Advanced Biotherapy Inc., of Los Angeles, said the FDA granted orphan drug designation for its investigational antibodies to interferon-gamma to treat immunologic corneal allograft rejection. The company added that development of its drug for corneal transplant rejection could open the door for preventing rejection of other transplanted organs such as the kidney, heart and liver. It also said it has an agreement with an unnamed clinical institute to begin studies of its antibody therapy to stop organ transplant rejection.
Artemis Pharmaceuticals GmbH, of Cologne, Germany, and Bayer AG, of Leverkusen, Germany, entered a cooperation agreement in mouse genetics. As part of that deal, Artemis will use its ArteMice platform to generate genetically engineered mice for Bayer. Bayer will use the mice in its human drug discovery research activities for gene function analysis as well as for the testing of drug candidates.
Avid Bioservices Inc., a wholly owned subsidiary of Peregrine Pharmaceuticals Inc., of Tustin, Calif., said it signed an agreement with an undisclosed biotechnology company for the cGMP manufacture of a recombinant protein to be used in upcoming clinical studies. Avid will take the client's cell line from cell bank production through process scale-up to delivery of cGMP-manufactured material for the trials, and will prepare the chemistry, manufacturing and controls section of the client's regulatory filings.
BioDelivery Sciences International Inc., of Newark, N.J., reported plans to establish an Israeli subsidiary, tentatively named Biorazyme Ltd., for the purpose of developing oral formulations of lysosomal storage enzymes such as glucocerebrosidase for Gaucher's disease. The new company initially will be majority owned by BDSI, with the remainder being owned by its Israeli joint venture partners. BDSI plans to sub-license its Bioral technology for the new formulations.
Chiron Corp., of Emeryville, Calif., initiated the ELITE (Early Intervention TOBI Eradication) trial in Europe to study benefits of TOBI tobramycin solution for inhalation in treatment of early onset Pseudomonas aeruginosa (PA) in cystic fibrosis (CF) patients. The trial will involve 120 CF patients and is designed to estimate the duration of eradication of PA following TOBI treatment. The goal of early treatment is to delay the onset of chronic PA infection. TOBI tobramycin solution of inhalation is an antibiotic approved in the U.S. and Europe for the treatment of CF in patients with PA.
Dharmacon Inc., of Lafayette, Colo., launched a library of ready-to-use SMARTpool siRNA reagents and individual siRNA duplexes designed to knockdown more than 550 genes involved in protein-kinase production. The library will allow high-throughput studies of kinase inhibitors for drug discovery and development, as well as advanced analysis of cell-signaling pathways. The launch is part of a broader expansion of Dharmacon's siGENE List, which includes a pre-synthesized SMARTpool siRNA reagent and four individual siRNA duplexes each designed to silence more than 1,500 genes. SMARTpool siRNA reagents are guaranteed to silence target gene mRNA expression by at least 75 percent; 85 percent of SMARTpool reagents reduce mRNA levels 95 percent or more.
Embrex Inc., of Research Triangle Park, N.C., said it would pay $2.3 million to acquire a Gender Sort prototype system from Advanced Automation Inc., of Greenville, S.C. Separately, the company's board extended a share-repurchase program, which was originally approved in August 2002. Embrex produces vaccines, as well as injection and detection devices, for the poultry industry.
Ester Neuroscience Ltd., of Herzlia, Israel, said the FDA granted the company orphan drug designation for Monarsen (formerly known as EN101), for the treatment of myasthenia gravis. An application for orphan status has been submitted to European authorities. A Phase Ib trial demonstrated that Monarsen appears to have superior efficacy, longer duration of action and a more favorable side effect profile than currently used medications. Patient recruitment for extended clinical trials is under way.
Henry Ford Hospital in Detroit said an approach using gene therapy and radiation therapy to treat prostate cancer has shown promising results for its safety and effectiveness. The study was published in this month's Cancer Research. Results show that patients experienced no significant side effects when treated with gene therapy and radiation, and the treatment lowered patients' prostate-specific antigen and eliminated cancer in many of them. Fifteen patients were enrolled in the study.
Iconix Pharmaceuticals Inc., of Mountain View, Calif., said that Eli Lilly and Co., of Indianapolis, selected Iconix to provide advanced chemogenomics profiling and analytical sciences. Iconix said it is pioneering the new field of chemogenomics, the integration of chemistry and genomics to profile drug candidates. It provides reference systems to predict toxic liabilities and side effects of drug candidates.
ImClone Systems Inc., of New York, and Bristol-Myers Squibb Co., also of New York, applied for Canadian regulatory approval to use Erbitux (cetuximab) in combination with irinotecan for patients with epidermal growth factor receptor-expressing, irinotecan-refractory metastatic colorectal cancer. The submission has been given priority review status. The product's FDA submission was accepted last month and is being reviewed under priority status in the U.S. as well. (See BioWorld Today, Oct. 14, 2003.)
Immtech International Inc., of Vernon Hill, Ill., said it completed negotiations with Medicines for Malaria Venture (MMV) to fund the clinical development of Immtech's oral drug candidate DB289 for the treatment of malaria. MMV will advance to Immtech funds to cover all projected costs for human clinical trials and regulatory expenses to license DB289 in at least one developed nation and one malaria-endemic country. MMV will also reimburse Immtech for a portion of its development and clinical trial costs related to malaria incurred to date. MMV focuses on malaria by supporting private/public funding of new drug development and clinical trials. Immtech expects next month to release a formal report on its Phase IIa trial results of DB289 for treating malaria in Thailand. Immtech's stock (AMEX:IMM) rose $3.20 Monday, or 22.9 percent, to close at $17.20.
Ingenuity Systems, of Mountain View, Calif., said the Genomics Institute of the Novartis Research Foundation in San Diego licensed the Ingenuity Pathways Analysis application for use in its research program. The web-delivered application enables biologists to discover, visualize and explore therapeutically relevant networks significant to their experimental results.
Inhibitex Inc., of Atlanta, completed enrollment in its Phase II trial of Veronate, being developed for the prevention of hospital-acquired staphylococcal infections in very-low-birth-weight infants. A total of 512 infants, weighing between 500 grams and 1,250 grams at birth, were enrolled in the trial. The principal objectives of the study are to select an appropriate dose to advance into a Phase III trial, to obtain estimates of the incidence of hospital-acquired infections in the very low-birth-weight infant population and to access the efficacy of Veronate in preventing those infections. Veronate is an antibody-based investigational drug being developed to prevent both Staphylococcal aureus and Staphylococcus epidermis infections.
Introgen Therapeutics Inc., of Austin, Texas, entered an agreement to conduct a Phase II study of its Advexin cancer therapy with the Southwest Oncology Group in San Antonio. The study will target Stage III or IV squamous-cell carcinoma of the oral cavity and oropharynx that is able to be surgically removed. About 60 head and neck cancer patients will undergo surgery and receive Advexin intraoperatively and postoperatively, and afterwards will receive a combination of chemotherapy and radiotherapy.
Medarex Inc., of Princeton, N.J., filed an investigational new drug application to initiate a Phase I/II trial of MDX-214 to treat patients with cancers that overexpress the epidermal growth factor receptor, or EGFR MDX-214 consists of recombinant human epidermal growth factor genetically linked to a fully human antibody fragment that is designed to activate cytotoxic killing of cancer cells by immune effector cells. An open-label, dose-escalation Phase I/II study is expected to accrue up to 48 patients with refractory or relapsed EGFR-expressing cancers, including cancers of the head and neck, breast, colon, prostate, lung and ovary.
Nanobac Pharmaceuticals Inc., of Tampa, Fla., said that scientists in Vienna, Austria, using diagnostics developed by Nanobac OY, reported finding nanobacterium in ovarian cancer patients. The discovery was published in the APMIS (Acta Pathologica, Microbiologica et Immunologica Scandinavica) journal. The study investigated whether nanobacteria are associated with microcalcification found in ovarian cancers. Positive nanobacterial results were found in all seven microcalcified specimens by immunohistochemical staining, transmission electron microscopy, ELISA and infrared spectroscopy.
Silicon Genetics Inc. of Redwood City, Calif., said GeNet 4.1 and GeneSpring 6.1, its latest versions of software for analyzing gene expression information, are available. New features include facilities to expedite compliance with the FDA Title 21 Code of Federal Regulations Part 11, which provide guidelines for companies using computerized systems to create and maintain records submitted to the agency as part of a regulatory filing.
Spectrum Pharmaceuticals Inc., of Irvine, Calif., reported the Nasdaq Listing Qualifications Panel determined it will continue listing the company's common stock on the Nasdaq SmallCap Market. On May 30, the panel decided to conditionally continue listing Spectrum's common stock. The company has met requirements for minimum stockholders' equity with third-quarter stockholders' equity of $13.4 million. Spectrum focuses on in-licensed drugs for cancer and supporting cancer patients.
Spotfire Inc., of Somerville, Mass., a provider of Guided Analytic applications and services, said that Celltech Group plc, of Slough, UK, deployed Spotfire's DecisionSite as its drug discovery analytic application standard for discovery research designed to speed the development of potential treatments for conditions such as cancer, osteoporosis and arthritis. DecisionSite is integrated into Celltech's core laboratory data system.
Tepnel Life Sciences plc, of Manchester, UK, said its shareholders approved its recently reported $4.3 million acquisition of Orchid Diagnostics, a unit of Orchid BioSciences Inc., of Princeton, N.J. The acquisition, which is expected to be completed in the next two weeks, establishes a direct U.S. sales operation for Tepnel to sell its DNA-purification products and services stateside. In the U.S., Orchid will be renamed Tepnel Lifecodes Corp., while in the UK it will be called Tepnel Diagnostics Ltd.
V.I. Technologies Inc., of Watertown, Mass., laid off half its work force as a result of an operating expense slowdown stemming from a recent decision to halt enrollment in a Phase III trial of its blood technology product, the Inactine Pathogen Reduction System. A data safety monitoring committee recommended halting the study after uncovering concerns related to antibody responses in patients receiving Inactine-treated red blood cells. The news shaved about two-thirds off the value of the company's stock in a single day last week. (See BioWorld Today, Nov. 19, 2003.)
Vasogen Inc., of Mississauga, Ontario, adopted the brand name Celacade (formerly called immune-modulation therapy) for its lead product, which remains in pivotal Phase III trials for chronic heart failure and peripheral arterial disease. Celacade is designed to target chronic inflammation by activating the immune system's physiological anti-inflammatory response to apoptotic cells.
Weill Medical College of Cornell University in New York said its scientists created a single-shot anthrax vaccine that might one day be used to protect against a bioterrorism attack. A study was conducted in an animal model and published in this month's Human Gene Therapy. The results suggest that the vaccine might act more quickly and effectively than a recombinant protein vaccine being developed by the U.S. military, Cornell said. The vaccine consists of genetically engineered anthrax toxin linked to human adenovirus.
Xcyte Therapies Inc., of Seattle, added Wells Fargo Securities LLC to its list of initial public offering underwriters while removing SG Cowen Securities Corp. and Dain Rauscher Inc. The company, whose lead Xcellerated T Cell product is being developed to treat illnesses such as cancer, autoimmune disorders and infectious disease, filed for a $75 million IPO last month. (See BioWorld Today, Oct. 14, 2003.)