Adamas Pharmaceuticals Inc., of Emeryville, Calif., reported the 340-mg dose of ADS-5102 resulted in a statistically significant improvement in overall Parkinson's disease clinical status, including levodopa-induced dyskinesia, when compared with placebo in a phase II/III study (p = 0.0036). The EASED trial, which enrolled 83 patients, met its primary endpoint, and the company intends to start a phase III study later this year. ADS-5102 is a controlled-release version of the approved drug amantadine. The data were presented at the American Academy of Neurology annual meeting.

Aradigm Corp., of Hayward, Calif., dosed the first patient in the ORBIT-3 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) phase III trial of Pulmaquin, a formulation of inhaled ciprofloxacin, to treat non-cystic fibrosis bronchiectasis. The clinical program consists of two worldwide, double-blind, placebo-controlled pivotal trials that will enroll about 255 patients each. In 2013, Aradigm granted an exclusive, worldwide license to its inhaled liposomal ciprofloxacin product candidates to Grifols S.A., of Barcelona, Spain.

Biogen Idec Inc., of Cambridge, Mass., presented data at the 66th American Academy of Neurology annual meeting in Philadelphia that reinforce the efficacy of Tecfidera (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis. A new post-hoc analysis from the phase III DEFINE and CONFIRM studies show that, at two years, Tecfidera taken twice daily significantly reduced annualized relapse rate by 60 percent and the proportion of patients who relapsed by 63 percent. The open-label, single-arm MANAGE study data show that gastrointestinal events were largely transient, occurred most frequently in the first month of therapy, and were mostly reported as mild to moderate in severity.

Flexion Therapeutics Inc., of Burlington, Mass., said the first patient has been dosed in a confirmatory phase IIb trial of FX006 for relieving pain associated with osteoarthritis of the knee. The drug is Flexion's non-opioid, sustained-release, intra-articular formulation of triamcinolone acetonide. The company expects to receive topline data in the first half of 2015.

Karyopharm Therapeutics Inc., of Natick, Mass., started a phase II trial of its oral selective inhibitor of nuclear export (SINE) compound Selinexor (KPT-330) in patients with glioblastoma following treatment with radiation and temozolomide. The study is being run in Copenhagen, New York and Boston. The primary goal is to determine the anti-tumor activity of single agent Selinexor in up to 30 patients with relapsed glioblastoma, as well as to document brain penetration of Selinexor and determine tolerability. Selinexor works by binding with the nuclear export protein XPO1, leading to the accumulation of tumor suppressor proteins in the cell nucleus, which reinitiates and amplifies the tumor suppression function.

Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., reported top-line results from the NX03-0040 phase II U.S. prostate cancer study in 146 patients. Results indicate an overall benefit in terms of reduced progression in patients with low grade localized prostate cancer treated with a single injection of NX-1207 into the area of the prostate where cancer was found. There were no significant safety issues or side effects associated with the drug. Patients given a single targeted injection of NX-1207 had less evidence of cancer progression in the treated area than untreated patients as determined by Gleason grade. The number of biopsy scores showing higher grade of malignancy was significantly lower overall for NX-1207 treated patients compared to controls in the treated area (p = 0.032), in the treated side of the prostate (p = 0.004, and in the prostate overall (p = 0.004). NX-1207 is in phase III development in the U.S. and Europe for benign prostatic hyperplasia.

Plandai Biotechnology Inc., of New York, was given the go-ahead to conduct human clinical trials in a three-month study comparing oral bioavailability in its Phytofare Catechin Complex to green tea extracts. The study will be conducted at the North West University in Potchefstroom, South Africa, where Plandai's two technologies, hydrodynamic sheering and Pheroid entrapment, will be tested. The trial is expected to begin in mid-May, with final results available in July.

Redhill Biopharma Ltd., of Tel Aviv, Israel, said results from a comparative bioavailability study conducted in Canada with RHB-102, an extended-release, once-daily oral pill formulation of the anti-emetic ondansetron, to prevent chemotherapy and radiotherapy-induced nausea and vomiting, showed that the exposure provided supports its effectiveness and safety. The trial included 20 healthy volunteers and supported a planned European marketing authorization application slates for the fourth quarter of 2014. The company also said it is now pursuing a new undisclosed indication for RHB-102 that would significantly expand the market potential.

Sanofi SA's Genzyme unit, of Cambridge, Mass., reported new magnetic resonance imaging (MRI) data from the Lemtrada (alemtuzumab) clinical development program. In Lemtrada patients from the two phase III trials (both treatment-naïve patients and patients who had active disease on another therapy), MRI effects observed after two years were maintained during the first year of the extension study. The data, presented at the 66th American Academy of Neurology (AAN) Annual Meeting, show that consistent effects were seen across key measures of disease activity and effects seen after two years of treatment were sustained at year three. During the third year of follow-up, more than 70 percent of patients were free of MRI activity indicative of acute inflammation, defined as gd-enhancing or new or enlarging T2 hyperintense lesions. T2 lesion volumes, which reflect the combined burden of permanent brain injury and new lesion formation, increased from year two to three but remained below pre-treatment baseline. And, approximately 80 percent of patients treated with Lemtrada did not receive a third course of treatment in the first year of the extension.

Synergy Pharmaceuticals Inc., of New York, reported top-line data from a phase IIb dose-ranging study of plecanatide in 424 patients with irritable bowel syndrome with constipation (IBS-C) that identified an effective, safe and well tolerated dose for phase III trials. Plecanatide demonstrated statistically significant improvement in complete spontaneous bowel movement frequency, the primary endpoint. Patients taking the plecanatide 3-mg dose experienced statistically significant improvement in change from baseline vs. placebo in abdominal pain and met the FDA overall responder endpoint for IBS-C over the 12-week treatment. The company expects to start phase III trials in the second half of this year. Plecanatide is a guanylate cyclase-C agonist, and a 16-amino-acid analog of the human gastrointestinal hormone, uroguanylin.

Titan Pharmaceuticals Inc., of South San Francisco, and partner Braeburn Pharmaceuticals Sprl, of Princeton, N.J., started a new phase III trial for Probuphine based on guidance from the FDA. The company received a complete response letter (CRL) in May 2013 for Probuphine, a subdermal implant designed for the maintenance treatment of opioid dependence in adults. The CRL requested additional clinical data demonstrating both the ability of Probuphine to show opioid blockade of relevant doses of agonists and the effect of Probuphine at higher doses than studied to approximate blood plasma levels associated with daily 12-mg to 16-mg sublingual doses of buprenorphine. The new study is expected to begin enrollment by mid-year and to be completed by the middle of 2015. The randomized, double-blind, double-dummy design experiment is expected to enroll approximately 180 patients into two parallel treatment arms. The study population will be clinically stable patients who are receiving maintenance treatment with an approved sublingual formulation containing buprenorphine at a daily dose of 8 mg or less. Patients will be randomized either to receive four Probuphine implants or to continue daily sublingual buprenorphine therapy. All patients are expected to be treated for six months, and the primary analysis will be a non-inferiority comparison of responders in the two arms. Titan's shares (NASDAQ:TTNP) swooned when the CRL was issued, falling from $1.66 to 32 cents. On Wednesday, it gained 7.6 percent to close at 64 cents. (See BioWorld Today, May 2, 2013.)