Following promising Phase II results with its short-acting anesthetic drug, Aquavan injection, MGI Pharma Inc. initiated a pivotal program consisting of two Phase III studies in patients undergoing minor surgical procedures.

The Minneapolis-based company will evaluate Aquavan injection (fospropofol disodium) in 300 patients undergoing colonoscopy in the first study, and 200 patients undergoing bronchoscopy in the second. The endpoints for both trials include sedation and treatment success, patient satisfaction, investigator satisfaction, and measures of sedation adequacy, recovery, clinical benefit and safety.

Aquavan is a water-soluble prodrug formulation of propofol designed to work by converting to active propofol and providing minimal to moderate sedation in minor surgeries.

Along with the two Phase III studies, MGI is planning to conduct an open-label study in 150 patients to assess the safety of a single dose in several different procedures, such as arthroscopy, bunionectomy, dilation and curettage, upper endoscopy, hysteroscopy, lithotripsy, arterio-venous shunt placement and trans-esophageal echocardiograms.

Patient enrollment for all trials is expected to conclude by the end of the year, with a new drug application submitted to the FDA in the first half of 2007.

MGI gained the rights to Aquavan through its July purchase of Baltimore-based Guilford Pharmaceuticals Inc. The acquisition was valued at about $179.6 million. (See BioWorld Today, July 22, 2005.)

If approved, the product would fit into MGI’s acute-care line, which also includes Aloxi (palonosetron hydrochloride) injection for postoperative nausea and vomiting.

In its earnings released last month, MGI said it also plans to begin pivotal studies this year with Dacogen in acute myelogenous leukemia and with ZYC101A to treat cervical dysplasia caused by the human papillomavirus.

The company reported a net loss of $10.8 million, or 14 cents per share, for the fourth quarter. As of Dec. 31, it had cash and investments totaling $104.2 million.

Shares of MGI (NASDAQ:MOGN) closed at $17.08 Tuesday, up 84 cents.

In other clinic news:

• Genmab A/S, of Copenhagen, Denmark, reported additional data from its Phase I/II trial of HuMax-CD20 in patients with active rheumatoid arthritis, demonstrating that 38 percent of those who received two doses of the drug achieved ACR50, and 15 percent achieved ACR70. The intent to treat analysis remains the same as previously reported, with 63 percent of patients achieving ACR20. The data were presented at the 10th Anniversary Inflammation and Immune Diseases, Drug Discovery and Development Summit in New Brunswick, N.J.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., received written response from the FDA that the agency is in agreement with its special protocol assessment for a Phase III trial of Puricase (PEG-uricase), and the company plans to implement the protocols in support of a marketing application for the orphan drug indication of controlling hyperuricemia in patients with symptomatic gout in cases in which conventional therapy is contraindicated or has been ineffective. The program consists of two replicate six-month trials of about 100 patients each, with a long-term open-label extension study to continue for two years. The primary endpoint for both will be an assessment of the proportion of patients who have normalized plasma uric acid at month three and month six of each study. Secondary endpoints, to be pooled from patients in both trials, will assess the reduction in burden of gout tophi using digital photography, reduction in the frequency of gout flares, improvement in the count of swollen and tender joints and improvements in patient-reported outcomes. Patient recruitment is expected to be completed toward the end of 2006 or early 2007, with a new drug application anticipated in late 2007.

• Arpida Ltd., of Basel, Switzerland, received the recommendation from an independent data and safety monitoring board to continue the Phase III trials for intravenous iclaprim for complicated skin and skin-structure infections. The panel conducted a planned review of data from the on-going ASSIST-1 (Arpida’s Skin and Skin Structure Infection Studies) trial.

• Coley Pharmaceutical Group Inc., of Wellesley, Mass., disclosed positive top-line interim data from the 12-week, randomized, controlled clinical study of Actilon (CPG 10101) in combinations with pegylated interferon and/or ribavirin for the treatment of chronic hepatitis C virus in the relapsed subset of treatment-experienced patients. The aim is to determine the tolerability and antiviral activity of various Actilon-containing regimens relative to pegylated interferon and ribavirin. Preliminary data from the study indicate that 12 out of 14 patients (86 percent) given a combination of Actilon with pegylated interferon and ribavirin achieved an early viral response (greater than 2 log reduction in serum HCV RNA at 12 weeks), compared to eight out of 14 patients (57 percent) who received a control combination of pegylated interferon and ribavirin. At 12 weeks, the Actilon combination therapy resulted in a 3.3 mean log reduction in HCV RNA level, compared to a 2.2 mean log reduction among patients receiving the control combination. The Actilon combination was well tolerated, and the kinds of adverse events observed were similar to those seen with the control combination.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., said enrollment has been completed in the company’s second Phase III trial for Sanctura XR, the once-daily formulation of Sanctura, currently marketed for overactive bladder. Earlier this month, the company reported the completion of enrollment in the first of its two Phase III trials. The second has more than 560 patients, and Indevus anticipates reporting results in July.

• Threshold Pharmaceuticals Inc., of Redwood City, Calif., completed enrollment in the Phase II, dose-response study in the U.S. evaluating TH-070 for the potential treatment of benign prostatic hyperplasia. Patients participate in the study for up to four and a half months. After a two-week placebo run-in period, patients will be randomized to receive placebo or one of four doses of TH-070 (5 mg, 25 mg, 50 mg, 150 mg) daily for 28 days, and will be followed off of therapy for an additional three months.