• Affibody Holding AB, of Stockholm, Sweden, received approval from Swedish regulators to begin an exploratory trial of a new approach for diagnosing an aggressive form of breast cancer. The approach, based on the company's targeting Affibody molecules, is designed to allow clinicians to both identify and locate breast cancer tumors overexpressing the cell membrane protein HER2. The approach uses nuclide-labeled Affibody molecules that selectively bind only to HER2 on cancer tumors, and a scanning camera that can detect radioactivity, both the primary tumor and any metastases expressing the HER2 protein. The trial of the molecular imaging agent is expected to begin soon.

• Alkermes Inc., of Cambridge, Mass., and Indevus Pharmaceuticals Inc., of Lexington, Mass., said that results of a Phase IIa trial showed that patients with chronic obstructive pulmonary disease treated with a single dose of ALKS 27 showed a statistically significant improvement in lung function compared with placebo. ALKS 27 is an inhaled formulation of trospium chloride using Alkermes' proprietary AIR pulmonary delivery system. The randomized, double-blind, placebo-controlled crossover study was designed to assess the safety, tolerability, pharmacokinetics and efficacy of ALKS 27 in 24 patients with moderate to severe COPD. During the study, patients received a single administration of two different dose levels of ALKS 27 and placebo, with each dose separated by a washout period. The primary objective of the study was to assess the effect of ALKS 27 as measured by the area under the curve of FEV1 over a 24-hour time period.

• CombinatoRx Inc., of Cambridge, Mass., dosed the first patient in its Phase IIb trial in knee osteoarthritis with CRx-102, an oral combination drug candidate for immuno-inflammatory diseases. The 250-patient trial, designated COMET-1 (Crx-102 Osteoarthritis Multi-center Evaluation Trial) is designed to test the drug's efficacy compared to placebo in with symptomatic knee osteoarthritis, with a primary endpoint assessed by the change in WOMAC pain score calculated from baseline to day 98. Secondary endpoints include the full WOMAC pain, stiffness, physical function parameters and patient global assessment scores.

• Cytheris SA, of Paris, expanded its clinical trial program for CYT107, a recombinant human interleukin-7, with the initiation of a Phase I/IIa clinical trial in HIV patients. The trial will be conducted at sites in France, Italy, Canada and the U.S. and follows the launch of previously announced Phase I/IIa trials of IL-7 in hepatitis C and oncology. The trials also follow the successful completion of four Phase I studies and are designed to investigate IL-7's potential for building immune system response. The HIV trial (CYT107-06) is a randomized, placebo-controlled, single-blind study of escalating doses in HIV-infected patients.

• DiObex Inc., of San Francisco, said it began dosing patients in a Phase IIb trial of DIO-902, a cortisol synthesis inhibitor being studied for the treatment of Type II diabetes. The 200-patient trial is a randomized, placebo-controlled, double-blind study designed to evaluate the safety and efficacy of DIO-902 and to determine dosing for pivotal Phase III studies. The primary efficacy endpoint is the change in HbA1c, a measurement of glycemic control, compared to placebo. Secondary endpoints include the change in total and LDL cholesterol, and the change in blood pressure. Top-line data from the trial are expected by the second half of 2008. The trial will be conducted at 20 centers in the U.S., Australia and New Zealand.

• Halozyme Therapeutics Inc., of San Diego, said it completed enrollment in its open-label, 27-patient Phase I/IIa trial of Chemophase for the treatment of superficial bladder cancer. The study of Chemophase along with the cancer drug mitomycin is evaluating the maximum tolerated dose and any dose-limiting toxicities. Interim data are expected in the first half of next year. Chemophase uses the company's rHuPH20 technology to enhance the delivery of chemotherapeutic agents.

• InterMune Inc., of Brisbane, Calif., began dosing the first patients in a Phase Ib trial evaluating ITMN-191 (also called R7227) in patients with chronic hepatitis C virus. ITMN-191 is a HCV protease inhibitor in development with partner F. Hoffmann-La Roche Ltd., of Basel, Switzerland. The placebo-controlled study in about 40 HCV patients will assess the effect of multiple doses of ITMN-191 as monotherapy on viral kinetics, viral resistance, pharmacokinetics, safety and tolerability.

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., began a Phase II trial to evaluate its rapid-acting Insulin Nasal Spray in about 20 patients with Type II diabetes. The randomized, crossover study will compare insulin spray formulations to placebo and to NovoLog insulin aspart (rDNA origin), an approved, rapid-acting injectable insulin, on post-meal glycemic control.

• Nektar Therapeutics Inc., of San Carlos, Calif., said that data from a single-dose, proof-of-principle Phase I trial on NKTR-118 (oral PEG-naloxol) demonstrated that the drug antagonized the morphine-induced delay in gastrointestinal transit time without reversing the central opioid effect as measured by pupillometry. NKTR-118 combines Nektar's small-molecule PEGylation technology with naloxol, a derivative of the opioid-antagonist drug naloxone, and is being studied for opioid-bowel dysfunction, including opioid-induced constipation. The single-dose, double-blind, placebo-controlled study measured the morphine-induced delay in gastrointestinal transit time, a peripheral effect, using the lactulose hydrogen GI motility test. Pupillometry, a measurement of the diameter of the pupil of the eye, was used to monitor antagonism of morphine-induced pupil constriction, a central nervous system effect. Escalating single oral doses of NKTR-118 up to 1,000 mg were studied in 48 subjects.

• Novacea Inc., of South San Francisco, initiated a randomized, placebo-controlled, multicenter Phase II trial of Asentar (DN-101) in patients with advanced pancreatic adenocarcinoma. The trial in about 132 subjects will evaluate the effect of weekly Asentar combined with weekly gemcitabine, plus or minus daily erlotinib (Tarceva) in the initial treatment of advanced pancreatic adenorcarcinoma. The primary endpoint is six-month survival rates, with secondary endpoints of objective response rates, duration of progression-free survival and overall survival. Asentar, a high-dose oral formulation of calcitriol, a biologically active form of vitamin D, also is being tested in a Phase III trial in advanced prostate cancer.

• Threshold Pharmaceuticals Inc., of Redwood City, Calif., said that results from a Phase II trial of glufosfamide in combination with gemcitabine for advanced pancreatic cancer demonstrated that six-month and one-year survival were 50 percent and 32 percent, respectively. Median progression-free and overall survival were 3.7 and 6.0 months. In the trial, 29 patients were treated, of which 28 patients with pancreatic adenocarcinoma previously untreated with chemotherapy were evaluated for response. Six of 28 patients achieved a partial response including one unconfirmed partial response. Median duration of confirmed responses was 8.4 months.

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