• Alchemia Ltd., of Brisbane, Australia, began recruitment for a Phase II trial of its cancer candidate HA-Irinotecan for small-cell lung cancer. Two patients have been dosed already, and the trial will enroll 40 patients total. The trial will evaluate tumor stem cell burden as a primary endpoint at the end of the trial. Secondary endpoints include progression-free survival, and safety will be measured by incidence of grade 3 and 4 toxicity.

• Amylin Pharmaceuticals Inc., of San Diego, Eli Lilly and Co., of Indianapolis, and Alkermes Inc., of Waltham, Mass., presented new analyses from the DURATION-3 and -4 trials demonstrating patients treated with the investigational compound Bydureon (exenatide extended-release for injectable suspension) saw improvements in select cardiovascular risk factors compared to patients who received commonly prescribed diabetes treatments. Patients who received Bydureon for the treatment of Type II diabetes had a greater weight loss (9.8 pounds) than conventional treatment, plus improvements in composite endpoints related to blood pressure and lipid levels. Findings were presented at the 47th European Association for the Study of Diabetes Annual Meeting in Lisbon, Portugal. Bydureon received marketing authorization in the European Union in June and is under review in the U.S., with a PDUFA date of Jan. 28, 2012. (See BioWorld Today, April 18, 2011.)

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., completed a pharmacokinetic study of LibiGel (testosterone gel) for female sexual dysfunction. The results showed that LibiGel increased levels of free testosterone, bioavailable testosterone and total testosterone in a study of 24 postmenopausal women. The pharmacokinetic study will be used as part of BioSante's new drug application submission package, planned for the fourth quarter of 2012.

• HemaQuest Pharmaceuticals Inc., of San Diego completed enrollment in a randomized multidose Phase II study of HQK-1001 in patients with sickle cell disease. The study, initiated in April, enrolled 52 patients at clinical sites in the U.S., Canada, Jamaica, Egypt and Lebanon to evaluate the safety and tolerability of HQK-1001. Secondary objectives include the effect on fetal hemoglobin and sickle cell crises. HemaQuest expects interim results from the study in late 2011 and final results in the first quarter of 2012.

• ImmunoCellular Therapeutics Ltd., of Los Angeles, reported updated long-term data from a Phase I trial of ICT-107, a cancer vaccine candidate for glioblastoma multiforme, which demonstrated a three-year overall survival rate of 55 percent compared to a rate of 16 percent based on historical standard of care (SOC). Data showed that 38 percent of newly diagnosed patients who received ICT-107 continue to show no tumor recurrence after three years, compared to the historic disease-free survival rate of 6 percent with SOC. Out of those patients, 19 percent remain disease-free after more than four years. ICT-107 is a dendritic cell-based vaccine designed to target multiple tumor-associated antigens for glioblastoma.

• Medicago Inc., of Quebec City, said its H5N1 influenza vaccine and H1N1 VLP-based vaccines were well tolerated with no adverse events and induced a strong antibody response in a Phase II trial. The study was carried out in 135 healthy volunteers who received a Medicago vaccine or placebo to find the optimal dose. Two doses were given 21 days apart. Data will be presented at the Fourth ESWI Influenza Conference, Malta 2011.

• Nektar Therapeutics Inc., of San Francisco, said its breast cancer candidate, NKTR-102, showed a high response rate and strong clinical benefit in a Phase II trial in metastatic breast cancer, even in subsets of patients with a poor prognosis. The drug was dosed every two weeks and every three weeks. Progression-free survival was 5.3 months, and overall survival was 13.1 months with dosing every three weeks. Its objective response rate was 29 percent, and 71 percent of patients had no tumor progression.

• Oncothyreon Inc., of Seattle, enrolled its first patient in a Phase II trial of PX-866 for prostate cancer. The trial will enroll 40 patients evaluating disease progression at 12 weeks from initiation of therapy. The drug targets phosphatidylinositol-3-kinase and is being developed for patients who no longer respond to hormone therapy.

• PolyMedix Inc., of Radnor, Pa., initiated a Phase II trial of PMX-30063, a defensin-mimetic antibiotic, in patients with acute bacterial skin and skin structure infections (ABSSSI). The study is expected to enroll 200 patients who have ABSSSI due to either methicillin-susceptible or methicillin-resistant Staphylococcus aureus. They will be randomized to receive one of three doses of PMX-30063 or Cubicin (daptomycin, Cubist Pharmaceuticals Inc.) and, following the treatment period, will be assessed for clinical and microbiologic response at both 48 hours and 72 hours, with re-evaluation at day 10 to 15 for test of cure. Interim data are expected later this year, with full data anticipated in the first half of 2012.

• Prana Biotechnology Ltd., of Melbourne, Australia, said researchers are planning recruitment for a Phase II trial of PBT2 in Huntington's disease. About 100 patients with early stages of the disease will be enrolled and followed for more than six months, with assessments for safety, tolerability and efficacy. Final results are expected in 2013.

• pSivida Corp., of Watertown, Mass., said it opened an investigational new drug application for a Phase I/II trial of its injectable, sustained-release insert designed to deliver the corticosteroid fluocinolone acetonide) in uveitis affecting the posterior segment of the eye. An insert of the same design is being developed to treat diabetic macular edema by pSivida licensee, Alimera Sciences Inc., of Atlanta, using Alimera's Iluvien brand name.

• Sanofi SA, of Paris, said that Lyxumia (lixisenatide), a once-daily GLP-1 receptor agonist under development for Type II diabetes, achieved its primary efficacy endpoint of significant HbA1c reduction vs. placebo in patients uncontrolled on metformin in the company's GetGoal-F1 trial. The study was designed to compare the efficacy and safety of lixisenatide vs. placebo in one-step and two-step dose increase regimens in terms of reduction in HbA1c. The randomized, double-blind, placebo-controlled, parallel group, multicenter study enrolled 482 people with Type II diabetes, randomized and exposed to a once-daily regimen of lixisenatide one-step dose increase (10 mcg for two weeks, then 20 mcg), lixisenatide two-step dose increase (10 mcg for one week, 15 mcg for one week, then 20 mcg) or placebo, as add-on to metformin. Top-line results indicated that lixisenatide reduced HbA1c from baseline to week 24 in both treatment regimens, compared with placebo (one-step: -0.92%; two-step: -0.83% vs. placebo: -0.42%; p < 0.0001). The company also reported pooled data from 2,900 Type II diabetics showed that initiating Lantus (insulin glargine [rDNA origin] injection) led to better glycemic control and comparable and modest weight gain vs. a comparator group consisting of other insulins, oral antidiabetics and dietary changes. The Lantus data were presented at the European Association for the Study of Diabetes meeting in Lisbon, Portugal.

• Silence Therapeutics plc, of London, and InteRNA Technologies BV, of Nijmegen and Utrecht, the Netherlands, inked an agreement to develop microRNA therapeutics to treat cancer. InteRNA will provide Silence with specific miRNA sequences, which Silence will formulate with its AtuPLEX delivery system to develop multiple candidate drugs. Silence and InteRNA will undertake in vitro and in vivo studies of candidate drugs developed under the agreement and select lead candidates for further evaluation. Silence is eligible to receive up-front fees as well as staged research payments. Financial terms were not disclosed.

• Spinifex Pharmaceuticals Pty Ltd., of Victoria, Australia, presented new animal data related to its candidate EMA401 in diabetic neuropathy at the 21st annual meeting of the Diabetic Neuropathy Study Group of the European Association for the Study of Diabetes on Sept. 11. The data showed that the drug corrected motor and sensory nerve conduction velocity. The drug also reduced pain and heat sensitivity and corrected sciatic nerve nutritive blood flow.

• Tranzyme Pharma Inc., of Research Triangle Park, N.C., presented data from a Phase II trial of TZP-102, for gastroparesis in diabetes showing the drug significantly improved symptoms of the disease and was well tolerated with no effect on weight or glucose control. Patients received oral TZP-102 for 28 days. The company plans to initiate a Phase IIb trial later in 2011.