• Advanced Viral Research Corp., of Yonkers, N.Y., enrolled the first patient in a Phase II open-label study exploring the effect of an investigational drug on patients with recurrent or advanced cancer. The study will examine the effect of a 4.0 mL subcutaneous dose of AVR118 on weight, appetite, performance status and other measures of quality of life in patients with recurrent or advanced malignancies. AVR118 will be administered daily for a trial period of 28 days. Patients who appear to benefit from the trial period dosing will be eligible to continue on AVR118, generating longer-term efficacy data.

• Anthera Pharmaceuticals Inc., of San Mateo, Calif., has completed enrollment and patient dosing in its Phase II clinical study of its lead compound, A-002 for stable coronary artery disease. Data analysis is scheduled to be completed by the end of the year. The PLASMA trial (Phospholipase Levels And Serological Markers of Atherosclerosis) is a multicenter, randomized, double-blind, placebo-controlled trial of about 400 patients with stable coronary heart disease. Subjects were randomized to receive four doses of A-002 or standard of care for up to eight weeks. The study is designed to investigate the safety and the efficacy of A-002 on dyslipidemia. The company is scheduled to meet with the FDA in the fourth quarter for an end-of-Phase II meeting to obtain concurrence on the design of the Phase III program.

• Avid Radiopharmaceuticals Inc., of Philadelphia, started enrolling patients in its proof-of-concept Phase I trial of 18F-AV-133, an imaging compound for movement disorders, including Parkinson's disease and essential tremor and dementias such as Lewy body dementia (DLB) and Alzheimer's disease. The compound, used with positron emission tomography imaging, targets vesicular monoamine transporters in the brain and might enable more accurate and earlier diagnoses of neurodegenerative diseases. About 30 patients will be involved in the study, which aims to determine whether 18F-AV-133 PET imaging can detect losses in nigrostriatal neurons in the brains of patients with Alzheimer's, Parkinson's and DLB.

• Centocor Inc., of Malvern, Pa., a Johnson & Johnson subsidiary, said findings from a Phase III study showed that more than two-thirds of patients with moderate to severe plaque psoriasis receiving two doses of ustekinumab (CNTO 1275) achieved at least a 75 percent reduction in psoriasis at week 12, the primary endpoint of the study, as measured by the Psoriasis Area and Severity Index (PASI 75). Results also showed that following one additional dose at week 16, a substantial proportion of patients receiving ustekinumab maintained a PASI 75 response through week 28. Those data were presented at a dermatology conference in Buenos Aires, Argentina. Centocor has exclusive marketing rights to ustekinumab in the U.S., and Janssen-Cilag, another J&J subsidiary, has rights elsewhere.

• Critical Therapeutics Inc., of Lexington, Mass., started a Phase II trial of zileuton injection as an adjunctive treatment for asthma. The randomized, double-blind, 36-patient trial will compare two doses of zileuton injection to placebo, measuring the effect on pulmonary function. Zileuton is the pharmaceutical ingredient in the company's marketed Zyflo tablets and Zyflo CR extended-release tablets for asthma.

• Crucell NV, of Leiden, the Netherlands, said results from its Phase I study of a rabies monoclonal antibody cocktail, which combines two human monoclonal antibodies, showed that the cocktail is well tolerated, provides the expected neutralizing activity and that it can be administered in combination with a rabies vaccine. Crucell is developing the antibody cocktail for the post-exposure prophylaxis of rabies, using its MAbstract and PER.C6 technologies. Data were presented at the rabies conference in Guanajuato City, Mexico.

• Peptimmune Inc., of Cambridge, Mass., initiated a Phase I trial of PI-2301, a second-generation peptide copolymer for the treatment of multiple sclerosis and other autoimmune diseases. The single ascending dose, randomized, double-blind, placebo-controlled trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of the drug in 56 healthy volunteers. Peptimmune anticipates beginning a repeat-dose study in multiple sclerosis patients in early 2008.

• Pharmasset Inc., of Princeton, N.J., has begun dosing in a Phase I study of R7128 in combination with Pegasys (pegylated interferon) plus Copegus (ribavirin) in up to 75 treatment-naive patients chronically infected with hepatitis C virus (HCV) genotype 1. R7128 is a prodrug of PSI-6130, an oral cytidine nucleoside analogue polymerase inhibitor of HCV being developed through Pharmasset's collaboration with F. Hoffmann La-Roche, of Basel, Switzerland. The study is a preliminary evaluation of safety, tolerability, pharmacokinetics and antiviral activity of R7128 in the clinically-relevant setting of combination therapy with the current standard of care for chronic HCV infection.

• Protox Therapeutics Inc., of Vancouver, British Columbia, completed enrollment of a target 12 patients and reported positive interim data in a Phase I trial of PRX302 in benign prostatic hyperplasia (BPH). The initial data indicated the drug is well-tolerated and shows promising signs of efficacy, including an ability to work quickly without altering sexual function. The maximum tolerated dose was not reached, and no serious adverse events occurred. Final data are expected by the end of the year, and a Phase II study is planned for early 2008. PRX302 also completed a Phase I trial in locally recurrent prostate cancer.

• Tapestry Pharmaceuticals Inc., of Boulder, Colo., has initiated a Phase II open-label, multicenter study of TPI 287 in patients with advanced pancreatic cancer. It is the second Phase II trial exploring the activity of TPI 287 in various tumor types. The first trial began earlier this year in advanced hormone refractory prostate cancer. The new trial will involve up to 65 patients with advanced stage, unresectable pancreatic cancer who have failed a prior gemcitabine-containing chemotherapy regimen. The trial will be conducted in 10 to 15 centers in the U.S., Europe and India.

• WEX Pharmaceuticals Inc., of Vancouver, British Columbia, said the analysis of its WEX-014 trial of tetrodotoxin in moderate to severe cancer pain showed that based on the primary endpoint, pain intensity difference, there was a nonstatistically significant trend toward more responders in the tetrodotoxin arm. However, using a composite endpoint evaluating decrease in pain outcome and improvement in quality of life, the number of responders to tetrodotoxin was significantly greater than the number of responders to placebo. Based on the analysis, the company has designed a Phase III multicenter, randomized, double-blind, placebo-controlled trial of approximately 120 patients with moderate to severe cancer-related pain. WEX has received a No Objection Letter from Health Canada for the trial and pretrial activities have commenced. The data are scheduled for publication in the Journal of Pain and Symptom Management.

No Comments