• Acusphere Inc., of Watertown, Mass., completed enrollment in its "32" trial, one of two Phase III trials for its lead product, AI-700. The trials are designed to demonstrate that stress echo with AI-700 is comparable to nuclear stress testing in the detection of coronary heart disease. The company expects to disclose data from the trial before the end of the second quarter. Acusphere intends to file a new drug application in the first half of 2007.

• Advaxis Inc., of North Brunswick, N.J., received the approval of the Ministry of Health of Mexico and, subject to the approval of the ethical committee of Hadassah Hospital, the approval of the Ministry of Health of Israel to commence in those countries a Phase I/II trial with Lovaxin C, a Listeria-based vaccine for cervical cancer.

• Altana AG, of Bad Homburg, Germany, said the FDA accepted for filing the company’s new drug application for Ciclesonide nasal spray for nasal symptoms associated with seasonal perennial allergic rhinitis. The company also submitted a new drug submission to Health Canada. Ciclesonide is the active substance of an inhaled corticosteroid that is approved in 35 countries worldwide to treat persistent asthma.

• Aradigm Corp., of Hayward, Calif., said partner Novo Nordisk A/S, of Bagsvaerd, Denmark, has restarted the Phase III program with the AERx insulin Diabetes Management System. More details are expected in April. In September 2004, after the firms decided to end early a Phase III trial with their inhaled insulin product because of problems with Type I diabetics, Novo agreed to buy all development and manufacturing rights to the AERx insulin program for $55 million. (See BioWorld Today, Sept. 30, 2004.)

• BioMS Medical Corp., of Edmonton, Alberta, said its MBP8298 delayed multiple sclerosis’ progression for five years in progressive patients with HLA-DR2 or HLA-DR4 immune response genes. Treatment and follow-up of patients from a Phase II study demonstrated that patients in this DR2 and DR4 responder group, who comprise up to 75 percent of MS patients, had a median time to disease progression of 78 months compared to 18 months for patients who received placebo. Details of the study and its findings will be presented at the 58th annual meeting of the American Academy of Neurology on April 4 in San Diego.

• CeNeS Pharmaceuticals plc, of Cambridge, UK, entered an agreement with Innovata plc, of Nottingham, UK, to acquire certain patent rights covering a proprietary synthetic method for the manufacture of CeNeS’ lead product, M6G. Terms of the deal were not disclosed. The drug, for postoperative pain, is in Phase III trials with data expected later this year.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., said the FDA set a PDUFA date of March 24 for its anti-infective drug, Cubicin (daptomycin for injection), in the treatment of S. aureus bacteremia and infective endocarditis. An FDA advisory committee recommended approval of the drug for those indications after reviewing Phase III trial data showing that Cubicin, as a monotherapy at 6 mg/kg, met the co-primary endpoints for non-inferiority vs. dual therapy standard of care. Analyst Gregory Wade, of Pacific Growth Equities, reiterated his "buy" rating on Cubist in anticipation of expanding sales of Cubicin. Shares of Cubist (NASDAQ:CBST), which were halted from trading pending the advisory committee’s decision, gained 88 cents Tuesday to close at $24.32.

• GenVec Inc., of Gaithersburg, Md., completed enrollment in its follow-on Phase I study of its AdPEDF gene therapy in patients diagnosed recently with wet age-related macular degeneration. The clinical trial involves 20 patients who received a single injection of one of two doses of AdPEDF. Study participants will be evaluated at three and 12 weeks to assess changes in their vision and to confirm the drug’s safety profile and will then be followed for one year after treatment. AdPEDF is an adenoviral-based vector containing the gene for human pigment epithelium-derived factor.

• Immatics Biotechnologies GmbH, of Tubingen, Germany, said recruitment of patients for its initial Phase I trial of a potential vaccine against renal cell cancer, IMA901, has been concluded sooner than planned. The company said it is confident that it will be able to report results in the third quarter.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., completed enrollment in its Phase II trial for pagaclone, in development for stuttering. That trial is designed as an eight-week study to evaluate the improvement in stuttering in adults receiving pagaclone vs. placebo, with data expected by mid-June. The company also finished enrolling patients in the first of its two ongoing Phase III trials of Sanctura XR, a once-daily formulation of its marketed overactive bladder product, Sanctura. Enrollment in the second trial is expected to be completed within 60 days, and, following positive results, Indevus anticipates filing a new drug application by the end of the year.

• Kyowa Hakko Kogyo Co. Ltd., of Tokyo, said it intends to submit a new drug application for KW-6002 (istradefylline) in Parkinson’s disease later this year, following the completion of three Phase III studies. One of those studies revealed a statistically significant reduction in the percentage of awake time spent in the "off" state, and showed improvement in reducing the "wearing off phenomenon" observed with long-term therapy of L-DOPA dopamine replacement. The other two trials did not demonstrate statistical significance, but showed a trend toward improvement in the motor function score, assessed using the Unified Parkinson’s Disease Rating Scale subscore III.

• OctoPlus Technologies NV, of Leiden, the Netherlands, completed a safety and tolerability study with OP-145 in patients with chronic otitis media (chronic middle ear infection) and has commenced a Phase II trial. OP-145 is a novel peptide that neutralizes the bacterial toxins that often keep chronic middle ear infections active. The compound is a co-development project between OctoPlus and Leiden University Medical Center.

• Titan Pharmaceuticals Inc., of San Francisco, started a Phase II study of DITPA (3,5-diiodothyropropionic acid) in elevated cholesterol levels. The study will evaluate the cholesterol-lowering properties of DITPA administered in combination with standard statin therapy in 60 individuals who are unable to achieve targeted cholesterol level reductions with statin therapy alone. The study is being conducted at the Johns Hopkins Medical Institutions in Baltimore.

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