• Agencourt Bioscience Corp., of Beverly, Mass., expanded its reagents product line with the release of a new kit for RNA isolation and purification. The RNAPrep kit is optimized for isolating total RNA from eukaryotic cultured cells.

• AlphaVax Inc., of Research Triangle Park, N.C., received a three-year, $4.8 million vaccine development grant from the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md. The award covers early development of a vaccine against severe acute respiratory syndrome.

• AnorMED Inc., of Vancouver, British Columbia, said it would submit its Phase III protocols for AMD3100, its candidate for stem cell transplant in cancer patients, to the FDA for special protocol assessment. At the company's end-of-Phase II meeting, the agency provided guidance on two randomized pivotal studies, one in non-Hodgkin's lymphoma and the other in multiple myeloma. AnorMED expects to enroll about 600 patients in its Phase III program and would, if accepted, begin the trials early next year.

• APT Pharmaceuticals, of Tucson, Ariz., began clinical studies of aerosolized hydroxychloroquine for treatment of respiratory diseases such as asthma, chronic obstructive pulmonary disease, rhinitis and severe acute respiratory syndrome. Safety and tolerability studies got under way in Australia, and the company plans to begin Phase II studies in asthmatics in the first quarter of next year. The studies will use the AERx pulmonary delivery system from Aradigm Corp., of Hayward, Calif.

• Avanir Pharmaceuticals Inc., of San Diego, said preclinical data reported at the American Physiological Society's Conference on Immunological and Pathophysiological Mechanisms in Inflammatory Bowel Disease in Snowmass, Colo., detailed the ability of its small molecules to target macrophage migration-inhibitory factor, a pro-inflammatory cytokine that plays a role in disorders such as rheumatoid arthritis, psoriasis and inflammatory bowel disease. In animal models of colitis, Avanir's compounds were effective in both preventing the progression of colitis and in reducing the signs and symptoms of ongoing colitis.

• Barrier Therapeutics Inc., of Princeton, N.J., and Healthpoint Ltd., of Fort Worth, Texas, announced a product development and commercialization collaboration for Zimycan, Barrier's antifungal candidate that has completed Phase III trials. Zimycan is a topical ointment consisting of 0.25 percent miconazole nitrate in a zinc oxide and petrolatum base. Barrier is developing it to treat infants with Candida-associated diaper dermatitis. Healthpoint will have the exclusive right to market the product in all approved indications in the U.S. and Canada. Healthpoint also will fund further clinical development in an adult indication. Barrier will receive milestone payments and revenue from the sale of Zimycan to Healthpoint, as well as the right to any new indications for the product.

• BioImage A/S, of Copenhagen, Denmark, signed an agreement with Merck & Co Inc., of Whitehouse Station, N.J., granting Merck a license to use its Redistribution technology in its drug discovery research. The Redistribution patent portfolio covers methods aimed at studying intracellular signaling events. Financial terms were not disclosed.

• Cardiome Pharma Corp., of Vancouver, British Columbia, said interim results of two studies for oxypurinol in congestive heart failure patients showed a statistically significant improvement in the left ventricle ejection fraction (LVEF), a measurement of cardiac function. One study showed an improvement of 3.3 percent in LVEF relative to placebo following 28-day oral dosing of oxypurinol, while the other study showed a 3.6 percent increase in LVEF following dosing. Cardiome is conducting a Phase II study testing the benefit of six months of daily dosing of oxypurinol in 400 heart failure patients. That trial should be completed in the second half of 2005.

• Cellegy Pharmaceuticals Inc., of South San Francisco, said UK regulatory authorities approved Cellegesic (nitroglycerin ointment) for the treatment of pain associated with chronic anal fissures. The British agency also agreed to act as a reference member state for regulatory filings for the product in other European Union member states. The product is branded Rectogesic outside the U.S. In the States, the FDA recently accepted for review the company's new drug application that was resubmitted earlier this summer. (See BioWorld Today, July 1, 2004.)

• Cellomics Inc., of Pittsburgh, released a new image-analysis software module called the Spot Detector BioApplication at the Society for Biomolecular Screening conference. The software module is designed to work with Cellomics' HCS instruments.

• ChondroGene Ltd., of Toronto, raised total gross proceeds of $500,000 in a brokered private placement in Canada. PowerOne Capital Markets Ltd. placed 526,316 shares at 95 cents a share. Power One was paid a fee of 6 percent, or $30,000, on the gross proceeds raised, plus a broker warrant entitling Power One to purchase common shares equal to 6 percent of the number of shares placed, or 31,578 shares, for a period of 24 months at 95 cents a share. The shares issued are subject to a four-month hold period. On Aug. 25, the company reported it had raised $5 million through Rodman and Renshaw, of New York.

• Cisbio international, of Orlando, Fla., released a new biomolecular screening solution, the HTRF-based cGMP Assay kit. The homegenous cGMP assay, which is based on the company's HTRF technology, was developed to measure cGMP, a cell signaling molecule, and more specifically, to monitor soluble and particulate Guanylyl Cyclases activity. Separately, Cisbio said it initiated a partnership with Euroscreen SA, of Brussels, Belgium, which will use Cisbio's HTRF cAMP assay for the validation of Euroscreen's recombinant cell lines and membranes expressing Gi and Gs-coupled receptors.

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., filed to adopt the trademark of "Oracea" for Col-101, the company's once-daily, modified-release formulation of doxycycline 40 mg for the treatment of rosacea in the U.S. Oracea is part of the inhibitors of multiple proteases and cytokines family of compounds.

• CombinatoRx Inc., of Boston, and the Spinal Muscular Atrophy Foundation in New York began a research and development collaboration. The research will apply the CombinatoRx combination high-throughput screening platform in an effort to discover drug combinations that up-regulate SMN protein levels. The company will receive two years of funding, the ownership of all intellectual property and commercial rights to all discovered products. Also, it will receive milestone payments as programs advance to the point of filing investigational new drug applications, and is eligible for increased funding to support clinical development of therapeutics for spinal muscular atrophy.

• Coremed Inc., of Chicago, said preclinical studies show that its Oncomer product has the potential to convert a solitary tumor into a bloodless mass. Findings showed that Oncomer distributes itself in the entire arterial tree, including its arterioles and capillaries, based on a study of an animal's celiac or placenta circulation, the company said.

• DOR BioPharma Inc., of Miami, was awarded a $5.2 million grant from the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md., for the development of its ricin vaccine, RiVax. DOR's biodefense division has been developing a ricin toxin vaccine in collaboration with the University of Texas Southwestern Medical Center. The vaccine has proved to be safe and effective in animal models.

• Elixir Pharmaceuticals Inc., of Cambridge, Mass., said findings reported at the Society for Biomolecular Screening meeting in Orlando, Fla., detail its discovery of orally bioavailable inhibitors of the human deacetylase SirT1. A member of the human sirtuin family of histone deacetylase enzymes, SirT1 is believed to be involved in the regulation of lifespan, the company said, adding that modulators of the enzyme class might be therapeutic agents for metabolic diseases, such as diabetes and obesity, as well as cancer and infectious diseases.

• Encysive Pharmaceuticals Inc., of Houston, closed its previously reported offering of 4 million common shares in an offering underwritten by Wachovia Capital Markets LLC. Wachovia also purchased an additional 600,000 shares pursuant to its previously exercised overallotment option. The shares were sold to the public at $7.94 apiece, and with the overallotment exercised, the offering raised gross proceeds of about $36.5 million. The company said it would use net proceeds for further clinical development, marketing and pre-launch activities related to Thelin, research and development of other product candidates, and general corporate purposes. (See BioWorld Today, Sept. 9, 2004.)

• EpiVax Inc., of Providence, R.I., was awarded a BioDefense Phase I Small Business Innovation Research grant by the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md., to develop a genome-derived, epitope-driven tularemia vaccine. The $859,773 grant will enable EpiVax to screen animal and human subjects for responses to tularemia epitopes.

• Genetronics Biomedical Corp., of San Diego, said its board approved a 1-for-4 reverse stock split. The stock began trading on a reverse split basis on the American Stock Exchange as of Monday. Genetronics is focused on building an oncology franchise based on its electroporation therapy.

• Insmed Inc., of Richmond, Va., said results reported at the European Society of Pediatric Endocrinology meeting detailed a nine-month analysis of therapy with SomatoKine (rhIGF-I/rhIGFBP-3 [mecasermin rinfibate]) for a patient with leprechaunism, the most extreme form of insulin resistance. The company said the analysis demonstrated improvements in growth, metabolic control and neurological development. Also, the patient has surpassed the average expected lifespan for leprechaunism and continues to receive therapy. No adverse effects were observed.

• InterWest Partners, of Menlo Park, Calif., closed a $600 million fund called InterWest Partners IX, which will invest in early stage life sciences and information technology companies. With the closing of the fund, the venture capital firm has raised more than $2 billion. InterWest said it plans to begin InterWest IX investments early next year.

• Karo Bio AB, of Huddinge, Sweden, said it would lay off 20 employees as part of a plan to restructure its operational activities. The company is looking to strengthen its efforts in pharmacology and chemistry, and the layoffs primarily affect staff in the early phase of drug discovery, as well as outside research operations. Certain development activities will be performed by external parties, and Karo plans to conduct its future development efforts within the current cost level in the next year and 2006. The company has drug discovery programs in women's health care, cancer, cardiovascular disease, atherosclerosis and diabetes.

• Large Scale Biology Corp., of Vacaville, Calif., said its Predictive Diagnostics Inc. subsidiary entered a co-marketing relationship with PerkinElmer Inc., of Boston. The arrangement calls for PerkinElmer to provide access to Predictive Diagnostics' BAMF technology along with the prOTOF 2000 MALDI O-TOF mass spectrometer. Financial terms were not disclosed.

• Medarex Inc., of Princeton, N.J., and Cell Genesys Inc., of South San Francisco, started a Phase I trial of GVAX prostate cancer vaccine, administered in combination with Medarex's fully human anti-CTLA-4 antibody, MDX-010, in patients with advanced prostate cancer. The trial is being conducted in Amsterdam, the Netherlands, at the University Hospital Vrije Universiteit Cancer Center. The companies entered a research and development collaboration in 2003. The multidose trial is expected to enroll up to 45 patients.

• Medinox Inc., of San Diego, said preclinical results of MX-1520 showing a potent ansickling effect were published in the June 2004 issue of The British Journal of Haematology. MX-1520 is a prodrug of vanillin, a popular food additive. In order to prevent the destruction of vanillin in the gastrointestinal tract, Medinox produced a variant of vanillin by attaching a linker to the vanillin molecule. When given orally to transgenic sickle cell mice, MX-1520 significantly reduced the percentage of sickled cells in the blood.

• Newron Pharmaceuticals SpA, of Bresso, Italy, started a Phase III trial with safinamide in 240 patients with Parkinson's disease. The double-blind, placebo-controlled, randomized study is being conducted in 31 centers worldwide. It is designed to compare two non-overlapping dose ranges of safinamide vs. placebo as add-on therapy to a stable dose of a single dopamine agonist in early stage patients. Safinamide has multiple mechanisms of action, including sodium channel blocking activity, calcium channel modulation, glutamate release, and a potent, selective and reversible inhibition of monoamine oxidase (MAO)-B, without an MAO-A effect and dopamine re-uptake inhibition.

• Perlegen Sciences Inc., of Mountain View, Calif., received a grant for a whole-genome association study of Alzheimer's disease by the National Institute on Aging. The goal of the study is to identify the genetic determinants of late-onset Alzheimer's disease. It will involve the use of Perlegen's high-density oligonucleotide array-based genotyping platform to genotype more than 1.5 million single nucleotide polymorphisms across the genome in late onset AD cases and controls.

• Proneuron Biotechnologies Inc., of Los Angeles, said the FDA granted orphan drug designation to ProCord, its autologous incubated macrophage therapy, to improve the motor and sensory neurological outcome in cases of acute spinal cord injury. In the U.S., there are about 11,000 new spinal cord injuries per year. ProCord is in an international, multicenter, randomized, controlled Phase II study in the U.S. and Israel.

• Qiagen NV, of Venlo, the Netherlands, and Evotec Technologies GmbH, of Hamburg, Germany, signed an agreement to promote the benefits of combining Qiagen's TOM-amidites chemistry-based RNAi products with Evotec's Opera platform. Financial terms were not disclosed.

• RxGen Inc., of New Haven, Conn., named Steven Gullans president and CEO. Most recently, he was chief scientific officer at U.S. Genomics Inc., of Woburn, Mass. Gullans replaces interim CEO Harry Penner, who will remain chairman of the company, a central nervous system therapeutics firm that also operates contract research services.

• Scimagix Inc., of San Mateo, Calif., which focuses on image informatics, reported the first installation of CellMine HCS, an instrument agnostic application for storing and mining cell-based assay data, at a pharmaceutical company.

• Scios Inc., of Fremont, Calif., said an observational study showed that Natrecor (nesiritide) was associated with significantly reduced in-hospital mortality and length of stay compared to inotropic agents, specifically dobutamine and milrinone, in acutely decompensated heart failure patients. The study was presented at the 8th annual scientific meeting of the Heart Failure Society of America in Toronto. Natrecor is approved to treat acutely decompensated congestive heart failure in patients with dyspnea.

• Thermo Electron Corp., of Waltham, Mass., completed its $65 million acquisition of InnaPhase Corp., of Philadelphia. With more than 100 employees and revenue expectations of about $26 million this year, InnaPhase supplies laboratory information management systems for the pharmaceutical and biotechnology markets. Such products will be integrated with the informatics product line at Thermo, a provider of analytical instruments. InnaPhase will continue to operate in Philadelphia as a Thermo Informatics division, under former CEO Jo Webber. LLR Partners Inc., also of Philadelphia, was InnaPhase's largest shareholder.

• Transkaryotic Therapies Inc., of Cambridge, Mass., said Paris-based Sanofi-Aventis granted the company a license to clinical trial results from a controlled Phase III trial evaluating Dynepo (epoetin delta) for the treatment of anemia in cancer patients treated with chemotherapy. TKT expects that top-line results of the trial will be available in the first half of 2005. If the data are positive, TKT intends to seek an expanded approval in Europe to include anemia associated with cancer chemotherapy. TKT regained marketing rights to Dynepo outside the U.S., according to a March agreement. However, it would only receive data from the study upon completion of U.S. patent litigation involving Dynepo with Amgen Inc., of Thousand Oaks, Calif. Dynepo was approved in the European Union in 2002 to treat anemia associated with renal disease in dialysis and pre-dialysis patients.

• Valeant Pharmaceuticals Inc., of Costa Mesa, Calif., paid $11.4 million to acquire European Union rights to Tasmar (tolcapone) from F. Hoffmann-La Roche Ltd., of Basel, Switzerland. Valeant already has rights in the U.S. and other markets. The drug is an adjunctive therapeutic agent used in combination with levodopa and DDCI for patients with severe Parkinson's disease who are not responding satisfactorily or are not appropriate candidates for other adjunctive therapies. The deal, expected to close by the end of next month, also calls for Valeant to pay royalties to Roche.

• Vaxin Inc., of Birmingham, Ala., entered a license agreement with Crucell NV, of Leiden, the Netherlands. The nonexclusive license agreement allows Vaxin to use Crucell's PER.C6 cell line for the development, manufacture and commercialization of its recombinant adenoviral vaccines against certain respiratory viruses. Crucell will receive an up-front payment, annual maintenance fees and royalties on future sales. Further financial details were not disclosed.

• Xtrana Inc., of Broomfield, Colo., terminated the previously reported negotiations with Aduromed Corp., of Bethel, Conn., regarding a business combination between the companies. Xtrana determined to end negotiations and terminate the non-binding letter of intent with Aduromed as a result of Xtrana's due diligence investigation of Aduromed and its business. Xtrana's interim CEO said the company would continue exploring potential transactions for merging or otherwise joining with another company.

• Ziopharm Inc., of New Haven, Conn., relocated its corporate and development offices to New Haven. The facilities will house the company's executive staff and medical and clinical affairs activities. Ziopharm was founded in January to develop and commercialize a portfolio of in-licensed cancer therapies.

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