• 4SC AG, of Martinsried, Germany, entered a research cooperation agreement with Schwarz Pharma AG, of Monheim, Germany. The aim is to identify a pre-development candidate for the prevention or treatment of a urological disorder. As part of the agreement, 4SC will receive research funds and is entitled to milestone payments. The deal also envisages that payments will be made when certain milestones in clinical development are reached, as well as revenue share, if the substance is brought to market successfully. Further details on the agreement were undisclosed.

• Affymetrix Inc., of Santa Clara, Calif., granted bioMerieux SA, of Marcy L'Etoile, France, long-term and comprehensive access to its GeneChip technology to develop and market in vitro diagnostic tests for breast cancer, as well as an option to expand the agreement into other cancer areas. The agreement gives bioMerieux nonexclusive rights to Affymetrix's arrays, instrumentation systems and future improvements to the technologies. Financial terms were not disclosed.

• American BioScience Inc., of Santa Monica, Calif., presented data at the Cardiovascular Revascularization Therapies Conference in Washington on the use of protein-engineered nanoparticle albumin bound paclitaxel (Coroxane) to treat restenosis following bare metal stenting of coronary arteries. The Phase I study enrolled 23 patients who were randomized to one of four dose groups and administered Coroxane intravenously immediately following the stenting procedure. Patients receiving less than 70 mg/m2 were free of any significant adverse events related to the drug.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, and partner Boston Scientific Corp., of Natick, Mass., said the FDA approved enhancements to the directions for use of the Taxus Express paclitaxel-eluting coronary stent system, indicating that patients receiving the stent may safely undergo magnetic resonance imaging (MRI) examination immediately following implantation. Boston Scientific's bare-metal stent system also received approval for immediate MRI exams.

• Australian Cancer Technology, of Sydney, Australia, said it will proceed with a pro-rata non-renounceable rights issue to raise A$5.7 million (US$4.4 million) for the company. The rights issue has been fully underwritten by BBY Ltd. Eligible shareholders will be offered one new share for every three shares they hold, as of April 26 at an issue price of 13 cents a share, which the company said is a "significant" discount to the one month volume-weighted average.

• Cell Therapeutics Inc., of Seattle, said a Phase III study of Trisenox consolidation treatment in newly diagnosed acute promyelocytic leukemia (APL) completed enrollment with about 500 patients. The study is being conducted under the Cooperative Research and Development Agreement between Cell Therapeutics and the National Cancer Institute. If Trisenox improves event-free survival, Cell Therapeutics might file a supplemental new drug application for the drug in first-line consolidation for APL patients.

• CoTherix Inc., of South San Francisco, formed a Collaborative Research and Development Agreement with Quadrant Drug Delivery Ltd., of Nottingham, UK, to develop an extended-release formulation of CoTherix's Ventavis (iloprost) inhalation solution. The goal is to reduce the frequency and duration of dosing. Financial terms were not disclosed. Ventavis is marketed in the U.S. to treat pulmonary arterial hypertension in patients with NYHA Class III or IV symptoms.

• CuraGen Corp., of New Haven, Conn., announced that Jonathan Rothberg informed its board of his intention to step down so the company can recruit a new CEO. Rothberg will remain CEO until a new one is appointed. CuraGen develops protein, antibody and small-molecule therapeutics for cancer, inflammatory diseases and diabetes.

• DNAPrint genomics Inc., of Sarasota, Fla., acquired an exclusive worldwide license from Harvard Medical School's Beth Israel Deaconess Medical Center to develop a longer-acting form of the anemia drug erythropoietin. DNAPrint said the royalty-bearing licensing agreement is part of its strategy to use recent genomics and chemistry advances to develop next-generation drugs that maximize the efficacy and minimize side effects by tailoring medication for specific individuals and well-defined population sectors. Financial terms of the agreement were not disclosed. DNAPrint uses genome research to develop services and products, such as its Ancestryby DNA product, its DNAWitness forensics tool and its Ovanome diagnostic tool for ovarian cancer.

• EntreMed Inc., of Rockville, Md., said data from a preclinical study of 2-methoxyestradiol (2ME2) in rheumatoid arthritis demonstrated that oral treatment of the drug resulted in a dose-dependent decrease in severity of arthritic disease as determined by standard clinical measurements. The company reported that the decrease in symptoms was accompanied by a marked inhibition of tissue and joint damage, and that 2ME2 appears to have disease-modifying anti-rheumatic properties. Data were presented at the XXXV International Congress of Physiological Sciences during the American Association of Immunologists meeting in San Diego.

• Gilead Sciences Inc., of Foster City, Calif., received early termination of the required waiting period with respect to the licensing agreement announced on March 22 granting Gilead exclusive rights to develop and commercialize Tokyo-based Japan Tobacco Inc.'s HIV integrase inhibitor, JTK-303. The agreement calls for Gilead to pay Japan Tobacco $15 million up front and up to $90 million in milestone payments, plus future royalties. (See BioWorld Today, March 23, 2005.)

• GlycoGenesys Inc., of Boston, initiated a Phase I/II dose-escalation trial of GCS-100LE in patients with multiple myeloma. Patients will receive the drug as a monotherapy in treatment cycles of two doses per week for two weeks followed by one week off therapy. If patients progress after two cycles or remain stable after four cycles, dexamethasone may be added to their treatment.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, reported additional data from preclinical studies demonstrating that second-generation investigational immune-regulating hormones (IRH) provided significant benefit in preclinical models of acute lung inflammation, septic shock and multiple sclerosis. In the studies, mice treated with second-generation IRH compounds showed increased survival and reduced inflammation compared to placebo-treated animals.

• ImaRx Therapeutics Inc., of Tucson, Ariz., said the first patient has been treated in a Phase II trial evaluating SonoLysis for the treatment of acute ischemic stroke. SonoLysis, which combines external ultrasound with ImaRx's nanobubble, is designed to clear blood clots without the use of invasive surgery or drugs using the lytic t-PA. Results of the 40-patient trial are expected to build on earlier studies that showed t-PA plus ultrasound works more efficiently than t-PA alone in dissolving clots.

• IP Holdings LLC, of Suffern, N.Y., said it formed with James Ryan a genomic start-up venture, Ryogen LLC, to commercialize an intellectual property portfolio developed by Ryan that pertains to segments of the human genome sequence and its applications to microarray manufacturing, gene testing and development of therapeutic agents. The genomic IP portfolio assigned to Ryogen includes 17 patents and patent applications.

• Ipsat Therapies, of Helsinki, Finland, reported positive Phase IIa trial data for its lead product, P1A. The product is designed to inactivate beta-lactam antibiotics in the lower intestinal tract, post-bloodstream absorption. The results were presented at the 15th ECCMID in Copenhagen, Denmark, a European conference on infectious disease. The study showed P1A, when given over a period of five days concurrently with ampicillin, a beta-lactam antibiotic, prevented the emergence of bacterial antibiotic resistance and depletion of healthy intestinal microflora, side effects commonly associated with antibiotic treatment.

• Kosan Biosciences Inc., of Hayward, Calif., said its Phase II trial of KOS-862 as a monotherapy for patients with metastatic breast cancer will proceed to full enrollment following successful completion of the interim analysis. The company plans to present data in the first half of the year that will detail the response rates found in the trial to date. Kosan also is evaluating KOS-862 in a Phase II monotherapy trial in prostate cancer, and it has advanced a next-generation epothilone, KOS-1584, into Phase I testing.

• Ligand Pharmaceuticals Inc., of San Diego, reported that the company earned a $1.5 million milestone payment from TAP Pharmaceuticals Products Inc., of Lake Forest, Ill., with TAP's submission of an investigational new drug application to the FDA to evaluate LGD2941 as a potential new therapy for the treatment of osteoporosis and frailty. LGD is a selective androgen receptor modulator developed as a result of a collaboration between Ligand and TAP.

• Living Cell Technologies Ltd., of Sydney, Australia, said its product, DiaBCell (encapsulated living islet cell) was well tolerated and caused no adverse reactions in treated monkeys during a six-month trial. Designed for Type I diabetes, DiaBCell is intended to supply insulin and control blood sugar when transplanted into diabetics. Monkeys in the trial received two doses, one at the start of the study and the second dose three months later, and LCT reported that monkeys receiving DiaBCell reduced their insulin requirements, while those given blank capsules needed more insulin than before the transplants.

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., entered a clinical research collaboration with the Mayo Clinic to evaluate Nastech's RNA interference-based therapeutic formulations in immune cells from patients with rheumatoid arthritis. The collaboration will involve the measurement of a series of inflammatory cytokines, including human tumor necrosis factor alpha, and the screening of formulations that contain siRNA sequences. Data demonstrating the successful preclinical, in vivo use of an RNAi-based drug directed against the expression of H-TNF-alpha was highlighted at the 2005 American Society for Biochemistry and Molecular Biology annual meeting in San Diego.

• Neoprobe Corp., of Dublin, Ohio, completed a license agreement with Enlyton Ltd. for U.S. Patent Nos. 6,418,338 and 6,760,612 B2. The patents provide Neoprobe with an extension of methodology patent protection for the RIGS technology through 2018. The RIGS system combines the company's gamma-detection device technology with a disease-specific radiolabeled cancer targeting agent, and a surgical method to locate tumor deposits not detectable by conventional methods.

• Scolr Pharma Inc., of Bellevue, Wash., said its board elected Michael Taglich as chairman. He succeeds David Howard, who is retiring. Taglich has served as a director of Scolr Pharma since August 2003 and is a founder and principal at the investment banking firm Taglich Brothers Inc. in New York.

• Serologicals Corp., of Atlanta, said its wholly owned subsidiary, Chemicon International Inc., of Temecula, Calif., expanded its exclusive worldwide agreement with Amrad Corp. Ltd. and The Walter and Eliza Hall Institute of Medical Research, both of Melbourne, Australia. Chemicon gains additional rights to further develop its embryonic stem cell products, Leukemia Inhibitory Factor (LIF) and ESGRO, into additional kits and combination products. The new agreement expands the 1999 license agreement covering LIF patent rights to include additional fields of use outside of therapeutics.

• Specialty Laboratories Inc., of San Diego, said it will participate in a joint working group on molecular diagnostics initiated by Sequenom Inc., of San Diego, and Siemens Medical Solutions, of Erlangen, Germany-based Siemens AG. Sequenom's MassArray Compact System, a genetic analysis platform, will be installed at Specialty's new clinical laboratory facility. The partnership between Siemens and Sequenom was announced in late 2004.

• TransForm Pharmaceuticals Inc., of Lexington, Mass., was acquired by Johnson & Johnson, of New Brunswick, N.J. The transaction was completed as announced on March 9 for $230 million. TransForm specializes in the discovery of formulations and crystalline forms of drug molecules. (See BioWorld Today, March 10, 2005.)

• Veritas Medicine Inc., of Cambridge, Mass., said researchers are further evaluating the investigational therapy OvaRex MAb (oregovomab) to determine the extent of remission in patients who have a favorable response to surgery and chemotherapy. Researchers also will assess survival, quality of life, immune response and safety in women with Stage III or IV ovarian cancer within four to 12 weeks of completing the last doses of initial chemotherapy. OvaRex was developed by Edmonton, Alberta-based AltaRex Medical Corp., with most of the rights licensed to Unither Pharmaceuticals Inc., a subsidiary of Silver Spring, Md.-based United Therapeutics Corp.

• ZioPharm Inc., of New Haven, Conn., said the FDA approved its investigational new drug application for the clinical development of its organic arsenic compound, ZIO-101. The company plans to initiate a dose-ranging Phase I trial of ZIO-101 in patients with hematological cancers this month. The trial will be conducted at the University of Texas M.D. Anderson Cancer Center in Houston.