¿ Antex Biologics Inc., of Gaithersburg, Md., said it developed a genomics-based platform that reveals the "blueprint" of infectious bacteria in their host environment. Using its new VEP (Virulence Expression Profiling) platform, the company said it can duplicate in the laboratory the way bacteria grow in the human body and identify the disease-causing proteins.
¿ Cangene Corp., of Toronto, said it began two separate pivotal studies of its human growth hormone product. The studies, assessing the ability to combat short stature in children with growth hormone deficiency and girls with Turner's syndrome, follow a bioavailability study last fall comparing the product to an approved drug. The trials are in Hungary and Poland, but are designed to support regulatory submissions in the U.S., Europe and elsewhere.
¿ Cel-Sci Corp., of Vienna, Va, reported that all six samples of blood sera tested from HIV-1 subtype C infected patients in South Africa recognized the HGP-30W AIDS vaccine sequence. The South African government has a free license to test and use the vaccine, which is nearing the end of Phase II trials in Europe and, according to Cel-Sci, is the only HIV vaccine designed for subtype C that has been tested in humans.
¿ Cephalon Inc., of West Chester, Pa., said its UK subsidiary, Cephalon Ltd., and Dompe SpA have won marketing clearance in Italy for Cephalon's Provigil (modafinil) Tablets for the treatment of excessive daytime sleepiness associated with narcolepsy. Dompe will market the product in Italy.
¿ EntreMed Inc., of Rockville, Md., raised $11 million by exercising its right to redeem Series 2 warrants that were issued in connection with a private offering in July 1999. Warrant holders purchased 430,669 shares, which would equal about $25.54 per share. Total proceeds from the warrants exercise related to that financing now are $24.2 million, and the company said it raised another $4.2 million this year from the exercise of options and other warrants. It now has about 15.7 million shares outstanding. (See BioWorld Today, July 29, 1999, p. 1.)
¿ GenVec Inc., of Gaithersburg, Md., received a $2 million milestone payment from the Parke-Davis Pharmaceutical Division of Morris Plains, N.J.-based Warner-Lambert Co. The payment stems from the development of a manufacturing technology for the Biobypass angiogenic agent, in development for coronary artery disease and peripheral vascular disease. The companies signed a $100 million agreement for the product in September 1997. (See BioWorld Today, Special News Bulletin, September 9, 1997.)
¿ ImClone Systems Inc., of New York, is collaborating with Princeton University to create a database for the identification of all genes responsible for proliferation, self-renewal and differentiation of hematopoietic stem cells. The project also will involve researchers from the universities of Pennsylvania and Kentucky. ImClone will have the exclusive right to negotiate licenses to the complete sequences that emerge from the research, and to the underlying expressed sequence tags.
¿ Immunomedics Inc., of Morris Plains, N.J., reported data from several studies of yttrium-90-radiolabeled LymphoCide, a humanized antibody (epratuzumab) against CD22, which is expressed by normal and malignant B-lymphocytes. In one study, a 71 percent response rate was achieved in patients with aggressive non-Hodgkin's lymphoma that had failed prior chemotherapy and, in some cases, bone marrow transplantation. The radiolabeled version is in development as an option for patients not responsive to the unlabeled antibody.
¿ Incyte Genomics Inc., of Palo Alto, Calif., and the Roy Castle International Centre for Lung Cancer Research in Liverpool, England, entered a collaborative agreement to study lung cancer genetics. The new agreement is part of Incyte's ongoing strategy to expand partnerships with the academic community. Intellectual property will be jointly owned and available for licensing through Incyte.
¿ Interneuron Pharmaceuticals Inc., of Lexington, Mass., said, after meeting with the FDA, that a single Phase III trial comparing trospium chloride to placebo in 300 to 400 patients with urinary incontinence would be sufficient for the filing of a new drug application. It licensed the product from Germany-based Madaus AG, which already markets it for that indication in certain European countries. Results from the Phase III trial are expected by the end of 2001.
¿ MedImmune Inc., of Gaithersburg, Md., said, effective at the end of the year, that David Mott will succeed Wayne Hockmeyer as CEO. Hockmeyer, who founded the company in 1988, will remain chairman. Mott has been the company vice chairman and chief financial officer since 1998. Before that he was president and chief operating officer and held other positions dating back to 1992.
¿ Mendel Biotechnology Inc., of San Francisco, received a two-year Small Business Innovation Research Phase II grant from the National Science Foundation. The company will apply the money toward development of commercially important crops using its WeatherGard technology for improved frost and drought tolerance.
¿ Microcide Pharmaceuticals Inc., of Mountain View, Calif., and Coelacanth Corp., of East Windsor, N.J., signed a collaboration agreement under which Coelacanth will provide compound libraries for screening in Microcide assays directed at identification of antiviral, antifungal and antibacterial therapeutics.
¿ Myriad Genetics Inc., of Salt Lake City, said it discovered a novel prostate cancer susceptibility gene, triggering a $1 million milestone payment from partner Schering-Plough Corp., of Madison, N.J., under their 1997 agreement. Myriad used a proprietary form of linkage analysis for the discovery. It retains all diagnostic rights to the gene and would receive royalties on therapeutics resulting from the discovery.
¿ Nanogen Inc., of San Diego, has sold its first NanoChip Molecular Biology Workstation. The purchaser was Aventis Research & Technologies, an affiliate of Aventis SA, of Strasbourg, France. The system's applications include genotyping.
¿ Neurocrine Biosciences Inc., of San Diego, has achieved early milestones in a melanocortin receptor research program in obesity and diabetes, and has won a Phase I grant from the National Institutes of Health supporting the research. The company's most advanced project in the field centers on development of orally active and selective agonists of melanocortin receptor 4.
¿ Novazyme Pharmaceuticals, an Oklahoma City start-up, has formed its management team, led by CEO John Crowley. The company will use phosphorylation technologies to seek enzyme-replacement therapies for 50 known lysosomal diseases, including Pompe's, Hurler's, Fabry's and Tay-Sachs diseases.
¿ Oncolytics Biotech Inc., of Calgary, initiated the first clinical study of Reolysin in patients with cancer. The Phase I trial will enroll 18 patients and examine intratumoral administration of the product, a human reovirus that infects and kills cancer cells with an activated Ras pathway.
¿ Onyx Pharmaceuticals Inc., of Richmond, Calif., and Warner-Lambert Co., of Morris Plains, N.J., initiated a Phase III trial of CI-1042 (ONYX-015) in the treatment of recurrent head and neck cancer. The company described its plans for the study last fall, as well as its intention to find a partner, which it did the next month. The randomized study will compare an intratumoral injection of the drug plus standard chemotherapy (5-FU and cisplatin) vs. chemotherapy alone in about 300 patients. CI-1042, a tumor-selective, oncolytic therapy designed to replicate in the presence of tumor tissue, also is being tested in earlier-stage trials in other cancer indications.
¿ Oxford BioMedica plc, of Oxford, UK, extended the scope of its collaboration with Aventis Pharmaceuticals Inc., of Frankfurt, Germany, giving Aventis access to its LentiVector gene delivery vectors in cardiovascular gene therapy programs. Also, Aventis exercised an option under their December 1998 agreement to include an additional angiogenic gene in development of cardiovascular disease products using BioMedica's Hypoxia Response Element.
¿ Panacea Pharmaceuticals Inc., of Rockville, Md., signed license and collaborative research agreements with Rhode Island Hospital/Brown University for human aspartyl beta-hydroxylase, the overexpression of which is associated with the transformation of normal cells to malignant tumors. Panacea gained exclusive worldwide commercialization rights for use in human cancers, and rights to all future developments. The company is pursuing development of preclinical candidates and said it plans to form partnerships around the technology.
¿ PathoGenesis Corp., of Seattle, reported that after a month on TOBI (tobramycin solution for inhalation), cystic fibrosis patients in a UK clinical trial experienced improved lung function, compared with no improvement in patients who received standard treatment with inhaled colistin (Colomycin). The data were presented at the 13th International Cystic Fibrosis Congress in Stockholm, Sweden.
¿ Synaptic Pharmaceutical Corp., of Paramus, N.J., filed a patent infringement suit against MDS Panlabs Inc., of Toronto, and Panlabs Taiwan Ltd., a Taiwanese corporation. The suit was filed in U.S. District Court in New Jersey and alleges that Panlabs infringed several issued U.S. patents relating to cloned human receptors and their use in binding assays.
¿ Visible Genetics Inc., of Toronto, and Genaissance Pharmaceuticals Inc., of New Haven, Conn., amended their 1996 licensing agreement covering Visible's use of single-tube, single-step DNA sequencing technology, called CAS, covered by U.S. Patent No. 5,427,911. The technology is a component of Visible's Trugene HIV-1 Genotyping Kit. The new agreement includes research and diagnostic applications in all areas. In addition, Visible has the right to sublicense the technology to third parties.