Beigene Ltd., of Beijing, received Clinical Trial Application approval from the CFDA to conduct phase I studies of BGB-283, a RAF dimer inhibitor for the treatment of solid tumors that harbor B-RAF mutations or other aberrations in the RAS-MAPK (mitogen-activated protein kinase) pathway. The trials in China will investigate BGB-283 in patients with B-RAF mutations in a range of tumors where no other effective targeted therapies are currently available in China. Additionally, BGB-283 will be investigated in patients with K-RAS/N-RAS mutated cancers.

Biondvax Pharmaceuticals Ltd., of Ness Ziona, Israel, said it received statistical analysis of results from a study demonstrating that its universal flu vaccine (M-001), administered in the BVX-005 phase II trial in 2012, provided participants with increased immunogenicity against future strains that did not exist at the time of the study – in particular the current newly emerged H3N2 influenza strain that caused the epidemic in the U.S. in 2015. Biondvax exposed the blood plasma samples from the BVX-005 participants, taken following the completion of the trial in 2012, to the H3N2 strain (A/Switzerland/9715293/2013) and examined the immunogenicity antibodies in each sample. Researchers found significantly increased level of protective antibodies against the H3N2 strain in the samples taken from participants that received the M-001 vaccine in comparison to the control group.

Celyad SA, of Mont-Saint-Guibert, Belgium, completed the injection procedure for the last patient enrolled in Chart-1, its European phase III trial for its lead cardiovascular disease product candidate C-Cure, an autologous cell therapy intended to guide cardiac tissue formation in patients with ischemic heart failure by harvesting the patient's own multipotent stem cells, reprograming these cells into cardiopoetic cells, and re-injecting these reprogrammed cells back into the patient. Celyad has initiated the nine-month follow-up period for the final patient and expects to release the full clinical data set for Chart-1 in the middle of 2016.

Charleston Laboratories Inc., of Jupiter, Fla., started its second clinical development program with a phase I study on its migraine drug candidate, CL-H1T, which contains fast-dissolving promethazine and sumatriptan, and is being developed as a treatment for migraine headache pain and migraine-induced nausea and vomiting.

Chimerix Inc., of Durham, N.C., reached enrollment of the targeted 200 patients in the phase III Advise trial evaluating brincidofovir for the treatment of adenovirus infection in immunocompromized patients. The trial began enrolling in March of last year. Patients with confirmed adenovirus infection receive brincidofovir orally twice-weekly for 12 weeks, and are followed for a minimum of 12 weeks after treatment. Brincidofovir is an oral nucleotide analog that has shown in vitro antiviral activity against all five families of DNA viruses that affect humans, including the herpes viruses and adenovirus.

Cidara Therapeutics Inc., of San Diego, started a phase I, randomized, double-blind, dose-escalation study to determine the safety, tolerability and pharmacokinetics of CD101 given intravenously in healthy subjects. CD101 is described as a long-acting antifungal that could ultimately provide physicians with a new treatment option for their patients fighting serious, life-threatening infections. An agent in the echinocandin class of antifungals, the compound is being developed for the treatment and prevention of systemic Candida infections, including candidemia and related cases of invasive candidiasis.

Dermira Inc., of Menlo Park, Calif., dosed the first patients in a phase III program for DRM04 in patients with axillary hyperhidrosis (excessive underarm sweating). The DRM04 program consists of two identical, randomized, double-blind, vehicle-controlled studies, Atmos-1 and Atmos-2, each enrolling about 330 patients. DRM04 is a topical, small-molecule, anticholinergic product designed to inhibit sweat production by blocking the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation.

Elite Pharmaceuticals Inc., of Northvale, N.J., completed patient enrollment and dosing for the phase III efficacy trial for ELI-200, an abuse-deterrent opioid product. The trial is designed to evaluate the efficacy and safety of abuse deterrent ELI-200 for the treatment of adults with moderate to severe pain following surgery. The study enrolled 163 patients at five clinical sites. Top-line efficacy and safety data from this study are expected to be announced near year's end, with submission of the new drug application expected shortly thereafter.

Galectin Therapeutics Inc., of Norcross, Ga., is collaborating with Exalenz Bioscience Ltd., of Modi'in, Israel, to use the BreathID test to monitor patients in a phase II study evaluating GR-MD-02, an investigational treatment for patients with cirrhosis associated with nonalcoholic steatohepatitis. The 156-patient, multicenter, randomized, placebo-controlled, double-blind clinical trial will evaluate the safety and efficacy of GR-MD-O2 for the treatment of liver fibrosis and portal hypertension in patients with NASH Cirrhosis. The device will be used to follow up the effect of treatment on patients with NASH cirrhosis, compared to standard medical tests.

Medivir AB, of Stockholm, Sweden, reported that Alios Biopharma Inc., part of the Janssen Pharmaceutical Cos., of Johnson & Johnson, has started a phase I trial to evaluate the potential effect of simeprevir and odalasvir (also known as ACH-3102), on the pharmacokinetics of AL-335 in healthy volunteers. The phase I, open-label, two-group study will compare simeprevir, odalasvir, a hepatitis C virus (HCV) NS5A inhibitor, and of AL-335, a nucleotide-based HCV polymerase inhibitor. The primary objective is to investigate the potential effect of simeprevir and odalasvir on the pharmacokinetics of AL-335 when administered in combination to healthy volunteers.

Protalix Biotherapeutics Inc., of Carmiel, Israel, reported positive results from its phase I trial of PRX-106, an orally administered plant cell-expressed recombinant anti-TNF fusion protein. PRX-106 demonstrated a favorable safety and tolerability profile and biological activity in the gut in 14 healthy volunteers. Subjects received once daily oral administrations for five consecutive days. In preclinical studies the compound alleviated immune-mediated hepatitis and reduced interferon gamma levels in a concanavalin A immune-mediated hepatitis mouse model. Additionally, oral administration of PRX-106 alleviated immune mediated colitis in a well-established mouse model, promoting serum levels of anti-inflammatory IL-10 and regulatory T-cells. Protalix is evaluating the best indication to take forward.

Swiftwater, Pa.-based Sanofi Pasteur, the vaccines division of Sanofi AG, reported that Vaccine published positive results from a new analysis of data from a large-scale, multicenter efficacy trial which revealed fewer serious cardio-respiratory events related to influenza in study participants 65 and older who received a higher-dose split-virus inactivated influenza vaccine compared to a standard-dose split-virus inactivated influenza vaccine.

Shionogi & Co. Ltd., of Osaka, Japan, said that once-daily naldemedine met its primary and secondary endpoints in a phase III study (COMPOSE II) for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. Naldemedine is an investigational, oral, peripherally acting mu-opioid receptor antagonist (PAMORA). This is the third phase III trial in which naldemedine met its primary and key secondary endpoints.