• Adolor Corp., of Exton, Pa., started a second Phase II study of ADL5859, a delta opioid agonist in development for pain. The study, designated 33CL232, is expected to enroll about 60 subjects and will explore the analgesic efficacy of the drug in treating inflammatory pain associated with rheumatoid arthritis. ADL5859 also is being tested in an acute pain study, which began in the second quarter, and the company anticipates a third trial in neuropathic pain to start later this year.

• Avicena Group Inc., of Palo Alto, Calif., said pooled analysis from three trials of AL-02, its drug in development for amyotrophic lateral sclerosis, showed an increase of 1.47-fold in median survival compared to results in patients receiving placebo. The three trials involved a total of 386 patients, and certain portions of those data formed the basis for the company's planned confirmatory Phase III trial set to start in 2008. That trial will evaluate AL-02's effect on the primary endpoint of median survival and secondary endpoints of ALS functional scores. Avicena plans to present further AL-02 data at an upcoming scientific conference.

• Cell Therapeutics Inc., of Seattle, and Systems Medicine LLC, a wholly owned subsidiary of CTI, enrolled the first patient to its complete Phase Ib trial of brostallicin in combination with either bevacizumab (Avastin, Genentech Inc.) or irinotecan in patients with advanced solid tumors. A third treatment arm, which will involve the use of brostallicin in combination with a cancer agent to be identified, will be added to the study following pharmacogenomic investigations using genomic-based search strategies. Brostallicin is a synthetic, second-generation DNA minor groove binder that has demonstrated preclinical activity in combination with standard cytotoxic agents, as well as with targeted therapies.

• ConjuChem Biotechnologies Inc., of Montreal, said final data from its Phase I/II study of PC-DAC:Exendin-4 compound for Type II diabetes confirmed preliminary data reported in March and showed that the compound was well tolerated and effective in lowering blood glucose when administered once weekly at each of dosing levels tested. Results from the 70-patient trial showed that reductions in mean fasting plasma glucose were statistically significant in all treatment groups vs. baseline and placebo over the five-week treatment period. Average reductions from baseline values for the 1 mg, 2 mg and 3 mg arms were -9 percent (baseline 154 mg/dL), -11 percent (baseline 172 mg/dL) and -7 percent (baseline 170 mg/dL), respectively. ConjuChem anticipates moving to a multidose Phase II study early next year, in which the product will be administered once a week for three months. PC-DAC:Exendin-4 is an insulinotropic peptide and an agonist for the glucagon-like peptide-1 (GLP-1) receptor.

• Flamel Technologies Inc., of Lyon, France, reported positive preliminary Phase I data from a trial comparing the safety, tolerability and long-acting activity of FT-105 vs. Lantus, an approved basal insulin. Results showed that FT-105 achieved a sustained release of recombinant human insulin over the course of the 36-hour pharmacodynamic study period, while pharmacokinetic results indicated that insulin concentrations were sustained for more than 48 hours in subjects following a single dose. FT-105 is a long-acting recombinant insulin formulation that uses a microparticulate adaptation of Flamel's Medusa nanoparticle delivery system. Flamel said it is seeking a licensing partner for that product.

• Micromet Inc., of Bethesda, Md., received approval to begin a German Phase II trial of MT103, a BiTE antibody targeting the CD19 antigen, in patients with acute lymphoblastic leukemia. That study will test whether the compound can remove residual tumor cells and thereby convert patients from a MRD-positive to a MRD-negative status with an improved time to relapse. MT103, which is licensed to Gaithersburg, Md.-based MedImmune for North American development and commercialization, also is in an ongoing Phase I trial in Europe in non-Hodgkin's lymphoma.

• Molecular Insight Pharmaceuticals Inc., of Cambridge, Mass., reported positive results from its Phase I dosimetry trial of Azedra (Ultratrace iobenguane I 131, or Ultratrace MIBG), its lead oncology molecular radiotherapeutic candidate, showing that the ultrapurity resulting from the Ultratrace technology used in Azedra produced no change in overall patient safety and that Azedra demonstrated increased efficacy and safety over available MIBG in preclinical animal models. Those results were presented at the nuclear medicine conference in Copenhagen, Denmark. Azedra, which has fast-track and orphan drug designations from the FDA, is in development to treat neuroendocrine tumors while minimizing side effects.

• Nventa Biopharmaceuticals Corp., of San Diego, completed enrollment of the first cohort in its Phase I trial of its new HspE7 in patients with cervical intraepithelial neoplasia (CIN). The study is expected to dose up to five cohorts comprising 24 patients, with four cohorts receiving 500 mcg of HspE7 and doses of 50, 500, 1,000 or 2,000 mcg of adjuvant containing Poly-IC, a Toll-like receptor-3 agonist. An additional cohort of six patients, receiving 1,000 mcg of HspE7 and 2,000 mcg of adjuvant might be added if deemed appropriate. Following successful completion of this trial, Nventa anticipates launching a Phase II study in patients with high-grade CIN.

• PTC Therapeutics Inc., of South Plainfield, N.J., reported additional data from a Phase II trial of PTC124 in patients with Duchenne's muscular dystrophy due to a nonsense mutation, which showed that administration of the drug is associated with qualitative increases in muscle dystrophin expression and with reductions in serum creatine kinase values. The trial enrolled 38 boys with loss of dystrophin due to a nonsense mutation in the dystrophin gene, and all received 28 days of PTC124 treatment at one of three dose levels, with the primary endpoint being an increase in dystrophin expression in muscle. An in vitro analysis demonstrated that the drug induced dystrophin expression in cultured muscle cells from all 35 of the evaluable samples, and the in vivo data indicated that, across all dose levels, 18 of 38 patients (47 percent) demonstrated visible improvement in the staining for dystrophin from muscle biopsies. Data were presented at the muscle society meeting in Sicily, Italy.