• Ambrilia Biopharma Inc., of Montreal, reported positive preliminary Phase III results for its prolonged-release formulation of Octreotide in acromegaly patients. The primary objective of this study comparing C2L to Sandostatin®LAR was met with both C2L and Sandostatin LAR, inducing a highly statistically significant decrease of insulin-like growth factor 1 (p<0.005 for both arms) and growth hormone (p<0.0001 for both arms) plasma levels. Data did not demonstrate non-inferiority, nor inferiority, of C2L over Sandostatin LAR, and the company said it would have been difficult to reach that endpoint due to the small patient population and large initial differences in both IGF-1 and GH values. No differences were observed between the two products in adverse events, which were mild and transient.

• Apthera Inc., of Scottsdale, Ariz., has submitted a Phase III clinical protocol and statistical analysis plan for registration of its lead cancer therapeutic, NeuVax to the FDA for review under a special protocol assessment. The international randomized, double-blind, placebo-controlled study will compare standard of care treatment vs. standard of care plus NeuVax for the prevention of recurrence in early stage, node-positive breast cancer patients. NeuVax is a HER2/neu peptide-based T-cell immunotherapy aimed at preventing disease recurrence and prolonging survival in cancer patients that have tumors expressing the HER2/neu oncoprotein. To date, clinical study results have demonstrated that NeuVax significantly reduces the rate of cancer recurrence while showing minimal side effects.

• Arpida Ltd., of Reinach, Switzerland, began patient screening for enrollment into its pivotal Phase III study of its TLT treatment on onychomycosis. The trial is expected to enroll a total of 220 patients with mild to moderate toenail onychomycosis to receive a one-time laser pretreatment followed by daily applications of a topical terbinafine. The comparator is 8 percent ciclopirox lacquer (Penlac) applied daily to nails that have not undergone a prior laser pretreatment. Treatment duration will be 48 weeks in both arms, and the primary endpoint is complete cure. Secondary endpoints include time to complete cure, as well as safety and tolerability of the TLT treatment.

• Cell Therapeutics Inc., of Seattle, said results of a Phase II study demonstrated that the addition of its Zevalin (ibritumomab tiuxetan) radioimmunotherapy to chemotherapy in previously untreated patients with non-follicular indolent non-Hodgkin's lymphoma was well tolerated and effective, producing a 100 percent complete remission at the end of treatment, with an estimated 89 percent of patients remaining in remission at three years. Zevalin is indicated for relapsed or refractory low-grade or follicular B-cell NHL, including patients refractory to rituximab (Rituxan, Genentech Inc. and Biogen Idec Inc.). Results were published in Cancer.

• Diamyd Medical AB, of Stockholm, Sweden, said the final analysis from its Phase IIb trial with diabetes vaccine Diamyd showed that the drug preserved beta cell function for 30 months in patients with type 1 diabetes. The 70-patient trial, conducted in Sweden, demonstrated statistically significant preservation of insulin secretion as well as a significant and specific immune response. Diamyd has submitted applications to begin Phase III trials in the U.S. and Europe.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., filed new data with the FDA relating to the existing new drug application for Nebido (testosterone undecanoate), a long-acting injectable testosterone therapy for male hypogonadism. The new Phase III data showed that lower, more frequent doses of Nebido were well tolerated and met their efficacy endpoints more rapidly than previously studied dosing regimens. The Nebido NDA originally was submitted to the FDA Aug. 28, 2007, and the Prescription Drug User Fee Act target action date is June 27, 2008. (See BioWorld Today, Aug. 29, 2007.)

• NovaBay Pharmaceuticals Inc., of Emeryville, Calif., received FDA clearance for its investigational new drug application seeking to begin clinical trials of NVC-422 for the prevention of catheter-associated urinary tract infections. NVC-422, a topical non-antibiotic anti-infective, is also undergoing clinical trials for reduction of surgical site infections and other hospital-based infections.

• Oramed Pharmaceuticals Inc., of Jerusalem, started Phase Ib testing of its oral insulin capsule for diabetes. The study will enroll healthy volunteers to determine the final formulation of the product.

• Oxford BioMedica, of Oxford, UK, said partner MolMed SpA, of Milan, Italy, received Italian regulatory clearance to begin a Phase III trial of its TK therapy in leukemia. TK therapy, a cell therapy designed to promote immune reconstitution in patients receiving hematopoietic stem cell transplantation from a partially compatible donor, utilizes Oxford's retroviral ex vivo gene delivery technology. The trial initiation triggered an undisclosed milestone payment to Oxford.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said Indian regulatory authorities approved its Phase II protocol for bavituximab in combination with chemotherapy in non-small-cell lung cancer patients. The trial's primary objective is to assess the overall tumor response rate (measured using RECIST data) in patients given Peregrine's drug and carboplatin plus paclitaxel, with up to 21 patients enrolled initially and expanded up to 49 patients pending promising results in the initial cohort. Secondary objectives include time to tumor progression, duration of response, overall patient survival and safety parameters. Bavituximab is a monoclonal antibody designed to bind to phosphatidylserine, a phospholipid that becomes exposed on the outside of cells that line the blood vessels of tumors.

• Protherics plc, of London, said partner AstraZeneca plc, of London, initiated an expanded Phase II program for CytoFab in severe sepsis. Although Protherics previously completed a Phase IIb trial of the drug, U.S. and European regulatory agencies had requested additional Phase II work with drug produced using a revised, scaled-up manufacturing process. AstraZeneca licensed CytoFab, an antitumor necrosis factor (TNF)-alpha polyclonal antibody fragment, from Protherics in a $341 million deal. (See BioWorld Today, Dec. 9, 2005.)

• Synosia Therapeutics, of San Francisco, said it successfully completed its first trial of SYN-111 (rufinamide), a sodium channel blocker discovered by Basel, Switzerland-based Novartis AG, and expects to start a Phase II study in general anxiety disorder later this year. Synosia licensed rights from Novartis in April to develop the compound in mood disorders. (See BioWorld Today, April 24, 2007.)

• Vyteris Inc., of Fair Lawn, N.J., said a Phase I trial conducted with Ferring Pharmaceuticals SA, of Saint-Prex, Switzerland, proved the ability of Vyteris' Smart Patch technology to deliver therapeutic levels of a peptide transdermally. The peptide delivered was intended to treat female infertility, although the trial was conducted in healthy volunteers.