• Anergis, of Epalinges, Switzerland, said patients with birch pollen allergy who received the company's allergy vaccine, AllerT, four years ago maintain an elevated level of antibodies against the allergen. In 2008 and 2009, 20 patients suffering from moderate to severe allergies to birch pollen were enrolled in a double-blind, randomized, placebo-controlled Phase I/IIa trial and received five subcutaneous injections over two months of either AllerT (N = 15) or placebo (N = 5). Four years later, all subjects were invited to return to the trial center. In subjects who had received AllerT, blood levels of so-called IgG4 antibodies against specific birch pollen allergens were similar to those reported after two years (in 2010) and still 4.5 times higher than the pre-treatment baseline level (p < 0.001).

• Cellceutix Corp., of Beverly, Mass., said patient dosing was initiated in a Phase I trial with Kevetrin, its anti-cancer drug candidate, at Harvard University's Dana Farber Cancer Center and Beth Israel Deaconess Medical Center.

• Depomed Inc., of Menlo Park, Calif., disclosed top-line results from a Phase II trial of DM-1992, the gastric-retentive, extended-release formulation of carbidopa/levodopa, in patients with advanced Parkinson's disease with motor fluctuations. The trial was a randomized, active-controlled, open-label, crossover study evaluating DM-1992 dosed twice daily against a generic version of immediate-release carbidopa/levodopa dosed as needed (mean daily dosing frequency = 4.8); 34 patients with advanced Parkinson's disease with motor fluctuations enrolled in the study at eight U.S. clinical centers. All enrolled patients completed the study. Baseline measurements were established over a three-day patient self-assessment period during which patients were maintained on existing Parkinson's medications. DM-1992 and the generic drug were each administered over a 10-day period that included a six-day dose optimization period, followed by a three-day patient self-assessment period and one in-clinic day for clinician evaluation and pharmacokinetic measurements. The primary endpoint for the study is change in percent "off" time during waking hours, as measured by patient self-assessment during the treatment period relative to the baseline period. Patients' mean baseline "off" time during waking hours was 5.4 hours per day (32.5 percent), compared to 4.5 hours (27.2 percent) during the DM-1992 self-assessment period and 5.5 hours (33.5 percent) for the generic comparator. The reduction in percent "off" time reported during the DM-1992 patient self-assessment period relative to the comparator was statistically significant (p = 0.047). DM-1992 was generally well tolerated in the study.

• Immatics biotechnologies GmbH, of Tuebingen, Germany, completed patient recruitment into the pivotal Phase III trial evaluating its lead cancer vaccine IMA901 for renal cell carcinoma (RCC). The trial has completed patient inclusion and it is expected that around 345 patients will be randomized across 10 countries in the US and Europe. The first (interim) overall survival results are expected during the first half of 2014. The trial is designed to show an overall survival benefit with IMA901 in combination with sunitinib (Sutent, Pfizer Inc.), standard first-line therapy in comparison to sunitinib alone in patients with metastatic and/or locally advanced RCC. The secondary endpoints include immune response to the peptides contained in IMA901, progression-free survival, safety and tolerability.

• Immunomic Therapeutics Inc. (ITI), of Lancaster, Pa., dosed the first patient in a Phase I trial of its lead vaccine candidate, JRC-LAMP-vax. The plasmid-based DNA vaccine, incorporating the company's LAMP technology, is being assessed for safety and immunological activity in patients with rhino-conjunctivitis symptoms caused by allergic reaction to Japanese red cedar pollen. Preclinical studies suggested LAMP-based vaccines induce a protective antibody IgG immune response consistent with a preferential MHC-II immune system presentation induced by LAMP. Enrollees in the study each received the first of a four-dose vaccine regimen and were followed for three hours, with no adverse events observed. ITI plans to complete study enrollment in November and dosing of patients early in 2013, followed by a Phase II trial beginning in 2013.

• Inotek Pharmaceuticals Corp., of Lexington, Mass., said its multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase II trial achieved its primary and secondary endpoints in evaluating the efficacy and safety of its eye drop trabodenoson (INO-8875) in primary open-angle glaucoma or ocular hypertension. Trabodenoson was found to reduce intraocular pressure (IOP) by approximately 7 mmHg at 28 days (p < 0.001) and was safe and well tolerated with good ocular tolerability and less eye redness than currently approved glaucoma treatments. The first-in-class, selective A1 subtype adenosine mimetic binds to epithelial cells in the trabecular meshwork, up-regulating gelatinases that clean out and remodel the meshwork, increasing outflow and restoring a healthier IOP. The data were presented at the Ophthalmology Innovation Summit in Chicago. Inotek plans to conduct a comprehensive late-stage development program for trabodenoson, including trials to complete the drug's Phase II development as first-line treatment and to explore efficacy in combination with a prostaglandin.

• MerLion Pharmaceuticals Pte Ltd., of Singapore, completed the first Phase I study using an intravenous (IV) formulation of the antibacterial candidate finafloxacin. The trial was a blinded, placebo-controlled, randomized, ascending single- and multiple-dose crossover study of finafloxacin administered to 58 healthy volunteers in the UK. The study results showed that single and multiple I.V. doses given once daily for seven days with up to 1,000 mg of finafloxacin were safe and well tolerated.

• Novartis AG, of Basel, Switzerland, said it plans to initiate pivotal trials of MEK162 (ARRY-162) in patients with NRAS mutant melanoma next year, with the goal of submitting regulatory filings on or after 2016. Novartis also plans to pursue clinical development in combination with a Raf inhibitor in BRAF mutant melanoma, with regulatory submissions projected on or after 2016. Array BioPharma Inc., of Boulder, Colo., licensed worldwide rights to develop and commercialize MEK162 as part of a MEK inhibitor deal with Novartis in April 2010. (See BioWorld Today, April 21, 2010.)

• Ocera Therapeutics Inc., of San Diego, said the first patient was enrolled in a Phase IIa study to test OCR-002 (ornithine phenylacetate) in acute liver injury, as well as in patients who have progressed to acute liver failure following acetaminophen overdose. The study, dubbed STOP-ALF, is expected to enroll a total of 24 patients with severe acute liver injury or acute liver failure and will measure safety and tolerability as the primary endpoint. Secondary endpoints will include measurement of drug plasma concentration, change in venous ammonia and neurological function. OCR-002 is designed to directly reduce circulating blood levels of ammonia, which, at high levels, is neurotoxic, associated with brain injury and may lead to hepatic encephalopathy.

• ProFibrix BV, of Leiden, the Netherlands, said it has enrolled more than half of the patients in its pivotal Phase III trial (FINISH-3) testing Fibrocaps, a mixture of blood-clotting proteins fibrinogen and thrombin formulated as a topical fibrin sealant, and also concluded a meeting of the data monitoring committee. FINISH-3 is designed to enroll a total of 672 surgical patients with mild to moderate surgical bleeding. The main objectives are to demonstrate superior efficacy of Fibrocaps vs. gelatin sponge within each of four surgical indications and to confirm overall safety results from the earlier Phase II studies. Pending a successful outcome, Fibrocaps is slated to be launched in 2014.

• Protalex Inc., of Summit, N.J., began screening patients in the U.S. for a randomized, multicenter, multiple-dose, dose-escalation Phase Ib study assessing the safety and tolerability of intravenous PRTX-100 administered weekly over five weeks in patients with active rheumatoid arthritis on methotrexate therapy. Secondary objectives include determining the effects of PRTX-100 on measures of disease activity, assessing the immunogenicity and evaluating the pharmacokinetic (PK) effect of repeated doses and determining possible relationships between the immunogenicity of PRTX-100 and safety, PK and efficacy. The sequential dose escalation phase will randomize up to 40 patients into cohorts starting at 1.50 ug/kg PRTX-100 or placebo, followed by up to 12 additional randomized patients for cohort expansion. The study is being conducted in the U.S. and South Africa.

• Stemline Therapeutics Inc., of New York, reported that a heavily pretreated patient with a drug-refractory and recurrent blastic plasmacytoid dendritic cell neoplasm (BPDCN) in a Phase I/II trial achieved a complete response following treatment with the firm's SL-401, a targeted therapy directed specifically to cells that overexpress the interleukin-3 receptor. The patient, a 40-year-old male, was treated with five daily doses of SL-401 and, at 30 days after treatment achieved a complete response, with no evidence of malignant BPDCN cells in his bone marrow or bloodstream and blood cell counts. He also experienced no serious side effects from SL-401 treatment.