• Avera Pharmaceuticals Inc., of San Diego, completed a Phase II study of gantacurium chloride as an adjunct to general anesthesia to enable rapid intubation of patients undergoing surgery. Gantacurium chloride is a new, non-depolarizing ultra-short acting neuromuscular blocker. The study was designed to evaluate the product in healthy adult patients undergoing endotracheal intubation prior to surgery under general anesthesia. It enrolled 230 subjects. The study achieved greater than 90 percent acceptable intubations at 60 seconds after injection.

• Callisto Pharmaceuticals Inc., of New York, decided to initiate a single-agent Phase II trial of Atiprimod in advanced carcinoid cancer patients. Originally planned as a Phase I/IIa trial, the decision to proceed directly to Phase II was based on a review of the Atiprimod safety and toxicity data obtained from two ongoing trials in advanced cancer and multiple myeloma patients. Based on the data, a fixed dosing regimen has been finalized for the planned single-agent Phase II trial in advanced carcinoid cancer patients. The new trial should be under way in the next few months.

• Cephalon Inc., of Frazer, Pa., said data from its Phase III program evaluating Gabitril (tiagabine hydrochloride) for generalized anxiety disorder did not reach statistical significance on the primary study endpoints. The company will conduct a complete analysis to assist in future clinical development plans for Gabitril in other therapeutic areas. Cephalon markets the product in the U.S. and Europe as an adjunctive therapy in adults and children 12 years and older in partial seizures.

• Ceragenix Pharmaceuticals Inc., of Denver, received institutional review board approval to begin a multicenter study involving 90 children, ages 6 months to 18 years, with moderate to severe atopic dermatitis. The study will compare the use of EpiCeram, a non-steroidal skin barrier cream that received FDA clearance in April, to Cutivate, a commonly used mid-strength topical steroid that is approved for use in infants and children. The objective is to see if EpiCeram can be as effective as a mid-strength steroid in eczema.

• Elite Pharmaceuticals Inc., of Northvale, N.J., completed a second pilot Phase I pharmacokinetic study of ELI-154, a once-daily oxycodone HCl. The patent pending product is intended to deliver more consistent levels of the drug to patients who take it for chronic pain. Currently, there is no once-daily oxycodone on the market. Pilot results demonstrated that ELI-154, when compared to OxyContin, was able to provide sustained blood levels over a 24-hour period while still achieving similar levels of drug in the early and latter parts of the period.

• Insmed Inc., of Richmond, Va., said clinical results show that IPLEX increases growth and improves blood sugar control in patients with severe insulin-resistance syndromes, specifically Leprechaunism and Type A syndrome; improves growth rate in children with severe primary IGF-I deficiency; and safely increases IGF-I levels in healthy adults without causing abnormal increases in free IGF-I levels. Findings were presented at the annual meeting of the Endocrine Society. IPLEX is approved in the U.S. as the only once-daily treatment for children with short stature associated with severe primary IGF-I deficiency.

• Microbix Biosystems Inc., of Toronto, and Angiogen LLC, of Chicago, said a new cancer drug combination that destroys solid tumors by preventing the growth of new blood vessels had encouraging early results in a Phase I trial. Significant biological results and one case of complete cancer remission have been shown under compassionate use conditions. The companies, which entered an agreement to commercialize the technology in April, are seeking funding to support further Phase I and II trials. Angiogen's Angiostatic Cocktail results in the human body generating an anticancer protein, termed Angiostatin 4.5.

• Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., said its new updated safety committee review of safety data for its ongoing multicenter U.S. Phase II trial of NX-1207 revealed no serious drug side effects. The cohort of enrolled subjects completed its drug dosing. NX-1207 is Nymox's lead candidate for benign prostatic hyperplasia.

• Omrix Biopharmaceuticals Inc., of New York, said patient enrollment in the multicenter, Phase III trial of the company's Thrombin stand-alone product candidate has been completed. The product is derived from human plasma and designed to provide effective hemostasis without the risk of adverse reactions associated with the use of bovine-sourced hemostats.

• Valera Pharmaceuticals Inc., of Cranbury, N.J., submitted an investigational new drug application to the FDA for VP004, a subdermal implant using Valera's Hydron technology to deliver naltrexone, over an extended period of time, for opioid addiction. The company is preparing for a Phase I/II, open-label study of its naltrexone implant in healthy volunteers with a history of opioid abuse.

• YM BioSciences Inc., of Mississauga, Ontario, said the independent Data Safety Monitoring Board for the pivotal Phase III trial of tesmilifene in metastatic and recurrent breast cancer completed its first planned interim safety and efficacy analysis and concluded that the trial continue as planned. The analysis is based on 215 events that occurred as of June 8. The second of three planned interim analyses is designed to occur after 256 events and is expected for the third quarter. The study is statistically powered to detect a 33 percent improvement in overall survival based on 384 events at the final analysis.

No Comments