• Akela Pharma Inc., of Montreal, completed enrolling patients in its Fentanyl Taifun Phase IIb trial. The product is a fast-acting fentanyl formulation delivered using the company's Taifun dry-powder inhaler platform. The multinational trial is being run in cancer patients on maintenance opioid therapy who have severe persistent pain. The first part of the trial is an open-label study to evaluate dosing. The second part includes 28 responders from the open-label arm randomized to receive the titrated doses or placebo. Safety and efficacy data from the double-blind, placebo-controlled extension arm are expected to be available by early September.

• EpiCept Corp., of Tarrytown, N.Y., said it will study EpiCept NP-1, its topical cream formulation of two FDA-approved drugs, amitriptyline (4 percent) and ketamine (2 percent), in a Phase III study in chemotherapy-induced peripheral neuropathy. The ATTRACT-CPN (Assessment of Topical Treatment Response with Amitriptyline and Ketamine: Combination Trial in Chemotherapy Peripheral Neuropathy) trial is expected to start before the end of this quarter and will enroll about 400 patients suffering from CPN for at least 28 days following the conclusion of chemotherapy. The primary endpoint for the 12-week trial is defined as the change in average daily pain intensity scores from baseline to the end point. Secondary endpoints include the percentage of patients whose pain intensity decreases are greater or equal to 30 percent from baseline and other measures. EpiCept also has initiated two additional Phase IIb trial of EpiCept NP-1, enrolling a total of 700 patients. The first of those studies will test the drug in diabetic neuropathy, with preliminary results expected in the fourth quarter, and the second study involves patients with peripheral herpetic neuropathy, with preliminary results expected in the first quarter of 2008.

• Gilead Sciences Inc., of Foster City, Calif., presented 144-week data from an ongoing Phase III trial, Study 934, comparing a once-daily regimen of Truvada (emtricitabine and tenofovir disoproxil fumarate) and Sustiva (efavirenz) to a twice-daily regimen of Combivir (lamivudine/zidovudine) and Sustiva in treatment-naïve adults with HIV. Data from 456 patients after 144 weeks of treatment showed 71 percent of Truvada/Sustiva patients compared to 58 percent of Combivir/Sustiva patients achieved and maintained viral load less than 400 copies/mL (p=0.004). Sixty-four percent of patients in the Truvada/Sustiva arm compared to 56 percent of patients in the Combivir/Sustiva arm achieved and maintained viral load less than 50 copies/mL (p=0.08). The mean increase from baseline in CD4 cell counts at week 144 was 312 and 271 cells/mm3 in the Truvada/Sustiva and Combivir/Sustiva arms, respectively (p=0.09). Also, a significantly greater percentage of patients in the Combivir/Sustiva group experienced adverse events that resulted in discontinuation of study medications compared to the Truvada/Sustiva arm (11 percent vs. 5 percent, respectively; p=0.01).

• Hoffmann-La Roche Inc., a subsidiary of Basel, Switzerland-based F. Hoffmann-La Roche Ltd., and Trimeris Inc., of Morrisville, N.C., disclosed interim results from BLQ (Below the Level of Quantification), an ongoing study evaluating the use of the fusion inhibitor Fuzeon (enfuvirtide) with the most recently approved boosted protease inhibitor, darunavir/ritonavir, in combination with other anti-HIV drugs. Data showed that 64 percent of the treatment-experienced patients at 24 weeks achieved undetectable HIV of less than 50 copies per mL of blood, and that baseline sensitivity to darunavir did not appear to influence patient response to the regimen. Also, 78 percent of patients achieved HIV levels of less than 400 copies per mL, and 86 percent achieved a viral load reduction of at least 1 log10. The prospective, open-label, single-arm, multicenter study is being conducted in the U.S. and Australia. Data came from the first 58 patients in the study.

• Isotechnika Inc., of Edmonton, Alberta, completed recruitment for the pivotal Phase III European/Canadian ESSENCE trial of ISA247 in psoriasis. Recruitment was closed at 638 patients. A second pivotal Phase III European psoriasis trial in 360 patients is expected to begin in the first quarter of 2008. That trial, along with the ESSENCE study, is designed to provide sufficient patient numbers to support regulatory approvals in Europe and Canada. The product is a calcineurin inhibitor.

• MedImmune Inc., a U.S. unit of London-based AstraZeneca plc, presented interim clinical data suggesting that its monoclonal antibody targeting the interleukin-5 receptor was well tolerated and showed evidence of biological activity in a Phase I study of adults with mild asthma. Results suggested that the antibody-dependent cellular cytotoxicity-enhanced molecule successfully depleted eosinophils, a class of white blood cells implicated in asthma and other inflammatory diseases. In addition to direct depletion of eosinophils, the antibody also aims to neutralize the activity of IL-5, which is believed to play a key role in the growth and development of eosinophils, the company said.

• Nventa Biopharmaceuticals Corp., of San Diego, published final results, including new immunological data, from a Phase II trial testing HspE7, a therapeutic vaccine for human papillomavirus-related diseases. Data from the study in women with high-grade cervical intraepithelial neoplasia were published in Gynecologic Oncology. Results showed 95 percent of patients had disease regression or their disease remained stable. Seven of 20 women (35 percent) had complete regression of their CIN II/III, one had regression to low-grade CIN, 11 had stable disease and one had progression due to enlargement of her lesion. Immune responses were seen in nine of the 17 women tested.

• Oncolytics Biotech Inc., of Calgary, Alberta, started enrolling patients in its UK trial of Reolysin in combination with docetaxel (Taxotere, Sanofi-Aventis Group) in patients with advanced cancers, including bladder, prostate, lung and upper gastrointestinal. The study has two components. The first is an open-label, dose-escalating, nonrandomized trial of Reolysin given intravenously with docetaxel every three weeks, and the second component will follow immediately and will involve the enrollment of a further 12 patients at the maximum dosage of Reolysin in combination with docetaxel. The primary objectives are to determine the maximum tolerated dose, dose-limiting toxicity, recommended dose and dosing schedule and safety profile of the combination therapy. Secondary objectives include the evaluation of immune response to the drug combination, the body's response to the drug combination compared to chemotherapy alone and any evidence of antitumor activity.

• Sygnis Pharma AG, of Heidelberg, Germany, said safety and tolerability were demonstrated in a 44-patient Phase IIa study of AX200 in stroke. The trial in Germany also provided hints of efficacy, Sygnis said. The company said results clear it for further study of AX200, which is designed to stop neuronal cell death in the acute phase of stroke, and to stimulate the regeneration of the already-damaged nerve tissue through the induction of new nerve cells and blood vessels and the reorganization of neuronal networks.

• Targacept Inc., of Winston-Salem, N.C., said partner AstraZeneca plc, of London, initiated a Phase IIb trial of AZD3480 (TC-1734) in Alzheimer's disease. The double-blind, placebo-controlled study is being conducted in about 500 patients in Western Europe, Eastern Europe and Canada. The trial is expected to be completed by the end of 2008. AstraZeneca also is scheduled to begin dosing in a Phase IIb trial of AZD3480 in cognitive deficits in schizophrenia in August. AZD3480, Targacept's lead product candidate, is designed to act selectively on neuronal nicotinic receptors.