• Active Biotech AB, of Lund, Sweden, said results from the Phase II study of its laquinimod (SAIK-MS) for the treatment of multiple sclerosis were presented Tuesday at the American Academy of Neurology's 56th annual meeting in San Francisco. The study showed that SAIK-MS can slow the progress of MS even in the absence of beta-interferon. The Phase II study involved 209 patients.

• Advanced Magnetics Inc., of Cambridge, Mass., began two Phase III studies for ferumoxytol, an intravenous iron-replacement therapeutic, in anemic chronic kidney disease patients who are not yet on dialysis. The company also plans to begin this quarter an additional Phase III efficacy study for ferumoxytol in anemic chronic kidney disease patients on hemodialysis. The company hopes to submit a new drug application by the end of 2005.

• Adventrx Pharmaceuticals Inc., of San Diego, said it received approval from the American Stock Exchange to list its stock under the trading symbol "ANX." The approval is contingent upon Adventrx's full compliance with all applicable listing standards on the date it begins trading, which the company expects to be Thursday. Adventrx is focused on commercializing medical research through licensing agreements with universities and research institutions. The company focuses on cancer and antiviral research.

• Biolog Inc., of Hayward, Calif., said its new Phenotype MicroArray technology was installed and is being used at Lawrence Berkeley National Laboratory in Berkeley, Calif. Phenotype MicroArrays are designed to allow scientists to test hundreds to thousands of cellular traits simultaneously.

• The Commonwealth Scientific and Industrial Research Organisation (CSIRO), Australia's national research agency, entered an agreement to license its DNA-delivered RNAi gene-silencing technology for certain crops to Bayer CropScience AG, of Monheim, Germany. Using RNAi, CSIRO plant industry researchers first demonstrated gene silencing in an organism in 1995. Bayer gained a worldwide license to develop, market and sell selected crop plant varieties incorporating the RNAi technology. Financial terms were not disclosed.

• CyDex Inc., of Palm Desert, Calif., said preclinical results of its Captisol-Enabled formulation of budesonide for asthma demonstrated potential for delivery by a variety of nebulizing inhalation devices. The findings support the feasibility of using Captisol to create solutions of inhaled corticosteroids, offering advantages such as reduced time of treatment and better accommodation. The study compared the delivery of Pulmicort Respules and a 5 percent Captisol and budesonide solution. Using four different nebulizing devices, the amount of Captisol-Enabled budesonide delivered in each case was higher than Pulmicort suspension.

• CytRx Corp., of Los Angeles, changed the name of its Worcester, Mass.-based subsidiary, Araios Inc., to CytRx Laboratories Inc. to reflect its mission of developing RNAi therapeutics in addition to small-molecule drugs for obesity and diabetes. CytRx Laboratories is located adjacent to the University of Massachusetts Medical School in the Worcester Biotechnology Park. In addition to changing its name, the company also formed a scientific advisory board. Separately, the company said its common stock would continue to trade on the Nasdaq SmallCap Market as "CYTRE," pending determination of a Nasdaq Qualifications Panel hearing scheduled for May 13. Its stock is subject to delisting as a result of the company's failure to file its annual report. CytRx said it continues to work with its independent auditors to complete the audit of its financial statements and to file as expeditiously as possible.

• EntreMed Inc., of Rockville, Md., concluded its Phase I trial with reformulated Panzem (2-Methoxyestradiol, or 2ME2) to evaluate the pharmacokinetics and safety profiles of several oral dosage forms of 2ME2. The best of those formulation approaches resulted in significantly higher peak blood levels of 2ME2 than those achieved with the original clinical formulation and demonstrated no additional toxicity. Further development efforts will focus on achieving sustained 2ME2 blood levels through dose and scheduling. The company plans to initiate additional oncology trials with a new formulation of Panzem in early 2005.

• Epigenomics AG, of Berlin, received funding from the German Ministry for Education and Research for a three-year project to design and develop new techniques for high-throughput early cancer screening based on DNA methylation. The German Ministry will contribute €1.1 million to the project, which will cost €2.7 million total. The project will begin in May.

• Geron Corp., of Menlo Park, Calif., entered a nonexclusive license agreement with XenoTrans Ltd., of Melbourne, Australia, which gained rights to use Geron's nuclear transfer technology to produce transgenic pigs. XenoTrans plans to use the pigs to generate organs suitable for transplantation into humans. Geron will receive a 25 percent equity interest in XenoTrans, as well as a share of XenoTrans' future revenues.

• Gilead Sciences Inc., of Foster City, Calif., said it is restructuring its commercial organization by separating its sales and marketing functions into a new commercial division. An executive vice president of commercial operations, who will report to Gilead's president and CEO, will lead the division. The commercial operations will be divided into North American, European and international divisions, and a new global commercial strategy group will be established. Gilead decided to restructure in anticipation of a launch in early 2005 of the fixed-dose co-formulation of Viread and Emtriva to treat HIV.

• Global Genomics AB, of Stockholm, Sweden, said that in a recent study its tangerine gene-expression profiling demonstrated superior sensitivity in detecting gene expression when compared to a leading microarray platform. Studies were performed on mouse liver tissue and validated by real-time polymerase chain reaction testing.

• Imagine Pharmaceuticals Inc., of San Diego, raised $3.7 million in a Series A round of financing. Keith Black is the scientific founder of the company, which is developing small molecules that enable the delivery of cancer therapeutics to metastatic and primary brain tumors. Investors included Forward Ventures, Domain Associates and RCT Bioventures West.

• Incyte Corp., of Wilmington, Del., filed a registration statement with the SEC relating to the resale of $250 million principal amount of its three and one-half convertible subordinated notes due 2011 and the shares of its common stock issuable upon conversion of the notes. The notes originally were issued in a private placement in February and March. Incyte will not receive any proceeds from any resale by the selling security holders of the notes or the shares issuable upon conversion of the notes.

• Inspire Pharmaceuticals Inc., of Durham, N.C., announced Phase II data of INS37217 in patients with mild cystic fibrosis (CF) lung disease, showing all three doses were well tolerated and 93 percent of patients completed the study. The study compared three doses of INS37217 respiratory to placebo in 90 patients with CF at 14 centers in the U.S. The most common adverse event was coughing. While the trial was not powered to demonstrate efficacy, patients receiving INS37217 had significantly better lung function compared to patients receiving placebo. Inspire has received orphan drug status and fast-track designations for the product in the CF indication. Inspire's stock (NASDAQ:ISPH) on Tuesday rose 18.4 percent, or $2.57, to close at $16.56.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said preclinical data reported at the American Academy of Neurology meeting in San Diego showed that an antisense drug suppressed the production of the mutant protein Cu/Zn superoxide dismutase (SOD1), a molecule associated with an aggressive form of amyotrophic lateral sclerosis. Rodents receiving the antisense inhibitor intraperitoneally showed a 90 percent reduction in SOD1 messenger RNA (mRNA) expression in the liver. Animals receiving the inhibitor intraventricularly showed a 50 percent reduction in SOD1 mRNA levels in brain and spinal cord tissues, accompanied by a significant reduction in SOD1 protein levels.

• Metaphore Pharmaceuticals Inc., of Fort Lee, N.J., said Phase II data demonstrated that the addition of M40403 to morphine improved the analgesic profile of morphine in every measure of analgesic efficacy, including faster onset, longer duration, greater peak effect and greater overall effect. The addition of M40403 did not increase morphine side effects. The Phase II trial was conducted at two U.S. centers and enrolled 350 patients with moderate to severe pain following dental surgery. Metaphore plans to develop M40403 for cancer pain and post-operative pain in patients in acute-care settings. A Phase II trial of M40403 is scheduled for the second quarter of 2004 in a bunionectomy pain model.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., said European regulatory authorities approved Velcade for treating multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression in their last therapy. The license is granted for marketing the drug in the European Union's 15 member states, plus Norway and Iceland. On May 1, Velcade will be approved in the 10 accession member countries as they join the EU. The product will be commercialized in Europe and other ex-U.S. territories by Ortho Biotech and Janssen-Cilag, divisions of Johnson & Johnson, of New Brunswick, N.J. Millennium markets Velcade in the U.S., where it received FDA approval about a year ago. (See BioWorld Today, May 15, 2003.)

• Miravant Medical Technologies Inc., of Santa Barbara, Calif., raised about $10.3 million through a private placement of about 4.6 million shares with a group of institutional investors. The company said it would use the funds for general corporate purposes. Separately, Miravant said Phase III findings reported at the Association for Research in Vision and Ophthalmology meeting in Ft. Lauderdale, Fla., showed that SnET2 provided a visual acuity benefit and slowed the progression of problematic neovascular lesions in two independent trials of patients with wet age-related macular degeneration. Last month, the company submitted a new drug application to the FDA seeking approval for the SnET2 treatment, which with PhotoPoint photodynamic therapy uses the photoreactive drug to selectively destroy the abnormal blood vessels and stabilize vision loss.

• Monsanto Co., of St. Louis, said the U.S. Environmental Protection Agency extended the registration of the company's YieldGard Rootworm corn product and its Bollgard II insect-protected cotton technology through the 2006 growing season. The extensions enable Monsanto and companies that have licensed its products to sell them through that period.

• Nanobac Life Sciences Inc., of Tampa, Fla., reported positive results from epidemiological research study demonstrating a correlation between the presence of antibodies to nanobacteria and coronary artery calcification (CAC) in asymptomatic individuals. CAC is the deposition of calcium plaque in the arteries of the heart. Study results showed that the Nanobac IgG test, which detects the presence of antibodies to nanobacteria, demonstrated a statistically significant benefit (p=0.017) with high CAC scores in asymptomatic patients. After adjustment for the established risk factors of coronary artery disease, the IgG test was found to be an independent predictor of CAC, the company said.

• NeoRx Corp., of Seattle, appointed Jerry McMahon CEO. Jack Bowman announced that he will retire as CEO and will not stand for re-election as a director of the company. McMahon most recently was president of Sugen Inc. NeoRx is a cancer therapeutics development company.

• Neose Technologies Inc., of Horsham, Pa., and MacroGenics Inc., of Rockville, Md., entered a research collaboration and license agreement on multiple monoclonal antibodies. Neose will apply its GlycoAdvance and GlycoPEGylation technologies to MacroGenics' compounds to improve the therapeutic properties of the proteins. MacroGenics will fund further development of the licensed compounds, and Neose is entitled to receive various option fees, milestone and royalty payments as products are developed and commercialized.

• Neurochem Inc., of San Francisco, said Phase II data of Cerebril to treat hemorrhagic stroke due to cerebral amyloid angiopathy (CAA) support a good safety profile and form the basis for advancing clinical development. In the study, there were no safety concerns found in patients treated with Cerebril, which was detected in the cerebrospinal fluid indicating its ability to cross the blood-brain barrier. Neurochem intends to initiate a Phase IIb trial in early 2005 to test Cerebril for the prevention of stroke recurrence in patients with CAA.

• Sanofi-Synthelabo SA, of Paris, said the European Commission authorized its merger with Aventis SA, of Strasbourg, France. Sanofi-Synthelabo said it filed a registration statement with the SEC, and would file additional documents as well. The French offer, the U.S. offer and the German offer are being made on substantially the same terms, and their completion is subject to the same conditions. It is intended that they will expire at the same time.

• Senesco Technologies Inc., of New Brunswick, N.J., said findings reported at this week's Association for Research in Vision and Ophthalmology meeting in Ft. Lauderdale, Fla., demonstrated that inhibition of its eIF5A (Factor 5A) gene might protect human optic nerve cells from apoptosis. Blindness caused by glaucoma can result from TNF-alpha-induced apoptosis. As a result, Senesco said inhibition of Factor 5A could be used as a means to protect glaucoma patients.

• Third Wave Technologies Inc., of Madison, Wis., and Innogenetics NV, of Ghent, Belgium, signed a four-year agreement for exclusive European marketing and distribution rights for select Invader molecular diagnostic products in the field of genetic testing. Innogenetics will market and distribute the Invader products for genetic testing of risk factors in the areas of cardiovascular diseases, blood coagulation and hearing disorders. Innogenetics will make minimum undisclosed payments to Third Wave during the agreement's term.

• Transkaryotic Therapies Inc., of Cambridge, Mass., named Wayne Yetter chairman to succeed Rodman Moorhead. Moorhead will remain on TKT's board and continue to chair its compensation committee. Yetter has served as a director at TKT since November 1999 and is chairman of the audit committee and a member of the nominating and corporate governance committee. Yetter is the former chairman and CEO of Synavant Inc., formerly a subsidiary of IMS Health Inc. TKT is focused on researching, developing and commercializing treatments for rare diseases caused by protein deficiencies.

• Xechem International Inc., of New Brunswick, N.J., and a sickle cell disease clinician from the State University of New York presented at the 27th annual meeting of the National Sickle Cell Disease Program in Los Angeles the latest results in the ongoing evaluation of Niprisan (new names Nicosan, Hemoxin) through in vitro and in vivo analyses. The animal studies showed the product was safe, and additional pharmacologic studies showed no significant organ damage. Phase I and Phase II studies have suggested that Niprisan is an efficacious anti-sickling drug.