• Advanced Biotherapy Inc., of Woodland Hills, Calif., demanded a delisting from the Berlin-Bremen Stock Exchange. The company learned it was listed on the Berlin-Bremen Stock Exchange, but never applied for listing. The company is waiting for a response. Advanced Biotherapy is focused on antibody and other anticytokine therapies for autoimmune disease.

• Allos Therapeutics Inc., of Westminster, Colo., filed an application in Europe to market RSR13 (efaproxiral) as an adjunct to whole-brain radiation therapy for patients with brain metastases originating from breast cancer. It was filed under the European Medicines Agency's centralized procedure, which is used when marketing authorization is filed for in all European member states simultaneously, and will be reviewed by the Committee for Medicinal Products for Human Use. The company recently received an approvable letter from the FDA for the product, despite a negative FDA panel meeting. (See BioWorld Today, May 4, 2004, and June 3, 2004.)

• Altachem Pharma Ltd., of Edmonton, Alberta, said its stock has been listed on the Berlin-Bremen Stock Exchange without its prior knowledge, consent or authorization. The company, which is developing products for HIV/AIDS and cancer, demanded the shares be delisted and is considering action against those responsible.

• Athersys Inc., of Cleveland, received a grant from the Juvenile Diabetes Research Foundation to fund research through its new Industry Discovery and Development Partnership Program that will focus on identifying proteins that promote the formation of pancreatic islet cells. The company said its researchers would apply its two technologies, RAGE (Random Activation of Gene Expression) and MAPC (Multipotent Adult Progenitor Cell), to identify, isolate and characterize proteins responsible for causing the differentiation of MAPCs along pancreatic islet cell lineages.

• Avanir Pharmaceuticals Inc., of San Diego, said data published in the current issue of the Journal of Immune Based Therapies and Vaccine showed that its anti-anthrax monoclonal antibodies protected rats from lethal anthrax toxins. Also, research conducted at the U.S. Army Medical Research Institute of Infectious Diseases on one of the company's anti-anthrax antibodies demonstrated in vitro activity against anthrax spores. The latter findings were reported at the American Society for Microbiology meeting in New Orleans.

• Biogen Idec Inc., of Cambridge, Mass., and Elan Corp. plc, of Dublin, Ireland, filed an application in Europe to market Antegren (natalizumab) as a treatment for multiple sclerosis. The submission includes one-year data from two ongoing Phase III trials, though the companies will not disclose the data in order to complete the two-year studies and protect their integrity. Last month, they submitted an application to the FDA for Antegren based on the same data. Biogen Idec and Elan first reported such plans earlier this year. (See BioWorld Today, Feb. 19, 2004.)

• Biolex Inc., of Pittsboro, N.C., and Centocor Inc., of Malvern, Pa., expanded their collaboration to include a limited scale-up of the first of three Centocor proteins expressed using Biolex's LEX System. Centocor added a fourth protein to the collaboration. At Centocor's option, Biolex may scale-up and manufacture those four proteins following the commercial line creation phase. Financial terms were not disclosed. The LEX System has shown its ability to significantly enable hard-to-make proteins, such as peptides and cytokines, as well as monoclonal antibodies.

• Biophage Pharma Inc., of Montreal, said its board asked Rosemonde Mandeville to take on the role of interim CEO as of July 1, in addition to his positions of company chairman and president. His appointment follows the voluntary resignation of Elie Farah. Biophage is developing anti-inflammatory products for humans and anti-infective products for antibiotic-resistant infections in livestock.

• Encysive Pharmaceuticals Inc., of Houston, intends to retain all marketing rights for now to Thelin, its selective endothelin antagonist in Phase III development for pulmonary arterial hypertension (PAH). The company had planned to license rights for marketing the product outside of North America, while preserving the U.S. and Canadian rights for itself. Encysive also may decide to market the product on its own worldwide.

• EPIX Medical Inc., of Cambridge, Mass., said the initial purchasers of $75 million in aggregate principal amount of 3 percent convertible senior notes due 2024 exercised their overallotment option to purchase an additional $25 million aggregate principal amount. The company expects the closing of the sale, totaling $100 million aggregate principal amount, to occur on June 7, resulting in net proceeds of about $96 million.

• Exelixis Inc., of South San Francisco, began a Phase I trial of XL647, an orally available cancer compound that targets multiple receptor tyrosine kinases that are implicated in tumor proliferation and angiogenesis. The dose-escalation study, which will be conducted at Stanford University Medical Center and the Mayo Clinic, will be conducted in patients with solid tumors for whom there is no alternative therapy.

• IntraBiotics Pharmaceuticals Inc., of Palo Alto, Calif., said underwriters of its recently reported public offering will exercise their option to purchase an additional 450,000 shares to cover overallotments. As a result, a total of about 3.5 million shares will have been sold in the public offering. The aggregate net proceeds to IntraBiotics, before expenses, are estimated to be $42.2 million. (See BioWorld Today, May 6, 2004).

• Juvaris BioTherapeutics Inc., of Pleasanton, Calif., entered an exclusive licensing agreement with Valentis Inc., of Burlingame, Calif., allowing Juvaris to use plasmid backbone in conjunction with DOTIM cationic lipid for the development and commercialization of therapeutic vaccine products. Valentis will receive cash payments from Juvaris, as well as potential milestone payments and royalties. Juvaris is responsible for the development, manufacturing and commercialization of products. Further details were not disclosed.

• Maxim Pharmaceuticals Inc., of San Diego, said 36-month patient follow-up data from the M01 Phase III study of Ceplene as a combination therapy to treat advanced metastatic melanoma demonstrate a statistically significant improvement in survival. The trial included 305 patients randomized to receive a combination of Ceplene and IL-2 or IL-2 alone. The data was published electronically in the June issue of the Journal of Cancer Immunology and Immunotherapy. Maxim expects to complete its current Phase III trial in melanoma patients with liver metastases this summer and amend its new drug application with the results in late 2004.

• Oxford BioMedica plc, of Oxford, UK, said preclinical data from its Innurex nerve repair program were reported at the American Society of Gene Therapy meeting in Minneapolis. The findings, which the company plans to submit for publication, show that Innurex is able to restore function to damaged limbs in a model of stretch injury.

• Panacos Pharmaceuticals Inc., of Gaithersburg, Md., said PA-457 inhibits HIV replication by blocking a late step in processing of the viral Gag protein, namely conversion of the capsid precursor to mature capsid protein. As a result, newly released viral particles are defective and non-infectious. PA-457 is active against virus isolates that are resistant to approved HIV drugs, including reverse transcriptase inhibitors and protease inhibitors. Panacos recently completed the first clinical trial of PA-457, which was found to be well tolerated and exhibited favorable oral bioavailability and pharmacokinetics.

• Pharmion Corp., of Boulder, Colo., reported that Thalidomide Pharmion was approved in Turkey for the treatment of multiple myeloma after the failure of standard therapies, as well as for the treatment of a complication of leprosy. Turkey is the third country outside the U.S. to approve thalidomide.

• Power 3 Medical Products Inc., of The Woodlands, Texas, reported initial results from its recently formed research agreement with Baylor College of Medicine to search for biomarkers that directly impact the diagnosis of neurodegenerative diseases. The company completed the first phase of clinical validation, testing serum proteins from 79 patients, including those with Lou Gehrig, Alzheimer's and Parkinson's diseases.

• Pro2Kem Ltd., of Dundee, UK, is opening an office in Chelmsford, Mass., in an effort to expand its marketing base in bioanalysis tools. Its first offering, the AggreKem Protein Aggregation Monitor, was launched last year.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., received orphan drug designation for its Thymosin beta 4 to treat epidermolysis bullosa, a rare genetic disease characterized by the presence of extremely fragile skin and recurrent blister formation. TB4 is a naturally occurring 43-amino acid peptide present in all human cells.

• Sangamo BioSciences Inc., of Minneapolis, said it expects to file an investigational new drug application in the second half of the year for a zinc finger DNA-binding protein transcription factor designed to up-regulate the expression of VEGF-A to treat diabetic neuropathy. In a rat model, a single treatment with the ZFP therapeutic resulted in a dose-dependent, statistically significant improvement in nerve function, the company said. Zinc finger proteins (ZFPs) are a naturally occurring class of DNA binding proteins.

• Targeted Genetics Corp., of Seattle, signed an exclusive worldwide license with the National Institutes of Health in Bethesda, Md., for patents that cover ITR (inverted terminal repeat) sequences as a promoter when using adeno-associated viral vectors for any product indication. Financial terms of the agreement were not disclosed.

• The Medicines Co. Inc., of Parsippany, N.J., received a letter from the FDA stating the company's application to amend the existing Angiomax (bivalidrudin) label is not approvable. The FDA said there were deficiencies in the study methods used and in the analysis of the clinical data submitted. The company would need to provide additional data before the changes could be approved. The Medicines Co. will meet with the FDA to discuss the letter. Its financial guidance for 2004 remains unchanged. The company filed the supplemental new drug application last August to amend the Angiomax product label in percutaneous coronary intervention. The product was approved in December 2000 for use with aspirin in unstable angina patients undergoing coronary angioplasty.

• University of Iowa researchers said findings reported at the American Society of Gene Therapy meeting in Minneapolis showed that using RNAi expressed from within adeno-associated virus vectors produced anatomical, pathological and functional protection from the inherited neurodegeneration in transgenic animals with Spinocerebella ataxia Type I. The neurodegenerative disease is caused by the expansion of the polyglutamine tract within the gene called ataxin-1, the same mechanisms underlying Huntington's disease.

• Vaccinex Inc., of Rochester, N.Y., completed a second round of financing totaling more than $8.4 million. Including those latest proceeds, Vaccinex has raised more than $20 million in investor funding. Pan Atlantic Bank and Trust Ltd., an early institutional investor in Vaccinex, led the financing. Proceeds will support the company's core operating and research activities and will be used to expand its internal antibody product development programs.

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