDAQ:PPHM) closed at 43 cents Monday, a gain of 3 cents.

• Sepracor Inc., of Marlborough, Mass., announced said the results of a large-scale, 707-patient Phase III study of Omnaris (ciclesonide) HFA, an aerosol nasal formulation of ciclesonide, for the treatment of seasonal allergic rhinitis in adults and adolescents met its primary efficacy endpoint by demonstrating a statistically significant reduction in the 24-hour reflective total nasal symptom score (TNSS). In addition, the product statistically significantly met its key secondary endpoints of improvement in the 24-hour instantaneous TNSS and the 24-hour reflective total ocular symptom score vs. placebo.

• Theratechnologies, of Montreal, announced positive results from a pooled analysis from both its Phase III trials evaluating tesamorelin for the treatment of excess abdominal fat in HIV patients with lipodystrophy. The results indicated that after 26 weeks of treatment (each trial was extended to 52 weeks), 543 patients treated with 2 mg daily of tesamorelin experienced reduction of visceral adipose tissue (VAT), preservation of subcutaneous adipose tissue (SAT) and an improvement in triglycerides, without significant changes in glucose parameters. Data were presented Monday at the annual Canadian Conference on HIV/AIDS Research in Vancouver.