• 4SC AG, of Martinsried, Germany, said it spun off of an independent company, Quattro Research GmbH, which develops software solutions for the integration of chemical and biological data in drug discovery and development. Quattro draws on know-how and software developments within 4SC. Its 4Scan technology for the virtual screening of large data sets does not constitute part of the spin-off.

• Acacia Research Corp., of Newport Beach, Calif., said its CombiMatrix group signed a research agreement with Case Western Research University in Cleveland for work in developing a diagnostic for Alzheimer's disease using the CustomArray platform. The university work is directed by Alzheimer's researcher Mark Smith, professor in the department of pathology.

• Acambis plc, of Cambridge, UK, named Gordon Cameron CEO. He served as the president of the company's U.S. division in Cambridge, Mass., since March 2001. He came to Acambis in 1996 as chief financial officer. Separately, Acambis changed the ratio of its American depositary receipts (ADRs), which are traded on the Nasdaq exchange, from one ADR for 10 ordinary shares to one ADR for two ordinary shares. ADR holders on record as of Feb. 20 will be issued four additional ADRs for every ADR held. There is no change to the company's ordinary shares, whose primary listing continues to be on the London Stock Exchange.

• Alteon Inc., of Parsippany, N.J., said efficacy and safety findings from a post hoc analysis of ambulatory blood pressure measurements in the Phase IIb Sapphire/Silver trial of ALT-711 support the potential for using the A.G.E. crosslink breaker as an antihypertensive agent with unique characteristics for the treatment of uncontrolled systolic hypertension. Data showed that ALT-711 treatment resulted in highly significant lowering of systolic blood pressures in patients with a baseline systolic ABPM of 140 mm Hg or greater, with little concurrent effect on diastolic blood pressure readings.

• Atrix Laboratories Inc., of Fort Collins, Colo., submitted a new drug application to the FDA for Eligard 45mg (leuprolide acetate for injectable suspension), a six-month, sustained-release product for hormone-sensitive, advanced prostate cancer. Already reported interim Phase III data suggested Eligard 45mg suppresses testosterone to low levels with minimal breakthroughs, a situation in which testosterone levels rise above the castrate threshold of 50 ng/dL. Sanofi-Synthelabo Inc., a unit of Sanofi-Synthelabo SA, of Paris, is marketing one-, three- and four-month extended-release Eligard products (7.5mg, 22.5mg and 30mg) in the U.S., and would market the six-month product should it receive approval.

• BioMarin Pharmaceutical Inc., of Novato, Calif., began its clinical program for the treatment of phenylketonuria (PKU), an enzyme deficiency disorder that can cause mental retardation and brain damage and affects at least 50,000 diagnosed people in the developed world. Originally projected to start at the end of next month, the first pilot trial will evaluate PKU patient responsiveness to the enzyme co-factor 6R-BH4. Expected to be completed in the second quarter, the study's goal is to define the 6R-Bh4 screening method that will be used to identify the population of PKU patients who most likely would respond to Phenoptin, BioMarin's form of 6R-Bh4.

• Cengent Therapeutics Inc., of San Diego, and the Center for Biophysical Sciences and Engineering of the University of Alabama at Birmingham, said they created the first integrated computational and physical structure determination service offering for in-house drug discovery efforts of the pharmaceutical and biotechnology industries. Cengent and the center provide a solution for 3-D, structure-based drug lead discovery and structure-based optimization. The service also may provide structurally validated initial drug leads in support of existing in-house screening efforts by providing compound pre-selection and overflow capacity.

• Cytopia Pty. Ltd., of Melbourne, Australia, and Myomatrix Therapeutics LLC, of Rensselaer, N.Y., said they achieved a milestone in their collaboration to develop treatments for cardiovascular disorders, including heart failure. Kinase inhibitors developed by Cytopia have been shown to block signaling pathways in cardiac myocytes that are associated with heart failure. The new data showed that in the in vitro cardiac myocyte model, Cytopia's specific molecules are more effective than the molecules tested in previous work at the State University of New York.

• Diversa Corp., of San Diego, entered a long-term contract with Fermic SA de CV, of Mexico City, to provide manufacturing capacity for the production of Diversa's enzyme products. Diversa will increase its available manufacturing capacity to a level sufficient for the production of enzyme products representing more than $100 million in potential future annual product sales by Diversa and its partners. Fermic will provide manufacturing capacity for enzymes exclusively to Diversa, which will co-invest in certain mutually agreed-upon capital equipment in exchange for credits for manufacturing services to be provided by Fermic.

• Exelixis Inc., of South San Francisco, said its scientists published two articles in the online edition of Nature Genetics describing the most complete functional genetic toolkit for studying a multicellular organism. The Exelixis collection includes specific disruptions in a majority of genes in the fruit fly, Drosiphila melanogaster, and the company called the toolkit an example of its ability to industrialize the use of model system genetics to identify modifiers of important disease pathways.

• Generex Biotechnology Corp., of Toronto, entered a collaboration with the Chinese Academy of Science in Shanghai to develop a vaccine for severe acute respiratory syndrome. Antigen Express, Generex's subsidiary, developed technologies to enhance the potency of DNA vaccines. Together they seek to create an effective DNA vaccine for protection against SARS infections. Antigen Express's technology focuses on modulating immune responses mediated by T helper cells.

• Genetronics BioMedical Corp., of San Diego, completed the special protocol assessment review process with the FDA for two pivotal Phase III studies to evaluate its MedPulser Electroporation Therapy System as a treatment for recurrent and second primary squamous cell carcinomas of the head and neck. Both protocols will compare the investigational system to surgery, with a primary endpoint designed to demonstrate that patients treated with electroporation therapy have superior preservation of function (e.g., eating, swallowing and talking) when compared to surgery.

• GPC Biotech AG, of Martinsried, Germany, said data published in this month's issue of Chemistry and Biology described its drug-target interaction technology, LeadCode. Human protein kinases represent a family of more than 500 enzymes that are drug targets for various therapeutic areas, including cancer. In the published study, LeadCode was applied to several cyclin-dependent kinase (Cdk) inhibitors. GPC Biotech has a program to develop Cdk inhibitors as anticancer drugs.

• Guilford Pharmaceuticals Inc., of Baltimore, said the National Institutes of Health in Bethesda, Md., began a Phase II trial to test the company's neuroimmunophilin ligand, GPI 1485, as part of a program investigating neuroprotective therapies for Parkinson's disease. The study is being funded by the National Institute of Neurological Disorders and Stroke, part of the NIH also located in Bethesda. Guilford said the institute selected GPI 1485 based on preclinical animal data. GPI 1484 also is in a Phase II trial for post-prostatectomy erectile dysfunction.

• Lorus Therapeutics Inc., of Toronto, said its common stock began trading on the American Stock Exchange under the ticker symbol "LRP." Lorus is developing products and technologies for the management of cancer.

• Marshall Edwards Inc., of Washington, began a clinical trial of the investigational anticancer drug phenoxodiol in patients with cancer of the cervix. In the study of patients with squamous cell carcinoma and adenocarcinoma of the cervix, vagina and vulva, subjects will have a primary diagnosis of cancer. It will evaluate the safety and ability of phenoxodiol when it is given as a monotherapy in early-stage cancer. Marshall Edwards licensed phenoxodiol from Novogen Ltd., of Sydney, Australia.

• MedImmune Inc., of Gaithersburg, Md., said preclinical findings published in the Feb. 15, 2004, issue of Clinical Cancer Research showed that elevated levels of PC cell-derived growth factor (PCDGF) may be an early signal of prostate cancer progression. Along with collaborators at A&G Pharmaceutical Inc., of Columbia, Md., and Indiana University, the researchers documented significantly higher levels of PCDGF expression in clinical samples of invasive prostate cancer tissue than in adjacent benign or normal tissue.

• Nabi Biopharmaceuticals Inc., of Boca Raton, Fla., called preliminary results of its Phase I/II trial of Civacir encouraging, noting that the product was well tolerated in both high- and low-dose treatment arms. The findings also revealed a trend toward a reduction in levels of ALT (serum alanine aminotransferase, a liver enzyme that measures liver function). The study was designed to evaluate the safety and pharmacokinetics of two dose levels of Civacir (hepatitis C immune globulin [human]), an antibody-based therapy being developed to prevent hepatitis C virus re-infection of transplanted livers in patients with chronic hepatitis C, vs. a control in a total of 18 patients who underwent liver transplantation due to hepatitis C-induced end-stage liver failure.

• NeoRx Corp., of Seattle, raised gross proceeds of about $9.7 million after entering a securities purchase agreement with certain institutional investors in a private placement. The company sold about 1.85 million common shares at $5.25 apiece, a 2 percent premium to the 10-day volume-weighted average of the stock. The investors also received five-year warrants to purchase 922,500 shares at an exercise price of $7 apiece. Reedland Capital Partners, a Division of Financial West Group, served as the placement agent in the financing.

• Pharmion Corp., of Boulder, Colo., said the FDA accepted its Vidaza new drug application for filing and granted priority review status for the NDA, reducing the standard agency response time to six months and targeting an agency response on or before June 29. The submission was based upon a National Cancer Institute-sponsored Phase III study of Vidaza (azacitidine for injectable suspension) for myelodysplastic syndromes, conducted by Cancer and Leukemia Group B, and two supportive Phase II studies conducted and sponsored by the same groups. Pharmion filed the NDA about two months ago. (See BioWorld Today, Dec. 30, 2003.)

• SuperGen Inc., of Dublin, Calif., told the SEC it plans to withdraw its proposed offering of 9.5 million common shares, which also included 250,000 shares to be offered by a selling stockholder. The company said its management would provide additional business updates during a financial results conference call later this week.

• Tissera Inc., of Tel Aviv, Israel, raised net proceeds of $1.6 million after completing a private equity placement with a group of individual and institutional investors. Tissera is developing tissue precursor regeneration technologies to address a variety of illnesses in which organ transplantation is necessary.

• Transkaryotic Therapies Inc., of Cambridge, Mass., said it will extend enrollment in its pivotal trial evaluating iduronate-2-sulfatase (I2S) enzyme replacement therapy for Hunter's syndrome (MPS II). The company intended to close enrollment this month, but with 84 patients currently enrolled and commitments to additional patients, it believes the study will reach its 90-patient target early next month. The extension allows TKT to fulfill commitments to four families from Japan who are relocating to the U.S. to participate in the trial, referred to as the AIM study (Assessment of I2S in MPS II). This effort, conducted with the help of TKT's partner for Japan, Genzyme Corp., also of Cambridge, may result in a slight over-enrollment.

• Varian Inc., of Palo Alto, Calif., added the Pursuit Diphenyl column to its line of laboratory consumable products for liquid chromatography. The company said the column contains bonded-phase chemistry that is more sensitive to analytes with double bonds or aromatic rings, both of which it called challenging for pharmaceutical and environmental scientists.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., said findings published in Nature Medicine showed that VX-680 blocked cancer cell proliferation and also triggered cell death in a range of tumor cell types. A selective small-molecule inhibitor of the Aurora kinases, which are known to be overexpressed in many tumor types, VX-680 was shown to reduce tumor growth in cancer models. Data from in vivo xenograft models indicated that VX-680 achieved complete inhibition of tumor growth at well-tolerated doses. Vertex's stock (NASDAQ:VRTX) gained 76 cents Monday, or 7.4 percent, to close at $10.97.

• Y's Therapeutics Co. Ltd., of Tokyo, raised 2.4 billion yen (US$22 million) through a Series B financing that included new and existing investors. The privately held company said it would use the proceeds to advance its product development pipeline, which includes antibody therapeutics and small-molecule products for oncology and autoimmune diseases. The financing was led by Softbank Investment Corp., with additional investments from Zenkoku Hosho Co. Ltd., Biovision Capital Corp. and unnamed venture capitalists.