• Amgen Inc., of Thousand Oaks, Calif., said an independent data monitoring committee recommended continuation of two Phase III trials testing Vectibix (panitumumab) in combination with chemotherapy in first- and second-line metastatic colorectal cancer following an interim review of pooled, blinded safety data. Those data, presented at the gastrointestinal symposium in Orlando, Fla., from 601 patients (302 receiving Vectibix plus FOLFOX and 299 receiving FOLFOX only), of which 99 percent received at least one cycle of therapy, showed adverse events including neutropenia (25 percent), diarrhea (10 percent), fatigue (4 percent) and nausea and pulmonary embolism (3 percent, respectively). The study, which is evaluating progression-free survival as its primary endpoint, completed its accrual of about 1,150 patients this month.

• EntreMed Inc., of Rockville, Md., said interim results from its Phase II study of Panzem NCD in combination with Avastin (bevacizumab, Genentech Inc.) in 29 evaluable patients with advanced or metastatic carcinoid tumors showed that 27 of them (87 percent) had stable disease and two patients (7 percent) had progressive disease as their best response. Results demonstrated that the combination of Panzem NCD and Avastin is well tolerated. Median progression-free survival and overall survival have not yet been reached, and nine patients remain on study. Those data were presented at the gastrointestinal symposium in Orlando, Fla.

• Lipoxen plc, of London, said a Phase I trial of SuliXen, a long-acting insulin candidate for Type I and Type II diabetes, has started. The Phase I study of Lipoxen's first product to enter clinical trials is being conducted in 12 healthy volunteers at the Federal State Center of Endocrinology in Moscow. In a crossover design, each volunteer will receive two doses of SuliXen in comparison with Sanofi-Aventis Group's insulin glargine, a long-acting insulin analogue. Lipoxen said it expects to report first results of the study in the second quarter of 2008.

• MethylGene Inc., of Montreal, and its collaborator Pharmion Corp., of Boulder, Colo., said clinical data from a Phase I/II trial showed that MGCD0103 could be safely administered in combination with Eli Lilly's Gemzar (gemcitabine) in patients with tumors. In the Phase I portion of the study, patients received an oral dose of MGCD0103 three times per week in 28-day cycles at escalating doses ranging from 50 mg to 110 mg. Gemzar was administered at the standard dose and schedule of 1,000 mg/m2 once per week for three weeks followed by one week of rest. The maximum-tolerated dose was defined, and the Phase II portion of the study is ongoing with a dose of 90 mg MGCD0103 in patients with pancreatic cancer. Of the 14 evaluable patients from the Phase I portion of the study, there were two partial responses, two unconfirmed partial responses and six stable disease.

• N30 Pharma, of Boulder, Colo., said it successfully completed a Phase I study of N30-201, a compound being investigated to treat reactive and obstructive airway diseases, including cystic fibrosis and asthma. The primary endpoint was patient safety and characterization of adverse events, but the company collected pharmacokinetic and pharmacodynamic data of ascending doses of N30-201, a nebulized formulation of s-nitrosoglutathione, an endogenous bronchodilatory molecule that serves as a crucial store of nitric oxide bioactivity in the human airway.

• OrthoLogic Corp., of Tempe, Ariz., said the FDA has accepted its investigational new drug application for AZX100, a synthetic preclinical 24-amino acid peptide, in dermal hypertrophic scarring. The firm said it will start a randomized, placebo-controlled, dose-escalation, single-center Phase I study in about 30 healthy adults males in the first quarter of 2008. The primary objective is to evaluate the initial safety and tolerability of AZX100 drug product in healthy adult subjects.

• Poniard Pharmaceuticals Inc., of South San Francisco, said safety data from a Phase I study of picoplatin in combination with 5-fluorouracil (5FU) and leucovorin (LV) as a first-line treatment for metastatic colorectal cancer (mCRC) suggested that picoplatin does not cause severe neurotoxicity, as is commonly seen in mCRC patients treated with the regimen of 5FU and LV with oxaliplatin. In addition, picoplatin demonstrated both good tolerability and no severe neuropathies when combined with 5FU and LV.

• pSivida Ltd., of Perth, Australia, said results of the Phase IIa clinical trial showed that BrachySil, an agent being investigated to treat advanced, inoperable pancreatic cancer, in combination with the chemotherapy agent gemcitabine, was well tolerated with no clinically significant adverse events. Data showed disease control in 82 percent of patients and an overall median survival of 309 days, the firm said. BrachySil, a combination of BioSilicon, a porous silicon, and the isotope phosphorus, a proven anticancer therapeutic, was found to be easily deliverable by endoscopic ultrasound, the company said.

• Trion Pharma GmbH, of Munich, Germany, said results of a Phase I trial showed that catumaxomab, a class of trifunctional antibodies, administered intraoperatively to patients with advanced gastrointestinal cancers was safe and well tolerated and led to substantial tumor cell destruction. In the trial, 12 patients undergoing surgery for advanced EpCAM positive gastrointestinal tumors received five escalating doses of catumaxomab. The first dose was given intraperitoneally during surgery immediately after tumor resection, while the four remaining doses were administered intraperitoneally on day 7, 10, 13 and 16 after surgery. The intraoperative application of catumaxomab is being tested in two Phase II studies in gastric cancer patients and in a Phase II study in ovarian cancer patients, the firm noted.

• Velcura Therapeutics Inc., of Ann Arbor, Mich., completed an investigational new drug application to start clinical trials of lead compound VEL-0230, a dual-acting compound designed to stimulate bone formation and to inhibit bone loss. The company plans to investigate the drug in diseases involving bone mineral disorders, such as bone loss related to multiple myeloma, bone metastases, rheumatoid arthritis and osteoporosis. The first trials are expected to start at the end of February.