Cempra Inc., of Chapel Hill, N.C., said it completed enrollment of 250 patients for its phase III trial in urogenital gonorrhea. Under a Cooperative Research and Development Agreement with the National Institute of Allergy and Infectious Diseases, the trial has been amended to include up to an additional 60 patients, consisting of women and adolescents with culture-proven gonorrhea. The study, called Solitaire-U, is testing oral antibiotic solithromycin against standard of care (ceftriaxone administered intramuscularly and oral azithromycin).
Helix Biopharma Corp., of Aurora, Ontario, said it opened patient screening for the 15th dose level cohort in its phase I/II trial of L-DOS47, its immunoconjugate-based drug candidate, in Poland. Helix said it will move into the phase II portion of the trial as soon as the maximum tolerated dose is observed or when cohort 16 is completed.
International Stem Cell Corp., of Carlsbad, Calif., said it entered a master clinical research agreement with the Florey Institute of Neuroscience and Mental Health to conduct phase I/IIa dose-escalation trial of human parthenogenetic stem cell-derived neural stem cells in Parkinson's disease patients. Interim results from the study are expected in October 2016.
Intra-Cellular Therapies Inc., of New York, said it started enrolling patients in the phase III trials in bipolar depression testing ITI-007-401 as a monotherapy and ITI-007-402 as adjunctive therapy to lithium or valproate. The program will consist of two randomized, double-blind, placebo-controlled trials, each enrolling about 550 patients with a clinical diagnosis of bipolar I or bipolar II disorder and who are experiencing a current major depressive episode. The primary endpoint for both trials is change from baseline at day 42 on the Montgomery-Åsberg Depression Rating Scale total score vs. placebo. Secondary endpoints include measures of social function and quality of life that may illustrate the differentiated clinical profile of ITI-007. Safety and tolerability are also being assessed in both trials. ITI-007 combines serotonin 5-HT2A receptor antagonism, dopamine receptor phosphoprotein modulation, glutamatergic modulation and serotonin reuptake inhibition into a single drug candidate.
Kamada Ltd., of Ness Ziona, Israel, said its pivotal phase II/III trial testing the firm's human rabies immune globulin (IgG, or Kamrab or Kedrab) therapy as a post-exposure treatment for rabies successfully met the trial's primary endpoint of noninferiority when measured against an IgG reference product. The company expects to file a biologics license application in mid-2016. Kamada has a strategic agreement with Kedrion SpA, of Lucca, Italy, for the clinical development and marketing of its IgG product, which will be branded as Kedrab in the U.S., subject to receiving marketing approval from the FDA.
Lightlake Therapeutics Inc., of New York, said an opioid antagonist drug will be tested in patients with cocaine use disorder at the University of Pennsylvania. The study, set to begin recruitment this month, will be funded by a Medications Development Centers of Excellence Cooperative Program from the National Institute on Drug Abuse. It plans to use functional magnetic resonance imaging to test the impact of the opioid antagonist on brain networks related to addiction-relevant processes such as reward and inhibition.
Merrimack Pharmaceuticals Inc., of Cambridge, Mass., said it filed an amendment to its ongoing phase II trial of MM-121 (seribantumab) in patients with heregulin-positive non-small-cell lung cancer (NSCLC) with the FDA, which includes a change in primary endpoint to overall survival to enable a potential registration opportunity for MM-121. The study is testing the fully human ErbB3-targeting monoclonal antibody in combination with docetaxel or pemetrexed, compared to docetaxel or pemetrexed alone, in patients with heregulin-positive, locally advanced or metastatic NSCLC. Secondary endpoints include progression-free survival, objective response rate, safety and quality of life measures.
Seattle Genetics Inc., of Bothell, Wash., and Bristol-Myers Squibb Co., of Princeton, N.J., said they started a phase I/II trial of Adcetris (brentuximab vedotin), a CD30-targeting antibody-drug conjugate, in combination with anti-PD-1 drug Opdivo (nivolumab) for patients with CD30-expressing relapsed or refractory B-cell and T-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma, peripheral T-cell lymphoma and cutaneous T-cell lymphoma. It marks the second of two trials being conducted under a previously announced clinical trial collaboration agreement between BMS and Seattle Genetics. The open-label trial is designed to evaluate the safety, tolerability and antitumor activity of the combination as the primary endpoints. About 120 patients are expected to be enrolled.
Selecta Biosciences Inc., of Watertown, Mass., said it dosed the first patient in its phase Ib trial to assess the safety, pharmacodynamic profile and efficacy of SEL-212, its lead immunotherapeutic product from the Synthetic Vaccine Particle platform, for refractory and tophaceous gout. About 53 patients with elevated uric acid levels will be enrolled to receive single ascending doses of SVP-Rapamycin, fixed doses of pegsiticase alone or SEL-212, which consists of SVP-Rapamycin co-administered with pegsiticase. Results are expected in the first half of 2016.
Tonix Pharmaceuticals Holding Corp., of New York, said it completed enrollment in the phase II AtEase trial of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of post-traumatic stress disorder (PTSD), exceeding the 240-patient goal. The randomized, double-blind, placebo-controlled, registration-quality trial is designed to evaluate the efficacy and safety of TNX-102 SL for the treatment of patients with military-related PTSD. Participants are treated with TNX-102 SL 2.8 mg, TNX-102 SL 5.6 mg or inactive control, sublingually once daily at bedtime for 12 weeks. The primary endpoint is the week 12 mean change from baseline score in the Clinician-Administered PTSD Scale for DSM-5.
Transgene SA, of Strasbourg, France, said results from the phase IIb portion of the phase IIb/III TIME trial published in The Lancet Oncology showed that TG4010 immunotherapy produced improvements in progression-free survival, overall survival, response rate and duration of response in non-small-cell lung cancer patients compared to control, and those improvements were even more notable in patients with a low level of the triple-positive activated lymphocytes, or TrPAL, biomarker, as well as in those patients with both low TrPAL and nonsquamous disease. TG4010 was well tolerated, and the nature and incidence of adverse events in the TG4010 arm were consistent with previous phase II studies.