• Ablynx, of Ghent, Belgium, reported positive interim results from the ongoing Phase I study of its lead development program, ALX-0081, an anti-thrombotic treatment. ALX-0081 is a first-in-class therapeutic nanobody targeting von Willebrand Factor, which can reduce the risk of thrombosis in patients with acute coronary syndrome. The interim analysis indicated the desired pharmacodynamic effect was observed as anticipated indicating the high potency of ALX-0081, and ALX-0081 was well tolerated and showed no serious adverse effects or dose limiting toxicity. Final results are expected by the end of September.

• Advanced Life Sciences Holdings Inc., of Chicago, said supplemental efficacy data from trial CL-06 of cethromycin, a once-a-day antibiotic for treatment of community acquired pneumonia, confirmed that it met its non-inferiority endpoint. Among the supplemental data was that modified intent-to-treat clinical cure rate showed cethromycin 82.9 percent (213/257) compared to Biaxin's 88.5 percent (224/253) [-11.9, +0.6]. Data released last month showed the clinical rate for cethromycin, a ketolide antibiotic, was 91.5 percent, lower than in the Biaxin arm but not in a statistically significant manner (p=0.0775). (See BioWorld Today, June 22, 2007.) The company expects to release top-line data on a second pivotal Phase III trial in September. The company's shares (NASDAQ:ADLS) dropped 52 cents Monday, or 19.5 percent, to close at $2.15.

• Alkermes Inc., of Cambridge, Mass., said preliminary results from a Phase I/II clinical trial of ALKS 29 in alcohol-dependent patients showed treated patients demonstrated statistically significant improvement compared to placebo in percent of days abstinent, percent of heavy drinking days and average number of drinks per day. Based on the results, the company plans to move forward with its development program for oral product candidates to treat alcohol dependence.

• Anesiva Inc., of South San Francisco, said preliminary longer-term, follow-up results from a Phase II study showing that a 1 mg treatment with Adlea (formerly 4975) in patients with moderate to severe osteoarthritis of the knee produced substantial reductions in pain that persisted for up to 12 weeks. Patients treated with Adlea demonstrated a 61 percent reduction in mean pain intensity from baseline to week one, and the analgesic effect was sustained at all subsequent weeks to the last scheduled in-clinic assessment at week eight, at which time a 64 percent reduction in pain from baseline was reported. At week 12, pain reductions were sustained. The company said it plans to advance Adlea into late-stage trials in various indications this summer, including a Phase II/III trial for osteoarthritis of the knee.

• Anthera Pharmaceuticals Inc., of San Mateo, Calif., completed enrollment of 200 patients in the Phase II PLASMA (Phospholipase Levels And Serological Markers of Atherosclerosis) trial ahead of schedule. The company plans to announce preliminary results later this year and is evaluating the further expansion of the trial. PLASMA is a dose-response study to evaluate the safety and efficacy of A-002 to reduce secretory phospholipase A2 (sPLA2) activity levels and other well established markers of inflammation and cardiovascular risk in patients with stable coronary artery disease. sPLA2 is a family of enzymes that are part of the inflammation process. The study is being conducted at sites in the U.S. and Europe.

• Maxygen Inc., of Redwood City, Calif., initiated a Phase IIa trial to evaluate the efficacy, safety and tolerability of MAXY-G34 in the treatment of chemotherapy-induced neutropenia. The pegylated granulocyte colony stimulating factor (PEG-GCSF) has shown in preclinical and Phase I studies to have novel and potentially superior properties compared to the current PEG- GCSF therapy. The Phase IIa ascending dose trial at multiple centers in Eastern Europe is the first trial of MAXY-G34 in patients. Approximately 30 patients with Stage I-III breast cancer will undergo TAC (docetaxel, adriamycin and cyclophosphamide) chemotherapy followed by next-day administration of either MAXY-G34 or Neulasta, as the control population.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., reported that as an induction therapy prior to stem cell transplantation, a Velcade-based therapy in newly diagnosed multiple myeloma patients produced a high complete remission/complete response (CR) rate of 20 percent, which led to a post stem cell transplantation CR rate of 43 percent. Those results were substantially stronger than those of a commonly used induction chemotherapy regimen vincristine, adriamycin and dexamethasone (VAD), which served as the comparative therapy. The data showed that the Velcade-based therapy, compared to VAD, nearly doubled the CR rate as induction therapy and provided a greater than 50 percent improvement in CR rate following stem cell transplantation. Achievement of CR is the goal of SCT therapy because achievement of CR increases both progression-free and overall survival. The data were presented at the 11th International Myeloma Workshop in Kos, Greece.