• Adenosine Therapeutics LLC, of Charlottesville, Va., completed a round of venture financing with the Emerging Technology Partners of Rockville, Md. In the transaction, the amount of which was not disclosed, the company also acquired adenosine screening technology from Aptus Pharmaceuticals Inc., of Gaithersburg, Md. The financing is structured as a first closing in a larger round of investment. Adenosine Therapeutics focuses on the discovery and development of pharmaceutical products that target adenosine receptor subtypes.

• Aegis Analytical Corp., of Lafayette, Colo., said its Discoverant software is being tested in two pharmaceutical manufacturing plants that belong to Merck & Co. Inc., of Whitehouse Station, N.J. The pilot evaluation is assessing the impact on manufacturing process performance and productivity of Discoverant, which has graphical and statistical tools to allow exploratory analysis of manufacturing data to identify opportunities for quality, yield and productivity improvement.

• Alkermes Inc., of Cambridge, Mass., reported the closing of the sale of an additional $25 million of its 2.5 percent convertible subordinated notes due 2023. The additional notes were sold as a result of the exercise by the initial purchaser of its option to purchase additional notes. As previously reported, the company sold $100 million of the convertible subordinated notes in August. (See BioWorld Today, Aug. 20, 2003.)

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said it intends to change its fiscal year end from Sept. 30 to Dec. 31, effective Dec. 31 this year. The step is being taken to synchronize the fiscal reporting period with the majority of its industry peers, the company said. The last day of Angiotech's most recent financial year was Sept. 30, 2002, and the last day of its transition financial year will be Dec. 31. Angiotech is focused on enhancing the performance of medical devices and biomaterials using pharmacotherapeutics.

• Antisoma plc, of London, paid $500,000 to acquire royalty rights to its lead product, R1549, from Cytogen Corp., of Princeton, N.J. More specifically, Cytogen relinquished royalties equivalent to 1.65 percent of net sales revenues, if any, of R1549. Antisoma will make an additional $500,000 payment upon the first commercial sale of the product, formerly called pemtumomab. Cytogen gained the rights after granting a license to technology upon which R1549 is based. R1549 is being co-developed by Antisoma and Roche, which has worldwide marketing rights under a November 2002 agreement. Antisoma said R1549 would complete a pivotal Phase III study in ovarian cancer between December and February, with findings to be released during the first half of next year.

• Aphios Corp., of Woburn, Mass., was awarded a Phase I Small Business Innovation Research grant from the National Center for Complementary and Alternative Medicine, a division of the National Institutes of Health in Bethesda, Md. The grant is for developing a smallpox therapeutic from marine microorganisms. The company plans to discover therapeutics by screening its library of marine molecules against Vaccinia variola, a less virulent surrogate pox virus.

• Astralis Ltd., of Fairfield, N.J., reported that the Phase I trial of Psoraxine for the treatment of moderate plaque psoriasis is under way. The trial, a double-blind, placebo-controlled study, will evaluate the safety of a single dose of Psoraxine in 20 patients with stable moderate psoriasis for more than three months and covering between 3 percent and 15 percent of the body surface. Secondary endpoints to measure efficacy, such as Psoriasis Area and Severity Index and quality of life improvement, will be analyzed. Psoraxine is a protein-based therapy believed to stimulate cells from the patient's immune system to reverse the inflammatory process responsible for psoriasis symptoms.

• Avigen Inc., of Alameda, Calif., received approval from the FDA and institutional review boards at The Children's Hospital of Philadelphia and Stanford University Medical Center to continue its Phase I trial of Coagulin-B for hemophilia B. The company said it made several changes to the trial protocol to enhance patient monitoring and add dose cohorts. The open-label, dose-escalation safety trial is evaluating Avigen's adeno-associated virus gene therapy vector containing the Factor IX gene infused into the liver. To date, six subjects with severe hemophilia B, with Factor IX levels below 1 percent, have received a single administration of Coagulin-B infused at three increasing dose levels. The trial was suspended once nearly two years ago. (See BioWorld Today, Oct. 9, 2001.)

• BioFocus plc, of Chesterford Research Park, UK, said it would receive an undisclosed cash payment after identifying lead compounds active against a kinase target belonging to Axxima Pharmaceuticals AG, of Munich, Germany. The leads originated from BioFocus' SoftFocus kinase-directed compound collection. Axxima plans to pursue a lead-optimization program with BioFocus, which also could receive ongoing research fees, interim success-based milestones and royalties following commercialization of any resulting products. Both parties also said they developed assays for targets implicated in HIV.

• BresaGen Ltd., of Adelaide, Australia, said its American depository receipt program received Level II status, requiring the company to comply with SEC reporting requirements, such as lodging its accounts under generally accepted accounting principles. BresaGen, which established a Level I ADR program with the Bank of New York in February 2001, called the step a precursor to potentially listing its ADRs on Nasdaq. For now, the ADRs trade over the counter under the symbol "BSGNY."

• Corixa Corp., of Seattle, reported Argentinean approval of Supervax, a prophylactic hepatitis B vaccine that combines Corixa's synthetic RC-529 adjuvant with the Hansenula polymorpha-based recombinant hepatitis B antigen belonging to Berna Biotech AG, of Bern, Switzerland. Corixa said clinical results showed seroprotection in more than 95 percent of individuals vaccinated with Supervax after two vaccinations one month apart. Berna plans to launch the product next year.

• CryoLife Inc., of Atlanta, said its subsidiary, Aurazyme Pharmaceuticals Inc., reported that preclinical trials of AZ-CINN-310 demonstrated accelerated destruction of breast cancer tumor cells at the site of activation with a single low dose of paclitaxel when AZ-CINN-310 was light-activated. AZ-CINN-310 uses a linker technology that combines Herceptin (from Genentech Inc., of South San Francisco) and paclitaxel. Aurazyme's technology is designed to release the drug after the antibody is attached to the tumor site through light activation, ultrasound or normal hydrolysis.

• EntreMed Inc., of Rockville, Md., granted exclusive worldwide rights to Oxford BioMedica plc, of Oxford, UK, to develop the localized delivery of two gene targets for vision loss. Oxford gained rights to use EntreMed's endostatin and angiostatin genes in its therapeutic RetinoStat program for age-related macular degeneration and diabetic retinopathy. EntreMed received an undisclosed initial cash payment and common stock in Oxford, and may collect up to $10 million based on regulatory and clinical milestones. EntreMed, which also could receive royalties on worldwide sales of resulting products, retains rights to gene therapy applications outside of localized delivery to the eye. It also retains rights to the endostatin and angiostatin proteins as it pursues commercialization of the two clinical drug candidates.

• Epimmune Inc., of San Diego, received an undisclosed milestone payment from Anosys Inc., of Menlo Park, Calif., which filed an investigational new drug application for a product that uses Epimmune technology under a license granted in August 2001. The company also received an additional license fee after regaining all rights to the technology covered by the agreement in Japan. Should Anosys exercise its rights to include Japan in the territory covered by the agreement, Epimmune said it would be entitled to an additional license fee payment. Its stock (NASDAQ:EPMN) gained 30.2 cents Tuesday, or 19.6 percent, to close at $1.84.

• EraGen Biosciences, of Madison, Wis., said the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, Md., awarded the company a biodefense grant to develop multiple diagnostic products using its GeneCode System. Under the two-and-a-half-year grant, EraGen will employ its diagnostic capabilities to produce rapid and specific diagnostics that target a list of Category A bioweapon agents.

• Exact Sciences Corp., of Marlborough, Mass., and Laboratory Corp. of America Holdings, of Burlington, N.C., released PreGen-Plus, a DNA-based stool test for the early detection of colorectal cancer. They said the noninvasive product has demonstrated a significantly higher point sensitivity for colon cancer than fecal occult blood testing, the only other noninvasive colorectal cancer screening option, and is comparable to other cancer screening tests such as the Pap smear for cervical cancer.

• eXegenics Inc., of Dallas, had another tender offer expire as Foundation Growth Investments LLC, of Chicago, and EI Acquisition Inc. terminated their offer to purchase all of eXegenics' outstanding common and preferred shares at 60 cents apiece. The unsolicited cash offer failed to draw a majority of the outstanding shares as of midnight Sept. 8., and all tendered shares will be returned by Foundation's depositary to the tendering stockholders. Foundation and EI Acquisition also terminated their consent solicitation with respect to eXegenics stockholders. A little more than a week earlier, a stock offer for eXegenics' shares put forth by AVI BioPharma Inc., of Portland, Ore., expired and was terminated. (See BioWorld Today, Sept. 3, 2003.)

• F2G Ltd., of Manchester, UK, entered a pair of screening collaborations with two Moscow-based partners. F2G will screen against a variety of targets and whole-cell screens using compounds belonging to Asinex Ltd., which also will allow F2G to develop the compounds as antifungal drugs. As active compounds suitable for preclinical and clinical development are identified and selected, F2G will gain intellectual property rights to them. In a separate agreement with InterBioscreen, F2G will work to find new systemic antifungal drugs by screening for antifungal activity against its HTS and whole-cell assays to further develop promising leads. The agreement includes an option to further collaborate on developing specific areas of interest. Financial terms were not disclosed.

• GeneMax Corp., of Blaine, Wash., said it formed an amended contract with Molecular Medicine BioServices Inc., of San Diego, for the production of Molecular Medicine's clinical vector for delivery of the TAP (transporters associated with antigen processing) genes used in GeneMax's lead product, an immunotherapy aimed to treat a variety of carcinomas. Financial terms were not disclosed. The production contract incorporates the use of an adenovirus-based vectoral technology from Crucell NV, of Leiden, the Netherlands, which was licensed and announced by GeneMax in August.

• ILEX Oncology Inc., of San Antonio, said the FDA granted fast-track status to its investigational compound clofarabine for refractory or relapsed acute lymphoblastic leukemia in children. Based on that designation and ongoing discussions with the agency, ILEX said it expects that an ongoing Phase II trial of the drug in pediatric acute lymphoblastic leukemia patients will be pivotal for registration.

• Immuno-Designed Molecules SA, of Paris, received approval from the FDA to launch a Phase I/II trial to test its therapeutic vaccine Collidem for the treatment of colorectal cancer. Collidem is composed of the patient's own dendritic cells associated with a combination of selected peptides licensed from Epimmune Inc., of San Diego. The trial is expected to involve 37 patients who have measurable metastasized colorectal cancer who have not responded to standard treatments.

• Inspire Pharmaceuticals Inc., of Durham, N.C., said the FDA accepted its filing of a new drug application for diquafosol tetrasodium ophthalmic solution, for the treatment of dry eye. The agency also indicated that no potential filing review issues were identified during a 60-day preliminary review period. The FDA granted priority review status for the application, which was submitted in late June, and set Dec. 24 as the target date for initial regulatory action.

• Invitrogen Corp., of Carlsbad, Calif., released its Block-iT RNA interference family of products, which includes synthetic short-interfering RNA, a Dicer system, a transfection kit and a transcription kit. The product suite is designed to provide a platform to study the effects of silencing genes.

• MedImmune Inc., of Gaithersburg, Md., began two Phase II trials of Vitaxin for metastatic melanoma and rheumatoid arthritis. MedImmune said the development-stage monoclonal antibody targets alpha-v-beta-3 integrin, a protein implicated in cancers and inflammatory diseases. The randomized, open-label melanoma study will involve 110 late-stage metastatic melanoma patients at more than 20 U.S. sites. The randomized, double-blinded, placebo-controlled rheumatoid arthritis trial will involve 300 active disease patients who are responding suboptimally to methotrexate at about 70 multinational sites.

• NicOx SA, of Sophia Antipolis, France, said it would present results from an endoscopy study with NCX 4016 after 21 days of administration, both as a monotherapy and in co-administration with aspirin, at November's American Heart Association meeting in Orlando, Fla. Gastric safety measured by endoscopy was significantly better for NCX 4016, a cardiovascular protective agent in Phase II development for peripheral arterial obstructive disease, both as a monotherapy and in combination with aspirin compared to aspirin alone. The endoscopic scores for NCX 4016 were equivalent to placebo. NCX 4016 also showed greater activity in the inhibition of inflammatory markers compared to aspirin.

• OncoGenex Technologies Inc., of Vancouver, British Columbia, and Isis Pharmaceuticals Inc., of Carlsbad, Calif., expanded their partnership to include the development of a second-generation antisense anticancer drug candidate, OGX-225. They labeled the compound the first bispecific antisense inhibitor, a single-stranded antisense drug designed to inhibit the production of two proteins simultaneously, to enter preclinical development. OGX-225 targets both insulin-like growth factor binding protein-5 and insulin-like growth factor binding protein-2, two molecules involved in the development of metastatic disease in hormone-regulated tumors such as prostate and breast cancers. Financial terms were not disclosed.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said that researchers at the Keck School of Medicine of the University of Southern California received a $464,000 grant from the Philip Morris External Research Program to conduct research on the use of Peregrine's Tumor Necrosis Therapy (TNT) for immunotherapy for lung cancer. The research will focus on the use of TNT to deliver various cytokines and chemokines to human lung cancer tumors. The research also will focus on identifying how the body responds to the immunotherapy by observing and measuring various lymphocyte subpopulations activated by the therapy.

• Primagen Holding BV, of Amsterdam, the Netherlands, entered an exclusive worldwide licensing agreement to commercialize the mitochondrial DNA detection and toxicity technology developed by the University of British Columbia in Vancouver. Financial terms were not disclosed. The company focuses on molecular tests that have individualized predictive value.

• Pro-Pharmaceuticals Inc., of Newton, Mass., a developer of cancer therapeutics, said its stock would begin trading today on the American Stock Exchange under the new trading symbol "PRW." The company is conducting Phase I trials of its Davant-1 cancer therapeutic.

• Stanford University Medical Center, of Stanford, Calif., researchers said they found in laboratory experiments a potential way to prevent HIV infections in women. They discovered that bacteria that naturally live in the body can be genetically enhanced for potent antiviral activity. Modifications to the unique approach could lead to bacteria programmed to prevent infections from other sexually transmitted diseases or even respiratory viruses, the researchers said.