• Amira Pharmaceuticals Inc., of San Diego, reported initial data from a Phase I study of AM461, an oral, selective antagonist of the DP2 receptor, showing that a dose proportional pharmacodynamic effect can be achieved with the drug. Data to date also demonstrate a good safety profile. AM461 is a back-up to Amira's lead DP2 antagonist, AM211, which has completed Phase I testing.

• Corimmun GmbH, of Martinsried, Germany, has started a Phase I trial with lead compound COR-1 for the treatment of heart failure. The first two dose groups (out of a total of five planned) have been well tolerated, no relevant side effects occurred. The trial is designed as a mono-centric, randomized, single blind, placebo-controlled study in 50 volunteers who will receive COR-1 or placebo intravenously as single ascending doses. Primary endpoints are safety and tolerability.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., announced the early closing of enrollment in its Phase II program for ecallantide (CB-500,929), in development to reduce bleeding in on-pump cardiac surgery, after a data safety monitoring board observed a statistical difference in mortality between the arms of the CONSERV-2 trial that it felt needed to be assessed before the trial could resume. The company said that while overall mortality was consistent with the patient population in the CONSERV-2 trial, the data show more deaths in the CB-500,929 arm. Initial review shows mortality observed in the trial was due to a variety of causes typically expected in a high-risk-for-bleed population undergoing cardiac surgery, Cubist said. There was no such imbalance detected in the CONSERV-1 trial, also being monitored by the board. Cubist said it decided that the best path forward, with more than 450 patients now enrolled in CONSERV-1 and CONSERV-2 combined, was to end enrollment, complete follow up of patients who have been treated, and move forward quickly toward data lock and a complete analysis of results. Shares of Cubist (NASDAQ:CBST) rose 57 cents to close at $17.86.

• Generex Biotechnology Corp., of Worcester, Mass., said an independent review of clinical results of Generex Oral-lyn showed that the oral insulin spray had a faster onset of action and shorter duration of action than insulin delivered subcutaneously. Those data were published in Diabetes, Obesity and Metabolism.

• Hyperion Therapeutics Inc., of South San Francisco, said the first patient has been enrolled in its Phase II trial of HPN-100 (glycerol phenylbutyrate). The multi-center study consists of an open label safety component followed by a randomized, double-blind, placebo-controlled study that will enroll approximately 140 patients with episodic hepatic encephalopathy. The primary efficacy measure will be the proportion of patients who exhibit a hepatic encephalopathy episode during the four-month treatment period.

• Neurologix Inc., of Fort Lee, N.J., has completed all planned surgeries in an ongoing Phase II trial of its gene transfer approach to the treatment of advanced Parkinson's disease. The controlled, double blinded, 44 patient trial is investigating the safety and efficacy of a non-dopamine approach to restore motor function in Parkinson's patients who are sub-optimally responsive to available drug therapy. The company expects to announce initial efficacy results from the trial in mid-2010.

• Pharmasurgics AB, of Gothenburg, Sweden, has received approval from the Swedish Medical Products Agency to begin a Phase II trial testing the safety and efficacy of PXL01 for the prevention of post-surgical adhesions in 140 patients undergoing hand surgery. The trial will monitor the safety and efficacy of PXL01 in reducing adhesion formation following flexor tendon repair surgery. The efficacy objective is to see an improvement in finger strength and mobility compared to placebo following surgery.

• Santarus Inc., of San Diego, said its collaboration partner Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals SpA of Lainate, Italy, has completed enrollment of 514 patients in the European Phase III trial to evaluate budesonide MMX administered over eight weeks for the induction of remission of mild or moderate active ulcerative colitis. This is the first of two induction trials. They expect to report preliminary top line results from the European Phase III trial in the first half of 2010.

• VIA Pharmaceuticals Inc., of San Francisco, has completed the last patient visit in its Phase II FDG-PET clinical trial of VIA-2291. The trial enrolled 52 patients and is designed to measure the impact of VIA-2291 on reducing inflammation in carotid plaque in treated patients. Patients were enrolled following an acute coronary syndrome event into the 24-week, randomized, double blind, placebo-controlled study. Endpoints include reduction in atherosclerotic plaque inflammation. Data are expected to be presented in early 2010.