• Akela Pharma Inc., of Montreal, said that, due to GLP deviations, the six-month inhalation preclinical toxicology studies for Fentanyl Taifun were deemed invalid by the FDA. No toxicological reasons were cited by the agency, the firm said. Akela said it currently is evaluating several alternative remedies and was confident that its submission for regulatory approval of Fentanyl Taifun will not be delayed by more than six months.

• BioLineRx Ltd., of Jerusalem, said results from a Phase IIa trial of BL-1020, a GABA-enhanced antipsychotic, showed statistically significant efficacy with no significant change in weight and no increase in extrapyramidal symptoms at study completion. The trial was an open-label, six-week study designed to determine the safety and maximum tolerated dose of BL-1020 in schizophrenic patients. The study was conducted on 36 treatment refractory hospitalized patients.

• Celgene Corp., of Summit, N.J., said data from a Phase II trial of apremilast (CC-10004) in 260 patients with moderate to severe plaque-type psoriasis were presented at the 66th American Academy of Dermatology meeting. The data showed that more patients on apremilast achieved significantly greater reductions in baseline Psoriasis Area and Severity Index scores compared to placebo, and that apremilast patients achieved a clinically meaningful improvement in Dermatology Life Quality Index scores. No serious drug-related adverse events were reported. Celgene plans to increase the dose of apremilast, a small-molecule phosphodiesterase 4 inhibitor, from 20 mg to 30 mg administered for six months.

• Kuros Biosurgery AG, of Zurich, Switzerland, completed enrollment of a targeted 10 patients into its Phase IIa trial of KUR-212, a combination of platelet-derived growth factor and fibrin sealant. The goal of the trial, which is being conducted in Germany, is to evaluate the safety and preliminary efficacy of KUR-212 in fixating autologous skin grafts to severe burns and improving wound healing.

• NanoBio Corp., of Ann Arbor, Mich., said final results from a prior Phase IIA study in herpes labialis, as well as interim findings from an ongoing Phase IIB study, indicated a significant improvement in time to healing for subjects treated with NanoBio's antiviral product, NB-001. The data are being presented at the American Academy of Dermatology meeting in San Antonio.

• Neuro-Hitech Inc., of New York, said top-line results from a Phase II clinical trial showed that patients with mild to moderate Alzheimer's disease receiving the high dosages of Huperzine A demonstrated a moderate improvement in cognitive function. However, the study missed its primary endpoint of cognitive change in the lower dosage group. The multicenter, randomized, double-blind, placebo-controlled trial of 210 patients with mild to moderate Alzheimer's disease compared the safety, tolerability and efficacy of either Huperzine A 200 mcg or 400 mcg administered orally twice a day for 16 weeks vs. placebo. The study measured the efficacy of Huperzine A on cognitive function, activities of daily living and behavior. Of the 210 patients enrolled in the study, about half received concomitant treatment with Forest Pharmaceuticals Inc.'s Namenda (memantine HCI).

• SciClone Pharmaceuticals Inc., of Foster City, Calif., said the first patient has been dosed in its Phase II clinical trial of RP101, a nucleoside analogue being investigated as an agent to enhance the beneficial effect of chemotherapy for the treatment of pancreatic cancer. In a previous Phase I clinical study in 22 late-stage pancreatic cancer patients, patients receiving RP101 in combination with gemcitabine, the current standard of care, had a median survival of 9.3 months compared with a historical control of approximately six months for patients treated with gemcitabine alone. The FDA has granted orphan drug designation to RP101 for the adjunct treatment of pancreatic cancer.

• Ziopharm Oncology Inc., of New York, initiated two Phase I/II trials. One trial will evaluate oral indibulin (ZIO-301) combined with Tarceva (erlotinib, OSI Pharmaceuticals Inc. and Genentech Inc.) for solid tumors, while the other will evaluate palifosfamide (ZIO-201) combined with doxorubicin for sarcoma. Indibulin is a synthetic antimitotic agent that binds to tubulin to arrest tumor cell growth. Palifosfamide is based on the sarcoma standard of care, ifosfamide. Shares of Ziopharm (NASDAQ:ZIOP) rose 29 cents, or 9.6 percent, to close at $3.30 Monday.