• ActivX Biosciences Inc., of La Jolla, Calif., said Kyorin Pharmaceutical Co. Ltd., of Tokyo, made an equity investment in the company. Including the undisclosed investment, Kyorin has committed nearly $8 million to ActivX. The companies are in a three-year collaboration to identify and optimize drug candidates to treat Type II diabetes.

• AMDL Inc., of Tustin, Calif., said its DR-70 test would be presented favorably next week at MEDICA in Dusseldorf, Germany, by University of Frankfurt researchers. Their abstract concluded that the DR-70 test differs reliably between cancer patients and healthy controls and could become a useful screening test for malignant diseases in clinical practice. Based on blood sera from 85 cancer patients and 100 healthy donors, the immunoassay showed a sensitivity of 91 percent and a specificity of 93 percent, it said.

• Amylin Pharmaceuticals Inc., of San Diego, filed a shelf registration with the SEC that would allow it to issue from time to time up to $175 million of common stock. The nature and terms of any offering will be established at the time of sale. Proceeds from any offering would be expected to be used to fund the company's research and development activities, principally AC2993 (synthetic exendin-4) and AC2993 LAR, potential commercialization of Symlin (pramlintide acetate) and general corporate purposes.

• Ardais Corp., of Lexington, Mass., said Bristol-Myers Squibb Co., of New York, entered a licensing agreement to access Ardais' BIGR Library and Suite of Bioinformatic Tools, a portfolio of human tissue-based products and services used in molecular profiling to identify and validate drug targets. Financial terms and other details were not disclosed.

• Ariad Pharmaceuticals Inc., of Cambridge, Mass., reported results of a newly published study demonstrating a way of creating clinically relevant animal models of human disease where none currently exist in cell-signaling regulation technology. For many degenerative disorders, such as hepatitis, the development of new drugs has been impeded by the lack of adequate animal models, a limitation that the company said can be overcome with the technique. A team of scientists used Ariad's regulated cell-death technology to create transgenic animals with controlled degrees of liver failure, for example, as reported in the current issue of Nature Biotechnology.

• AVI BioPharma Inc., of Portland, Ore., reported at this week's American Heart Association meeting in Chicago the results of two independent studies that demonstrated the feasibility of treating cardiovascular restenosis without the use of special drug delivery catheters or drug-coated stents. The preclinical studies used AVI's microbubble delivery technology to deliver its Resten-NG Neugene antisense drug to balloon-injured coronary arteries. In one study, Resten-NG was detected in the coronary vessels four hours after delivery and inhibition of c-myc, the target of Resten-NG, was observed, while a larger study also observed significant reductions in the vessel wall thickness and in the area of vessel restenosis.

• Biacore International AB, of Uppsala, Sweden, reported the introduction of its cell-based assay system. The new system, Procel, is designed specifically for cell-based secondary screening and pharmacology profiling of potential new drug leads and will complement Biacore's existing molecular-based systems for drug discovery. Biacore said Procel is the first automated system dedicated to high-content profiling of compounds targeting G protein-coupled receptors and ion channels.

• Bolder BioTechnology Inc., of Wheat Ridge, Colo., was awarded a $100,000 Small Business Innovation Research grant from the National Cancer Institute, a division of the National Institutes of Health in Bethesda, Md. The grant will support research to attempt to develop longer-acting, more potent forms of human angiostatin using Bolder's targeted protein modification technologies.

• Cell Therapeutics Inc., of Seattle, reported an exchange offer for its outstanding $175 million 5.75 percent convertible subordinated notes due 2008. In the exchange, CTI will exchange the existing notes for $102.9 million 5.75 convertible senior subordinated notes due 2008. The proposed exchange ratio is 0.588 of a new note for each existing note. The new notes will be senior in right of payment to the existing notes, and subordinated to CTI's senior debt. The conversion price of the new notes is $10 per share. Prior to June 21, 2004, the company will be permitted to provisionally call the new notes if CTI's common stock has traded above $15 for 20 trading days within a 30 consecutive trading day period.

• Cel-Sci Corp., of Vienna, Va., entered into an agreement with Proxima Concepts Ltd., of London, to develop an oral formulation of Cel-Sci's CEL-1000, which has shown high levels of protection against herpes simplex, malaria and cancer in animal testing. The oral compound studies initially will evaluate its ability to prevent and/or treat infection with herpes, and perhaps also malaria, in animal models. Prior tests with all three diseases involved injection delivery. Financial terms were not disclosed.

• Chiron Corp., of Emeryville, Calif., said it entered multiyear agreements with the primary U.S. blood collection organizations for supply, service and support of Chiron's Procleix HIV-1/HCV Assay and System. Details of the agreements with the American Red Cross, America's Blood Centers, Association of Independent Blood Centers and the U.S. military were not disclosed. Procleix incorporates nucleic acid testing technology to detect HIV-1 and HCV RNA in donated blood and plasma during the very early stages of infection, before the agents can be detected by immunodiagnostic screening technologies.

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., reported at this week's American Heart Association meeting in Chicago positive results of a pilot trial in which Periostat (doxycycline hyclate) was found to significantly lower levels of the inflammatory marker C-reactive protein (CRP) among acute coronary syndrome patients. The study, which randomized 50 patients to either a 20 mg twice-a-day dose of Periostat or placebo, found that Periostat significantly reduced serum levels of interleukin-6, two matrix metalloproteinases, MMP-2 and MMP-9, and CRP, with the latter reduced by an average of 46 percent from baseline.

• Collgard Biopharmaceuticals, of Boston, said that two preclinical studies showed that Tempostatin (halofuginone hydrobromide) could reverse existing liver fibrosis in animal models that closely resemble human disease. The results were presented at the 53rd annual meeting of the American Association for the Study of Liver Diseases in Boston earlier in the month. The studies suggested that Tempostatin has both antifibrogenic and fibrolytic activity, working to prevent the formation of fibrosis as well as breaking down the distorting extracellular matrix by inducing the enzymes MMP 3 and MMP 13.

• Connetics Corp., of Palo Alto, Calif., said it in-licensed the right to access the clinical, regulatory and manufacturing records of an approved and marketed dermatological product. Connetics said it plans to reformulate and market the unnamed product using its foam delivery vehicle, though it did not disclose the target market.

• Copernicus Therapeutics Inc., of Cleveland, completed a first close of $2 million toward a private financing round of $2.5 million. It said the funding would support continued development of an aerosol cystic fibrosis gene therapy product, as well as other products based on its DNA nanoparticle technology.

CV Therapeutics Inc., of Palo Alto, Calif., reported at this week's American Heart Association meeting in Chicago that CVT-3146 produced a dose-dependent increase in coronary blood flow velocity in an open-label Phase II study of 36 patients undergoing cardiac catheterization. At all doses studied, CVT-3146 caused a rapid increase in coronary blood flow velocity that was at or near peak within 30 to 40 seconds. Doses of intravenous CVT-3146 greater than or equal to 100 micrograms caused a maximal response that was similar to that caused by intracoronary adenosine. The selective A2A-adenosine receptor agonist for potential use as a pharmacologic stress agent in cardiac perfusion imaging studies is being developed jointly with Fujisawa Healthcare Inc., a subsidiary of Fujisawa Pharmaceutical Co. Ltd., of Osaka, Japan.

• Durect Corp., of Cupertino, Calif., signed an exclusive agreement with BioPartners, of Zug, Switzerland, for the development of a sustained-release formulation of recombinant interferon alpha for hepatitis C. BioPartners will develop and commercialize the product in areas including the U.S., Europe, Japan, Australia, New Zealand and the Middle East. The product will be developed using Durect's drug delivery technology, Saber, and BioPartners' daily recombinant interferon alpha product. The companies will share the funding of certain preclinical development activities. BioPartners is responsible for additional activities and all clinical activities. Durect is scheduled to receive milestone payments and royalties. Specific financial terms were not disclosed.

• Ixion Biotechnology Inc., of Alachua, Fla., was awarded by the National Institute for Allergy & Infectious Diseases, a unit of the National Institutes of Health in Bethesda Md., a Phase II Small Business Technology Transfer Research grant for research titled "M3 Receptor: Diagnostic Marker for Sjogren's Syndrome." The $504,690 award is its 12th such grant in three years, totaling nearly $3.5 million in funding for Ixion, a firm developing cell-based therapies to treat metabolic disorders.

• Microbix Biosystems Inc., of Toronto, signed an agreement with a leading undisclosed pharmaceutical company for worldwide rights to its lead biotherapeutic drug, ThromboClear, a generic version of Abbokinase, made by Abbott Laboratories, of Abbott Park, Ill. Microbix is to receive a royalty rate of 35 percent of the gross margin, and the partner will assume responsibility and all costs for commercializing ThromboClear.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., entered a three-year collaboration with The Cleveland Clinic in Cleveland to discover disease biomarkers and drug targets for the advancement of cardiovascular medicine. The alliance brings together the clinic's expertise in clinical practice and research with the genetic, genomic and technologic expertise of Millennium. The agreement will be focused on capturing data to further personalized medicine efforts in specific areas of cardiovascular disease to optimize patient care. The long-term goal is to develop a broad program in genetics and pharmacogenomics that supports the advancement of the company's cardiovascular pipeline and research in the areas of thrombosis, atherosclerosis, growth factor receptors and myocardial infarction.

• Miravant Medical Technologies, of Santa Barbara, Calif., presented preclinical results of its treatment in development for atherosclerotic vulnerable plaque at the American Heart Association meeting in Chicago. The studies showed that intracoronary PhotoPoint PDT significantly depleted problematic inflammatory plaque cell populations. Also, in advanced preclinical models, PhotoPoint PDT induced apoptosis, reducing macrophages associated with plaque. Those and earlier studies suggest that PhotoPoint PDT may prove useful in stabilizing VP, the unstable, rupture-prone plaque in arteries that causes a majority of heart attacks and many strokes, the company said. PhotoPoint PDT employs light activation of a photosensitizing drug and is designed to produce cytotoxic free radicals.

• Molecular Mining Corp., of Cambridge, Mass., said it released GeneLinker Gold version 3.0 and GeneLinker Platinum version 2.0 Expression Analysis Software.

• Morewood Molecular Sciences Inc., of Pittsburgh, received a second Phase I Small Business Innovation Research grant from the National Institutes of Health for $100,000. Morewood also completed a new round of angel funding totaling $550,000. Morewood said it expects its technology ultimately to be useful on the front end of drug discovery to reduce bottlenecks.

• Saegis Pharmaceuticals Inc., of Half Moon Bay, Calif., entered a multiyear research agreement with Johns Hopkins University in Baltimore, building on an existing research relationship to give Saegis exclusive access to a drug development platform designed to identify and evaluate compounds for treating age-related cognitive decline. Saegis said it would use Parallax to evaluate its portfolio of in-licensed molecules as well as to identify targets for development.

• Sangamo Biosciences Inc., of Richmond, Calif., said it extended and expanded its zinc finger protein therapeutic development programs with Edwards Lifesciences Corp., of New York, to evaluate therapies for cardiovascular and vascular disease based on Sangamo's zinc finger DNA binding protein transcription factors. The agreement includes up to $3.5 million in research and development funding and milestone payments including $1.95 million for research and development activities performed in 2002 and $1 million in 2003. Also, the companies agreed to collaborate on using zinc finger-binding protein transcription factors for the regulation of phospholamban for the treatment of congestive heart failure.

• Syn X Pharma Inc., of Toronto, introduced a test for congestive heart failure that combines two biomarkers: cardiac troponin I and NT-proBNP. Syn X received a U.S. patent for the blood test last month. Together, the markers are more accurate in predicting patient outcomes than a single marker, the company said. The NT-proBNP marker in the test was developed in-house by Syn X scientists. NT-proBNP belongs to the family of natriuretic peptides that are reported to closely parallel disease severity in congestive heart failure.

• VaxGen Inc., of Brisbane, Calif., reported that Halifax Fund LP, the largest investor in VaxGen's May 2001 $20 million equity financing, converted all 15,000 of its Series A 6 percent cumulative convertible preferred stock into 1,085,138 shares of VaxGen common stock. The conversion eliminates $15 million of redeemable convertible preferred stock from VaxGen's balance sheet. The conversion price was $14.13 per share. VaxGen's stock (NASDAQ:VXGN) fell $3.68 Tuesday, or 18.8 percent, to close at $15.92. (See BioWorld Today, May 25, 2001.)

• Zonagen Inc., of The Woodlands, Texas, said the FDA will require an additional two-year rodent study in order to lift the clinical hold on Vasomax, a drug being investigated to treat erectile dysfunction. The company said it does not anticipate doing another study, although it maintains the drug is safe in humans. Zonagen is in the process of merging with Lavipharm Corp., of East Windsor, N.J. The clinical hold was placed on the Vasomax program in 1999. (See BioWorld Today, Aug. 11, 1999, and Nov. 1, 2002.)