• A.P. Pharma Inc., of Redwood City, Calif., began a Phase I trial with APF530 to treat chemotherapy-induced nausea and vomiting. APF530 combines its Biochronomer bio-erodible drug delivery system with granisetron and is designed to provide three to five days of continuous relief following a subcutaneous injection. The trial is designed to determine the safety and tolerability of the drug in 18 healthy volunteers at a single site in the UK. The study should be completed by mid-year. A.P. Pharma expects to file an investigational new drug application to move into Phase II studies later this year.

• Advancis Pharmaceuticals Corp., of Germantown, Md., appointed its co-founder and CEO Edward Rudnic chairman, effective May 1. The company's current chairman and co-founder, James Isbister, is retiring. Advancis focuses on the development and commercialization of pulsatile drug products in infectious disease.

• GenVec Inc., of Gaithersburg, Md., raised $12.6 million in gross proceeds after completing the sale of 4 million common shares at $3.15 apiece to various institutional investors. The stock was offered under a shelf registration statement declared effective by the SEC in January. Stonegate Securities Inc. served as placement agent.

• Gilead Sciences Inc., of Foster City, Calif., reported 144-week data at the European Association for the Study of the Liver meeting in Berlin, detailing a trial, called Study 438, of its oral antiviral drug Hepsera (adefovir dipivoxil 10 mg) in patients with hepatitis B "e" antigen-negative/anti-hepatitis B "e" positive chronic hepatitis B virus. Among 70 patients who received continuous Hepsera treatment over 144 weeks, 79 percent achieved undetectable levels of serum HBV DNA (less than 1,000 copies/mL), compared with 69 percent after 96 weeks. The median reduction in serum HBV DNA levels among Hepsera-treated patients was about 3.6 log10 copies/mL at week 144. Hepsera also provided sustained improvement in liver function through 144 weeks, as measured by blood levels of the liver enzyme alanine aminotransferase (ALT). The proportion of patients with ALT levels above the upper limit of normal at baseline whose ALT levels returned to normal at 144 weeks was 88 percent (n=62).

• Idenix Pharmaceuticals Inc., of Cambridge, Mass., presented one-year data from a Phase IIb trial comparing telbivudine alone or in combination with lamivudine vs. a lamivudine monotherapy in chronic hepatitis B patients. Study results showed that patients treated with telbivudine achieved a significantly greater reduction of hepatitis B virus replication and higher rates of normalization of ALT compared with lamivudine monotherapy. Data from the telbivudine and lamivudine combination arms demonstrated an increase in antiviral efficacy when compared to lamivudine monotherapy, but there was no advantage over telbivudine alone. All treatment regimens were well tolerated with no safety issues.

• Illumina Inc., of San Diego, began shipping its BeadStation 500G, a system for performing DNA analysis using Illumina's SNP genotyping technology. The benchtop product is designed for research labs that have throughput requirements ranging from 6,000 to 300,000 genotypes per day.

• Inologic Inc., of Seattle, achieved the second milestone in its development of INO-4995 for cystic fibrosis, receiving an undisclosed payment from Cystic Fibrosis Foundation Therapeutics Inc. (CFFT). The development of INO-4995 is funded in part by a $1.5 million award from CFFT, a nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation. The milestone included the demonstration of potency of INO-4995 in a CF mouse nasal potential difference model.

• Inspire Pharmaceuticals Inc., of Durham, N.C., filed a $140 million shelf registration statement with the SEC to sell up to that amount worth of common stock from time to time. The company said it would use any resulting proceeds for clinical development, product commercialization, discovery research and preclinical activities, as well as for working capital and general corporate purposes.

• Locus Pharmaceuticals Inc., of Blue Bell, Pa., reported data at the Keystone Structural Genomics meeting that confirm its computationally directed, fragment-based drug design technology. Findings demonstrated that when applied toward the p38 protein, the application of Locus' core technology in silico resulted in the prediction of five binding sites on the p38 protein (including known sites), the reproduction of affinities and binding site modes of known p38 inhibitors by computationally reconstructing such inhibitors and de novo identification of synthetic designs for those binding sites.

• Metabasis Therapeutics Inc., of San Diego, said Valeant Pharmaceuticals Inc., of Costa Mesa, Calif., paid $1 million in a milestone payment to Metabasis for the initiation of a Phase II study of remofovir in patients with chronic hepatitis B infection. Valeant licensed remofovir, an orally active prodrug of adefovir, from Metabasis in October 2001.

• Northfield Laboratories Inc., of Evanston, Ill., raised $2.3 million from investors who purchased an additional 409,483 shares of common stock as part of an overallotment option. The company raised $15 million in January in a financing to fund a pivotal trial of its lead product, PolyHeme. Northfield has received about $29.3 million in gross proceeds from equity sales this fiscal year. SG Cowen Securities Corp. acted as placement agent. (See BioWorld Today, Jan. 27, 2004.)

• Prana Biotechnology Ltd., of Melbourne, Australia, said Phase II data of PBT-1 showed that the use of the drug for 18 months markedly slowed the decline in cognitive function associated with Alzheimer's disease. The treatment also was well tolerated. The data came out of an extension study in which nine of the original 18 patients participated. The company expects to move PTB-1, a metal protein-attenuating compound, into a larger trial.

• SeraCare Life Sciences Inc., of Oceanside, Calif., signed an agreement to purchase substantially all the assets of the BBI Diagnostics and BBI Biotech Research Laboratories divisions of Boston Biomedica Inc., of West Bridgewater, Mass., for $30 million in cash, plus the assumption of certain liabilities. The purchase price is subject to adjustment based on the amount of net assets at the closing. SeraCare, which manufactures and provides biological materials and services for diagnostic tests, drug production and research applications, expects the acquisition to be accretive by the first full fiscal quarter after closing.

• The Mayo Clinic in Rochester, Minn., established a research program in the genomics of addiction with a long-term goal of predicting and preventing alcoholism and other chemical dependencies. The five-year program initially will delve into research to identify human genes that contribute to vulnerability to alcoholism, followed by the development of methods to use the genetic information.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., said it plans to advance its antiviral therapies for hepatitis C virus infection based on positive Phase II and preclinical studies. Phase II data showed that the triple combination of Vertex's product merimepodib with pegylated interferon-alpha and ribavirin was well tolerated and indicated an enhanced antiviral activity. Vertex plans to initiate larger Phase IIb studies this year to evaluate the ability of merimepodib to increase sustained viral response rates in HCV patients. In preclinical studies, Vertex's second HCV product, VX-950, decreased viral replication by 10,000-fold to undetectable levels. Vertex plans to begin a Phase I trial in healthy volunteers this year. The company owns worldwide development and commercialization rights for both products.

• Xcyte Therapies Inc., of Seattle, began a Phase II trial for Xcellerated T Cells to treat patients with relapsed multiple myeloma. The study is expected to enroll 30 patients at about 10 medical centers in the U.S. It will evaluate the safety and biologic and therapeutic activity of the product. In the first Phase II trial, Xcellerated T Cells were studied in patients undergoing high-dose chemotherapy followed by peripheral blood stem cell transplantation. Researchers observed rapid and sustained lymphocyte recovery, and a majority of patients had clinical responses. With the new study, researchers will look at the product without additional antitumor therapy.