• A.I. Software Inc., of Vancouver, British Columbia, said it acquired all the issued and outstanding shares of Israeli stem cell research firm Pluristem Ltd. A.I. Software, which purchased Pluristem for cash obtained in a recently completed private placement, plans to change its name to Pluristem Life Systems Inc. As part of the acquisition, A.I. Software received licensing rights to stromal-cell bioreactor equipment and process that assists in the expansion of stem cells. Financial terms were not disclosed.

• Adprotech Ltd., of Cambridge, UK, was awarded orphan drug status by the FDA for APT070 in the prevention of delayed graft function in solid organ transplant. APT070 is designed to reduce ischemia reperfusion injury by binding to transplanted tissue and protecting it from attack by a component of the recipient's immune response known as the complement system, following reinitiation of blood flow after grafting.

• Affymetrix Inc., of Santa Clara, Calif., said its new GeneChip array aims to catalyze research into the SARS virus and is now available to the research community through a collaboration involving partners in the government, not-for-profit and business sectors. The SARS-CoV array program is part of an ongoing effort by the National Institute for Allergy and Infectious Diseases of the NIH to promote genomics approaches to improve the understanding of pathogenic microbes and the diseases they cause.

• Alkermes Inc., of Cambridge, Mass., reported Phase II results showing that patients treated with once-monthly injections of Vivitrex, in combination with psychosocial therapy, experienced a 50 percent reduction in heavy drinking days compared to patients receiving placebo injections in combination with psychosocial therapy. Vivitrex, an extended-release formulation of naltrexone using Alkermes' Medisorb technology, is being further evaluated in more than 600 patients in a Phase III study for the treatment of alcohol dependence. (See BioWorld Today, April 2, 2002.)

• AMDL Inc., of Tustin, Calif., said that as of Wednesday it had raised about $887,000 net of placement agent fees, in its private offering of units consisting of convertible notes and stock purchase warrants. The notes were automatically converted into an aggregate of about 2.6 million shares of AMDL common stock when AMDL received approval for the listing of those shares on the American Stock Exchange. AMEX also approved the listing of the approximate 2.6 million shares issuable upon exercise of the warrants included in the units.

• Amrad Corp. Ltd., of Victoria, Australia, will receive a $5 million up-front payment from Merck & Co. Inc., of Whitehouse Station, N.J., as part of an exclusive licensing and multiyear research collaboration with Merck Sharp & Dohme Pty. Ltd., Merck's Australian subsidiary. Merck could end up paying up to $112 million if it develops products for all indications included in the agreement, such as asthma, other types of respiratory disease and oncology. Amrad also would receive royalties for commercialized products. The parties will work together to investigate drug candidates, with Merck being solely responsible for all clinical development and marketing. The specific products or technology in the deal were not disclosed, though mention was made of work Amrad is doing in the area of cellular growth factors.

• Auxilium Pharmaceuticals Inc., of Norristown, Pa., reported data showing that older hypogonadal men with diabetes treated with Testim testosterone gel had significant improvements in sexual performance and lean body mass without any changes in exercise. Patients treated with Testim also experienced a decline in glucose levels. The results were presented at ENDO 2003, the Endocrine Society's 85th annual meeting in Philadelphia.

• Avidex Ltd., of Oxford, UK, said it has progressed with its monoclonal T-cell receptor technology and that the company is now able to engineer T-cell receptors with high affinity and specificity. Full results are expected to be published in a peer-reviewed journal.

• BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania, launched its Greenhouse Fund's second investment cycle for early stage projects in the field of human health. Prospective Greenhouse Fund recipients may go online at www.bioadvance.com to register. The $20 million fund is designed to help biomedical entrepreneurs move commercially promising therapeutics, medical devices and discovery technologies from the laboratory to the stage where they are capable of securing venture capital or corporate funds.

• Biolex Inc., of Pittsboro, N.C., signed a research collaboration with Centocor Inc., of Malvern, Pa., to examine the feasibility of producing three proteins using Biolex's Lemna Expression System. Biolex said it possesses a transformational plant-based system for the development of human therapeutic proteins. Biolex will be responsible for the expression of Centocor's three therapeutic proteins. Centocor has the option to have Biolex scale-up and manufacture the proteins following the feasibility phase. Financial terms of the collaboration were not disclosed.

• Biosyn Inc., of Huntingdon Valley, Pa., submitted an investigational new drug application to the FDA for the development of UC-781 as an HIV microbicide. Biosyn plans to initiate trials investigating UC-781's safety, and later efficacy. UC-781 is an HIV non-nucleoside reverse transcriptase inhibitor that has shown to be active in vitro, specifically against HIV-1.

• Cel-Sci Corp., of Vienna, Va., entered a cooperative agreement to test CEL-1000 against SARS, smallpox, vaccinia, West Nile virus and several other diseases with the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md., and the U.S. Army Medical Research Institute of Infectious Diseases. The testing is designed to determine whether the peptide, which Cel-Sci said appears to activate innate and Th1-type immune responses to induce a broad-spectrum protection against infection in animal models, could be used as a potential treatment and/or preventive agent against these diseases. Cel-Sci's stock (AMEX:CVM) gained 26 cents Monday, or 38.8 percent, to close at 93 cents.

• ChondroGene Ltd., of Toronto, reported that the proposed acquisition of GeneNews Inc., of Ontario, was approved by shareholders at the company's annual and special meeting. The company executed a letter of intent with GeneNews and its shareholders, in which the company agreed to acquire all of the outstanding shares of GeneNews through the issuance of 4 million shares of ChondroGene Ltd. to the shareholders of GeneNews at 50 cents per share plus C$100,000 (US$73,693) payable in cash. The transaction is expected to close no later than July 31.

• Congressional Pharmaceutical Corp., of Bethesda, Md., said it would present data at next month's American Association for Cancer Research meeting in Washington showing that one of its genoprotective agents conferred delayed radioprotection to human endothelial cells. The company said that low doses of the drugs, represented by its lead compound Phosphonol, would provide both significant protection from the mutagenic effects of low-dose radiation exposure as well as prolonged protection against radiation-induced cell killing.

• Corixa Corp., of Seattle, said the initial purchaser of its recent offering of 4.25 percent convertible subordinated notes due 2008 exercised its option to purchase an additional $15 million in principal amount of the notes, raising the aggregate gross proceeds from a private equity placement and the sale and issuance of the notes to $130 million. The closing for the additional purchase is expected today. Corixa said it would use the net proceeds from both transactions for research and development and general corporate purposes. (See BioWorld Today, June 10, 2003.)

• Eukarion Inc., of Bedford, Mass., said data published in the June 18, 2003, online issue of The Proceedings of the National Academy of Sciences showed that its synthetic catalytic scavenger compounds reversed age-related learning deficits in mice. In the studies, middle-aged mice were treated continuously for three months with low doses of EUK-189 or EUK-207. During that period, control mice similarly treated with the vehicle experienced a significant decrease in learning ability, a decrease almost fully prevented by treatment with either EUK-189 or EUK- 207. In addition, several markers of oxidative stress in the brain were significantly lowered.

• Generex Biotechnology Corp., of Toronto, reported study details at last week's ENDO 2003, the 85th annual meeting of the Endocrine Society in Philadelphia. The studies further show that the company's Oralin insulin formulation has the potential to be used safely and effectively in place of injected insulin to treat patients with Type I and Type II diabetes, the company said. Oralin is delivered as a fine spray via the company's Rapidmist device to the buccal cavity, where it is absorbed through the buccal mucosal lining.

• Genome Canada said the Canadian government announced at the BIO 2003 conference in Washington that $65 million would be made available for a competition on applied genomics and proteomics research in human health. The competition is designed to fund research proposals focused on the development and application of genomics and proteomics tools to improve the prediction, prevention and treatment of human disease for individuals and populations.

• Genomics Collaborative Inc., of Cambridge, Mass., said it has signed more than 30 GCI Access agreements since Jan. 1, including partnerships with 11 new biotechnology and pharmaceutical customers. The GCI Access program permits customers to use its Global Repository, a worldwide collection from more than 120,000 patients who have contributed appropriately consented DNA, RNA, sera and snap-frozen tissue samples linked to detailed medical information.

• GTx Inc., of Memphis, Tenn., provided a summary of preclinical data on its SARMS (Selective Androgen Receptor Modulator) program presented at the 85th annual meeting of the Endocrine Society in Philadelphia. The data summarized the company's evaluation of structure-activity relationships for androgen receptor binding and activation, as well as pharmacologic effects and tissue selectivity of SARMs developed by GTx. Results showed that SARMs have potential therapeutic applications in osteoporosis, muscle wasting and benign prostatic hypertrophy.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, reported additional Phase II data at the National Foundation for Infectious Diseases Conference on Antimicrobial Resistance in Bethesda, Md., showing that AIDS patients treated with its lead infectious disease compound, Immunitin (HE2000), experienced a statistically significant reduction in the total number of all opportunistic infections over the 13-month study compared to placebo (p=0.03). The trial was conducted in South Africa in late-stage HIV patients who have progressed to AIDS, with an average starting CD4 count less than 50.

• IGEN International Inc., of Gaithersburg, Md., said it would receive $23 million after entering an agreement to sell products based on its Origen technology for the detection of specific biological agents important to the U.S. Department of Defense. The four-year contract provides for product sales to the U.S. Army, including $7 million over the next year. Various laboratories and field sites of the Department of Defense, as well as other U.S. government agencies, will use the products for the detection of agents or toxins in environmental samples.

• Immtech International Inc., of Vernon Hills, Ill., began patient enrollment in an expanded Phase IIa trial of DB289, its oral drug candidate for malaria. The Thailand-based trial is designed to test the safety and efficacy of DB289 against both the Plasmodium vivaxx and Plasmodium falciparium strains of malaria, the two most common and deadly forms of the disease. Each patient will be dosed two times daily for five days and will remain at the trial site for an additional 23 days to ensure that the malaria parasite is cleared from the bloodstream.

• Inpharmatica Ltd., of London, entered an agreement with ArQule Inc., of Woburn, Mass., to acquire certain ArQule assets, to take an assignment of its 10,000-square-foot Cambridge laboratories and to license certain intellectual property. Fifteen former ArQule employees will join Inpharmatica following the deal. ArQule has searched for a buyer of its ADME business for two years and was forced to cut staff by 128 people, or 31 percent, in December. Separately, Inpharmatica launched Biopendium Online, a new version of its Biopendium annotation resource that is accessible via the Internet. (See BioWorld Today, Dec. 12, 2002.)

• LifeCell Corp., of Branchburg, N.J., entered a license and collaboration agreement with the newly formed National Stem Cell Centre (NSCC) in Queensland, Australia. One of NSCC's research initiatives will focus on combining stem cells with acellular tissue matrices. In addition to granting NSCC rights to use the LifeCell technology internally, LifeCell will grant the NSCC an exclusive license to processing technology and distribution of regenerative tissue matrix products for specific indications in Australia and New Zealand. LifeCell will receive royalties from products distributed by NSCC in those markets.

• Maxim Pharmaceuticals Inc., of San Diego, reported preliminary results of two additional clinical trials of its lead candidate, Ceplene (histamine dihydrochloride), for patients with Stage IV malignant melanoma, at the International Melanoma Research Congress meeting in Philadelphia. Maxim said findings from a 163-patient Phase II trial in the U.S. and an international, 241-patient Phase III trial provide additional data regarding Ceplene's safety and efficacy that complement results from a prior U.S.-based Phase III trial reported last year. Maxim said it would file for European approval in November, with a third Phase III trial ongoing to support U.S. approval. (See BioWorld Today, June 13, 2003.)

• MDS Pharma Services, of Montreal, introduced a drug development program for therapeutic monoclonal antibodies, offered through the company's drug development programs service. The program is designed to aid in guiding a monoclonal antibody compound through molecular design, pharmacology, manufacturing process design, product quality control and nonclinical and clinical development. MDS also opened a new facility in Bothell, Wash.

• MicroIslet Inc., of San Diego, reported positive preliminary data from its preclinical study showing interim results of transplants using MicroIslet's technology in about 50 small animals. MicroIslet's technology is based on microencapsulating pig islet cells for treatment of insulin-dependent diabetes. A group of streptozotocin-diabetic NOD/SCID mice were transplanted with MicroIslet's porcine islet cells and at various dosing levels were able to normalize blood glucose levels in all animals within one week of transplantation. To date, the grafts had remained functional for up to 10 weeks after implantation.

• Micromet AG, of Munich, Germany, published results from two preclinical studies of MT103, a representative of its class of antibody derivatives called BiTE (Bispecific T-Cell Engager). The data, recently published in the Journal of Immunology and Leukemia, provide further evidence of the potency and precision of MT103 in cancer cell elimination and suggest the compound also has high potential for the treatment of chronic lymphocytic leukemia. Micromet is preparing the initiation of a Phase I trial in that indication.

• Nautilus Biotech, of Paris, said it raised €4 million after completing a private equity round with a syndicate of four investment funds. Nautilus said it would use the proceeds to further develop its service model and move its improved interferon-alpha into advanced preclinical development. Together with existing investors Matignon Technologies and Rothschild Venture Partners, two new institutions added investments in Nautilus: FCJE and Pre-IPO Invest, a Banque du Louvre's venture capital company.

• Nektar Therapeutics, of San Carlos, Calif., said it plans to offer $100 million aggregate principal amount of convertible subordinated notes in a private offering to qualified institutional buyers. The figure could reach $125 million if an overallotment option is exercised in full. The seven-year notes will be convertible into common shares of Nektar, which said it would use net proceeds for general corporate purposes that may include possible repurchases of outstanding convertible subordinated notes and debentures, investing in or accelerating various product development programs, undertaking potential acquisitions and developing technologies. The company previously was named Inhale Therapeutics Systems Inc.

• Neose Technologies Inc., of Horsham, Pa., filed a shelf registration statement with the SEC to allow the company to offer and sell up to $75 million of its common stock from time to time. Terms of any such future offerings would be established at the time of the offering.

• Neurochem Inc., of Montreal, said a preliminary analysis of data from a recently completed Phase II trial of Alzhemed in patients with mild to moderate Alzheimer's disease revealed promising results relative to primary and secondary objectives. The multicenter, randomized, double-blinded, placebo-controlled and parallel-designed study resulted in no questionable safety findings in patients treated with Alzhemed. Alzhemed's pharmacokinetic profile was detected in the cerebrospinal fluid of the patients, suggesting an ability to cross the blood-brain barrier. Patients with the greatest decrease in amyloid protein in the cerebrospinal fluid were all on Alzhemed, and the majority of patients on the highest dose of Alzhemed showed stable results on a cognitive function test at the six-month point when an ongoing open-label extension study began.

• Northwest Biotherapeutics Inc., of Bothell, Wash., said it would receive $816,000 after selling the right to receive any future royalties from products derived from an unidentified antibody target to Medarex Inc., of Princeton, N.J. As part of simultaneous cost-cutting measures, Northwest lowered its staff by eight employees, or 42 percent, and relocated its facilities to a less-expensive space. Among those released was Chairman and CEO Daniel Wilds, who will retain both posts but not as an employee.

• Paradigm Genetics Inc., of Research Triangle Park, N.C., entered a collaboration to identify genetic markers of acetaminophen toxicity in the liver with the University of North Carolina at Chapel Hill and the National Institute of Environmental Health Science, a unit of the National Institutes of Health in Bethesda, Md. Paradigm will conduct biochemical-profiling experiments on tissue and biofluid samples from rat and human subjects exposed to acetaminophen, and then integrate its results with gene expression profiling and histopathology data from the institute and clinical data from the university. Intellectual property rights to the biomarkers and diagnostics will be determined based upon inventorship.

• PhageTech Inc., of Montreal, appointed Pierre Etienne president and CEO. Etienne joined PhageTech from Pfizer Inc., where he most recently held the position of vice president of worldwide development operations. He joined Pfizer in 1989. PhageTech is a private company focused on the discovery and development of new classes of antibiotic drugs, based on its efforts in phage genomics.

• Phytopharm plc, of Cambridge, UK, entered an agreement with the Oxford Project to Investigate Memory and Ageing (OPTIMA), affiliated with the University of Oxford in the UK, regarding the clinical development of PYM50028, an oral treatment for dementias including Alzheimer's disease. OPTIMA will enroll patients with memory impairment in the Phase II proof-of-principle study, which is expected to begin in the fourth quarter. The randomized, double-blind, placebo-controlled study will evaluate the safety, efficacy and pharmacokinetic profile of PYM50028 after repeated oral administration in dementia. The study is scheduled for completion in the fourth quarter of 2004.

• Pozen Inc., of Chapel Hill, N.C., reported data at the American Headache Society meeting in Chicago, including findings from a Phase III study demonstrating that MT 300 is effective in providing sustained pain relief for the acute treatment of migraine. Late last year, Pozen filed for FDA approval of the product, which is being developed as an improved formulation of dihydroergotamine in a prefilled syringe suitable for at-home use. (See BioWorld Today, Dec. 18, 2002.)

• Praecis Pharmaceuticals Inc., of Waltham, Mass., initiated the regulatory submission process for Plenaxis (abarelix) in the European Union with the submission of an initial marketing authorization application in Germany. The company is seeking approval in the EU under the mutual recognition procedure to market Plenaxis for treating a broad population of hormonally responsive prostate cancer patients.

• Ribapharm Inc., of Costa Mesa, Calif., said its board determined that the unsolicited tender offer of Costa Mesa-based ICN Pharmaceutical Inc. to acquire all of the outstanding shares of Ribapharm common stock not already held by ICN, for $5.60 per share, is inadequate. The Ribapharm board recommended that Ribapharm stockholders reject ICN's unsolicited tender offer and urged Ribapharm stockholders not to tender their shares.

• Rigel Pharmaceuticals Inc., of South San Francisco, received stockholder approval at a June 20 annual meeting for all eight proposals submitted for stockholder vote identified in Rigel's 2003 proxy statement. Among the proposals were Rigel's recently reported financing, a reverse stock split and changes in its stock option plans. Rigel had previously reported it had entered a definitive agreement on April 29 to raise $46 million. (See BioWorld Today, May 1, 2003.)

• Serono SA, of Geneva, reported positive Phase II results at the International Psoriasis Symposium in New York, showing that patients treated with a 150-mg subcutaneous dose of onercept three times per week showed a significant improvement in their psoriasis area and severity index score. After 12 weeks of therapy, 54 percent of the 43 onercept patients demonstrated 75 percent or greater improvement vs. 12 percent of the 43 placebo patients (p<0.001). Also, 74 percent of patients on the anti-TNF agent achieved 50 percent or greater improvement vs. 26 percent in the placebo group (p<0.001).

• Teva Pharmaceutical Industries Ltd., of Jerusalem, said data reported at this week's European Neurological Society meeting showed that relapsing-remitting multiple sclerosis patients who failed to respond to treatment with Avonex (interferon beta-1a, from Biogen Inc.) experienced a significant reduction in relapses after switching to noninterferon Copaxone (glatiramer acetate injection). After switching to Copaxone, the 85 patients experienced a mean annualized reduction of relapses from 1.13 annually to 0.47 annually (p=0.0001). Neurologic disability recorded by measuring expanded disability status scale did not show worsening while on treatment with Copaxone.

• Unigene Laboratories Inc., of Fairfield, N.J., was awarded a Small Business Innovation Research grant from the National Institutes of Health in Bethesda, Md., to use technology to identify peptides that may have therapeutic value. The $125,000 grant will help fund the initial phase of Unigene's collaborative discovery program with the University of South Florida. During that stage, Unigene and USF will use a new technology that they jointly developed to aid in the discovery of peptides.

• VaxGen Inc., of Brisbane, Calif., opened its new biopharmaceutical manufacturing facility in South San Francisco. The facility includes 17,000 square feet for the production of complex proteins made through recombinant bacterial fermentation and mammalian cell culture. That type of manufacturing is used to make vaccines, monoclonal antibodies and therapeutic proteins. The new facility is designed to manufacture VaxGen's anthrax vaccine and AIDS vaccine candidates, as well as other biopharmaceuticals. VaxGen's stock (NASDAQ:VXGN) gained 71 cents Monday, or 14.2 percent, to close at $5.71.

• Viventia Biotech Inc., of Toronto, and Affitech A/S, of Oslo, Norway, entered a research collaboration to identify antigens on various cancer cells and to select antibodies targeting those antigens for subsequent development as potential therapeutics. Affitech will employ its human antibody libraries and its discovery and screening technologies, including its AffiScreen platform, to cancer cells in order to simultaneously discover cell surface targets and their respective antibodies. Viventia subsequently will apply its ImmunoMine screening and Unlock target-identification platforms to further characterize and validate those antigens and antibodies.