• Advanced Viral Research Corp., of Yonkers, N.Y., plans to begin a Phase II trial of AVR118 in cachexia-related symptoms in cancer patients. The study initially will enroll at least 14 cancer patients suffering cachexia, a syndrome characterized by muscle wasting, anorexia and severe fatigue, and pending positive results, could increase enrollment to 32 patients or more. AVR118 is a cytoprotective agent.

• Akela Pharma Inc., of Montreal, reported positive results from the extension part of its 50-patient Phase IIb trial of Fentanyl Taifun, which showed statistically significant differences compared to placebo in the measured primary and secondary efficacy variables, resulting in faster and superior pain relief. The study involved cancer patients with severe persistent pain on maintenance opioid therapy. In the intent-to-treat population, the median time to significant pain relief, as measured by a decrease of at least two points on the numerical pain scale, was 5.2 minutes for the treated group, and the mean difference in sum of pain intensity difference was statistically significantly in favor of the Fentanyl Taifun arm for the whole 60-minute pain episode, compared to placebo. Fentanyl Taifun is a fast-acting fentanyl formulation delivered using the Taifun dry powder inhaler platform.

• Alba Therapeutics Corp., of Baltimore, said the FDA cleared its investigational new drug application for oral AT-1001 for the preservation of endogenous insulin production capacity in new-onset Type I diabetes, and the company plans to initiate an exploratory study in that indication next year. AT-1001, an inhibitor of barrier dysfunction that has been shown to block intestinal permeability, is in Phase II studies for celiac disease. Alba intends to submit another IND for the drug in Crohn's disease.

• Antisoma plc, of London, reported positive survival data from a Phase II trial of ASA404 in combination with carboplatin and paclitaxel chemotherapy in patients with non-small-cell lung cancer. Median survival time was 14.9 months, median time to tumor progression was 5.5 months and tumor response rate was 37.9 percent. The addition of ASA404 to chemotherapy was found to be well tolerated. Data were presented at the lung cancer conference in Seoul, South Korea. ASA404 is a vascular-disrupting agent partnered with Basel, Switzerland-based Novartis AG, which plans to move the drug into Phase III testing in NSCLC early next year.

• Ardea Biosciences Inc., of Carlsbad, Calif., said it successfully completed Phase I studies of RDEA806, an HIV non-nucleoside reverse transcriptase inhibitor, in healthy volunteers, and plans to initiate a Phase IIa proof-of-concept study in HIV-infected patients before the end of this year, with results possibly available by the first quarter of 2008. Pending positive results, a larger Phase IIb study could start in the second quarter of next year.

• AtheroGenics Inc., of Atlanta, saw its shares fall 35 percent after presenting diabetes data at the cardiology meeting in Vienna, Austria, from the company's ARISE Phase III trial. Results showed that its anti-inflammatory agent, AGI-1067, significantly lowered levels of glycated hemoglobin A1c, with greater improvement seen in subjects with higher baseline A1c levels, and that effect was seen in patients with or without diabetes. The data showed a marked reduction in the development of new onset diabetes in patients with impaired fasting glucose, and in patients with diabetes, AGI-1067 demonstrated a 22 percent reduction in hard cardiovascular events of cardiovascular death, cardiac arrest, myocardial infarction and stroke. While positive, those data were not as impressive as investors had hoped. AtheroGenics' stock (NASDAQ:AGIX), which had run up over the last few days in anticipation of the diabetes data, sank $1.04 Wednesday to close at $1.96. The company, which shifted the focus of AGI-1067 to diabetes after the drug missed its primary cardiovascular endpoint in the ARISE trial, began enrolling patients last month in its Phase III ANDES (AGI-1067 as a Novel Anti-Diabetic Agent Evaluation Study) trial in Type II diabetes mellitus. (See BioWorld Today, Aug. 24, 2007.)

• Avigen Inc., of Alameda, Calif., started a Phase II trial of AV650 (tolperisone HCl) in spasticity associated with multiple sclerosis. The study will enroll up to 150 patients to receive doses of the drug up to 900 mg for one month, followed by a six-month open-label safety extension. The primary endpoint will be measured by the Ashworth scale, a tool for measuring increased movement, with secondary endpoints including Brief Pain Index, painful spasm diaries and clinical impression of change. Tolperisone is an oral, small molecule marketed for neuromuscular spasticity and spasm in Europe and Asia. Avigen is developing AV650 for commercialization in the North American market under a license and supply agreement with Sanochemia Pharmazeutika AG, of Vienna, Austria.

• Biomira Inc., of Edmonton, Alberta, said three-year survival data from its Phase II trial of Stimuvax MUC-1 vaccine suggested that the drug, in combination with best supportive care (BSC), might provide survival benefits to patients with unresectable Stage IIIb non-small-cell lung cancer who had either responded or had stable disease after initial radio-chemotherapy, compared with patients receiving BSC alone. Updated results showed that almost twice as many patients (49 percent) were still alive in the Stimuvax arm compared with the BSC arm (27 percent), representing a 45 percent reduction in mortality. Patients with Stage IIIb locoregional disease who received Stimuvax also experienced a 17.3-month difference in median survival compared to patients receiving BSC alone (30.6 months vs. 13.3 months, respectively.) Those results were presented at the lung cancer conference in Seoul, South Korea.

• CV Therapeutics Inc., of Palo Alto, Calif., said results from the MERLIN TIMI-36 study showed that Ranexa (ranolazine extended-release tablets) reduced both ventricular and atrial arrhythmias over placebo. Patients receiving Ranexa had a 37 percent reduction in their relative risk of ventricular tachycardia lasting eight beats or more, and there were fewer episodes of sudden cardiac death observed in patients taking Ranexa (56) than in patients taking placebo (65). Data were published in Circulation and presented at the cardiology conference in Vienna, Austria. CV Therapeutics said it believes that data from the MERLIN TIMI-36 study could support a label expansion for Ranexa to first-line angina, and the company expects to submit a supplemental new drug application this fall.

• Depomed Inc., of Menlo Park, Calif., reported results from a Phase IIa proof-of-concept study of Omeprazole in gastroesophageal reflux disease (GERD), showing advantages of the drug's delivery in two evening pulses to patients suffering with nocturnal acid breakthrough (NAB) associated with GERD. The study's objective was to determine whether the delivery of a dose of omeprazole with dinner, followed by a second dose four hours after dinner, would reduce the incidence of NAB. In the nine patients who achieved blood levels from both doses, none experienced NAB, while three patients in the single-dose arm had NAB. Omeprazole, a proton pump inhibitor, is approved for GERD.

• Evotec AG, of Hamburg, Germany, said results from its first Phase II trial of EVT 201 in patients with primary insomnia showed that all endpoints achieved an even higher level of statistical significance than top-line data in June indicated. Data from the 67-patient study demonstrated that the drug met both co-primary endpoints of Total Sleep Time and Wake After Sleep Onset. Statistical and clinically meaningful effects also were found on both the Latency to Persistent Sleep and Total Sleep Time in the second half of the night, indicating strong effects on both sleep onset and sleep maintenance. Data were presented at the sleep conference in Cairns, Australia. EVT 201, a partial positive allosteric modulator of the GABAA receptor complex, is in a second Phase III trial in elderly patients with primary insomnia, with top-line results expected in October.

• Exelixis Inc., of South San Francisco, reported interim data from a Phase II trial of XL647, a receptor tyrosine kinase inhibitor, in non-small-cell lung cancer showing that, to date, more than 60 percent of evaluable patients have had partial responses or stable disease as their best response. Responses also have been observed in patients with and without activating mutations in the epidermal growth factor receptor. The ongoing study involves previously untreated patients with Stage IIIb or Stage IV NSCLC who have adenocarcinoma histology and meet one of three requirements: Asian descent, female or no or minimal smoking history. Data were presented at the lung cancer conference in Seoul, South Korea.

• Icagen Inc., of Research Triangle Park, N.C., initiated a Phase I study of ICA-105665, a small-molecule compound for epilepsy. ICA-105665 is designed to activate certain subtypes of KCNQ ion channels underling a potassium current important in the regulation of the resting potential and electrical firing of certain nerve cells. The single-dose study is expected to enroll healthy male volunteers, and pending positive data, a subsequent study will begin to assess multiple doses. Proof-of-concept studies are in the planning stages.

• LifeCycle Pharma A/S, of Horsholm, Denmark, started a head-to-head study of LCP-Tacro, its once-daily tacrolimus tablet, vs. Advagraf (tacrolimus prolonged release, Astellas Pharma Inc.) in healthy volunteers, with results expected before the end of this year. The company hopes to show that its product has advantages over the approved immunosuppressant. Meanwhile, LifeCycle is conducting two Phase II trials, one in kidney transplantation, with results anticipated either by year-end or early 2008, and the other in liver transplant patients, which is expected to begin enrollment in the next few months.

• MediGene AG, of Martinsried, Germany, completed patient recruitment for its Phase I/II trial of NV1020 in colorectal cancer patients with liver metastases. The company previously reported positive results from the first part of the trial before adding another 18 patients for treatment with the maximum dosage. Following four weeks of treatment, the course of the disease will be observed, with the duration of that observation period depending upon patients' responses to treatment. Final analysis is expected during 2008. NV102 is an oncolytic herpes simplex virus designed to selectively multiply in tumor cells to destroy the tumor.

• Pharmacyclics Inc., of Sunnyvale, Calif., said results from a Phase II trial of Xcytrin (motexafin gadolinium) injection as a single-agent in non-small-cell lung cancer patients who failed at least one platinum-based chemotherapy regimen demonstrated a confirmed response rate of 5 percent, or three partial responses. Seventeen patients (30 percent) had stable disease. Median survival was 9.2 months, with one-year survival at 34 percent. A second ongoing study of Xcytrin in combination with Alimta (pemetrexed, Eli Lilly & Co. Inc.) showed that 18 of 24 evaluable patients (75 percent) have achieved stabilization of their tumors, with three of the 18 still on treatment. For the 35 patients evaluable for survival, the median survival time exceeds one year, with an actuarial one-year survival rate of 52 percent. Those data were presented at the lung cancer conference in Seoul, South Korea.

• Provectus Pharmaceuticals Inc., of Knoxville, Tenn., gained approval to start Phase II testing of Provecta in Stage III and Stage IV metastatic melanoma. In the 80-patient trial, Provecta will be injected into up to 20 tumors per patients, with additional treatment made eight to 16 weeks, if necessary, after the initial injection. Response will be observed for one year, during which data will be gathered for assessment of objective response rate, progression-free survival, quality of life and safety. CT imaging will be used to monitor changes in any internal metastases.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., said updated Phase II data for ozarelix in benign prostatic hypertrophy showed that ozarelix significantly improved scores for International Prostate Symposium Score (IPSS), which was the primary endpoint, as well as for secondary endpoints, which included IPSS improvement by >30 percent change and uroflow values (Qmax), at 12 and 28 weeks, compared to placebo. Ozarelix, a GnRH antagonist that is administered intramuscularly, also was found to be well tolerated and maintained statistically significant and clinically meaningful efficacy in the treatment of lower urinary tract symptoms secondary to BPH for six months following dosing. Data were presented at the Societye Internationale d'Urologie meeting in Paris.

• Theratechnologies Inc., of Montreal, said it notified investigators to end recruitment by Sept. 11 for its confirmatory Phase III trial of tesamorelin (TH9507) in HIV-associated lipodystrophy, thereby meeting the company's goal of completing enrollment in the third quarter. Patients recruited on or before this date will be screened, and those eligible will be enrolled in the study within the next few weeks. The 400-patient trial is designed to confirm the results from the first Phase III study by evaluating the daily administration of 2 mg of tesamorelin for 26 weeks, with the primary endpoint of a reduction of visceral adipose tissue. The trial is being conducted under a special protocol assessment reviewed by the FDA. Top-line data are expected in the first half of 2008.

• YM BioSciences Inc., of Mississauga, Ontario, reported positive preliminary results from the first two cohorts of the Phase I portion of its Phase I/II trial of nimotuzumab in combination with radiation in non-small-cell lung cancer patients who are unsuitable for radical chemotherapy. Of the six patients in the first cohort, four showed partial responses and two showed stable disease as of Aug. 14, and the median overall survival of the group was 41.5 weeks. Of the seven patients in the second cohort, two have had partial responses and five have had stable disease. Median overall survival of that group has not been reached but exceeds 25 weeks. Data were presented at the lung cancer conference in Seoul, South Korea, and those results will be used to determine dosing for the Phase II component, which will evaluate nimotuzumab, a humanized monoclonal antibody targeting the epidermal growth factor receptor, with a primary endpoint of overall survival.

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