• Aeolus Pharmaceuticals Inc., of Research Triangle Park, N.C., said its recently announced name change from Incara Pharmaceuticals Corp. took effect on Friday. As a result, its stock trading symbol changed from "ICRA" to "AOLS." The stock will continue to trade on the Over-the-Counter Bulletin Board, and also as of Friday, on a 1-for-10 reverse stock split-adjusted basis. Its stock dropped 65 cents Friday, or 27.1 percent, to close at $1.75.

• Ascend Therapeutics Inc., of Herndon, Va., began a Phase II study to evaluate the efficacy and safety of Andrin (transdermal dihydrotestosterone gel) to prevent prostate growth in middle-aged men. The trial, which will be conducted in conjunction with the University of Sydney in Australia, will involve 100 healthy men older than 50. Participants will apply either DHT or a placebo gel to their shoulders, upper arms and thighs every day for 24 months. Preliminary results are expected in the middle of 2006.

• Biopolymer Engineering Inc., of Eagan, Minn., said findings published in the July 15, 2004, issue of The Journal of Immunology detailed the identification of a natural carbohydrate that recruits innate immune cells to assist monoclonal antibodies in the killing of cancer cells, providing a third mechanism by which this immunotherapy destroys tumors. The mechanism, discovered by researchers at the James Graham Brown Cancer Center at the University of Louisville, relies on an orally administered yeast beta 1,3/1,6 glucan called WGP Beta Glucan, which the company owns. The carbohydrate binds to specific receptors on neutrophils and enables them to see the cancer as foreign. The antibodies and complement attract the primed neutrophils to the site of the cancer where it joins the attack.

• Centocor Inc., of Malvern, Pa., said new guidelines issued by the American College of Cardiology and the American Heart Association are in favor of using ReoPro (abciximab) in acute heart attack patients who are having a balloon or stenting procedure (PCI). ReoPro, a glycoprotein IIb/IIIa inhibitor, is indicated for adjunctive use with PCI for the prevention of cardiac ischemic complications in patients undergoing the procedure. It was developed and is manufactured by Centocor. ReoPro is marketed and distributed worldwide, except in Japan, by Eli Lilly and Co., of Indianapolis.

• Ciphergen Biosystems Inc., of Fremont, Calif., introduced its next-generation ProteinChip System, Series 4000, which features the Pattern Track biomarker discovery-to-assay process. The process integrates Ciphergen's ProteinChip Arrays, SELDI-TOF-MS detection, and Biomarker Patterns software to enable biomarker discovery and development of predictive, high throughput SELDI-based assays. Separately, Ciphergen said findings reported at the International Conference on Alzheimer's Disease in Philadelphia detail 10 studies involving its SELDI ProteinChip Technology for various aspects of Alzheimer's research. The studies have identified multiple biomarkers and biomarker patterns, the company said, adding that the findings might lead to improved early detection of Alzheimer's and also might suggest new targets for therapeutic intervention.

• Dragon Pharmaceutical Inc., of Vancouver, British Columbia, said Ecuadorian regulatory authorities approved its recombinant erythropoietin (EPO) product. In addition to China, India, Egypt, Brazil and Peru, Dragon's EPO now is approved and marketed in six countries in Asia, South America and the Middle East. The company said it expects additional regulatory approvals among other non-patented countries.

• Incyte Corp., of Wilmington, Del., said the SEC declared effective its registration statement for the resale of $250 million principal amount of its 3.5 percent convertible subordinated notes due 2011 and the shares of its common stock issuable upon conversion of the notes. The notes were originally issued in a private placement in February and March. Incyte will not receive proceeds from any resale of the shares by holders.

• InterMune Inc., of Brisbane, Calif., completed the repurchase of all of its remaining 5.75 percent convertible subordinated notes, totaling $97 million, due July 15, 2006. The company will pay about $102.6 million, which includes accrued interest of $2.8 million and a premium of $2.8 million. InterMune will take a charge this quarter of about $4.1 million, which includes the premium and a non-cash charge of $1.3 million for the acceleration of the deferred issuance costs associated with the notes. InterMune began the process in February of removing the notes from its balance sheet. The company will save about $8.4 million per year in interest payments as a result of the repurchase. (See BioWorld Today, Feb. 12, 2004.)

• Medivir AB, of Huddinge, Sweden, and Biovitrum AB, of Stockholm, Sweden, entered a research collaboration to develop a drug candidate for Type II diabetes. Biovitrum brings metabolic disease experience to the deal, given its ongoing clinical and preclinical research programs in this area, while Medivir will provide its protease knowledge and technologies to complement the research. Financial terms were not disclosed.

• Pharmaxis Ltd., of Sydney, Australia, completed enrollment in its Phase II trial to evaluate the effects of Bronchitol on patients with bronchiectasis. The double-blinded, placebo-controlled crossover trial includes 59 children and adults from 15 to 70 who suffer from the respiratory disease, a form of chronic obstructive lung disease. Its primary objective is to compare the effects of twice-daily Bronchitol on the disability and handicap associated with bronchiectasis before and after treatment, and against placebo.

• Transkaryotic Therapies Inc., of Cambridge, Mass., received fast-track designation from the FDA for iduronate-2-sulfatase to treat Hunter syndrome. TKT began a pivotal study with I2S in September 2003. That study is scheduled for 12 months and will involve 96 patients. The company expects top-line results in the second quarter of 2005. TKT would then submit regulatory applications in the U.S. and Europe in the second half of that year.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., and London-based GlaxoSmithKline plc received marketing approval from the European Commission for Telzir (foseamprenavir) to treat HIV infection in adults in combination with other anti-HIV medications. Vertex earned a $1.5 million milestone payment in connection with the approval. Protease inhibitors, like Telzir, act by inhibiting the HIV-1 protease enzyme leading to the formation of immature virus and preventing the infection of new cells. Telzir has demonstrated its ability when combined with other antiretroviral drugs to reduce the concentrations of HIV in plasma in both antiretroviral treatment-na ve and experienced patients. Vertex and GSK co-discovered Telzir and will co-promote the product in key markets in Europe. The FDA approved Telzir (called Lexiva in the U.S.) last fall.

• Zonagen Inc., of The Woodlands, Texas, said the U.S. Court of Appeals for the Fifth Circuit affirmed the June judgment of the U.S. District Court for the Southern District of Texas dismissing the one claim remaining from the consolidated class-action lawsuit against the company. On July 15, the Court of Appeals denied the plaintiff's request for a rehearing. The case was originally brought up in May 1998 alleging that Zonagen and its officials made false and misleading statements relating to patents on Vasomax and Chito-ZN (formerly ImmuMax), and trials of Vasomax. A new drug application for Vasomax for erectile dysfunction was submitted in 1998, but the FDA required a rodent study to be completed, then kept the drug on hold. Schering-Plough Corp., of Madison, N.J., later dropped its partnership with Zonagen for technologies that included Vasomax. Earlier this year, Zonagen said it plans to out-license Vasomax.

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