• Acacia Pharma Ltd., of Cambridge, UK, reported Phase II data showing that APD515, an optimized oromucosal formulation of a currently marketed muscarinic agonist, significantly reduced the symptoms of xerostemia (dry mouth) compared to placebo, hitting the primary endpoint. The study involved 32 patients who received a week of APD515 treatment and a week of placebo, in a randomly assigned order, with a week’s washout in between. The average score for dry mouth was 26.01 after treatment with APD515 vs. 43.52 after placebo (p = 0.0005). Acacia initially intends to develop the drug for use in advanced cancer patients, up to 80 percent of whom suffer some degree of xerostemia, either as a result of their disease or as a consequence of treatment.

• Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., said the independent data monitoring committee overseeing the firm’s ongoing pivotal Phase III study of Firdapse (amifampridine phosphase) in Lambert-Eaton myasthenic syndrome (LEMS) recommended that the study continue as planned based on a review of safety and clinical data. The study is designed to enroll 36 LEMS patients, with top-line data expected in the second quarter of 2014. Catalyst picked up rights to Firdapse last year in as sublicensing deal with San Rafael, Calif.-based Biomarin Pharmaceutical Inc.

• DBV Technologies, of Bagneux, France, said the data and safety monitoring board for its ongoing Phase IIb VIPES (Viaskin Peanut’s Efficacy and Safety) study, which met for the second time last month, concluded that the study presented no safety concerns and could proceed as per protocol. The trial is enrolling 221 patients with peanut allergies. Top-line data are expected in the second half of 2014. Viaskin Peanut has fast-track designation in the U.S.

• Endocyte Inc., of West Lafayette, Ind., and Merck & Co. Inc., of Whitehouse Station, N.J., said data from the Phase II PRECEDENT trial were published online in the Journal of Clinical Oncology, showing that administration of vintafolide plus pegylated liposomal doxorubicin (PLD) vs. PLD alone in women with platinum-resistant ovarian cancer resulted in a median progression-free survival of five months compared to 2.7 months for those treated with PLD alone (p = 0.031). Those results are the basis for the vintafolide regulatory application under review in Europe for the treatment of folate receptor-positive platinum-resistant ovarian cancer in combination with PLD. Enrollment is ongoing in the Phase III PROCEED trial of vintafolide, along with investigational companion imaging agent etarfolatide, in platinum-resistant ovarian cancer. Shares of Endocyte (NASDAQ:ECYT) gained $1 . 19, or 11 .6 percent, to close Tuesday at $11 .42.

• Globeimmune Inc., of Louisville, Colo., said it earned a milestone payment from Gilead Sciences Inc., of Foster City, Calif., under the terms of the companies’ 2011 agreement to develop and commercialize Tarmogen products for use in conjunction with Viread (tenofovir disoproxil fumarate) and other therapies for the treatment of chronic hepatitis B virus (HBV) infection. The milestone is based on the initiation of a Phase II trial testing GS-4774 (formerly GI-13020) in patients with chronic HBV. The open-label study will evaluate different doses of the drug in virally suppressed patients, with a primary endpoint defined as the decline in serum HBV surface antigen. The GS-4774 Tarmogen consists of whole, heat-killed, recombinant S. cerevisiae yeast genetically modified to express HBV antigens. (See BioWorld Today, Oct. 26, 2011.)

• Helix Biopharma Corp., of Aurora, Ontario, said it completed an interim review of its ongoing Phase I/II study of L-DOS47 in Poland, with the drug demonstrating tolerability for all patients treated within all cohorts. Data showed that at least one patient from each of the four cohorts had a radiological assessment of stable disease. Duration of treatment increased with each dose escalation up to Cohort 3, and dosing in Cohort 4 remains ongoing. One patient in Cohort 3 was dosed for six cycles without disease progression. None of the patients treated to date have had a partial or complete response as determined by RECIST. L-DOS47 is an immunoconjugate-based candidate developed using Helix’s DOS47 technology. It’s currently in testing as a treatment for certain patients with non-small-cell lung cancer.

• Insmed Inc., of Monmouth Junction, N.J., said it completed patient enrollment in its Phase II study of Arikace (liposomal amikacin for inhalation) for patients with recalcitrant nontuberculous mycobacterial lung disease in the U.S. and Canada. The primary endpoint is the semi-quantitative measurement of the change in mycobacterial density on a seven-point scale from baseline to the end of the randomized portion of the trial on day 84. Arikace has received orphan drug, qualified infectious disease product and fast-track designations in the U.S.

• Portola Pharmaceuticals Inc., of South San Francisco, reported interim findings from a Phase II study of Andexanet alfa, its investigational Factor Xa inhibitor antidote, in healthy volunteers who received Factor Xa inhibitor Eliquis (apixaban, Bristol-Myers Squibb Co. and Pfizer Inc.). Data showed a rapid or nearly complete reversal of the anticoagulation effect of Eliquis at two minutes following completion of the bolus, which was sustained during infusion for up to two hours. Pivotal studies of Andexanet alfa are slated to start in 2014.

• Redhill Biopharma Ltd., of Tel Aviv, Israel, presented data at the American College of Gastroenterology meeting in San Diego from an independent, single-center, retrospective study with 10 pediatric patients, ages 8 to 17, suffering from Crohn’s disease. Patients were treated with an earlier formulation of the company’s RHB-104 anti-MAP (Mycobacterium avium subspecies paratuberculosis) combination therapy, with results showing a clinical remission rate of 80 percent, as measured using the Pediatric Crohn’s Disease Activity Index. Patients were treated for six months to 117 months. Redhill is tesing RHB-104 in a Phase III study in adult Crohn’s patients. (See BioWorld Today, Aug. 21, 2013.)

• Trevena Inc., of King of Prussia, said data from its first-in-human study, published in the Journal of Clinical Pharmacology, showed that TRV130, a small-molecule G protein-biased ligand at the mu-opioid receptor, demonstrated dose-dependent increases in exposure, with subjects experiencing no nausea and vomiting. Trevena anticipates initiating a Phase II trial in the first half of next year. TRV130 is in development for moderate to severely acute pain.