• Australian Cancer Technology Ltd., of Sydney, said its soon-to-be-acquired U.S. business, Galenica Pharmaceuticals Inc., of Birmingham, Ala., signed an agreement allowing the use of its lead product, the GPI-0100 adjuvant, by New York-based Memorial Sloan-Kettering Cancer Center in a series of clinical trials. Memorial Sloan-Kettering intends to use GPI-0100 in conjunction with specific vaccine antigens in several clinical trials in patients with melanoma, sarcoma, neuroblastoma, small-cell lung cancer and cancers of the breast or ovary. If antibody responses are demonstrated in the trials, the vaccine adjuvant will move into Phase II trials. Australian Cancer announced in May its intention to acquire Galenica for $5 million.

• Barrier Therapeutics Inc., of Princeton, N.J., said its drug Liarozole received orphan drug designation for the treatment of congenital ichthyosis. There are no prescription drugs approved for that indication in the U.S. In prior Phase II and Phase III trials, oral Liarozole was well tolerated and a majority of patients showed improvement. The drug previously was granted orphan drug status by the European Commission.

• Cellomics Inc., of Pittsburgh, entered a nonexclusive, worldwide patent license agreement for its core HCS patent portfolio with UK-based GE Healthcare, a unit of General Electric Co. GE Healthcare also will gain rights to broker sublicenses of Cellomics' HCS patent portfolio to key pharmaceutical companies. The agreements will broaden the availability of high-content screening through the licensing of Cellomics' portfolio. Financial details were not disclosed.

• Celltech Group plc, of Slough, UK, said the FDA approved Codeprex (codeine polistirex/chlorpheniramine polistirex) extended-release suspension CIII for cough relief. The drug uses Celltech's Pennkinetic extended-release drug delivery technology to provide 12-hour dosing. Codeprex is the first codeine-based cough suppressant to provide 12-hour dosing.

• Chiron Corp., of Emeryville, Calif., granted a nonexclusive license to Prosetta Corp., of San Francisco, for the research, development and commercialization of therapeutics against certain hepatitis C virus drug targets. The licensing agreement is the first providing what it called a "no entry cost" option for use of the company's HCV technology. The terms are intended to provide flexibility to licensees by confirming the availability of no up-front or annual payments. The licenses, which include milestone and royalty payments on products developed using the technology, are available to companies that seek to use it for new therapies, Chiron said.

• Chromos Molecular Systems Inc., of Burnaby, British Columbia, entered a definitive agreement to acquire CellExSys Inc., of Seattle. A majority-owned subsidiary of Targeted Genetics Corp., also of Seattle, CellExSys will provide Chromos with T-cell therapy technology and a preclinical pipeline to support product development to treat infectious diseases and cancers. Chromos agreed to fund certain of CellExSys' operational costs through closing. It will acquire all of the issued and outstanding shares of CellExSys by issuing 1.5 million Chromos common shares, worth about C$1.2 million (US$884,500), and a convertible debenture of about C$3.4 million to CellExSys shareholders at closing. If the debenture is fully paid in common shares of Chromos, CellExSys shareholders would receive up to about 17.2 percent of Chromos, based on current shares issued and outstanding.

• Cytogen Corp., of Princeton, N.J., said new data on Quadramet (samarium SM 153 lexidronam injection) presented at the 51st annual meeting of the Society of Nuclear Medicine show it might have anticancer activity. The data resulted from an independent study evaluating the safety and efficacy of Quadramet in conjunction with chemotherapy to treat bone metastases secondary to prostate cancer. Quadramet is available as a non-narcotic alternative for pain relief from bone metastases associated with prostate, breast, multiple myeloma and other cancers. In a study of 30 patients, the median survival was 18 months in the combination group vs. 11 months in the non-combination group. Cytogen's stock (NASDAQ:CYTO) rose $1.38 Tuesday, or 12.1 percent, to close at $12.81.

• Dynavax Technologies Corp., of Berkeley, Calif., began a Phase II/III trial of its hepatitis B prophylactic vaccine in Singapore. The double-blind study will compare the vaccine candidate with London-based GlaxoSmithKline plc's marketed vaccine Engerix B. The trial will involve 80 subjects not immunized against hepatitis B at two study centers in Singapore and is expected to be completed in early 2005. Patients will receive three injections over six months, with antibody titer levels measured four weeks after each injection. The primary endpoint will be comparative protective antibody titer levels measured after the third injection.

• Fulcrum Pharmaceuticals Inc., of Las Vegas, said that Charles Blitzer was appointed president and CEO. Most recently, Blitzer served as chairman and CEO of MGI Pharma. Founded in 2002, Fulcrum applies computational chemistry, structural biology and thermodynamics for the accelerated design and development of drug products.

• Galileo Genomics Inc., of Montreal, and Perlegen Sciences Inc., of Mountain View, Calif., completed a linkage disequilibrium-based genome-wide scan (LD-GWS) of Crohn's disease in the Quebec Founder population. The study identified two disease genes, NOD2/CARD15 and OCTN, as well as more than 10 new regions associated with Crohn's disease. The scan was performed on 1,500 people using more than 248,000 single nucleotide polymorphism markers distributed throughout the human genome, resulting in 372 million genetic analyses.

• Generex Biotechnology Corp., of Toronto, reported the presentation of a research abstract by the chief scientific officer of its Antigen Express immunomedicines subsidiary. The paper was on the "Transmucosal Delivery of Therapeutics by RapidMist Technology and TH-1 T-helper cell li-Key/MHC Class II Peptide Vaccine Against Cancer and HIV." The inventor of the technology at Generex developed a method for aerosolized delivery of proteins and peptides through the buccal mucosa by a RapidMist device using a pressurized fluorocarbon.

• Gloucester Pharmaceuticals Inc., of Cambridge, Mass., presented results from an ongoing Phase II trial with FK228 in a poster at the recent annual meeting of the American Society of Clinical Oncology in New Orleans. The multi-arm trial is enrolling patients with cutaneous T-cell lymphoma (CTCL) and relapsed peripheral T-cell lymphoma (PTCL). To date, 46 patients have been enrolled in four arms of the study. Nine of 18 patients with CTCL who had received no more than two previous cytotoxic chemotherapy regimens achieved objective responses, for an overall response rate of 50 percent. Of 20 patients with PTCL, five achieved a partial response for an overall response rate of 25 percent. The trial is sponsored by the National Cancer Institute in Bethesda, Md.

• ILEX Oncology Inc., of San Antonio, sold its UK-based clinical research and regulatory service office to the contract research organization Ergomed Clinical Research Ltd., of Frankfurt, Germany. The office was previously owned and operated by ILEX Services Ltd., a subsidiary of ILEX Oncology Services Inc. Ergomed will become a preferred provider of services to ILEX and will continue to provide site management, monitoring and project management services for ongoing clinical studies outside the United States.

• Immusol Inc., of San Diego, initiated a collaboration with Affymetrix Inc., of Santa Clara, Calif., that will facilitate the discovery and characterization of new, as well as existing, targets for cancer therapies. Immusol will use Affymetrix's GeneChip technology to identify oncology pathways from its engineered tumor cells in biological assays. Specific terms were not disclosed.

• Molecular Insight Pharmaceuticals Inc., of Cambridge, Mass., said a novel polymer-peptide conjugate developed at the University of Maryland that uses the company's SAAC technology demonstrated an ability to target prostate cancer tumor vessels. Molecular Insight's technology is used to carry diagnostic or therapeutic radionuclides with matching distribution. The results were presented at the Society of Nuclear Medicine's annual meeting in Philadelphia.

• MultiCell Technologies Inc., of Warwick, R.I., said that effective Tuesday, the company's trading symbol on the Over-the-Counter Bulletin Board changed from "EXTI" to "MUCL." MultiCell provides non-tumorigenic functional hepatic cells and cell lines to pharmaceutical companies for induction studies, as well as toxicity screening for drug discovery.

• Nabi Biopharmaceuticals Inc., of Boca Raton, Fla., began the first in a series of additional clinical studies of StaphVAX (Staphylococcus aureus polysaccharide conjugate vaccine). The studies will target cardiovascular and orthopedic surgery patients in the U.S. and Europe, with the goal of providing evidence that a vaccine against S. aureus bacterial infections can raise high levels of antibodies capable of providing protection in patients at-risk for the infections. The Phase IIb immunogenicity study will include 200 patients at 10 U.S. centers. They will be evaluated over a six-month period. The results are expected to support Nabi's 2005 biologics license application filing in the U.S. and to be added as a supplement to the European filing. StaphVAX is in a Phase III trial in end-stage renal disease patients.

• NitroMed Inc., of Bedford, Mass., said its lead nitric oxide-enhancing COX-2 inhibitor moved into Phase II trials under the direction of Merck & Co. Inc., of Whitehouse Station, N.J. The companies are in a three-year collaboration to develop nitric oxide COX-2 inhibitors to treat pain and inflammation, as well as other conditions and diseases. To date, NitroMed has received $24.2 million in payments, and the research collaboration has achieved two milestones. In December, NitroMed received a $5 million milestone payment for advancing the compound into Phase I testing.

• PamGene International BV, of s-Hertogenbosch, the Netherlands, and Jerini Peptide Technologies, a division of Jerini AG, of Berlin, established a collaboration to provide a new technology for kinase studies. PamGene's ability to generate kinetic read-outs of multiple kinase activities on its 3-dimensional microarray platform will be complemented by JPT's peptide expertise and peptide libraries, the companies said. The joint product offering has been designed to benefit signal transduction-focused medicinal chemistry groups.

• Paradigm Genetics Inc., of Research Triangle Park, N.C., and Experimental Pathology Laboratories Inc., of Herndon, Va., entered a collaboration to further the development of Paradigm's automated pathology software. Paradigm specializes in the development and application of software for the objective mathematical quantification of tissue changes in disease and toxicology and the automated screening of tissue slide normality. EPL provides veterinary pathology expertise.

• PharmaMar SA, of Madrid, Spain, said an investigational new drug application was accepted by the FDA for the clinical testing of Aplidin. The IND allows the start of two Phase II studies in the U.S., one in patients with multiple myeloma and another in prostate cancer patients. Aplidin is an antitumor agent derived from the marine tunicate Aplidium albicans. It induces activation of apoptosis combined with blocking of cell division in the G1/G2 phase of the cell cycle in tumor cells.

• Point Therapeutics Inc., of Boston, began a Phase II trial of its lead compound, talabostat (PT-100), to treat advanced chronic lymphocytic leukemia (CLL). The single-arm study is designed to evaluate the antitumor activity of talabostat in combination with Rituxan in up to 54 patients with advanced CLL who have failed a fludarabine/rituximab-containing regimen. The primary clinical endpoint will be overall tumor response. At the mid-point of the study, tumor response rates will be compared to historical response rates of current therapies to determine whether the trial should continue. Secondary endpoints include complete response rate, duration of tumor response, time to disease progression and survival.

• Praecis Pharmaceuticals Inc., of Waltham, Mass., said it received clearance from the FDA to resume its Phase I trial of PPI-2458 in non-Hodgkin's lymphoma. The FDA had issued a clinical hold based on a preliminary neuropathological finding in an animal safety study, but notified Praecis that the issues have been resolved. PPI-2458 blocks a novel molecular target involved in cancer and autoimmune diseases. Praecis also said the Centers for Medicare and Medicaid Services assigned a permanent billing code for Plenaxis (abarelix for injectable suspension) under the Healthcare Common Procedural Coding System for use by hospitals, in connection with outpatient administration of the drug. As of July 1, hospitals may use the code to bill Medicare electronically for the use of Plenaxis.

• ProdiGene Inc., of College Station, Texas, said its plant-produced recombinant bovine-sequence trypsin, TrypZean, now is available. Trypsin is a serine protease produced by the pancreas that catalyzes the breakdown of proteins. It has several commercial applications, including the production of insulin, in the manufacture of both human and veterinary vaccines, cell culture and wound care.

• Tercica Inc., of South San Francisco, said it expects to join the Russell 3000 index when the broad-market index is reconstituted on Friday, according to a preliminary list of additions issued by Russell Investment Group. Membership in the Russell 3000 means automatic inclusion in either the large-cap Russell 1000 Index or small-cap Russell 2000 Index. The final membership will be posted July 6. Tercica is focused on the development and commercialization of rhlGF-1 for the treatment of short stature, diabetes and other endocrine system disorders.

• Unigene Laboratories Inc., of Fairfield, N.J., said it would receive a $4 million milestone payment from GlaxoSmithKline plc, of London, after beginning a Phase I trial of an oral formulation of parathyroid hormone (PTH) they are developing in collaboration. Under the two-year-old license agreement, GSK received an exclusive worldwide license to develop an oral formulation of PTH under Unigene's manufacturing and oral delivery patents. The agreement could have a value to Unigene, before royalties, PTH sales and reimbursement for development activities, of up to $150 million.

• Varian Inc., of Palo Alto, Calif., introduced its first-ever Narrow Bore Triple Resonance MAS probes, a nuclear magnetic resonance probe line that allows protein NMR laboratories to run biological solids experiments on existing systems. Biosolids experiments allow access to the 70 percent of all cellular proteins, such as membrane proteins, that are considered solids because they are not free in intracellular fluid. The studies could provide researchers with insight into molecules associated with Alzheimer's disease and HIV, Varian said.

• Vasogen Inc., of Toronto, said results from its Phase II trial of Celacade (immune modulation therapy) in patients with advanced chronic heart failure were accepted for publication in the Journal of the American College of Cardiology. As previously reported, the key finding from the trial was a significant reduction in the risk of death and all-cause hospitalization for advanced heart failure patients receiving Celacade, compared to those receiving placebo.

• ViroPharma Inc., of Exton, Pa., terminated its exchange offer for up to about $99 million of its new 6 percent convertible senior plus cash notes due 2009 for up to all of the $128 million of its currently outstanding 6 percent convertible subordinated notes. It was a condition of the exchange offer that holders of the outstanding notes tender a minimum of 80 percent, but the condition was not satisfied, as about 3.7 percent of the notes were tendered. ViroPharma, which is developing products for cytomegalovirus and hepatitis C, previously extended the exchange offer twice in order to hold informal discussions about revising terms. But those proposed by the noteholders related to equity dilution and price were not acceptable to ViroPharma, which plans to continue to explore alternative methods of restructuring its convertible subordinated debt.

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