• Axonyx Inc., of New York, completed its second Phase I study with Posiphen to treat Alzheimer's disease progression. The double-blind, placebo-controlled multiple ascending-dose safety and pharmacokinetic study showed that the mean Posiphen blood levels associated with well-tolerated doses in humans are higher than those associated with potentially beneficial effects on beta-amyloid metabolism in animal models. The buildup of beta-amyloid is believed to be causative of the dementia of Alzheimer's disease and its progression. No serious adverse events were reported in the Phase I trial.

• BioAlliance Pharma SA, of Paris, started a pivotal Phase III trial in the U.S. of its antifungal agent, Loramyc (miconazole Lauriad). The product is a once-daily, 50-mg, extended-release bioadhesive buccal tablet and a first-line local treatment for oropharyngeal candidiasis, an oral fungus that is common among immunocompromised patients. The trial will enroll HIV-positive patients who have contracted OPC, and its results, if positive, should allow the product to be registered. BioAlliance already has completed two Phase III trials in Europe, one in patients with cancer of the head and neck after radiotherapy, and the other with HIV-positive patients.

• Biomira Inc., of Edmonton, Alberta, said its commercialization partner, Prima BioMed Ltd., of Melbourne, Australia, reported favorable results in its CVac ongoing Phase IIa trial in ovarian cancer. A second analysis of data indicated that so far 21 percent of patients in the trial have achieved either a clinical response to treatment or stabilization of their disease. The trial recruited 28 late-stage progressive ovarian cancer patients who have no therapeutic alternative, and 21 went on to complete the requisite dosing of three injections of CVac. The trial should be complete in the fourth quarter.

• BioMS Medical Corp., of Edmonton, Alberta, received regulatory approval to start a Phase II trial to investigate the safety and efficacy of MBP8298 in patients with relapsing-remitting multiple sclerosis in the first of several European countries. Patient enrollment should begin in the third quarter, and BioMS expects 30 sites to participate. The trial is a 12-month, double-blind, placebo-controlled study that will enroll up to 215 patients. It will be followed by a 15-month active treatment open-label extension period.

• Cell Therapeutics Inc., of Seattle, said preliminary results of a Phase I/II study of pixantrone combined with fludarabine, dexamethasone and rituximab to treat patients with relapsed indolent non-Hodgkin's lymphoma (NHL) demonstrated a 95 percent overall response rate with 77 percent of patients experiencing complete disappearance of their tumors. The data were presented at the Rodman & Renshaw 3rd Annual Global Healthcare Conference in Monte Carlo, Monaco. Pixantrone also is in an ongoing Phase III study in aggressive NHL.

• Curis Inc., of Cambridge, Mass., said preliminary clinical data suggested that a topical Hedgehog antagonist studied in 34 patients with basal-cell carcinoma was generally well tolerated. The data are from a Phase I trial that is part of Curis' ongoing collaboration with South San Francisco-based Genentech Inc. to develop a topically administered Hedgehog small-molecule antagonist for the potential treatment of basal-cell carcinoma. Results were presented at the 39th Annual Australasian College of Dermatologists Scientific Meeting.

• GPC Biotech AG, of Martinsried, Germany, said a Phase I study evaluating satraplatin, in combination with Xeloda (capecitabine) in patients with advanced solid tumors has opened for accrual. Xeloda is an oral form of 5-FU. The Phase I study, which is expected to enroll up to 24 patients, is an open-label trial being conducted at Northwestern University Medical Center in Chicago. Pharmion GmbH, a wholly owned subsidiary of Pharmion Corp., of Boulder, Colo., has exclusive commercialization rights to satraplatin for Europe and certain other territories.

• Manhattan Pharmaceuticals Inc., of New York, received Swiss regulatory approval to begin its Phase IIa study with oral Oleoyl-estrone for obesity. The study is designed to evaluate the safety, efficacy and pharmacokinetics of two 14-day dosing cycles. It will enroll 100 subjects who will be divided into four treatment groups: placebo, 5-mg, 10-mg or 20-mg administered once daily.

• Marshall Edwards Inc., of Washington, a majority-owned company of Sydney, Australia-based Novogen Ltd., reached an agreement with the FDA under the special protocol assessment process for a pivotal study of its cancer drug, phenoxodiol. The Ovature study will enroll 470 patients in the U.S., the UK, other parts of Europe and Australia, and is designed to test the ability of phenoxodiol to restore sensitivity of late-stage ovarian cancers to carboplatin. Patients will receive carboplatin with phenoxodiol or with placebo in the two treatment arms. The primary endpoint is progression-free survival, with overall survival as a secondary endpoint. The drug received fast-track designation for platinum-resistant or refractory ovarian cancer from the FDA in 2004 based on Phase II data. Earlier this week, Marshall Edwards licensed two additional oncology compounds in the same class as phenoxodiol from Novogen. (See BioWorld Today, May 16, 2006.)

• Migenix Inc., of Vancouver, British Columbia, received a notice of authorization from Health Canada to begin a Phase II viral kinetics study of MX-3253 (celgosivir) in treatment-na ve, hepatitis C patients. The study is designed to demonstrate improved antiviral activity when celgosivir is used in combination with peginterferon alfa-2b, with or without ribavirin, as compared to treatment with peginterferon alfa-2b and ribavirin. Enrollment is expected to begin next month, with results in late 2006 or early 2007.

• Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., said long-term efficacy results from its Phase I/II testing of NX-1207 in benign prostatic hyperplasia indicated significant symptomatic improvement at 29 to 34 weeks after initial treatment. The mean AUA Symptom Score for patients treated with NX-1207 showed a 6.9 point greater improvement compared to controls. No serious safety issues were reported.

• Theravance Inc., of South San Francisco, said it enrolled the last patient in its first Phase III program of telavancin, an investigational antibiotic, in patients with complicated skin and skin-structure infections due to Gram-positive bacteria, including resistant strains such as methicillin-resistant Staphylococcus aureus. More than 1,800 patients have been enrolled overall, and the company expects to have more than a third of those with confirmed MRSA infections at baseline. In November, Theravance entered a collaboration with Tokyo-based Astellas Pharma Inc. for worldwide development and commercialization of telavancin, excluding Japan. (See BioWorld Today, Nov. 9, 2005.)

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., and GlaxoSmithKline plc, of London, said preliminary 48-week results from a head-to-head clinical study indicated that Lexiva (Telzir; fosamprenavir calcium) 700 mg plus ritonavir 100 mg given twice daily was comparable to Kaletra (lopinavir/ritonavir fixed-dose combination) given twice daily in treatment-na ve HIV patients. All patients also received a once-daily fixed-dose combination of abacavir 600 mg and lamivudine 300 mg as the backbone of antiretroviral therapy. The study enrolled 887 patients and showed that 73 percent of patients receiving Lexiva/ritonavir maintained suppression of viral replication, compared with 71 percent of those receiving Kaletra. Both regimens were generally well tolerated.

• Voyager Pharmaceutical Corp., of Raleigh, N.C., reported data from a Phase II study showing that leuprolide acetate, when used in conjunction with standard Alzheimer's therapy, stabilized the cognitive and functional decline of women with mild to moderate Alzheimer's disease. The findings are the result of a subgroup analysis involving 50 of the 109 patients enrolled in 48-week study who received leuprolide acetate along with cholinesterase inhibitor therapy. Data were presented at the 9th International Geneva/Springfield Symposium on Advances in Alzheimer Therapy in Geneva.

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