• Avexa Ltd., of Melbourne, Australia, presented further data from its Phase IIb trial on apricitabine (ATC), at the International AIDS Society meeting in Sydney, Australia. Avexa in March reported the trial met its endpoints. ATC is a cytidine analogue, an inhibitor of HIV reverse transcriptase. Among the new information was that ATC demonstrated significant clinical activity against a range of drug-resistant HIV, including HIV strains harboring the lamivudine-resistance mutation (M184).

• BioChem Solutions Inc., of Miami, said it now is committed to proceeding with Phase III trials of Arthromir and Alphamir, drugs that have been developed and derived from trioxolane. The studies in Kenya will include two groups of 200 people. Testing will be done for the treatment of acute respiratory infections, rheumatoid arthritis and HIV.

• Biolex Therapeutics Inc., of Pittsboro, N.C., and partner OctoPlus NV, of Leiden, the Netherlands, reported positive initial results from its ongoing SELECT (Safety and Efficacy of Locteron: European Clinical Trial)-1 Phase IIa study of Locteron, a controlled-release interferon alpha product for chronic hepatitis C. Data from the 12-week study in combination with ribavirin showed an early virologic response in 100 percent of the patients treated. A dose response was observed, with patients treated with the 320 mcg and 480 mcg doses of Locteron demonstrating a greater reduction in hepatitis C virus than those treated with 160 mcg dose at all measurement times. Average viral reduction after 12 weeks was 4.5 log10 for the 320 mcg dose and 4.2 log10 for the 480 mcg dose, compared to 1.8 log10 in the 160 mcg group. Five of eight (63 percent) of patients in the two highest dose cohorts had undetectable levels of HCV compared to one of eight (13 percent) in the lowest dose group. Complete and final results from the study will be reported in the fourth quarter.

• Javelin Pharmaceuticals Inc., of Cambridge, Mass., began treating patients in the second of two planned Phase III studies of Dyloject, (diclofenac sodium), an injectable nonsteroidal anti-inflammatory drug, in moderate to severe postoperative pain following elective orthopedic surgery. A total of 240 patients will be randomized to receive one of three doses of Dyloject, one of two doses of IV ketorlac or placebo. The primary efficacy endpoint will be the sum of pain intensity differences (SPID), as measured on the 0-100 mm Visual Analog Scale. The company recently completed enrollment in the first Phase III study, which focuses on postoperative pain after elective abdominal surgery, and top-line results from that trial are expected by the end of the year.

• Repros Therapeutics Inc., of The Woodlands, Texas, released endometrial biopsy findings from its three- and six-month studies of Proellex in the treatment of uterine fibroids and endometriosis, respectively. Positive efficacy and safety data were reported on the progesterone receptor modulator in April and June. New data showed patients exposed to the drug for up to six months demonstrated a benign endometrium based on the biopsies.

• Targacept Inc., of Winston-Salem, N.C., initiated a Phase I trial of TC-5619, a small molecule designed to modulate the activity of the neuronal nicotinic receptor subtype known as alpha7. The Phase I study is designed to evaluate safety, tolerability and pharmacokinetics of TC-5619 in healthy volunteers. The alpha7 NNR is believed to be associated with various biological functions including regulation of inflammation arising from injury or infection, and cognitive functions. It also may have neuroprotective roles, the company said.

• Threshold Pharmaceuticals Inc., of Redwood City, Calif., initiated a Phase I trial of TH-302, its first hypoxia-activated prodrug, in patients with advanced solid tumors. The study is expected to enroll about 50 patients, with up to six patients per dose level participating in the dose escalation phase and an additional six patients enrolled after the maximum tolerated dose has been established. Primary objectives of the study are to determine MTD and dose-limiting toxicities of TH-302, which is administered as a 30-minute intravenous infusion, while secondary objectives include establishing pharmacokinetics and assessing anti-tumor activity, as measured by objective response rate, duration of response, progression-free survival, overall survival and various safety parameters.

• Tranzyme Pharma Inc., of Research Triangle Park, N.C., started a Phase IIb trial of TZP-101, a ghrelin agonist, in postoperative ileus. The trial is expected to enroll up to 250 patients to receive either TZP-101, via a 30-minute infusion, or placebo, with the primary endpoint of assessing the drug's impact on postoperative time to recovery of gastrointestinal function as defined by the time to first bowel movement. TPZ-101 also is in development for severe gastroparesis.

• Uluru Inc., of Addison, Texas, began a clinical study to evaluate the mobility of severely burned joints treated with its Hydrogel Nanoparticle Wound Dressing. The study in about 40 patients will compare the product to the standard-of-care dressing. Separately, Uluru shares began trading on the American Stock Exchange under the ticker symbol "ULU."