• AEterna Laboratories Inc., of Quebec City, and its Zentaris GmbH wholly owned subsidiary reported Phase II data at an investor and analyst meeting in New York showing cetrorelix use was associated with a statistically significant improvement of pain score in two groups of 25 endometriosis patients who received placebo or a depot formulation of cetrorelix by two intramuscular injections, with a one-month interval (p<0.001). Data from two trials including 250 benign prostatic hyperplasia patients demonstrated a dose-dependent improvement in clinical symptoms, including International Prostate Symptom Score and maximum uroflow in the cetrorelix-treatment group compared to placebo. Findings on another compound, from an in vivo study of perifosine, showed a combination with radiation led to complete tumor regression.

• Amylin Pharmaceuticals Inc., of San Diego, filed a resale registration statement with the SEC in connection with its recent private placement of $200 million of 2.5 percent convertible senior notes due 2011. Upon being declared effective, the registration statement will allow selling securityholders to publicly resell the convertible notes and the common stock issuable upon their conversion.

• Androclus Therapeutics, of San Diego, said Phase I/IIa data of AT-001 to treat rheumatoid arthritis were published in the Proceedings of the National Academy of Sciences, showing biological efficacy with no significant side effects. AT-001 is a short, engineered oral peptide with disease-specific immunomodulatory activity. Patients were treated with AT-001 orally for six months. The peptide induced a change from pro-inflammatory to regulatory T-cell function. AT-001 is in a multicenter Phase II trial in RA, sponsored by the National Institutes of Health in Bethesda, Md.

• Arakis Ltd., of Little Chesterford, UK, and Vectura Ltd., of Chippenham, UK, said their collaborative project, AD 237, an inhaled bronchodilator treatment for chronic obstructive pulmonary disease (COPD), completed a Phase IIa trial to study the safety and efficacy of a range of single doses in 45 COPD patients. The results showed that an optimized inhaled formulation of the drug offers a long-acting, once-daily profile. The companies now are planning a Phase IIb study in the U.S. to begin later in 2004. AD 237 contains an antimuscarinic drug, which is approved and marketed for nonrespiratory indications.

• Benitec Ltd., of Queensland, Australia, is paying about $5.5 million to acquire Avocel Inc., of Sunnyvale, Calif. Through the transaction, Benitec gained an advanced therapeutic development program using DNA-directed RNAi (ddRNAi) to target the hepatitis C virus, and established Benitec Inc. as its a wholly owned U.S. subsidiary. Benitec, which expects that a ddRNAi-based therapeutic will enter the clinic next year, is issuing 7.6 million shares to Avocel, representing about 9 percent of Benitec's share capital.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., completed its previously reported $17.7 million private placement of shares of its common stock and warrants. About 3 million shares were sold at $6 each. Investors also received warrants to purchase 442,350 shares at $7 per share. Net proceeds totaled about $16.5 million and will be used to fund the late-stage development of the company's pipeline, including Bio-E-Gel in a pivotal Phase II trial to reduce the frequency and severity of hot flashes, and LibiGel, soon to complete a Phase II trial for female sexual dysfunction, as well as for general corporate purposes. (See BioWorld Today, May 13, 2004.)

• Centocor Inc., of Malvern, Pa., said findings from the patient registry TREAT (Crohn's Therapy, Resource, Evaluation and Assessment Tool) would be reported at the Digestive Disease Week meeting in New Orleans. The 6,000-patient registry is evaluating the safety of Remicade (infliximab) vs. conventional therapies for Crohn's disease. Separately, Centocor and Schering-Plough Corp., of Kenilworth, N.J., began a trial to evaluate Remicade vs. azathioprine alone and in combination for Crohn's disease. Labeled SONIC (Study of Immunomodulator Na ve patients in Crohn's disease), it is the first clinical trial to compare a biologic therapy to a conventional therapy in Crohn's disease patients, Centocor said.

• Enzo Biochem Inc., of Farmingdale, N.Y., said glucocerebroside (GC) modulates specific immune regulatory cells and might be a candidate to treat immune-mediated diseases, such as Crohn's disease, hepatitis B, hepatitis C and HIV. In mice, GC demonstrated an immunomodulatory effect by analysis of intrahepatic and intrasplenic lymphocytes for NKT, CD4 and CD8 markers, and by measurement of serum IFNa, IL-2, IL-12, IL-4 and IL-10 cytokine levels. The company now expects to begin clinical studies.

• F. Hoffmann-La Roche Ltd., of Basel, Switzerland, said new international consensus guidelines for Fuzeon (enfuvirtide) were published in the May 17, 2004, edition of AIDS. The consensus panel of nine experts agreed that Fuzeon benefits pre-treated patients across all subgroups studied, including those taking few or no other active drugs. The panel also found that patients who have a higher CD4 count achieve optimal outcomes when using Fuzeon. In other news, Hoffmann-La Roche Inc., of Nutley, N.J., said data of CellCept (mycophenolate mofetil) demonstrated better patient and graft survival in liver and kidney transplant patients compared to those receiving treatment regimens not including CellCept. CellCept is FDA approved for the prevention of organ rejection in kidney, heart and liver. The data included more than 25,000 organ recipients that received CellCept-based treatment regimens.

• Gamida-Cell Ltd., of Jerusalem, was approved for a $1.3 million grant by The Office of the Chief Scientist, Ministry of Industry, Trade and Labor. The grant is part of an overall approved budget of $3 million by the office for Gamida's StemEx research and is earmarked for both in-house and subcontractor activity. Gamida-Cell will receive the funding during the course of 2004. The grant is in addition to an overall $5 million grant that Gamida-Cell is to receive during the next three years to support its participation in the Israel Stem Cell Consortium.

• GenVec Inc., of Gaithersburg, Md., said findings on TNFerade reported at the Digestive Disease Week meeting in New Orleans showed a dose-related improvement in local tumor control, tumor markers and percentage of patients undergoing surgical resection. In addition, dose-related progression-free survival rates at one, three and six months post treatment were reported in the 37-patient study.

• Geron Corp., of Menlo Park, Calif., published research that identifies genes active in human embryonic stem cells (hESCs) and in hESCs undergoing differentiation. The work was performed under Geron's prior collaboration with Celera Genomics Group, of Rockville, Md., and was published online Monday in Nature Biotechnology. The work elucidated signaling pathways operative in hESCs that likely play roles in their growth and differentiation. That information will be used to facilitate derivation of useful differentiated cell types for therapy and might also lead to the development of tools for drug discovery, the company said.

• Guilford Pharmaceuticals Inc., of Baltimore, granted exclusive rights to Link Pharmaceuticals Ltd., of Horsham, UK, to market, sell and distribute Gliadel Wafer (polifeprosan 20 with carmustine implant) in Germany, France, Benelux, Austria and Switzerland. Link will be responsible for obtaining pricing approvals in each of the countries, which are in addition to an existing contract for the UK. Guilford received $500,000 at signing and could receive milestone payments totaling up to $2 million. If Gliadel is approved for initial surgery in France and Germany, Guilford will receive a $750,000 milestone payment. The product is approved for use in 13 countries outside the U.S. and Canada to treat recurrent glioblastoma multiforme.

• IDEA AG, of Munich, Germany, reported the positive outcome of a clinical study testing the efficacy and safety of IDEA-070, for the treatment of painful and inflammatory skin reactions induced by different challenges, such as sunburn. The trial was designed to compare the effects of IDEA-070 with placebo on UVB-induced skin inflammation in 37 healthy volunteers. The measure of the study was the threshold-to-heat-induced local pain following specified UVB irradiation. Further objectives included a comparison with an equal volume of a commercial product containing hydrocortisone-21-acetate, the testing of two lower doses of IDEA-070 and an evaluation of different application regimens.

• InterMune Inc., of Brisbane, Calif., presented data of a retrospective clinical analysis done in collaboration with the New Jersey Medical Liver Center evaluating Infergen plus Actimmune in patients chronically infected with hepatitis C virus who have failed to respond to therapy with pegylated interferon alpha 2 plus ribavirin. About half of patients treated with pegylated interferon alpha 2 plus ribavirin did not respond. Of 32 nonresponder patients receiving 24 weeks of therapy with Infergen and Actimmune, 47 percent had undetectable levels of HCV RNA in their blood. In a separate study of Infergen plus ribavirin combination therapy in the same type of patient showed the combination results in a sustained virologic response rate of 27 percent and 23 percent for an induction-dose arm and a fixed-dose arm, respectively. Another study of Infergen plus ribavirin for 48 weeks showed a clinically significant end-of-treatment virologic response rate of 43 percent.

• Introgen Therapeutics Inc., of Austin, Texas, said preclinical data published in the current issue of Cancer Research detail studies of two oncolytic viruses that have potential as new cancer therapies. In an animal model of colon cancer, injection of either INGN 007 or VRX-009 into tumors suppressed tumor growth more efficiently than a negative control (fivefold and 10-fold suppression, respectively). Also, INGN 007 completely suppressed tumor growth in a lung cancer model. Introgen licensed rights to the oncolytic viruses and other related technologies from VirRx Inc., of St. Louis.

• Kosan Biosciences Inc., of Hayward, Calif., said a study demonstrated the potency of its lead motilin agonists, showing minimal tachyphylaxis. The study evaluated Kosan's motilin agonists in two in vitro gastric contractility models. Motilin agonists are stimulators of gastric motility and act as prokinetic agents, which have potential in treating diabetic gastroparesis, post-surgical ileus and gastroesophageal efflux.

• Luminex Corp., of Austin, Texas, appointed Patrick Balthrop president and CEO. Balthrop most recently was at Fisher Scientific International Inc., where he served as president of Fisher Healthcare. Luminex develops and makes biological testing technologies with applications in the life sciences industry.

• NeoRx Corp., of Seattle, signed an agreement with the nuclear pharmacy services business of Cardinal Health Inc., of Dublin, Ohio, for distribution of NeoRx's Skeletal Targeted Radiotherapy (STR) product to Phase III clinical sites to study it in multiple myeloma. Financial terms were not disclosed. NeoRx is developing STR for use with high-dose chemotherapy and autologous stem cell transplantation to treat multiple myeloma and other cancers in which stem cell transplantation is indicated.

• Oxigene Inc., of Waltham, Mass., said a clinical investigator found antitumor activity and no unexpected toxicity in a Phase I study of the company's lead vascular targeting agent, Combretastatin A4 Prodrug (CA4P). The company also is conducting a dose-escalation Phase Ib/II study of CA4P in combination with carboplatin and paclitaxel in advanced cancer and advanced ovarian cancer; a Phase I/II study of CA4P in combination with the iodine-labeled monoclonal anti-CEA antibody A5B7 in advanced colorectal cancer; and a Phase I/II study of CA4P in combination with radiotherapy in advanced cancer of the lung, head and neck and prostate.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., presented a review of Vascular Targeting Agent (VTA) technologies, suggesting advantages over other cancer therapies such as access of the target and a better mechanism of action. VTAs are agents that bind specifically to tumor blood vessels and shut down blood flow to the tumor resulting in tumor cell death. Data showed treatment with VTAs led to reductions in tumor blood flow and death of tumor cells in the core of the tumor.

• Solvay Pharmaceuticals BV, of Brussels, Belgium, and Bristol-Myers Squibb Co., of New York, entered a worldwide agreement for the Solvay compound SLV319, which is in Phase I development with potential for use in treating obesity and other metabolic disorders. The parties will jointly develop and commercialize SLV319 on a global basis. The agreement involves the payment of a $10 million signing fee by BMS. Further milestone payments are based on the successful outcome of certain development and regulatory stages. SLV319 belongs to a class of agents called CB1 antagonists, which work by blocking the canabinoid type 1 receptor.

• SRI International, of Menlo Park, Calif., received a three-year grant from the National Institute of General Medical Sciences, part of the National Institutes of Health in Bethesda, Md., to expand development of the MetaCyc metabolic pathway database. MetaCyc is a collaboration between SRI and the Carnegie Institution, Department of Plant Biology.

• Tecan Group Ltd., of Mannedorf, Switzerland, entered an agreement to develop and co-market high-throughput screening products with fluorescence lifetime technology with Pierce Biotechnology Inc., of Rockford, Ill. Tecan will apply its Ultra Evolution Detection Platform for high-throughput fluorescence lifetime measurements, while Pierce will lend its high-throughput screening assay technologies. Financial terms were not disclosed, though the partners will co-promote each other's technologies in sales and marketing literature for their respective technology.

• The Children's Hospital of Philadelphia and Drexel University College of Medicine in Philadelphia said their researchers published findings on the website of Nature Genetics detailing their discovery of a gene for Cornelia de Lange syndrome, a disabling, multisystem genetic disease that affects an estimated one in 10,000 children. The team identified a large gene on chromosome 5, which they named NIPBL (Nipped B-like). Mutations giving rise to Cornelia de Lange syndrome occur at different locations within that gene.

• The Nasdaq Stock Market Inc., of New York, completed its semi-annual re-ranking of the Nasdaq Biotechnology Index, which will become effective May 24. The re-ranking resulted in 26 securities being added to the index. The securities include AEterna Laboratories Inc., Bioveris Corp., Curis Inc., Cypress Bioscience Inc., Depomed Inc., DOV Pharmaceutical Inc., Dyax Corp., Forbes Medi-Tech Inc., Oscient Pharmaceuticals Corp., Guilford Pharmaceuticals Inc., Genelabs Technologies Inc., Illumina Inc., Keryx Biopharmaceuticals Inc., LifeCell Corp., Maxim Pharmaceuticals Inc., Myogen Inc., Northfield Laboratories Inc., Nuvelo Inc., Orchid BioSciences Inc., Pharmacyclics Inc., Pharmion Corp., Serologicals Corp., Seattle Genetics Inc., Vasogen Inc., Vivus Inc. and ZymoGenetics Inc.

• VaxGen Inc., of Brisbane, Calif., said it is examining whether it should recognize revenue from its National Institute of Allergy and Infectious Diseases contract and other similar contracts as it incurs related costs, instead of recognizing them only after completing contract milestones. If the revenue-recognition policy is changed, VaxGen would restate its financial results. It would result in a material decrease in the net loss applicable to common stockholders and an increase in revenue for the combined periods. VaxGen will not meet its deadline for filing results of the quarter ended March 31, resulting in the suspension of filing covering the resale of 655,078 shares of common stock issuable upon exercise of warrants from the May 2001 financing. The Series A warrants and the underlying common stock will be redeemable for cash after June 5.