• Cytogen Corp., of Princeton, N.J., said seven-year outcome data relating to Prostascint (capromab pendetide), its monoclonal antibody-based agent that targets prostate-specific membrane antigen to image the extent and spread of prostate cancer, showed that biochemical disease-free survival for patients in whom the Prostascint scan showed disease confined to the prostate was 91 percent vs. 66 percent by the ASTRO criteria. The study evaluated 239 patients, 217 of which had local disease and 22 with extraprostatic disease. Data were presented at the 101st American Urological Association annual meeting in Atlanta.

• GenVec Inc., of Gaithersburg, Md., said Kenneth Chang, a clinical investigator for several studies involving GenVec's investigational cancer drug TNFerade, presented updated survival information from a clinical study demonstrating the potential use of TNFerade in treating patients with esophageal cancer. In an oral presentation at the annual Digestive Disease Week conference in Los Angeles, Chang reviewed evidence of esophageal tumor response to TNFerade when delivered by intratumoral injection once per week for five weeks with concurrent chemoradiation (cisplatin, 5-FU, radiation). Also, GenVec announced findings from the first clinical study of TNFerade in patients with locally advanced pancreatic cancer, reporting TNFerade was generally well tolerated up to the maximum tolerated dose and that there were positive dose-dependent effects of TNFerade on disease progression, local tumor response and resectability, and overall survival.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., reported top-line results from its Phase II trial of pagoclone in persistent development stuttering showing that the drug produced a statistically significant benefit in multiple primary and secondary endpoints compared to placebo and was well tolerated. Data from the eight-week, 88-patient study showed that patients receiving pagoclone demonstrated a statistically significant reduction in the frequency and duration of stuttering, as measured by the Stuttering Severity Instrument Version 3, when compared to placebo. Results also showed a numerically superior rating on the Stuttering Severity Scale for the pagoclone-treated group over placebo. Indevus said it plans to meet with the FDA in an end-of-Phase II meeting to discuss plans for further clinical development.

• New River Pharmaceuticals Inc., of Radford, Va., and its marketing partner, Shire plc, of Basingstoke, UK, reported that treatment with NRP104 (lisdexamfetamine dimesylate) demonstrated a significant reduction in the symptoms of attention deficit hyperactivity disorder in children ages 6 to 12, according to a Phase III study presented at the American Psychiatric Association annual meeting in Toronto. New River filed a new drug application for NRP104 in pediatric patients with ADHD, and recently initiated a Phase III study of the drug in adult ADHD patients. (See BioWorld Today, May 24, 2006.)

• NicOx SA, of Sophia Antipolis, France, completed patient enrollment in the first Phase III trial for HCT 3012. The randomization of 820 patients with osteoarthritis of the knee at 120 clinical sites in the U.S. was initiated in late December and has been completed ahead of the projected timelines, it said. Results are anticipated in the fourth quarter. HCT 3012 is a nitric oxide-donating derivative of naproxen.

• Predix Pharmaceuticals Holdings Inc., of Lexington, Mass., completed enrollment a month ahead of schedule in its first Phase III trial of PRX-00023, a long-acting 5-HT1A agonist, in patients with generalized anxiety disorder. The 310-patient trial is the first of at least two pivotal studies expected in GAD, and is designed to evaluate the efficacy of Predix's drug as measured by the change from baseline in the HAM-A scale, over placebo. Predix signed a merger agreement in April to be acquired by Cambridge, Mass.-based EPIX Pharmaceuticals Inc. in a deal valued at about $90 million, plus a potential $35 million milestone payment. (See BioWorld Today, April 4, 2006.)

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., and Wyeth Pharmaceuticals, a division of Wyeth, of Madison, N.J., presented positive Phase III trial results for methylnaltrexone at the Digestive Disease Week conference in Los Angeles. The results are from the second pivotal Phase III trial of the subcutaneous form of the investigational drug methylnaltrexone for opioid-induced constipation in patients with advanced illnesses, such as cancer and cardiovascular disease. The companies entered a license and co-development agreement for the development and commercialization of methylnaltrexone in December.

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., reported results from one investigator-initiated trial of Xifaxan (rifaximin) tablets in pouchitis, which showed that 82 percent of patients treated with rifaximin 400 mg twice a day demonstrated significant improvement. About 80 percent of patients receiving rifaximin 200 mg three times a day also showed significant improvement. Results were presented at the Digestive Disease Week meeting in Los Angeles.

• Synta Pharmaceuticals Corp., of Lexington, Mass., said the first patients have been dosed in two separate Phase IIa studies of its lead immunomodulatory compound, apilimod mesylate (STA-5326), in rheumatoid arthritis and common variable immunodeficiency. Apilimod mesylate is an oral small molecule designed to selectively inhibit the production of the interleukin-12 protein family, including IL-12 and IL-23. It is in an ongoing Phase IIb trial in Crohn's disease.

• Vion Pharmaceuticals Inc., of New Haven, Conn., initiated a pivotal Phase II trial of Cloretazine (VNP40101M) as a single agent in previously untreated elderly patients with de novo poor-risk acute myelogenous leukemia. Accrual of about 85 patients is expected to take about a year. Cloretazine, an alkylating agent, is an ongoing pivotal Phase III study in combination with cytarabine in 420 patients of any age with relapsed AML. That study is expected to reach its interim evaluation point in the second half of this year.

• VioQuest Pharmaceuticals, of Basking Ridge, N.J., initiated a Phase I/IIa trial to assess VQD-002, triciribine-phosphate (TCN-P). The trial is being conducted in up to 20 patients with diverse solid tumors, where abnormal levels of phosphorylated Akt (protein kinase B) have been observed. VQD-002 is a targeted tricyclic nucleoside that was originally developed by the National Cancer Institute and is being developed at the Moffitt Cancer Center in Tampa, Fla.

No Comments