Acambis plc, of Cambridge, UK, began a Phase II trial of its MVA smallpox vaccine, MVA3000. Acambis is co-developing MVA3000 with its process development and manufacturing partner, Baxter Healthcare SA. MVA3000 is being developed for use in people for whom the traditional smallpox vaccine is contraindicated, such as patients with disorders of the immune system or skin conditions such as eczema. The randomized, double-blind, placebo-controlled study will involve 700 healthy adults, half of whom have been previously vaccinated against smallpox.
Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said its board approved a rights agreement under which its stockholders will receive preferred stock purchase rights. The agreement is designed to protect the long-term value of the stockholders' investment and was not adopted in response to any current attempt to acquire the company, it said.
BioCurex Inc., of Richmond, British Columbia, published its tissue and serum Recaf results in the June 2005 issue of IVD Technology. The article was initially requested in 2003, and it was originally limited to the detection of cancer cells on tissue sections. Publication was then postponed in order to include the results obtained on serum samples.
Critical Therapeutics Inc., of Lexington, Mass., said its Phase II study of Zyflo Filmtab (zileuton tablets) in patients with moderate to severe inflammatory facial acne did not show statistical significance in its primary efficacy endpoint. The patients treated with the drug showed a mean reduction in inflammatory lesions of 11.5, compared to a mean reduction of 9.1 lesions in the placebo group. Zileuton was found to be safe and well tolerated. The company said it will further analyze data before determining the next steps for the product's development.
Crucell NV, of Leiden, the Netherlands, plans to begin clinical development of its combination of two human monoclonal antibodies against rabies, discovered last year using the company's MAbstract technology. Crucell's discovery offers the potential for a replacement for the serum products that are in use to treat rabies. Each year about 55,000 people die of rabies because of insufficient care or lack of appropriate treatment. Crucell's rabies antibody product is highlighted in the July 2005 Journal of Virology.
CV Therapeutics Inc., of Palo Alto, Calif., started a clinical program for CVT-6883, an orally available A2B-adenosine receptor antagonist, intended to treat asthma with once-a-day dosing. By blocking the A2B-adenosine receptor, CVT-6883 may limit or prevent mast cell degranulation, which leads to asthma and cardiopulmonary disease. The company is conducting a Phase I study in 24 healthy adults.
Digene Corp., of Gaithersburg, Md., entered an agreement with Georgetown University to settle litigation pending in the U.S. District court for the District of Columbia. The litigation began in October 2004 and relates to a license agreement with Georgetown for a patent and patent applications relating to human papillomavirus (HPV) type 52, as well as patents relating to the use of the L1 gene sequence to detect specific HPV types. As part of the settlement, Digene will pay ongoing royalty and technology fees to the university, expected to be about 5 percent to 6 percent of product sales. Digene also will pay the university a total of $7.5 million by Oct. 15.
DNAPrint Genomics Inc., of Sarasota, Fla., said it acquired an 18 percent stake in Biofrontera AG, of Leverkusen, Germany, for /1.5 million (US$1.8 million). Two DNAPrint executives, Richard Gabriel and Hector Gomez, remain on the Biofrontera board. Biofrontera is in Phase II trials with its BF-Derml product, a compound for chronic itching and welts caused by the exposure to cold or other allergens.
Encysive Pharmaceuticals, of Houston, said the Cardio-Renal Division of the FDA anticipates filing Encysive's new drug application for Thelin (sitaxsentan) on July 23 under a standard review classification. Thelin 100 mg is being evaluated as a once-daily oral treatment for patients with pulmonary arterial hypertension. The FDA Prescription Drug User Fee Act target action date for Thelin is March 24. Encysive filed the NDA in May. (See BioWorld Today, May 26, 2005.)
GeneLink Inc., of Margate, N.J., reported that a collaborative study between its scientists and a group led by Michael Miles at the University of Cincinnati Medical Center using GeneLink's genetic technology has identified associations between two single nucleotide polymorphisms and an altered CoQ10 redox ration in patients with metabolic syndrome. The study was performed on 52 adults with metabolic syndrome and compared to 35 healthy controls. Results will be presented at the International Congress of Clinical Chemistry and American Association for Clinical Chemistry meeting in Orlando, Fla., later this month.
Genentech Inc., of South San Francisco, priced its previously announced $2 billion offering, which includes $500 million principal amount of 4.40 percent senior notes due 2010, $1 billion principal amount of 4.75 percent senior notes due 2015 and $500 million principal amount of 5.25 percent senior notes due 2035. The sale of the notes is expected to close July 18.
Gentium SpA, of Villa Guardia, Italy, said the FDA agreed that Gentium's chemistry, manufacturing and controls submission provided the adequate characterization of defibrotide for the company's planned Phase III trial for the treatment of hepatic veno-occlusive disease with multi-organ failure.
Hemosol Corp., of Toronto, delivered the first shipment of Hepalean products under its contract with Organon Canada, the pharmaceutical division of Akzo Nobel, after receiving a license from Health Canada following an inspection of the company's Meadowpine manufacturing facility. Hemosol and Organon signed an agreement in 2004 to make Hemosol the exclusive Canadian manufacturer and supplier of Hepalean products to Organon.
Indevus Pharmaceuticals Inc., of Lexington, Mass., started a Phase II trial of pagoclone in patients with persistent developmental stuttering. The trial will enroll 120 adults at 16 sites in the U.S. Pagoclone is a non-benzodiazepine, selective GABA-A receptor agonist that has been shown to reduce the symptoms of panic disorder and generalized anxiety disorder without causing sedation or withdrawal effects.
Ligand Pharmaceuticals Inc., of San Diego, earned a $1.6 million milestone payment from Eli Lilly and Co., of Indianapolis, with Lilly's initiation of Phase II studies on LY674, a peroxisome proliferation activated receptor modulator for the treatment of atherosclerosis. LY674 was discovered through the research collaboration agreement between Lilly and Ligand.
Medicure Inc., of Winnipeg, Manitoba, completed the 16-week treatment period in the Phase II study of MC-4232 in patients with coexisting Type II diabetes and hypertension. The company expects the clinical results to be available later this summer. The data will provide direction for Medicure's Phase III program.
Merck KGaA, of Darmstadt, Germany, will acquire most of the global rights for the cancer treatment UFT (tegafur-uracil), used in colorectal cancer, from Taiho Pharmaceutical Co. Ltd., of Japan. Taiho will supply the capsules to Merck for its territories and will retain rights in Japan, South Korea, Taiwan, Malaysia and Singapore. Financial details were not disclosed.
Odyssey Thera Inc., of San Ramon, Calif., entered an agreement with Bristol-Myers Squibb Co., of New York, to profile selected BMS compounds in Odyssey Thera's cell-based assays in order to characterize mechanisms of action and pathway activity.
OSI Pharmaceuticals Inc., of Melville, N.Y., said Health Canada approved Tarceva (erlotinib) for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer following failure of first or second-line chemotherapy. OSI and partner, South San Francisco-based Genentech Inc., also reported that the New England Journal of Medicine published results from the pivotal Phase III study showing Tarceva improved survival in patients in advanced NSCLC. Results demonstrated that patients receiving Tarceva had a 30 percent reduction in the risk of death compared with patients receiving placebo, and that the median survival was 6.7 months for the Tarceva arm vs. 4.7 months for the placebo arm.
Perlegen Sciences Inc., of Mountain View, Calif., said it is conducting a high-density whole-genome association study of bipolar disorder in collaboration with Pritzker Neuropsychiatric Disorders Research Consortium. DNA samples systematically collected by projects that participated in the National Institute of Mental Health's Bipolar Disorder Genetics Initiative and control samples from the NIMH Molecular Genetics of Schizophrenia Initiative will be used in the study. The collaborators will conduct a comparative study of genetic variation in patients with BPD vs. matched, unaffected controls.
Senesco Technologies Inc., of New Brunswick, N.J., said results of a mouse cancer study conducted at the University of Waterloo in Ontario showed that the mice that received the company's Factor 5A treatment had a 41 percent average reduction in tumor weight compared with the untreated mice. The Factor 5A technology was used to treat mice with a type of melanoma that has an affinity for lung tissue that results in metastatic lung tumors.
Spectrum Pharmaceuticals Inc., of Irvine, Calif., said the Journal of Pharmacy & Pharmacology published data showing that Spectrum's SPI-1620 selectively increases the delivery of paclitaxel to animal model tumors by about 300 percent, with no significant change in delivery to normal organs. Results also showed that the product does not affect the pharmacokinetics of paclitaxel in breast tumor-bearing rats. SPI-1620 is an endothelin B agonist designed to stimulate receptors on endothelial cells to selectively dilate blood vessels in the tumor to increase the delivery of cancer drugs.
Stem Cells Sciences plc, of Edinburgh, Scotland, raised £6 million (US$10.5 million) as part of its initial public offering and listing on the Alternative Investment Market, part of the London Stock Exchange. The capital raising was conducted by Collins Stewart plc in the UK.
Synthetic Blood International Inc., of Costa Mesa, Calif., said it sold original, discount, unsecured convertible debentures in the aggregate principal amount of $1.85 million, together with warrants to purchase 8.4 million shares of common stock over a period of three years at an exercise price of 24 cents per share. Proceeds of the financing will be used to fund the company's ongoing Phase II trial with Oxycyte, a perfluorocarbon blood substitute and therapeutic oxygen carrier, as well as for working capital purposes.