• Atrix Laboratories Inc., of Fort Collins, Colo., said patients in the Eligard 45mg (leuprolide acetate for injectable suspension) Phase III trials have completed the first six months of treatment and received the second injection required under the clinical protocol. Atrix expects to complete the study by the end of the year.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., signed a Cooperative Research and Development Agreement with the U.S. Army's Medical Research Institute of Infectious Diseases for the development of biodefense vaccines. The institute agreed to grant BioSante an exclusive license to any U.S. patent application or issued patent as a result of the agreement. Financial terms were not disclosed.

• Cambrex Corp., of East Rutherford, N.J., said it is constructing a new facility to accommodate four cGMP suites dedicated to cell therapy manufacturing. The expansion will increase the company's manufacturing capacity by 100 percent. The facility and the first two suites are expected to be completed and validated by December.

• Cellectis SA, of Paris, France, said data were published in Nucleic Acids Research that demonstrated an engineered meganuclease induces homologous recombination in yeast and mammalian cells. Meganucleases trigger the spread of genetic mobile elements through targeted homologous recombination. The authors used different fusions of homing endonuclease of the LAGLIDADG family to obtain novel active proteins, Cellectis said. The results show that LAGLIDADG proteins are made of separable DNA binding domains that can be recombined.

• Chiron Corp., of Emeryville, Calif., presented at the 26th European Cystic Fibrosis Conference in Belfast, Ireland, results from a TOBI tobramycin solution for inhalation study. The study involved 184 cystic fibrosis patients 6 to 15 years old and showed that those undergoing TOBI treatment in conjunction with routine care were less likely to be hospitalized for respiratory symptoms or to be treated with oral antibiotics than those getting routine care alone. Separately, it noted the expiration of the waiting period associated with its pending acquisition of PowderJect Pharmaceuticals plc, of Oxford, UK. The acquisition was announced in May and valued PowderJect at $880 million. (See BioWorld Today, May 20, 2003.)

• Ciphergen Biosystems Inc., of Fremont, Calif., said its ProteinChip Technology is being used by Health Canada's National Microbiology Lab, Beijing Clinical SARS Testing Center and the Genomic Institute of Singapore, among others, to search for biomarkers associated with severe acute respiratory syndrome. Separately, Ciphergen said it launched its Interaction Discovery Mapping platform based on the SELDI ProteinChip Biomarker System.

• Contract Pharmaceuticals Ltd. Canada, of Mississauga, Ontario, said it acquired Innopharm Inc., of Markham, Ontario, combining the two privately held firms' contract manufacturing and laboratory operations. Financial terms were not disclosed.

• Debiopharm SA, of Lausanne, Switzerland, and GenOdyssee SA, of Les Ulis, France, entered a collaboration in which GenOdyssee grants Debiopharm the exclusive worldwide license to develop and commercialize a compound in the therapeutic areas of oncology, oncology-associated side effects and virology from the GenOdyssee portfolio. Debiopharm will fund development of the product, including manufacturing, preclinical and clinical trials up to its registration. GenOdyssee will receive cash up front and a milestone payment from Debiopharm when the product enters Phase III trials, as well as a share of revenues from the licensing out to a commercial partner.

• Eksigent Technologies, of Livermore, Calif., said it would unveil its NanoLC Proteomics System at next week's American Society of Mass Spectrometry meeting in Montreal. Eksigent said the liquid chromatography system is designed to allow nanoscale liquid chromatography and mass spectrometry without flow splitting, providing improvements in detection sensitivity and reproducibility for liquid chromatography and mass spectrometry proteomics studies.

• Elite Pharmaceutical Inc., of Mahwah, N.J., responded to the resignation of Atul Mehta, its chairman, president and CEO. Mehta resigned amid differences with the board regarding the firm's management and direction. Mehta said the board "has taken actions which completely undermine my ability to direct and manage the company's affairs." Mehta, who said he led Elite's research and development efforts, added that he would seek alternative opportunities to continue his work to develop and market controlled-release drug delivery systems. Elite separately confirmed the resignation and said a majority of the board had notified Mehta that sufficient grounds existed for the termination of his employment pursuant to his employment agreement. Elite said its board appointed John Moore as chairman and retained Bernard Berk as CEO.

• EntreMed Inc., of Rockville, Md., and Corvas International Inc., of San Diego, published findings in the June 1, 2003, issue of Cancer Research demonstrating that the growth of primary and metastatic tumors in animal models was prevented when scientists blocked the activity of a naturally occurring complex of two proteins that activates blood clotting (tissue factor and factor VIIa). The partners added that the data demonstrated for the first time that the TF/fVIIa inhibitors' antitumor activity is independent of the pathway related to blood clotting. Such a discovery could lead to new therapies that have antitumor activity without affecting processes involved in normal blood clotting.

• EpiTan Ltd., of Melbourne, Australia, signed collaborative research agreements with Monash University in Melbourne and the Institute of Medical and Veterinary Science in Adelaide, Australia, to help develop a topical formulation of Melanotan. Financial terms were not disclosed.

• Genaera Corp., of Plymouth Meeting, Pa., said it regained full compliance with the Nasdaq SmallCap Market's listing requirements after its shares closed above $1 for more than 10 straight days in the second half of last month. The company previously had until Sept. 18 to meet the prerequisite.

• Genesis Bioventures Inc., of New York, said its portfolio company, Prion Developmental Laboratories, is in late-stage development of its rapid lateral flow tests for transmissible spongiform encephalopathies such as bovine spongiform encephalopathy, also called mad cow disease, and chronic wasting disease.

• Genta Inc., of Berkeley Heights, N.J., said preclinical data published in the Proceedings of the Annual Meeting of the American Society of Clinical Oncology showed Genasense (oblimersen sodium) enhanced the effectiveness of Campath (alemtuzumab, from ILEX Oncology Inc., of San Antonio) against both chronic lymphocytic leukemia and non-Hodgkin's lymphoma cells. Genta said its lead anticancer compound inhibits production of Bcl-2, a protein expressed in malignant cells from patients with both diseases.

• GenVec Inc., of Gaithersburg, Md., reported early data on its research of hearing loss and balance disorders. Proof-of-principle studies conducted at the University of Michigan using the atonal homologue MATH-1 and GenVec's technology showed the generation of new hair cells in mature mammalian inner ears. The studies are published in the June 2003 issue of the Journal of Neuroscience.

• GlaxoSmithKline, of Research Triangle Park, N.C., a division of GlaxoSmithKline plc, of London, issued a final call for submissions for its Drug Discovery and Development Research Grant Program. Researchers working on HIV-AIDS drug therapies will have until July 31 to apply. GSK will award $500,000 in research grants for HIV-AIDS drug research in recognition of the need to produce new alternatives. Grants will range from $25,000 to $150,000.

• Introgen Therapeutics Inc., of Austin, Texas, said a cancer patient with metastatic melanoma showed regression of multiple tumors including a complete regression of one lesion after treatment with Introgen's mda-7 therapeutic, INGN 241. A report of final Phase I and initial Phase II evaluation of INGN 241 was presented during the annual meeting of the American Society of Clinical Oncology in Chicago.

• Isotechnika Inc., of Edmonton, Alberta, reported final data from a Phase IIa kidney transplant study of ISA247 at the American Transplant Congress in Washington, showing that its lead immunosuppressive drug was well tolerated and efficacious as the study met all of its primary and secondary endpoints. More specifically, the trial demonstrated that stable kidney transplant patients on ISA247 experienced no change in kidney function when compared to patients in the cyclosporine arm, the study's primary endpoint. Secondary endpoints included safety parameters associated with graft rejection in ISA247 patients as well as measures of the compound's pharmacodynamics and pharmacokinetics.

• Medicure Inc., of Winnipeg, Manitoba, said it is moving ahead with a submission to begin Phase II/III development of MC-4232 in hypertension. The company said the FDA agreed in principle to Medicure's plan in a pre-investigational new drug application meeting and the company expects to begin the initial study in the third quarter.

• Nabi Biopharmaceuticals, of Boca Raton, Fla., said it received a complete response letter from the FDA for the biologics license application for Nabi-HB Intravenous, its hepatitis B antibody product. The BLA, which seeks approval for preventing re-infection with hepatitis B in liver transplant recipients that are hepatitis B positive, was filed in November. Nabi said it expects to file a complete response letter to the FDA as soon as supplemental statistical analyses can be run on the data that were submitted. The product is approved for preventing infection with hepatitis B virus upon acute exposure.

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., began a Phase II study of its intranasal apomorphine hydrochloride product for male erectile dysfunction. About 120 subjects who are 50 or more years old - with or without erectile dysfunction - will be included in the trial. No efficacy assessments will be made in the multicenter, double-blinded, randomized, placebo-controlled study.

• NexMed Inc., of Robbinsville, N.J., said results from a pharmacokinetic study support the safety of NexACT permeation enhancers in the development of transdermal products. Post-dose blood sampling from a double-blinded trial of 20 erectile dysfunction patients who randomly received a single dose of placebo or one of three different doses of Alprox-TD, indicated low or undetectable plasma levels of alprostadil, the active drug in Alprox-TD, its metabolites and the NexACT enhancers.

• OxiGene Inc., of Watertown, Mass., said the FDA granted fast-track designation for OxiGene's lead tumor-starving compound, Combretastatin A4 Prodrug (CA4P), for advanced anaplastic thyroid cancer. A Phase II study in that indication is under way, and OxiGene also has applied for the FDA's orphan drug status for CA4P in anaplastic thyroid cancer. Oxigene's stock (NASDAQ:OXGN) jumped $3.29 Wednesday, or 83.5 percent, to close at $7.23.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said a report showing that certain chemical agents make tumor blood vessels more responsive to Peregrine's Vascular Targeting Agent effector, called truncated tissue factor, was published in the current issue of Arteriosclerosis Thrombosis Vascular Biology. Peregrine is developing truncated tissue factor as a cancer compound that selectively causes blood clots to form within tumor blood vessels, thus cutting off oxygen and nutrients to tumor cells and causing tumor cell death.

• Scynexis Europe Ltd., of Cambridge, UK, entered a research collaboration focused on anticancer therapeutics with Molecular Engines Laboratories, of Paris, which will access compounds produced by the Scynexis automated Medchem-Factory and use its HEOS (Hit Explorer Operating System) software. Specific financial terms were not disclosed, although Molecular Engines said it would retain intellectual property and exclusive worldwide rights to products in exchange for technology access fees and other compensation for Scynexis technologies and services.

• Transgenomic Inc., of Omaha, Neb., and Geron Corp., of Menlo Park, Calif., entered an expanded licensing agreement covering the manufacture of phosphoramidate and thio-phosphoramidate oligonucleotides. Under the nonexclusive agreement, Transgenomic gains rights to the patent estate acquired by Geron in 2002 from Lynx Therapeutics Inc., of Hayward, Calif., to manufacture phosphoramidate-based oligonucleotides, as well as chemical building blocks required for their synthesis, for use in diagnostic and therapeutic applications. In addition to receiving royalties on products for research use, Geron also will receive a royalty on sales of diagnostic and therapeutic products.

• ZymoGenetics Inc., of Seattle, reported the initiation of a third clinical study with recombinant human Factor XIII (rFactor XIII). The Phase I multiple-dose escalation study is in healthy volunteers and designed to evaluate the safety and pharmacokinetics of rFactor XIII. The company also reported that the FDA granted orphan drug designation for rFactor XIII for the treatment of Factor XIII deficiency.