• Amsterdam Molecular Therapeutics, of Amsterdam, the Netherlands, said positive interim data from its pivotal trial of Glybera (AMT-011) confirmed the outcome of a previous study conducted in the Netherlands, demonstrating safety and efficacy of Glybera for lipoprotein-lipase deficiency. Data showed that the treatment was well tolerated, and resulted in reduced fat concentrations in all patients, with one exception. In all patients with fat accumulations in skin or retina, those accumulations disappeared or were reduced. Those results were presented at the American Society of Gene Therapy meeting in Boston. Glybera is a gene therapy product designed to correct the genetic defect in lipoprotein-lipase deficient patients.

• F. Hoffmann-La Roche Ltd., of Basel, Switzerland, said data from a randomized Phase III study demonstrated that Xeloda plus Herceptin, South San Francisco-based Genentech Inc.'s treatment for HER2-positive breast cancer, prolonged survival without disease progression by nearly three months compared to chemotherapy alone. In addition, continuation of Herceptin nearly doubled the percentage of patients responding to treatment from 27 percent to 48 percent. Time to disease progression was increased from 5.6 months for Xeloda alone to 8.2 months in the Herceptin plus Xeloda arm.

• Genmab A/S, of Copenhagen, Denmark, initiated a Phase I/II study of zalutumumab in combination with irinotecan chemotherapy in colorectal cancer. The study will include up to 97 patients who have failed standard chemotherapy and whose disease has progressed during or within three months of stopping cetuximab (Erbitux)-based therapy. The open-label study consists of two parts. In both parts of the study, patients will receive weekly doses until disease progression. The first part will include three to 15 patients who will receive weekly doses of first 8 mg/kg of zalutumumab in combination with bi-weekly irinotecan and, if safe, patients subsequently will receive 16 mg/kg zalutumumab in combination with irinotecan. The second part will enroll 14 to 82 patients to receive weekly doses of zalutumumab with or without bi-weekly irinotecan administration until disease progression.

• Genta Inc., of Berkeley Heights, N.J., said preliminary results from a melanoma pilot study showed a high objective response rate in patients treated with the company's lead oncology product, Genasense (oblimersen sodium) injection. In that study, Genasense was used to potentially enhance the clinical activity of temozolomide (Temodar) by Schering Plough Inc., of Kenilworth, N.J., combined with Abraxane (paclitaxel protein-bound particles for injectable suspension) by Abraxis Bioscience Inc., of Los Angeles. In a related Phase I study, Genasense was safely administered on a twice-weekly basis for three consecutive weeks at a dose of 900 mg/m2 infused intravenously over two hours.

• GlaxoSmithKline plc, of London, said its MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) showed a positive trend of clinical response in a Phase II study in patients with metastatic melanoma. The company also presented data regarding the use of the genetic profiling of melanoma in predicting clinical outcomes of treatment with MAGE-A3 ASCI, showing that those markers enabled researchers to establish a correlation between the expression of given genes and the clinical response induced by the MAGE-A3 ASCI in metastatic melanoma. In addition, the company presented data on the genetic profiling of patients with non-small-cell lung cancer, demonstrating that a predictive gene signature similar to that observed in melanoma was associated with a lower rate of disease recurrence in the MAGE-A3 treated group.

• Targeted Genetics Corp., of Seattle, said additional interim data from a Phase I/II study showed that tgAAC94, which is designed to inhibit tumor necrosis factor-alpha (TNF-alpha) in patients with inflammatory arthritis, resulted in administrative site reactions following 12 percent of injections, but was otherwise well tolerated. Although the trial was not powered to detect a significant difference between treated and placebo subjects, a 30 percent decrease in the global visual analogue scale was experienced by 42 percent of subjects vs. 19 percent of placebo subjects 12 weeks after the first injection. A 2-point decrease in swelling was noted in 16 percent of treated subjects and 19 percent of placebo subjects 12 weeks after the first injection. Those data were presented at the American Society of Gene Therapy meeting in Boston.

• TransMolecular Inc., of Cambridge, Mass., initiated a Phase I trial of nonradiolabeled TM601, a synthetic peptide derived from scorpion venom, in malignant glioma. The study will enroll up to 36 adult patients with progressive or recurrent malignant glioma who have failed first-line, standard therapy. The primary objectives are to determine the safety and tolerability of TM601, to determine the target recommended Phase II dose and the biologically active dose of TM601 when administered intravenously and to study the pharmacokinetics of TM601 at each dose level. The secondary objectives are to evaluate the anti-tumor effects of TM601 by analysis of imaging response, to assess time to progression, progression-free survival and overall survival.