• Acusphere Inc., of Watertown, Mass., entered an agreement to lease commercial manufacturing space in Tewksbury, Mass. The specialty pharmaceutical company plans to develop the facility to meet its anticipated initial commercial production needs for AI-700, an ultrasound contrast agent in Phase III trials for the detection of coronary heart disease.

• ArQule Inc., of Woburn, Mass., said a Phase I study of ARQ 501 as monotherapy continues to enroll patients. The drug has been well tolerated, the company said, and dose escalation will continue to identify the maximum tolerated dose. In the latter part of the year, a new Phase Ib/II study combining ARQ 501 with gemcitabine will open to enroll patients with advanced pancreatic cancer. Planning also is under way for additional studies to start next year.

• Chiron Corp., of Emeryville, Calif., said it has delivered the first 1 million doses of its Fluvirin influenza vaccine to U.S. distributors in preparation for the upcoming flu season. The company expects to deliver 52 million doses to the U.S. market this season through regular shipments over the next few months, including 2 million doses later in the season for a national stockpile held by the U.S. Centers for Disease Control and Prevention in Atlanta. Chiron said the supply level represents an increase of more than a third compared to Fluvirin deliveries during the last flu season.

• Kiwa Bio-Tech Products Group Corp., of Los Angeles, reincorporated itself in the state of Delaware. The company develops products for the agricultural and environmental protection markets.

• Lorus Therapeutics Inc., of Toronto, said data reported at the International Congress of Immunology and Conference of the Federation of Clinical Immunology Societies in Montreal covered a number of in vivo and in vitro experiments that demonstrated the involvement of specialized immune cells, called NK cells, in the antitumor response elicited by Virulizin. Treatment with the drug results in expansion and activation of NK cells in the spleen with a subsequent increase in NK cell infiltration into tumors. In NK cell-depleted animals, Virulizin-mediated antitumor response was significantly diminished.

• Oscient Pharmaceuticals Corp., of Waltham, Mass., said it would change its ticker on the Nasdaq exchange from "GENE" to "OSCI" effective with the market's Aug. 4 opening. The change reflects the company's new name; previously it was called Genome Therapeutics Corp.

• OxiGene Inc., of Waltham, Mass., said it sent a letter to Germany's Berlin-Bremen Exchange demanding that the company be delisted and that trading of its common stock cease immediately. OxiGene never requested a listing on the exchange and noted concern that the Berlin-Bremen exchange could be used as a vehicle for stock manipulation through arbitrage and other mechanisms. The company is developing vascular-targeting compounds designed to selectively target and destroy new blood vessels.

• Project BioShield was signed into law Wednesday by President George Bush. Under the law, the government is compelled to spend $5.6 billion over a decade to purchase countermeasures for biological and chemical threats. BioShield is designed to encourage further research and development of such products, guaranteeing companies a contract to sell their products to the government. Regarding the president's signature, Tommy Thompson, secretary of Health and Human Services, released a prepared statement saying, "We will now be able to quickly purchase important medical countermeasures in the event of a threat to our country. This law also sends a clear signal that the U.S. government is prepared to be a full partner with the research community in the fight against bioterrorism." (See BioWorld Today, July 23, 2003, and May 20, 2004.)

• Seattle Genetics Inc., of Bothell, Wash., began a Phase II trial of SGN-15, an antibody-drug conjugate, for non-small-cell lung cancer. The trial will use a biomarker to assist in evaluating the optimized dosing schedule of SGN-15 in combination with Taxotere. Prior clinical trials have demonstrated that the simultaneous administration of SGN-15 and Taxotere may result in improved overall survival compared to Taxotere alone, and preclinical studies have indicated that administration of SGN-15 prior to Taxotere can significantly enhance the therapeutic effect of the combination regimen compared to simultaneous administration of the two drugs. The open-label study will accrue about 30 evaluable patients into two groups that will receive SGN-15 plus Taxotere either simultaneously or separated by a three-day interval.

• Serologicals Corp., of Norcross, Ga., registered a mixed shelf statement with the SEC to sell from time to time up to $300 million worth of common and preferred stock, as well as debt securities. The company, which provides biological products and enabling technologies, said it would use any resulting funds for general corporate purposes, including working capital, capital expenditures, investments in or loans to subsidiaries, acquisitions, refinancing of debt and the repurchase of equity.

• Transkaryotic Therapies Inc., of Cambridge, Mass., said the company and its former CEO, Richard Selden, received Wells notices from the staff of the SEC in connection with a previously announced investigation. It relates to Transkaryotic's disclosures and public filings with regard to Replagal and the status of the FDA's approval process for the drug, as well as transactions in the company's securities.

• Velcura Therapeutics Inc., of Ann Arbor, Mich., said it developed an array that aids the development of bone disease therapies by enabling researchers to follow global changes in gene expression during human bone formation. The company worked with Affymetrix Inc., of Santa Clara, Calif., to design and produce the array using Affymetrix's CustomExpress Array Program.

• Viral Genetics Inc., of Azusa, Calif., said results of a trial conducted at China's National AIDS Center in Beijing suggest that patients receiving no additional anti-HIV therapy had sustained decreases in viral load after treatment with VGV-1. The mean PCR RNA viral load for all patients at baseline was 4.902 log. By day 180 during the no-treatment follow-up period, plasma HIV RNA was suppressed with a mean change of -0.70 log from baseline. By day 270, viral load remained suppressed with a mean change of -0.484 log from baseline.

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