• Advanced Magnetics Inc., of Cambridge, Mass., and Cytogen Corp., of Princeton, N.J., reported study results of clinical data showing that magnetic resonance imaging with Combidex, an ultra-small superparamagnetic iron oxide contrast agent, is effective for the preoperative assessment and staging of axillary lymph nodes in patients with breast cancer. The results were reported in the November 2002 issue of Radiology. The study involved 18 patients with breast cancer, all of whom were scheduled for surgery. When imaging evaluation results were compared to histopathologic analysis, results of axillary lymph node staging with Combidex resulted in a sensitivity of 82 percent, specificity of 100 percent and a positive predictive value of 100 percent.

• Alfacell Corp., of Bloomfield, N.J., reported publication of an article in the Nov. 15, 2002, issue of International Journal of Oncology. The study, designed to compare the relative sensitivity of normal lymphocytes to several leukemia cell lines after treatment with ranpirnase, the active component in Onconase, found that Onconase is able to enhance activation-induced apoptosis of normal human lymphocytes.

• Amersham Biosciences, the life sciences business of Amersham plc, of London, released its Tricorn High Performance Columns designed for high-resolution purification of proteins, peptides and other biomolecules. The new line replaces Amersham's HR columns prepacked with media such as Superdex and MonoBeads, also used in laboratory-scale protein separations.

• AuRx Inc., of Glen Burnie, Md., said the one-year follow-up data for the Phase I/II trial of the AuRx therapeutic vaccine for treatment of genital herpes was discussed at the Eugene Bereston Lecture in Baltimore. Data showed, among other things, the vaccine prevented all signs and symptoms of recurrent genital herpes in 43.5 percent of the patients for 12 to 15 months. The number of herpetic episodes in the treated group was reduced 71 percent from the previous year (p<0.001).

• Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., said a clinical study found that individuals switching from a protease inhibitor-based regimen to a PI-sparing, NNRTI-based regimen using Viramune (nevirapine) sustained viral suppression and had improved triglyceride levels. Researchers also observed that individuals who switched from PI-based to Viramune-based treatment experienced fewer interruptions in therapy. Results of the study were presented at the 6th International Congress on Drug Therapy in HIV Infection in Glasgow, Scotland. Viramune is a non-nucleoside reverse transcriptase inhibitor designed for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.

• DeCode genetics Inc., of Reykjavik, Iceland, entered a pharmacogenomics agreement with Wyeth, of Madison, N.J. As part of an observational study to treat respiratory disease, DeCode will use its in vitro pharmacogenomics knowledge to generate gene expression data related to one of Wyeth's candidate drugs. Financial terms were not disclosed.

• EntreMed Inc., of Rockville, Md., received notice that Celgene Corp., of Warren, N.J., filed a lawsuit against the U.S. Patent and Trademark Office to block the issuance of EntreMed patent applications protecting its latest drug candidate, ENMD 0995. EntreMed said Celgene is requesting that the U.S. District Court issue preliminary and permanent injunctions to withdraw specific 3-amino thalidomide EntreMed patent applications from issuance. The thalidomide analogue entered Phase I trials last week and was designated by the FDA an orphan drug to treat patients with multiple myeloma.

• Genaera Corp., of Plymouth Meeting, Pa., said E.I. du Pont de Nemours and Co., of Wilmington, Del., entered an option agreement for certain antimicrobial peptide intellectual property held by Genaera. The option is in place for up to three years from October and provides reimbursement to Genaera for patent-related expenses. Specific financial terms were not disclosed.

Genomatica Inc., of San Diego, reported publication in the Nov. 14, 2002, issue of Nature an article detailing its ability to predict the adaptive evolution of a microbial organism. Genomatica said it describes for the first time a computer model of cell functioning that has been experimentally validated for its capability to predict the outcome of evolutionary processes.

• GenoMed Inc., of St. Louis, established a clinic to deliver preventive molecular medicine in St. Louis. GenoMed's chairman and chief medical officer initially will oversee the staffing of the clinic, which will dispense GenoMed's treatments, such as an intervention for kidney failure, and diagnostic tests.

• Gen-Probe Inc., of San Diego, said the Center for Biologics Evaluation and Research at the FDA granted two new intended uses for Gen-Probe's licensed nucleic acid test for the detection of human immunodeficiency virus type 1 and hepatitis C virus in donated blood. The HIV-1/HCV assay, which is marketed by Chiron Corp., of Emeryville, Calif., under the Procleix name, was approved for screening voluntary donations of source plasma and for use as a discriminatory HIV test for clinical diagnosis. The HIV-1/HCV assay was first approved for commercial sale for screening donated blood in February 2002. Separately, Gen-Probe initiated an arbitration proceeding with respect to its collaboration with Bayer Corp., of Tarrytown, N.Y. Under the terms of the agreement, Bayer acquired the exclusive rights to distribute nucleic acid diagnostic tests designed and developed by Gen-Probe for the detection of HIV, hepatitis and other specified viruses, subject to certain conditions, Gen-Probe said. Gen-Probe said that Bayer failed to fulfill the conditions required to maintain exclusive distribution rights. The demand seeks confirmation that the agreement grants Gen-Probe a co-exclusive right to distribute the viral diagnostic tests that are the subject of the agreement.

• GenVec Inc., of Gaithersburg, Md., presented data at the 75th Scientific Sessions of the American Heart Association in Chicago. The Phase II trial involved 20 sites and 71 patients. Data from the trial showed, among other things, an improvement in total time to chest pain on the treadmill and total exercise time on a treadmill at both three and six months, improvements in patient quality of life and improvements in patient function. The primary analysis showed a trend toward improvement in the Biobypass group in ST segment depression of 24 seconds at three months, which was the primary endpoint. That improved to 1.1 minutes at six months, which was a statistically significant difference from placebo (p=0.024).

• Guilford Pharmaceuticals Inc., of Baltimore, elected to withdraw its regulatory application in Europe, filed in January, seeking an expanded indication for its Gliadel Wafer cancer therapy for use during initial surgery for malignant glioma. Instead, Guilford said it plans to focus on obtaining an expanded label for Gliadel in the U.S. It received a non-approvable letter in the spring from the FDA. Guilford said it also plans to resubmit all data, including the long-term follow up data, to European regulatory authorities at a later date. (See BioWorld Today, March 21, 2002.)

•Hemispherx Biopharma Inc., of Philadelphia, Pa., said its board adopted a stockholders rights plan. Under the plan, rights will be distributed as a dividend at the rate of one right for each outstanding share of the company's common stock held by stockholders of record as of the close of business on Nov. 29, 2002. The plan is meant to protect shareholders in the event of a person or group acquiring or commencing a tender or exchange offer to acquire 15 percent or more of the common stock.

• Hemosol Inc., of Toronto, said it received FDA clearance to begin a Phase II trial to assess Hemolink (hemoglobin raffimer) in patients having orthopedic surgery. Hemosol said it expects the trial, along with a trial under way in primary coronary artery bypass grafting surgery, will form the basis for the initiation of a Phase III program. It said the completion of a separate coronary artery bypass trial will not be necessary in order to proceed to Phase III. Hemosol's stock (NASDAQ:HMSL) jumped 50 cents Wednesday, or 42.4 percent, to close at $1.68.

• Henogen SA, of Charleroi, Belgium, reported progress in its agreement with the Institut Pasteur in Paris to develop a vaccine for the diarrheic disease shigellosis. Phase I data have shown the vaccine to be well tolerated and immunogenic in both children and adults.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, reported at the Joint International Tropical Medicine Meeting held in Bangkok, Thailand, study results demonstrating that two of its immune-regulating hormones, HE2100 and HE2200, provided significant protection to animals exposed to chemotherapy. In the placebo-treated group, animals were neutropenic for a total of 41 percent of the observations. In contrast, both HE2200 and HE2100 showed statistically significant improvement in the number of observations of neutropenia, with HE2200-treated animals showing neutropenia for only 15 percent of the observations and HE2100 showing no neutropenia for all animals during the 20-day observation period.

• Immune Network Ltd., of Vancouver, British Columbia, entered a joint venture with SoLogic Pty Ltd., of Australia, subject to a 30-day due diligence period. The joint venture will review all Immune Network intellectual property and developments and is expected to focus initially on the early commercialization prospects of Immune Network's patent-pending drug combination that target treatment of certain inflammatory disorders.

• Immune Response Corp., of Carlsbad, Calif., released its third-quarter earnings and said it might be forced to file for bankruptcy in the near future. In its earnings, the company said: "As of the date of filing of this quarterly report, we have limited cash resources available to fund our planned operations. If we are unable to obtain funding in the next few days, the company will need to consider ceasing its ongoing business operations and the filing by the company of a petition for liquidation or reorganization under the bankruptcy code." Immune Response also said: "Cheshire Associates has indicated that it will consider providing limited debt financing to the company for the 30 to 60 days following the date of [filing its third-quarter report]. However, if and to the extent the company is unable to achieve during that period of time the costs reductions contemplated by the restructuring program commenced by the company in September 2002, Cheshire Associates has indicated that it will likely cease providing funds to the company immediately thereafter." In September, Immune Response said it was reducing its staff in an effort to cut costs by $1.8 million per quarter and also narrow its focus to its most advanced product, the HIV therapeutic vaccine, Remune. Immune Response's stock (NASDAQ:IMNR) fell 47 cents, or 42 percent, to close at 65 cents Wednesday. (See BioWorld Today, Sept. 10, 2002.)

• ISTA Pharmaceuticals Inc., of Irvine, Calif., completed a private placement of $40 million of its common stock and warrants exercisable for an additional $6 million of common stock to investors including The Sprout Group, of Menlo Park, Calif.; Sanderling Venture Partners, of San Mateo, Calif.; Investor Growth Capital Ltd., of Palo Alto, Calif.; Gund Investment Corp., of Princeton, N.J.; KBL Healthcare, of New York; MDS Capital, of Toronto; and the Ontario Teachers' Pension Plan Board. In addition, $4 million of promissory notes previously issued to several of the same investors in ISTA's September bridge financing were converted into shares of common stock concurrently with the consummation of the private placement. (See BioWorld Today, Sept. 20, 2002.)

• Provectus Pharmaceuticals Inc., of Knoxville, Tenn., acquired Valley Pharmaceuticals Inc. Valley Pharmaceuticals was transferred to the founders of Provectus through a split with Photogen Technologies Inc. The acquisition was accomplished via a merger with a Provectus subsidiary. That merged entity, called Xantech Pharmaceuticals, is now a wholly owned subsidiary of Provectus. Financial terms were not disclosed.

• Sepracor Inc., of Marlborough, Mass., said a class action lawsuit has been brought against it and certain of its current and former officers in the U.S. District Court for the District of Massachusetts. The plaintiff claims to represent all purchasers of Sepracor convertible debt securities from Dec. 4, 2000, through March 6, 2002, and seeks unspecified damages on their behalf. The plaintiff alleges that the defendants misled the purchasers of Sepracor's convertible debt securities concerning prospects for Sepracor's drug candidate, Soltara, though the company intends to defend the matter.

• United Therapeutics Corp., of Silver Spring, Md., reported data at the 75th Scientific Sessions of the American Heart Association in Chicago. The data indicate that patients suffering from forms of pulmonary arterial hypertension might increase their chance of survival if treated with United Therapeutics' Remodulin. According to the Bethesda, Md.-based National Institutes of Health patient registry, patients with the primary pulmonary hypertension form of the disease are expected to have a 46 percent chance of surviving three years if untreated. However, the data presented show that similar patients if treated with Remodulin would increase their survival rate to 69.8 percent at three years, the company said.

• Vernalis Group plc, of London, launched its antimigraine treatment, frovatriptan, in Germany by Berlin-Chemie, an affiliate of the Menarini Group, of Florence, Italy. The product will be marketed under the trademark Allegro. Frovatriptan, already marketed in the U.S., is approved in 15 European countries.

• Vivus Inc., of Mountain View, Calif., initiated a trial to evaluate VI-0162, its product for premature ejaculation. The product is given orally and the trial is expected to be completed during the second quarter of 2003. Vivus focuses on therapies for quality-of-life disorders for men and women.