• Acadia Pharmaceuticals Inc., of San Diego, said initial results from an ongoing trial of ACP-104 in patients with schizophrenia show the drug to be safe and well tolerated. Results are based on 10 patients who received single doses of ACP-104 (N-desmethylclozapine) or placebo on separate days. Acadia plans to expand the study to test higher-than-expected doses of the drug, and is also conducting an ongoing 14-day study designed to evaluate the safety and pharmacokinetics of ACP-104, as well as provide preliminary indications of antipsychotic efficacy.

• Advancis Pharmaceutical Corp., of Germantown, Md., began enrollment for its new Phase III trial of Amoxicillin Pulsys in adults and adolescents with pharyngitis/tonsillitis. The non-inferiority trial, expected to enroll at least 600 patients throughout the 2005/2006 respiratory infection season, will evaluate the company's once-daily pulsatile version of 775-mg amoxicillin for 10 days vs. 250 mg of penicillin VK dosed four times per day for 10 days. Advancis anticipates completing enrollment by June of next year and reporting results during the third quarter of 2006. Depending upon the results, the company hopes to submit a new drug application for the product in late 2006. A prior Phase III study, which tested Amoxicillin Pulsys administered daily for seven days against the standard 10-day therapy of penicillin, missed its primary endpoint earlier this year, failing to show non-inferiority and falling short of the 85 percent bacterial eradication rate required by the FDA. (See BioWorld Today, June 17, 2005.)

• Affymax Inc., of Palo Alto, Calif., reported positive preclinical data on Hematide, showing the effect of radioactively labeled Hematide in rodent models. The data were presented at the American Society of Nephrology's Renal Week 2005 in Philadelphia. Hematide is a peptide-based drug designed to stimulate the production of red blood cells that is being studied in a Phase IIa trial in patients with end-stage renal disease who are on dialysis. A second study is evaluating the drug in chronic kidney disease, and Affymax plans to begin a third trial for the treatment of anemia in cancer patients later this year.

• Idenix Pharmaceuticals Inc., of Cambridge, Mass., reported that valopicitabine combined with pegylated interferon demonstrated significantly greater viral suppression after 12 weeks of treatment compared to retreatment with ribavirin plus pegylated interferon in an ongoing Phase IIb trial in chronic hepatitis C genotype 1 patients who were non-responders to previous therapy. The results will be presented today at the 56th annual meeting of the American Association for the Study of Liver Diseases in San Francisco. Valopicitabine, a once-daily, orally administered drug, is intended to block HCV replication by specifically inhibiting the HCV RNA polymerase.

• ImClone Systems Inc., of New York, said that Daniel Lynch, CEO since February 2004, has resigned his positions of CEO and director by mutual agreement with the board. Philip Frost, currently executive vice president and chief scientific officer, will serve as interim CEO while the board conducts an external search for a permanent CEO. Frost will continue to serve as the company's chief scientific officer.

• Lexicon Genetics Inc., of The Woodlands, Texas, and Taconic Farms Inc., of Hudson, N.Y., formed a collaboration for the marketing, distribution and licensing of certain knockout mice made by Lexicon. Lexicon initially will make available more than 1,000 distinct lines of mice, each with a single gene knocked out, for use by pharmaceutical and biotechnology companies and other researchers. Taconic will provide breeding services and licenses for the lines and will distribute the mice to customers. Financial terms were not disclosed.

• Luminex Corp., of Austin, Texas, said its partner, Tm Bioscience, of Toronto, reported last week the availability of an upper respiratory viral panel that detects all the major human respiratory viruses, including H5N1 and severe acute respiratory syndrome corona.

• Myogen Inc., of Denver, achieved its target enrollment of 186 patients in ARIES-1, one of the company's two pivotal Phase III trials of ambrisentan in patients with pulmonary arterial hypertension. Myogen expects to report top-line results in the second quarter of 2006. The company had initially expected to complete enrollment in mid-2005, but announced a six-month delay in February due to difficulty in finding enough treatment-na ve patients. The second Phase III study, AIRES-2, remains on schedule, and Myogen expects to release results in December. (See BioWorld Today, Feb. 4, 2004.)

• Oxxon Therapeutics Inc., of Boston, said interim data from a 52-week Phase IIa study of its vaccine comprising a PrimeBoost immunotherapeutic approach in patients with chronic hepatitis B found that the therapy was safe and generally well tolerated. The data will be presented today at the 56th annual meeting of the American Association for the Study of Liver Diseases in San Francisco.

• Pharmaxis Ltd., of Sydney, Australia, completed its fund raising with gross proceeds of A$87 million (US$63 million) through the sale of 39.4 million shares. Of those shares, 1.3 million were American depository shares issued to U.S. institutional investors at a price of $24.16 per ADS. Each ADS represents 15 ordinary company shares. In Australia, 19.9 million ordinary shares were issued to Australian and other non-U.S. investors for A$2.20 per share, equivalent to the ADS price. Proceeds will be used to complete the development of Pharmaxis' lead product candidates: Aridol, for asthma management, and Bronchitol, for cystic fibrosis and chronic obstructive pulmonary disease.

• Point Therapeutics Inc., of Boston, said results of a 42-patient Phase II study of its cancer drug, talabostat, in patients with Stage IV melanoma show that two patients had a response to talabostat, as defined by RECIST (a 30 percent or greater reduction in tumor size), with one of those patients experiencing a complete response. The Kaplan-Meier estimates for single-agent talabostat are 7.1 months for median survival and 1.5 months for median progression-free survival. The data were presented at the International Society for Biological Therapy of Cancer meeting in Alexandria, Va.

• Pro-Pharmaceuticals Inc., of Newton, Mass., said preclinical and Phase I data of its cancer drug Davanat indicate that the product exhibits broad spectrum enhancement of tumor drugs, including 5-fluorouracil (5-FU), irinotecan, and Avastin (bevacizumab, from South San Francisco-based Genentech Inc.) in human colon and breast tumors. Data were presented at the annual Conference of the Society for Glycobiology in Boston. The company has an ongoing Phase II trial of Davanat plus 5-FU in colorectal cancer patients that are refractory to 5-FU, and has received clearance in Europe to begin a Phase III trial for second line treatment in patients with metastatic colorectal cancer.

• Select Vaccines Ltd., of Melbourne, Australia, said positive results from its first preclinical studies of a potential vaccine against hepatitis C support acceleration of its hepatitis C development program. The company reported an immune response in mice after just one dose. The vaccine is being developed by the company's platform technology, which uses virus-like particles to generate a protective immune response against infection.

• Solbec Pharmaceuticals Ltd., of Perth, Australia, received orphan drug designation from the FDA for its lead cancer compound, Coramsine, for the treatment of metastatic renal-cell carcinoma. Solbec plans to advance Coramsine to the market within three to five years.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., reported data confirming the tolerability and antiviral activity of its oral protease inhibitor, VX-950, in the treatment of hepatitis C in a 14-day study. The data were presented at the 56th American Association for the Study of Liver Diseases annual meeting in San Francisco. Vertex initially reported positive findings from interim data in May. The company expects to file an investigational new drug application to support Phase II development of the drug. (See BioWorld Today, May 11, 2005.)

• Viventia Biotech Inc., of Toronto, said the FDA designated the company's lead drug, Proxinium, as a fast-track product for the treatment of patients with recurrent squamous-cell carcinoma of the head and neck. Proxinium is designed to combine a cytotoxic protein payload with the tumor-targeting characteristics of a monoclonal antibody. The company said a single molecule of the cytotoxic protein payload, Pseudomonas exotoxin, is capable of killing a cancer cell.