Amira Pharmaceuticals Inc., of San Diego, has begun a Phase I study of AM211 for the treatment and control of inflammatory and allergic diseases linked to the arachidonic acid pathway. AM211 is an oral, selective antagonist of the receptor DP2, which is a potential target for the treatment of asthma, chronic obstructive pulmonary disease and allergic rhinitis. The study is designed to obtain safety and proof-of-mechanism data for AM211.
Elusys Therapeutics Inc., of Pine Brook, N.J., has begun a second Phase I human safety trial of Anthim, a high-affinity humanized and deimmunized monoclonal antibody targeting the anthrax toxin protective antigen. The dose-escalation trial in 45 healthy volunteers is designed to expand the human safety database.
Genomic Health Inc., of Redwood City, Calif., reported results of a Japanese study demonstrating that the Oncotype DX breast cancer assay had significant prognostic value in women with estrogen receptor-positive early-stage breast cancer. Of those patients, Oncotype DX identified a large portion as having a low likelihood of distant recurrence. Data were presented at the Kyoto Breast Cancer Consensus Conference International Convention in Kyoto, Japan.
NanoBio Corp., of Ann Arbor, Mich., said the FDA has approved the company's investigational new drug application for the Phase I study of NB-1008, a seasonal influenza vaccine administered via a nasal dropper. The trial is a randomized, controlled study in the U.S. of 120 healthy human volunteers. The primary endpoints are safety and immunogenicity as determined by neutralizing serum antibodies. NB-1008 uses a nanoemulsion-based adjuvant to achieve an immune response using a fraction of the antigen required by currently available injectable vaccines.
OctoPlus NV, of Leiden, the Netherlands, said its licensee Biolex Therapeutics, of Pittsboro, N.C., has begun patient dosing in the SELECT-2 Phase IIb study of Locteron, a controlled-release formulation of interferon alpha for the treatment of chronic hepatitis C. The study is being conducted in the U.S. and Europe in 100 treatment-naïve, genotype-1, chronic hepatitis C patients. Patients will be randomized into one of four dosing cohorts of Locteron administered once every two weeks or a control arm consisting of PEG-Intron administered every week, with all patients receiving weight-based ribavirin. Patients will be treated for 48 weeks and will be followed for an additional 24 weeks to determine the sustained virologic response rate.
Paion AG, of Aachen, Germany, has begun a Phase Ib multiple-dose study with the new short-acting intravenous anesthetic/sedative CNS 7056 in volunteers undergoing colonoscopy. The randomized, open, dose-escalation multiple dose study will evaluate the sedation and recovery profile of CNS 7056 in volunteers undergoing colonoscopy. In the first part of the study, the reversal of sedation induced with CNS 7056 by the benzodiazepine antagonist, flumazenil, will be examined in a double-blind design. In the subsequent open part of the trial volunteers will receive three different dosages of CNS 7056 followed by "top-ups."
Palau Pharma SA, of Barcelona, Spain, said the first patient has been enrolled in a Phase II trial of dersalazine sodium for the treatment of mild to moderate ulcerative colitis. The study is a Phase II multicenter, randomized, double-blind, parallel group, two placebos and active reference controlled study of the safety and activity of dersalazine sodium when administered to patients with active, mild to moderate ulcerative colitis. Eighty subjects will be studied in three parallel groups (dersalazine sodium, mesalazine and placebo), with a randomization of 2:1:1.
Pantec Biosolutions AG, of Ruggell, Liechtenstein, reported positive results in a Phase I trial of a triptorelin patch used in conjunction with the company's Painless Laser Epidermal System technology. All volunteers considered the method to be convenient and simple, and there were no reports of any adverse events. Results showed that serum levels of triptorelin exceeded those required for therapeutic effect. Triptorelin is administered daily by subcutaneous injection in the induction phase of in vitro fertilization protocol.
Peregrine Pharmaceuticals Inc., of Tustin, Calif., said updated preliminary data from the initial cohort of 21 patients in its Phase II trial evaluating bavituximab in combination with carboplatin and paclitaxel showed that 11 of 17 evaluable patients with locally advanced or metastatic non-small-cell lung cancer achieved an objective tumor response according to RECIST criteria, after completing the maximum six treatment cycles. The company also reported that patient dosing is under way in the expansion stage of the trial, which will enroll an additional 28 patients for a total of 49 patients overall.
Poniard Pharmaceuticals Inc., of South San Francisco, reported results of a Phase II trial of picoplatin in patients with recurrent small-cell lung cancer, in which the drug demonstrated a survival benefit in patients who failed prior platinum-containing first-line chemotherapy or who progressed within six months of first-line therapy. The median overall survival was 27 weeks, and the median one-year survival was 17.6 percent. Data were published in the Journal of Clinical Oncology.
QRxPharma Ltd., of Sydney, Australia, said it completed a Phase III program pilot study showing that MoxDuo immediate-release reduced pain significantly more than component doses of morphine and oxycodone and, when compared to equianalgesic doses of morphine and oxycodone, MoxDuo IR produced fewer and less intense side effects. The 197-patient study evaluated MoxDuo vs. morphine and oxycodone in managing acute pain during the first 24 hours following a scheduled surgical procedure (bunionectomy). In terms of reduced pain intensity scores and other related measures, the analgesic effects of 12mg/8mg MoxDuo IR were 80 percent to 100 percent greater than the two individual components. The company said those results provide sample size guidance for the upcoming Phase III combination rule study required for a new drug application submission in 2010.
Tolarex Ltd., of Ein Kerem, Israel, said it received approval from the Ministry of Health of Israel to start a Phase I/IIa trial of its therapy candidate in graft-vs.-host disease. The first study is expected to enroll 12 patients. Tolarex's technology is designed to induce immune tolerance to encourage the immune system to refrain from attacking the patient's body.
Viralytics Ltd., of Sydney, Australia, has received ethics committee approval to increase the dosage levels of Cavatak in its Phase I intravenous breast cancer, prostate cancer and melanoma trial. Dosing will now begin at what was the highest dosing level of the original trial schedule and escalate to approximately 100-fold higher levels than planned for in the original design. Overall, Cavatak continues to be well tolerated by late-stage cancer patients participating in all three Viralytics Phase I trials, the company said.