• Alfacell Corp., of Bloomfield, N.J., said the Therapeutic Goods Administration in Australia granted Onconase (ranpirnase) orphan drug status for the treatment of malignant mesothelioma. The orphan drug program allows a reduction in costs through waiving fees, as well as a priority evaluation period. Onconase, which previously received orphan status in Europe, is in a Phase IIIb trial for malignant mesothelioma.

• BioDelivery Sciences International Inc., of Morrisville, N.C., moved its headquarters to the Research Triangle Park area of North Carolina. The Morrisville headquarters already is the location of BDSI's subsidiary, Arius Pharmaceuticals, while the company maintains a research facility in Newark, N.J., and administrative offices in Tampa, Fla. BDSI uses drug delivery technologies to develop and commercialize new formulations of proven therapeutics.

• Cellegy Pharmaceuticals Inc., of South Francisco, said interim results of a two-center study of Rectogesic nitroglycerin ointment 2 percent for the treatment of symptomatic chronic hemorrhoids indicated that mean anal sphincter pressure was decreased 30 minutes after the first dose of the topical product. Patients reported significant improvement in pain, bleeding, irritation and difficulty with bowel movement, and symptomatic improvement increased over time, even after the cessation of Rectogesic. The product also was reported to be well tolerated. Results were presented at the 10th Congress of Asian Federation of Coloproctology in Singapore.

• Dyax Corp., of Cambridge, Mass., reported on the status of its clinical development program for DX-88 in hereditary angioedemia, which is in a joint venture with Genzyme Corp., also of Cambridge. Dyax is advancing it into a clinical trial to evaluate the safety and pharmacokinetics of a subcutaneous route of administration. To date, Dyax has completed two Phase II trials successfully. The new trial is expected to be completed during the first half of the year.

• Immunomedics Inc., of Morris Plains, N.J., said a patient with severe resistant systemic lupus erythematosus (SLE), who developed human antichimeric antibodies against rituximab, responded to the company's new humanized anti-CD20 monoclonal antibody. Immunomedics said the case report demonstrates that B-cell depletion is effective in the management of patients with severe resistant SLE, including those with a host antibody against rituximab. Immunomedics expects to launch two pivotal Phase III trials in the first half of this year in patients with moderate to severe lupus with the lead B-cell targeted antibody, epratuzumab.

• MediciNova Inc., of San Diego, announced the enrollment of patients in a Phase II study of MN-001 in asthma. An orally administered leukotriene receptor antagonist, MN-001 also is an inhibitor of phospodiesterases III and IV, 5-lipoxygenase and thromboxane A2. MediciNova licensed the product from Kyorin Pharmaceutical Co. Ltd., of Tokyo.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., received FDA approval to expand the use of Velcade for patients with multiple myeloma who have received at least one prior therapy. The approval was based on data from a Phase III APEX study that compared single-agent Velcade to high-dose dexamethasone and demonstrated a significant survival advantage with Velcade. A survival advantage also was seen in second-line MM patients. The proteasome inhibitor Velcade (bortezomib) received accelerated approval for relapsed and refractory MM nearly two years ago. The company said Monday's approval doubles the number of U.S. patients who could potentially benefit from Velcade to about 22,000. Velcade is being co-developed with Johnson & Johnson Pharmaceutical Research and Development LLC, a unit of New Brunswick, N.J.-based Johnson & Johnson, with Millennium responsible for U.S. commercialization and J&J units Ortho Biotech and Janssen-Cilag commercializing Velcade outside the U.S. (See BioWorld Today, May 15, 2003.)

• Power3 Medical Products Inc., of The Woodlands, Texas, entered a research agreement with New Horizons Diagnostics Corp., of Columbia, Md., for the development of antibody-based diagnostic tests for neurodegenerative disease using the company's identified protein biomarkers.

• RegeneRx Biopharmaceuticals Inc., of New York, said its stock would begin trading Monday on the American Stock Exchange under the ticker symbol "RGN." It was on the Over-the-Counter Bulletin Board. The company's primary focus is the commercialization of its Thymosin beta 4, a 43-amino-acid peptide and principal component of the company's technology platform.

• Serologicals Corp., of Atlanta, said its wholly owned subsidiary Upstate Group Inc., of Lake Placid, N.Y., obtained the rights from the University of California to sell the anti-ZAP-70 monoclonal antibody for diagnostic use. Studies show that the levels of expression of the ZAP-70 protein strongly predict the aggressiveness of chronic lymphocytic leukemia, the company said. One such study was published in the May 2003 issue of the New England Journal of Medicine and cites the use of Upstate's anti-ZAP-70, clone 2F3.2, monoclonal antibody.

• St. Jude Children's Research Hospital in Memphis, Tenn., said that natural killer immune system cells can be genetically modified to brandish an "on switch" that prompts them to aggressively attack and kill leukemic cells. That finding, from researchers at St. Jude, suggests a way to improve the outcome of children who receive treatment for acute lymphoblastic leukemia or other blood cancers. Results of the study are published in the current online issue of Blood.

• Tanox Inc., of Houston, executed an agreement with Sunol Molecular Corp., of Miramar, Fla. to acquire Sunol's tissue factor antagonist program for the treatment of inflammatory disease and cancer. Tanox will receive all tissue factor antagonist assets from Sunol, including anti-tissue factor monoclonal antibodies and related technologies and intellectual property, as well as nonexclusive rights to certain technologies and related intellectual property for protein and antibody expression.

• Tessera Inc., of Seattle, released its first product, ProstaMark EPCA (Early Prostate Cancer Antigen), as an analyte-specific reagent for commercial use in pathology laboratories to assist pathologists in determining if cancer is present in the prostate. Tessera's EPCA test is available at Unipath LLC, of Denver, and soon will be offered by laboratories and cancer centers.

• Vion Pharmaceuticals Inc., of New Haven, Conn., said it commenced dosing in the Phase III pivotal trial of its cancer agent cloretazine in relapsed acute myelogenous leukemia. The primary endpoint of the trial is the objective response rate. Secondary endpoints include time to progression, duration of response, overall survival and toxicity. An interim analysis is planned.