• Advanced Bio/Chem Inc., of The Woodlands, Texas, entered an agreement to search for neurodegenerative disease biomarkers in collaboration with the Baylor College of Medicine in Houston. Advanced Bio/Chem, which does business as ProteEx, did not release further terms of the agreement.

• AGY Therapeutics Inc., of South San Francisco, said findings identifying a protein with the potential to limit neurological damage induced by stroke or trauma, and therefore potentially useful in acute brain injury, were published online and will be published in the August issue of Nature Medicine. The article describes experiments by AGY in collaboration with scientists at the Wallenberg Neuroscience center in Sweden, the University of California at Davis, and the State University of Campinas in Brazil.

• Aphton Corp., of Miami, said in a letter to shareholders it believes results from its Phase III trial conducted outside the U.S. with G17DT as a monotherapy for advanced pancreatic cancer patients are sufficient for filing for marketing approval in the European Union, Canada and Australia. Subsequent to those filings it had planned to file for approval to market in the U.S. However, its focus has shifted from preparing to file first in foreign countries and later in the U.S. to preparing to file first in the U.S. and soon thereafter in foreign countries. It is working on the documentation to request a meeting with the FDA to discuss filing and hopes to meet with the agency in the fourth quarter.

• Austrianova, of Vienna, Austria, said its cell therapy product for pancreatic cancer was designated an orphan medicinal product. The company is planning clinical trials in multiple sites to compare the therapy to commonly used chemotherapies. The product is cells encapsulated in small beads. The cells have been genetically modified to carry a gene that allows them to activate a chemotherapeutic agent.

• Avant Immunotherapeutics Inc., of Needham, Mass., said Phase I data published in Atherosclerosis support the feasibility, immunogenicity and safety of its cholesterol ester transfer protein (CETP) vaccine, CETi-1, in raising HDL cholesterol. The dose-ranging, placebo-controlled trial found that eight of 15 patients receiving a second vaccine injection developed a dose-related immune response, and all four patients treated with the highest dose showed a long-lasting antibody response. Avant said it has nearly completed a Phase II trial of the vaccine, which is designed to elicit antibodies that bind and inhibit the activity of CETP, blocking the ability of that protein to transfer cholesterol from HDL to LDL and thus causing HDL cholesterol levels to rise. Results are expected in the fourth quarter.

• Benitec Ltd., of Queensland, Australia, extended its collaborative effort to investigate the role of specific genes in Type II diabetes with the Garvan Institute of Medical Research in New South Wales. Benitec, which will provide Garvan with an increased number of its DNA-directed RNA interference constructs directed against an expanded range of potential drug targets, retains a first option to commercial rights to any resulting intellectual property and therapies against the gene targets. The initial part of the collaboration identified genes responsible for insulin-independent diabetes.

BioReliance Corp., of Rockville, Md., and Q-One Biotech Group Ltd., of Glasgow, Scotland, entered a letter of agreement providing for a period of exclusive negotiations in connection with a proposed acquisition of Q-One Biotech by BioReliance. The proposed transaction would involve the purchase by BioReliance of all of the outstanding capital stock of Q-One in an all-cash transaction expected to be financed through a new senior secured credit facility and a portion of existing cash resources. Terms were not disclosed. The parties agreed in principle on many of the major terms of the proposed transaction, including the pricing mechanism, and Q-One and its principal shareholders have agreed to deal exclusively with BioReliance for an undisclosed period to negotiate mutually acceptable definitive agreements.

• Chemical Diversity Labs Inc., of San Diego, entered a drug discovery partnership with the University of New Mexico in Albuquerque. The school will use its algorithms to verify the company's computational focusing of targeted libraries and to select a library of small-molecule compounds for screening as potential ligands for a peptide-activated GPCR for which none are known. Financial terms were not disclosed.

• Compugen Ltd., of Tel Aviv, Israel, said it would transfer its Bioccelerator product line to Biocceleration Ltd. in exchange for certain fixed payments during about the next two years and for royalties from future sales of the product line and any future products based on the Bioccelerator intellectual property. The transfer is expected to take place by the end of August. The Bioccelerator product line accelerates similarity searches in nucleotide and protein databases. Biocceleration Ltd. was established by a group of private investors.

• Cyntellect Inc., of San Diego, a subsidiary of Oncosis LLC, said Oncosis was awarded a Small Business Innovation Research Phase I grant from the National Human Genome Research Institute, a division of the National Institutes of Health in Bethesda, Md. Oncosis will use the $183,000 grant to study high-throughput gene silencing by using Cyntellect's Laser-Enabled Analysis and Processing platform for optoinjection of nucleic acids, causing subsequent RNA interference.

• CytoGenix Inc., of Houston, granted an option to exclusively license manufacturing and distribution of its anti-herpes topical cream in the People's Republic of China to Phanuel Pursuits Ltd., an international trading company in the British Virgin Islands. CytoGenix called the compound effective in combating both genital and labial herpes. Financial terms were not disclosed.

• Entelos Inc., of Foster City, Calif., and the Massachusetts Institute of Technology in Cambridge are collaborating to better understand the breakdown of communication signals in certain immune system cells. The collaboration will study the key intracellular communication hubs of T lymphocytes to quantitatively map intracellular pathways that respond to different stimuli and then regulate response by the cells. Entelos will then integrate the cell-signaling models within its Immunology PhysioLab Platform, a series of interrelated models of immunology and inflammation.

• Foundation Growth Investments LLC, of Chicago, and its EI Acquisition Inc. unit said they remain committed to acquiring all of the outstanding stock of eXegenics Inc., of Dallas. Last month, eXegenics' board unanimously rejected an unsolicited tender offer by EI Acquisition. Instead, it entered an agreement to be bought in an $11 million, all-stock purchase by AVI BioPharma Inc., of Portland, Ore. EI Acquisition said the eXegenics board "continues to jeopardize stockholder value" by considering the all-stock AVI offer. (See BioWorld Today, July 17, 2003.)

• Galen Holdings plc, of Craigavon, Northern Ireland, commented on the recent rise in its share price. The company is in preliminary discussions that might lead to an offer for Galen Holdings, it said. It advised shareholders to take no further action at this time and said a further announcement will be made "in due course." Industry rumors have Barr Laboratories Inc., of Woodcliff Lake, N.J., as a potential suitor, although that was not confirmed by Galen. Galen's stock (NASDAQ:GALN) rose $6.77 Thursday, or 16.6 percent, to close at $47.55.

• IBEX Technologies Inc., of Montreal, said it issued 475,000 common shares, valued at $296,000 as of July 15, and made a cash payment of $104,000 to continue to retain rights to arthritis biomarkers it acquired a year ago after purchasing privately held HDM Diagnostics & Imaging Inc., of Toronto. Under the acquisition, IBEX is required to pay former HDM shareholders $400,000 per year through cash, IBEX stock or a combination of the two, for the first three years following the acquisition. Last July, IBEX paid $500,000 and issued 2 million common shares to acquire HDM.

• Inpharmatica Ltd., of London, said Japanese company Riken took a nonexclusive subscription to Inpharmactica's Biopendium, a proteome annotation resource. Financial terms were not disclosed. Inpharmatica secured the agreement in conjunction with PharmaDesign, of Tokyo. PharmaDesign will provide Riken with primary training and support over the period of the subscription.

• Medarex Inc., of Princeton, N.J., said it plans to privately offer $100 million of convertible senior notes expected to be due in 2010. Medarex, which said they would be convertible into its common stock at a price to be determined, said it would use net proceeds for general corporate purposes including repayment of outstanding debt and acquisitions of products or companies.

• MelTec GmbH, of Magdeburg, Germany, said its founder, Walter Schubert, was awarded three U.S. patents related to amyotrophic lateral sclerosis (ALS). They also will be issued in Europe. But he said he would suspend all patent rights to MelTec until its business structure is reorganized. Schubert invented MELK Robotic Technology, which enables protein networks to be mapped directly in morphologically intact cells and tissues. He said a new therapeutic approach and compounds for ALS and cancer, derived from protein network analysis, are in MelTec's pipeline. Regarding ALS, he added that "it is essential that every effort is made to explore the targets and disease mechanisms found and to develop a therapy."

• Molecular Probes Inc., of Eugene, Ore., said Caltag Laboratories, of Burlingame, Calif., is launching a series of flow cytometry and microscopy products incorporating Molecular Probes' Alexa Fluor dyes and tandem conjugate technologies.

• Novartis AG, of Basel, Switzerland, said Japanese regulatory authorities approved Glivec (imatinib) for KIT (CD117)-positive gastrointestinal stromal tumors. The product, already approved in the U.S., European Union and more than 70 other countries, received Japanese orphan drug status for that indication in October. It is named Gleevec in the U.S.

• PharmaMar, of Madrid, Spain, said Aplidin received orphan drug status in Europe for acute lymphoblastic leukemia, granting 10-year marketing exclusivity in the European Union for that indication subject to successful regulatory approval. Aplidin, its second marine-derived compound in clinical development, is in Phase II trials for solid tumors including renal, colorectal, head and neck, pancreatic and non-small-cell lung cancers, as well as medullary thyroid carcinoma.

• SeraCare Life Sciences Inc., of Oceanside, Calif., paid $4 million to acquire all the assets of BioMedical Resources and a related company, a privately held provider of disease-state antibody products used for calibrators and controls, which have annual sales in excess of $3 million. The purchase was paid with $400,000 worth of SeraCare stock and the balance in cash. All of BioMedical Resources' employees are expected to join SeraCare, which provides blood and plasma-based products and services.

• SIGA Technologies Inc., of New York, and TransTech Pharma Inc., of High Point, N.C., reported the discovery of a class of small molecules that are effective against a mouse hepatitis virus, which is a closely related surrogate to the coronavirus that causes severe acute respiratory syndrome, it said. The companies' scientists are working with the U.S. government to evaluate the compounds against the human SARS coronavirus. SIGA and TransTech scientists used similar methods to discover anti-smallpox drugs that they expect to evaluate in animals later this year.

• Simulations Plus Inc., of Lancaster, Calif., released its third software product for pharmaceutical research called QMPRchitect. The product is designed to enable researchers to build artificial neural network predictive models from their own data more quickly than before.

• TransForm Pharmaceuticals Inc., of Lexington, Mass., received a contract from the U.S. Defense Advanced Research Projects Agency (DARPA) to develop a prototype system for the discovery of methods and compositions to control in vitro cell differentiation. The system, being developed as part of DARPA's engineered tissue constructs program, will enable microarray based screening of complex mixtures that control and promote cell growth and differentiation. TransForm will conduct biological experimentation and apply its informatics and automation expertise to develop applications to interpret the results.

• Valentis Inc., of Burlingame, Calif., initiated a Phase II trial of its Del-1 angiogenesis gene. One hundred patients with peripheral arterial disease, specifically intermittent claudication, will be randomized to receive either Del-1 or placebo. The trial is being conducted in 12 centers in the U.S. Enrollment is expected to be completed in the first quarter of 2004 and data are expected in the third quarter of 2004.

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