• Abraxis BioScience Inc., of Los Angeles, has reached an agreement with the FDA under the special protocol assessment process on the Phase III trial design of a pivotal study of Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) for the treatment of non-small-cell lung cancer in the first-line setting. The Phase III trial is a randomized, open-label trial comparing weekly 100 mg/m2 Abraxane (days 1, 8 and 15 of each cycle) and 200 mg/m2 Taxol (paclitaxel) Injection every three weeks. Carboplatin will be administered at AUC=6 on day one of each cycle repeated every three weeks in both treatment arms. The study will enroll approximately 1,000 patients with Stage IIIb and IV non-small-cell lung cancer. The primary endpoint is overall response rate, and enrollment of the trial will begin immediately.

• Affectis Pharmaceuticals AG, of Munich, Germany, has started a Phase II trial to study the efficacy and safety of Cimicoxib as a treatment for depression. The first patient has been enrolled at the Clinic of Psychiatry and Psychotherapy at the Ludwig-Maximilians-University in Munich. The double-blind, randomized, placebo-controlled study will include a total of 134 patients and is being conducted at multiple centers in Germany.

• Alpharma Inc., of Bridgewater, N.J., said results from a Phase II study showed that ALO-01, an extended-release morphine sulfate plus sequestered naltrexone, provided similar effectiveness to Kadian (morphine sulfate extended-release) capsules in osteoarthritis patients with moderate to severe chronic pain. Results also showed that ALO-01 maintained pain reduction throughout the study and that the sequestered naltrexone did not interfere with patients' pain relief. Data were presented at the anesthesiologists meeting in San Francisco.

• Antisoma plc, of London, has unveiled further data from its 74-patient randomized Phase II trial of ASA404 in hormone-refractory prostate cancer. The trial compares patients receiving 1200 mg/m2 ASA404 plus docetaxel with patients receiving docetaxel alone. Results thus far show PSA response rates were markedly higher in patients receiving ASA404 (59 percent vs. 37 percent with docetaxel alone); tumor response rates in patients assessable by RECIST were higher in patients receiving ASA404; time to disease progression was marginally longer in patients receiving ASA404; and safety findings suggested that addition of ASA404 to chemotherapy was generally well tolerated. ASA404 also is being tested in lung cancer.

• BioMS Medical Corp., of Edmonton, Alberta, reported on interim safety observations from MAESTRO-01, its on-going Phase III trial of MBP8298 for the treatment of secondary progressive MS, in two poster presentations at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Prague, Czech Republic. One poster presentation demonstrated that the safety profile of the drug continues to look strong in a large multinational clinical trial setting, and the second poster showed that MS patients with HLA-DR2/DR4 immune response genes, potentially account for more than 70 percent of the overall MS population in Europe and Canada.

• Biopure Corp., of Cambridge, Mass., is undertaking a revamped clinical development program and said it expects to further its ischemia development in heart attack patients. Biopure expects to move on several fronts, emphasizing clinical development in Europe. Three Phase II clinical trials are proposed and being designed for 2008: one in heart attack patients, one to address anemia in chemotherapy patients instead of, or in addition to, erythropoietin-stimulating agents, and one to investigate possible improvement of quality of life in the terminally ill.

• Bradmer Pharmaceuticals Inc., of Toronto, conducted a pre-Phase III meeting with the FDA at which the agency concurred with Bradmer's proposed design of the Phase III trial for its lead drug, Neuradiab, a treatment for newly diagnosed glioblastoma multiforme, the most common form of brain cancer. The agreed-upon trial, with about 380 patients in each of the experimental and control arms, has the possibility to actually shorten the study trial duration and to improve the statistical probability of success, Bradmer said. It anticipates a 24-month enrollment period and an interim efficacy analysis on overall survival at approximately month 39 post-trial initiation, or at 470 mortality events. Should an additional efficacy analysis be required, it would occur at 626 events.

• Columbia Labs, of Livingston, N.J., said a reanalysis of a series of studies of vaginally administered progesterone vs. intramuscular (IM) progesterone injections demonstrated that, when evaluating optimal dosing, clinical results are comparable for early pregnancy support in assisted reproductive technology cycles. Also, the reanalysis demonstrated that vaginal progesterone is associated with a significantly lower rate of miscarriage than IM progesterone. Those data were presented at the American Society for Reproductive Medicine annual meeting in Washington.

• Critical Therapeutics, of Lexington, Mass., has begun patient enrollment in the LEUKO study, a randomized, double-blind, placebo-controlled efficacy Phase III trial examining the effects of Zyflo (zileuton tablets) used to treat adults with chronic obstructive pulmonary disease. The trial will examine the effectiveness of Zyflo at reducing the length of a hospital stay for adults who are hospitalized for a COPD exacerbation, or a worsening of their COPD symptoms. Secondary outcomes will include lung function improvement, treatment failure at 30 days (defined as intubation, hospital readmission or urgent visit for COPD symptoms or intensification of therapy), health-related quality of life and urinary leukotriene levels. The trial is being sponsored and funded by the National Heart, Lung and Blood Institute and is being conducted by the COPD Clinical Research Network. Enrollment of 520 patients is planned for 19 inpatient hospitals at 10 academic centers in the U.S.

• Dynogen Pharmaceuticals Inc., of Waltham, Mass., reported Phase Ib results of DDP733 (pumosetrag) nocturnal gastroesophageal reflux disease (NGERD) program, which demonstrated proof-of-concept and overall safety and tolerability data. A total of 28 healthy volunteers in the study were given a high-fat meal to induce gastroesophageal reflux and were then randomized to one of three dose levels of DDP733 and placebo. The 0.5 mg dose achieved statistical significance over placebo on the primary endpoint of reduction in the number of reflux events. The drug is an orally administered prokinetic in development for NGERD and irritable bowel syndrome with constipation. Dynogen anticipates starting a Phase II study of DDP733 in GERD patients in 2008. Data were presented at the gastroenterology meeting in Philadelphia.

• Genzyme Corp., of Cambridge, Mass., announced that top-line, three-year data from a completed Phase II trial comparing alemtuzumab with Rebif (interferon beta- 1a) for the treatment of multiple sclerosis. Overall efficacy results demonstrated that alemtuzumab provides a significant treatment effect that has been found to last three years among patients in the study. Analysis of the first co-primary endpoint showed that patients taking alemtuzumab experienced at least a 73 percent reduction in the risk for relapse after three years of follow-up when compared to patients treated with interferon beta-1a. That difference was highly statistically significant in favor of the alemtuzumab patients with a p-value less than the pre-specified value (p=0.00396) assigned for the three-year analysis. Analysis of the other co-primary endpoint showed that patients taking alemtuzumab experienced at least a 70 percent reduction in the risk for progression of clinically significant disability when compared to patients treated with interferon beta-1a. The data were presented at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Prague, Czech Republic. News of the results sent shares of Genzyme (NASDAQ:GENZ) up $3.06, or 4.3 percent, to close at $74.77.

• MGI Pharma Inc., of Minneapolis, and its partner Helsinn Healthcare SA, of Lugano, Switzerland, presented results of a Phase III study evaluating the safety and efficacy of Aloxi (palonosetron hydrochloride) Injection compared to placebo for the prevention of postoperative nausea and vomiting following elective inpatient gynecologic or breast surgery. The results showed that the study successfully met the primary efficacy endpoint of complete response. Complete response rates for the selected dose of Aloxi 0.075 mg were significantly higher than those for placebo during the 0-24 (56 percent vs. 36 percent) and 24-72 (70 percent vs. 52 percent) hour time periods following surgery (p < 0.0166). The data were presented at the Annual Meeting of the American Society of Anesthesiologists in San Francisco. PALO-04-07, along with PALO-04-06, a randomized, multicenter Phase III trial focusing on elective outpatient laparoscopic abdominal or gynecological laparoscopic surgery, served as the basis of a supplemental new drug application that was accepted for filing by the FDA July 9.

• Neuromed Pharmaceuticals, of Vancouver, British Columbia, has reached an agreement with the FDA under a special protocol assessment for the pivotal Phase III trial of NMED-1077 (OROS Hydromorphone) for the treatment of chronic pain. The trial will be a randomized withdrawal, placebo-controlled, double-blind study conducted at multiple centers in the U.S. The primary outcome measure is pain intensity at endpoint assessed by patients with an 11-point Likert Numerical Rating Scale. The study will target enrollment of 272 patients into the double-blind, randomized withdrawal phase, and will evaluate the safety and efficacy of NMED-1077 in the treatment of chronic low back pain.

• Ocera Therapeutics Inc., of San Diego, said data from the first cohort of patients in an exploratory Phase II study of AST-120 in active pouchitis showed that four weeks of treatment led to a significant decrease in symptoms and endoscopy scores in 10 patients. Results showed that 44.4 percent of the patients achieved clinical remission and 55.6 percent achieved a clinical response. Data were presented at the gastroenterology meeting in Philadelphia.

• The Medicines Co., of Parsippany, N.J., said a retrospective analysis from ECLIPSE safety trial of intravenous antihypertensive therapies showed that improved perioperative blood pressure control in patients undergoing cardiac surgery is strongly associated with a reduced risk of kidney dysfunction within 30 days following the procedure. The analysis presented at the American Society of Anesthesiologists meeting in San Francisco showed a statistically significant association between BP excursions and kidney dysfunction (defined by creatinine being above 2.0 mg/dL, with minimum increase of 0.7mg/dL) at 30 days. Specifically, the risk of kidney dysfunction was more than 75 percent greater in patients with the worst BP control.

• Wyeth Pharmaceuticals, of Collegeville, Pa., and Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., announced plans to initiate two, four-week Phase II trials to evaluate daily dosing of oral methylnaltrexone in patients with chronic, nonmalignant pain who are being treated with opioids and are experiencing opioid-induced constipation (OIC). Approximately 40 sites will participate in each of these two multicenter, double-blind, randomized, placebo-controlled, studies, which are being conducted by Wyeth. Each trial is expected to enroll approximately 120 patients who are receiving opioids to help manage their chronic pain and have OIC. Both studies are expected to take about six months to complete.