• Adventrx Pharmaceuticals Inc., of San Diego, initiated manufacturing of peptides that comprise its therapeutic vaccine for HIV, known as EradicAide, in order to prepare pharmaceutical-grade product to dose HIV-infected patients in a Phase Ib/IIa trial. The company plans to file an investigational new drug application later this year. Peptisyntha Inc., of Torrance, Calif., a wholly owned subsidiary of Solvay America Inc., will manufacture the peptides for EradicAide in its research and development and GMP-compliant manufacturing facilities.

• AlphaRx Inc., of Richmond Hill, Ontario, reported the completion of the first, commercial-size batch of Flexogan, an arthritis and muscle pain reliever. It is AlphaRx's first topical product to incorporate its BCD (Bioadhesive Colloidal Dispersion) drug delivery system, and it can now be delivered across Canada.

• American Bioscience Inc., of Los Angeles, said a federal court of appeals ruled in its favor regarding a patent challenge on a chemical analogue to the cancer drug Taxol. A lower court ruling found in favor of Florida State University in Tallahassee, which said two of its professors should have been named as inventors in the patent and that three American Bioscience researchers should not have been. But American Bioscience demonstrated that the compound is one of a number of new anticancer drugs in its development pipeline and that FSU researchers did not contribute to the invention.

• Auxilium Pharmaceuticals Inc., of Norristown, Pa., said the UK Medicines and Healthcare products Regulatory Agency approved Testim, a patented testosterone gel, for marketing in the UK. Testim, which was launched in the U.S. in February, is indicated for testosterone replacement therapy to restore serum testosterone levels in men. The launch of Testim is planned for later in 2003.

• Calba Tech Inc., of Irvine, Calif., said it is engaged in substantive discussions with a company producing gene expression solutions using gene silencing and RNAi technology and is moving forward with potential acquisition. The companies executed a nondisclosure agreement that covers nearly all possible terms and conditions. Calba Tech is focused on acquiring, incubating and developing early stage, life science-based companies that are developing next-generation products and technologies.

• Ciphergen Biosystems Inc., of Fremont, Calif., opened its newest Process Proteomics Center near Boston. The center is designed to provide solutions to difficult protein-production issues. The center's services will include approaches to research and large-scale protein expression optimization, chromatography purification development, analytical method development and biomanufacturing process development.

• Dendreon Corp., of Seattle, said the SEC declared effective its registration statement related to its previously reported merger with Corvas International Inc., of San Diego. Each company's shareholders will vote on the proposed all-stock merger, originally valued at about $73 million, at their respective annual meetings, scheduled for the end of next month. (See BioWorld Today, Feb. 26, 2003.)

• Elitra Pharmaceuticals Inc., of San Diego, said Paul Hamelin was promoted to CEO and has been elected to the board. Hamelin joined Elitra in May 2002 as president and chief operating officer, after spending 22 years as a pharmaceutical executive with such companies as Pharmacia Corp., Abbott Laboratories and Eli Lilly and Co. Harry Hixson, the former CEO, will remain as chairman. Elitra focuses on antimicrobial drug discovery and their identification, development and commercialization.

• Entropin Inc., of Indio, Calif., was notified by the Nasdaq Listing Qualifications Panel that effective Thursday, its common stock and warrants were delisted from the Nasdaq SmallCap Market for failure to comply with the $1 minimum bid price requirement. The company expects its common stock and warrants will trade on the OTC Bulletin Board under the same symbols "ETOP" and "ETOPW."

• Esperion Therapeutics Inc., of Ann Arbor, Mich., reported initial results from a multiple-dose, multicenter Phase II study of ETC-216 (AIM or ApoA-l Milano/phospholipid complex) in patients with acute coronary syndromes. The study met its primary efficacy objective of demonstrating statistically significant regression of atherosclerosis. The trial was a randomized, double-blind study evaluating the efficacy of ETC-216 at two different levels of intravenous infusions compared to placebo and involved 47 patients. The primary endpoint was the change in percent atheroma volume for the evaluable patients in the combined treatment arms comparing end-of-treatment values to baseline values as measured using intravascular ultrasound. Esperion's stock (NASDAQ:ESPR) rose $2.81 Thursday, or 19 percent, to close at $17.61.

• eXegenics Inc., of Dallas, continues to be the subject of a takeover bid by Foundation Growth Investments LLC and EI Acquisition Inc., which lowered their cash offer price from 40 cents per share to 37 cents apiece for all of eXegenics' outstanding common shares and Series A convertible preferred stock. They also extended the expiration date of their offer to Aug. 1. A day earlier, eXegenics' board said the offer "represents a grossly inadequate and unfair price," and outlined its intention to file materials with the SEC in opposition to the consent solicitation.

• F. Hoffmann-La Roche Ltd., of Basel, Switzerland, said Roche Diagnostics launched the AmpliChip CYP450 microarray in the U.S., and it is the company's first microarray for clinical applications. The product is designed to enable clinical, diagnostic laboratories to identify certain naturally occurring variations in two genes, CYP2D6 and CYP2C19, which it said play a major role in metabolism.

• Genmab A/S, of Copenhagen, Denmark, said results of a primate study showed that HuMax-CD20 was effective in depleting B cells, the target for treating non-Hodgkin's lymphoma, in both blood and lymph nodes. Also, in a study that lasted up to 92 days, the compound depleted such B cells four times longer than the effect from rituximab, a marketed anticancer treatment against the same target. Genmab, which reported no adverse effects during the study, said HuMax-CD20 is undergoing manufacturing development in preparation for clinical trials.

• Genta Inc., of Berkeley Heights, N.J., began four U.S.- and Canada-based clinical trials with its lead anticancer drug, Genasense (oblimersen sodium), under sponsorship from the National Cancer Institute in Bethesda, Md. The studies include a Phase II trial of Genasense plus interferon-alpha in patients with advanced kidney cancer; a Phase I/II trial evaluating Genasense alone for advanced Waldenstrom's macroglobulinemia, a disease of malignant plasma cells related to multiple myeloma; a Phase I trial in combination with gemcitabine (Gemzar, from Eli Lilly & Co.) in patients with advanced solid tumors, focusing on patients with pancreatic cancer; and a Phase I trial in combination with CHOP-R (a standard chemotherapy program comprised of cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab [Rituxan, from Genentech Inc. and Idec Pharmaceuticals Inc.]) in previously untreated patients with advanced non-Hodgkin's lymphoma.

• ImClone Systems Inc., of New York, received a $3 million payment related to a clinical development milestone under a license agreement for Erbitux from Merck KgaA, of Darmstadt, Germany. ImClone issued 150,007 common shares to Merck at a 10 percent premium to market value as provided in the license agreement. The milestone stemmed from Merck's ability to move forward with Erbitux's development in non-small-cell lung cancer. The agreement dates back four and a half years, when Merck licensed rights to develop Erbitux outside of the U.S. and Canada, and gained a coexclusive right to develop the compound in Japan. (See BioWorld Today, Dec. 16, 1998.)

• Introgen Therapeutics Inc., of Austin, Texas, said treatment began in patients using INGN 225, its anticancer vaccine that uses its Advexin drug in a new way to create a highly specific therapeutic vaccine. Previously published preclinical data demonstrated that 60 percent of animals treated with INGN 225 were protected against tumor development, Introgen said, adding that when dendritic cells were activated, 100 percent protection against tumors was achieved.

• Maxim Pharmaceuticals Inc., of San Diego, said an arbitration panel ruled that it is not liable for claims asserted by certain former shareholders of Cytovia Inc., also of San Diego. The panel also determined that Maxim should be awarded reasonable attorney fees, costs and expenses in an amount yet to be determined. In October 2001 and May 2002, certain former Cytovia shareholders filed complaints in California Superior Court against Maxim related to the firms' merger three years ago. (See BioWorld Today, July 13, 2000.)

• Medicure Inc., of Winnipeg, Manitoba, raised C$7.65 million (US$5.65 million) after closing a previously reported private equity financing with a syndicate led by Research Capital Corp., of Toronto, and including First Associates Investments Inc., of Toronto, and Paradigm Capital Inc. Medicure, which sold about 9 million shares at C85 cents per share, including an overallotment option, said the latest funding combined with prior cash resources would allow it to accelerate clinical development of its lead compound, MC-1, and its latest drug candidate, MC-4232.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., said Phase II results published in this week's New England Journal of Medicine indicated that 35 percent of Velcade-treated patients experienced a complete, partial or minimal response relative to their relapsed and refractory multiple myeloma disease severity, with 10 percent experiencing complete responses. The multicenter study included 202 patients who had averaged six prior therapeutic regimens, with 91 percent of the 193 evaluable patients who had myeloma refractory to the most recent therapy received. Overall median survival and duration of response also were reported for the heavily pretreated study population. Last month, the FDA approved Velcade (bortezomib) for multiple myeloma. (See BioWorld Today, May 15, 2003.)

The Mississauga Biotechnology Consortium is being awarded up to C$200,000 (US$ 148,000) in funding from the Ontario government as part of a local-based business plan, with an estimated matching contribution from the consortium expected to total about C$200,000. The first phase of the Biotechnology Cluster Innovation Program, part of the Ontario government's C$51 million biotechnology strategy, will award up to C$2.2 million for business plans outlining biotechnology infrastructure projects, with total estimated matching contribution from recipients and business partners expected to be C$3 million. The second C$27.8 million phase will support the implementation of those projects, which include commercialization centers, research parks and other regional initiatives.

• Mount Sinai Hospitals's Samuel Lunenfeld Research Institute in Toronto said its Blueprint Initiative research program released the first complete public database curation standards document in the field of proteomics. The document details the standards and process by which curators are building the Biomolecular Interaction Network Database (BIND). The BIND database and its associated software tools are freely available to both academics and companies worldwide.

• Myogen Inc., of Denver, along with researchers at the University of Texas Southeastern Medical Center at Dallas, reported the first possible cardiac application of histone deacetylase (HDAC) inhibitors. Inhibition of HDAC was shown in vitro to block cardiac hypertrophy, a condition prominent in chronic heart failure patients. In a paper published in the Journal of Biological Chemistry, Myogen and UT Southwestern reported that inhibition of HDACs with small-molecule inhibitors blocks the development of pathological cardiomycyte hypertrophy in cultured cells.

• North American Scientific Inc., of Chatsworth, Calif., said data reported at this week's Society of Nuclear Medicine meeting in New Orleans showed that its radiolabeled annexin localizes preferentially on apoptotic cells in unstable plaque. Investigators said they were able to use radiolabeled annexin binding to apoptotic cells to show that therapeutic interventions, such as diet or drugs, reduce the number of dying macrophages in such atheromas and could be useful in treating unstable plaque.

• Northwest Biotherapeutics Inc., of Bothell, Wash., completed its in vitro preclinical assessment of a battery of monoclonal antibodies directed against the cancer-associated target CXCR-4. Two of the studied antibodies inhibited tumor cell division and exhibited other anticancer properties. The company said its scientists were the first to discover that CXCR-4 is overexpressed in cancer.

• Novavax Inc., of Columbia, Md., said the FDA informed the company that it may need additional time beyond July 12 for a full review of the company's Estradiol Partner Transfer Study Report submitted in May. Under the Prescription Drug User Fee Act, the statutory minimum extension time is 90 days, which results in a new goal date for a decision on the approvability of Estrasorb of Oct. 10. Estrasorb is a transdermal emulsion for estrogen replacement therapy.

• OraSure Technologies Inc., of Bethlehem, Pa., said it would sell 250,000 OraQuick Rapid HIV-1 Antibody Tests, along with training materials and services, to the Centers for Disease Control and Prevention in Atlanta. The CDC purchase, which totals $2 million for 50 locations across the U.S., is expected to be fulfilled by Dec. 31.

• Proneuron Biotechnologies Inc., of Los Angeles, and Craig Hospital in Denver reported the establishment of Proneuron's cell processing center in Denver. Following the successful completion of its Phase I studies, that center will enable Proneuron, pending FDA approval, to start Phase II trials and provide its autologous macrophage treatment to spinal cord patients in the U.S. within 14 days of their injuries. It is anticipated that following the necessary approvals, enrollment in the study will begin at Craig in the fall.

• Proterion Corp., of Piscataway, N.J., received a $1 million credit facility from KBK Financial Inc., of Houston, in exchange for first-priority security interest on certain of its assets. Funding against the credit will be used to support working capital needs at Proterion, which is developing instrumentation for particle sizing and biomolecular characterization of protein molecules.

• Ribapharm Inc., of Costa Mesa, Calif., said it was disappointed to learn that ICN Pharmaceuticals Inc., also of Costa Mesa, filed suit Wednesday against Ribapharm and all but one of its directors in the Court of Chancery for the state of Delaware. The litigation challenges the adoption by Ribapharm of the stockholders rights plan that Ribapharm reported Monday, and it alleges both breach of contract on the part of Ribapharm and breach of fiduciary duty on the part of the directors named.

• Schering AG, of Berlin, acquired exclusive worldwide development and marketing rights for an antibody-based therapeutic fusion protein from Philogen S.r.l., of Siena, Italy. Schering said the compound, which consists of a fusion protein with antitumor activity that binds to an angiogenesis-associated antigen expressed by several solid tumors, could have the potential to treat tumors by triggering immunological mechanisms. Financial terms were not disclosed.

• Scios Inc., of Sunnyvale, Calif., said about 300 leading heart failure investigators and research coordinators attended the 2003 National ADHERE Registry Mid-Year Investigator meeting in New York this week. ADHERE (Acute Decompensated Heart Failure National Registry) is a first-of-its-kind national registry that prospectively collects observational data designed to track and study the medical management of patients hospitalized with acute heart failure.

• The Immune Response Corp., of Carlsbad, Calif., raised $1 million after completing a private placement of short-term promissory notes with accredited investors. The 12 percent notes are due Sept. 30, or when the company completes a subsequent private placement with net proceeds of more than $1.3 million. The company also issued 166,666 common shares to the investors and agreed to register them for resale. Immune Response, which plans to use net proceeds from the offering for general corporate purposes, also reported plans to launch a Phase II trial of Remune in Italy. The trial is designed to measure the immunological effects of the compound in HIV-infected patients who have never received antiretroviral drug therapy.

• Tm Bioscience Corp., of Toronto, said it acquired a nonexclusive license from The Hospital for Sick Children in Toronto and the University of Michigan in Ann Arbor for the use of their cystic fibrosis gene mutation patents in the company's Tag-It Mutation Detection Kit for Cystic Fibrosis. Tm Bioscience is a DNA-based diagnostics company developing a suite of genetic tests.

• Tripos Inc., of St. Louis, entered a collaboration with ChanTest Inc., of Cleveland, to develop a model that predicts which drug compounds are likely to produce cardiac liability due to blockage of the hERG ion channel. Tripos will select and provide compounds for testing by ChanTest, from which Tripos will develop the predictive model and employ it to examine clients' data resulting from ChanTest's analysis of lead candidates. Financial terms were not disclosed.

• Virtual Drug Development Inc., of Brentwood, Tenn., entered an agreement with the University of Ulster's Coleraine campus and Queens University in Belfast, Ireland, to develop peptides produced by amphibians to fight multiple drug-resistant bacteria, cardiovascular diseases and cancer. The partnership resulted in the formation of AmphiBiotics Ltd., which will be a subsidiary of VDDI Pharmaceuticals. Researchers said that because their peptide drugs kill bacteria by attacking their membranes in a nonspecific fashion, and because the membranes have evolved over hundreds of millions of years, it would be unlikely that the microorganisms could mutate quickly enough to develop resistance.