• Alfacell Corp., of Bloomfield, N.J., said an article in the May 2003 issue of Laboratory Medicine evaluated the company's flagship product, Onconase. The article summarized preclinical findings relating to the structure and mechanical mechanisms of the drug, as well as its use in the growth of targeted therapies. Onconase is scheduled to be evaluated in a federal program against the human coronavirus implicated in SARS. The drug is designed to work by irreparably destroying RNA.

• Altus Biologics Inc., of Cambridge, Mass., said results from a Phase I trial of its enzyme replacement therapy, TheraCLEC, showed it to be safe and tolerable across a range of doses. TheraCLEC is being investigated for malabsorption as a result of pancreatic insufficiency. Altus said the findings also prompted it to begin a multicenter, dose-ranging trial to assess the safety and clinical activity of TheraCLEC in cystic fibrosis patients.

• Amarin Corp. plc, of London, entered a settlement of patent litigation with Ivax Corp., of Miami. The litigation concerns two U.S. patents licensed to Amarin by Eli Lilly and Co., of Indianapolis, upon Amarin's acquisition from Elan Corp., of Dublin, Ireland, the exclusive U.S. license rights to Permax (pergolide mesylate) tablets. In return for a sublicense, Amarin would receive royalty payments from Ivax's sale of any pergolide products.

• Ardais Corp., of Lexington, Mass., said Xantos Biomedicine AG, of Munich, Germany, will access the Ardais BIGR Library to obtain clinical genomics resources. Xantos will apply Ardais' tissue-based products and services to validate the clinical relevance of targets in inflammatory and degenerative diseases identified using its XantosScreen technology. Financial terms were not disclosed.

• AVI BioPharma Inc., of Portland, Ore., filed for orphan drug designation for its West Nile virus Neugene antisense drug. The first application of the company's Neugene compounds, Resten-NG, is designed to treat cancer, cardiovascular restenosis and other cell proliferation disorders.

• BD Biosciences, of San Jose, Calif., a unit of Becton, Dickinson and Co., and Open Biosystems, of Huntsville, Al., completed a commercial licensing agreement for the BD Creator gene cloning and expression system. Open Biosystems was granted a worldwide nonexclusive license to make, use and sell clone sets in the BD Creator technology format. Financial terms were not disclosed.

• British Biotech plc, of Cambridge, UK, and MerLion Pharmaceuticals Pte Ltd., of Singapore, signed a two-year research agreement to discover and develop new classes of antibacterial ribosomal inhibitors from natural sources. The collaboration will combine British Biotech's knowledge in ribosomal biology and structure-based drug design, including site specific assays, crystallography and NMR technology with MerLion's collection of natural product samples, its high-throughput screening capabilities and natural product and medicinal chemistry expertise. Financial terms were not disclosed.

• CePeP AB, of Stockholm, Sweden, entered a pilot program with DGI BioTechnologies Inc., of Edison, N.J. The parties will conduct a study to deliver Hotspot Ligands that are antagonists to DGI's drug targets across the plasma membrane in animal models using CePeP's cell-penetrating peptide technology as the delivery tool. Favorable outcome of the program might result in a formal research and development collaboration between the companies, they said.

• CV Technologies Inc., of Edmonton, Alberta, raised C$2.55 million (US$1.85 million) after closing a private placement of up to 25.5 million units priced at 10 cents apiece. Each unit consists of one common share and one common share purchase warrant, exercisable into common shares at 12 cents apiece but that expire two years from their issuance. CV received C$550,000 of the gross proceeds after closing the deal, resulting in the issuance of 5.5 million units. The common shares are subject to a restricted trading or seasoning period until Sept. 14. Insider participation totaled 500,000 units. Brubuck Inc., affiliated with company vice chairman Bruce Buchanan, purchased the 20-million-unit balance that is exercisable in tranches of up to 2.5 million every three months beginning no later than Oct. 31. As a result, Brubuck and Buchanan own about 20.6 percent of CV's outstanding common shares.

• ExonHit Therapeutics SA, of Paris, joined with European research centers to start the Alternative Splicing Database project, an initiative in the post-genomics field that highlights the importance of alternate RNA splicing. The project is funded under the Fifth Framework Program and aims to build a human database of all the alternatively spliced genes to develop new diagnostics tools for major human diseases such as cancer, neurodegeneration and infertility.

• Invitrogen Corp., of Carlsbad, Calif., said the U.S. Court of Appeals for the Federal Circuit ruled in its favor after appealing a decision handed down in its original lawsuit against Stratagene Corp., of La Jolla, Calif. On Jan. 31, 2002, a U.S. District Court ruled against Invitrogen in its suit relating to the manufacture of competent cells. The appellate decision overturns the prior ruling, establishes broad applicability for Invitrogen's competent cell patent and remands the case back to the district court for further decisions. Invitrogen's U.S. patent No. 4,981,797 specifies a process by which E.coli cells can be treated to make them more effective at absorbing foreign DNA.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., initiated a Phase I trial of ISIS 113715 for Type II diabetes. The product is a second-generation antisense drug designed to improve defective insulin signaling by targeting PTP-1B. The trial is expected to enroll 20 healthy volunteers.

• Laureate Pharma LP, of Princeton, N.J., said its recently installed, 200-liter, stirred-tank bioreactor is operational and fully validated for contract manufacturing services. The privately held company said a 2,000-liter unit would be operational later this year as well for development and production of monoclonal antibody products and other recombinant protein products expressed using mammalian cell culture.

• Lynx Therapeutics Inc., of Hayward, Calif., initiated a service agreement with the Institute for Systems Biology in Seattle to study prostate cancer gene expression using Lynx's Massively Parallel Signature Sequencing technology. Funding for the study was provided through an award to the institute from CapCURE, a nonprofit public charity with private sources of funding for prostate cancer research. Lynx will receive payments for the genomics discovery services it performs on samples provided by the institute.

• MGI Pharma Inc., of Minneapolis, named Leon Moulder CEO, succeeding Charles Blitzer, who remains as chairman. Moulder served as president and chief operating officer of MGI since May 2002. MGI is an oncology-focused biopharmaceutical company that acquires, develops and commercializes products that address the unmet needs of cancer patients.

The National Cancer Institute in Bethesda, Md., said Nature published news of its development of a mouse model of the premature aging syndrome called Hutchinson-Gilford Progeria syndrome. The results of the animal study were reported less than a month after publication of the discovery of the gene responsible for progeria in children in Science and Nature. The findings described a single inaccuracy in the Lamin A gene that appears to account for the syndrome. In the new study, researchers reported that mice with a specific mutation in the same gene have symptoms consistent with those of progeria patients. There is no treatment for progeria.

• Pfizer Inc., of New York, said it provided dozens of its experimental compounds to the U.S. government for testing against a strain of the coronavirus associated with SARS. The compounds, shared with the United States Army Medical Research Institute of Infectious Diseases and the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md., have shown moderate in vitro activity against severe acute respiratory syndrome. Pfizer said it continues to identify additional compounds from its chemical library.

• Pro-Pharmaceuticals Inc., of Newton, Mass., began dosing patients in a Phase I trial of its Davant product at the Ochsner Cancer Institute in New Orleans. The trial tests Davant in combination with 5-FU, a combination that, in preclinical trials, improved 5-FU's effectiveness and reduced its toxicity, the company said. The trial is part of a multicenter study in cancer patients with advanced solid tumors who have failed standard surgical, radiation and chemotherapeutic regimens.

• Repligen Corp., of Waltham, Mass., plans to conduct a clinical trial of RG1068, synthetic human secretin, in patients with schizophrenia, with the objective of determining if the improvements in social interaction found in a Phase II study in autism can be replicated in patients with schizophrenia. The Phase II trial will evaluate the potential of multiple doses of RG1068 to treat symptoms of schizophrenia, including social interaction and communication deficits. Separately, Repligen said it initiated a collaboration with Boston University Medical Center to evaluate three approaches to quantifying changes in the symptoms of autism. Also, Cure Autism Now (CAN) announced it awarded three grants to fund the development of new tools to quantify changes in the symptoms of autism in clinical trials. The grants are funded by CAN and Repligen.

• Rosetta Biosoftware, a business unit of Rosetta Inpharmatics Inc., a wholly owned subsidiary of Merck & Co. Inc., of Whitehouse Station, N.J., and Agilent Technologies Inc., of Palo Alto, Calif., introduced the Rosetta Luminator system version 2.0, a client-server bioinformatics system for storing and analyzing microarray data.

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., said its Phase III study of Rifaximin completed enrollment with about 400 adults in Mexico, Guatemala, India and Peru. The study is designed to evaluate the compound's efficacy in treating traveler's diarrhea caused by enteric pathogens. Salix said it expects to file an amendment to its new drug application in or prior to November.

• Silicon Genetics Inc., of Redwood City, Calif., released the BioScript Library for use with its GeneSpring and GeNet software solutions. The BioScript Library is based on the visual scripting capabilities of GeneSpring, an expression analysis software package.

• Spherics Inc., of Lincoln, R.I., appointed Ze'ev Shaked CEO and a board member. He will head Spherics' management team. Shaked joins the company from Ilex Oncology Inc., where he served as chief operating officer and, previously, as president of Ilex Products. Spherics focuses on drug delivery systems.

• TM Bioscience Corp., of Toronto, added two genetic tests to its development pipeline: the Tag-It Mutation Detection Kit for P450-2C9 and the Tag-It Mutation Detection Kit for P450-2C19, which will be available at the end of 2003 and the first half of 2004, respectively. The products are designed to identify the presence or absence of mutations common in patients with atypical drug metabolism.

• Zelos Therapeutics Inc., of Waltham, Mass., appointed Robert DuFresne CEO. DuFresne was previously president and CEO of ConjuChem Inc. Zelos is developing parathyroid hormone analogues for the treatment of osteoporosis and other indications.

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