Advanced Biotherapy Inc., of Woodland Hills, Calif., raised about $3.7 million through the private placement of subordinated convertible pay-in-kind notes during a span of about two months ending June 14. The notes bear interest at 11 percent per year payable in cash or additional convertible debt, and are convertible into shares of common stock at 25 cents per share, subject to certain antidilution rights. The notes were placed in two series, with the first maturing on Sept. 30, 2004, of which about $1.1 million was placed, and the second maturing on June 1, 2006, of which about $2.5 million was placed this month. Also, the company said it will file a Phase I investigational new drug application with the FDA for two autoimmune diseases.
Agencourt Bioscience Corp., of Beverly, Mass., said it sequenced the genome of the bacterium Rickettsia sibirica, in collaboration with the Centers for Disease Control and Prevention in Atlanta, and the University of Maryland School of Medicine in Baltimore. The three groups will continue to analyze the genome to develop new therapeutics, diagnostic reagents and vaccines for diseases caused by certain rickettsial organisms, including several that have been identified as potential bioterrorism agents.
Antisoma plc, of London, said results from two Phase I trials of its vascular targeting agent Dmxaa were reported at the International Conference on Vascular Targeting in Cambridge, Mass., showing the drug to be well tolerated as a monotherapy at doses that reduced tumor blood flow and increased the production of serotonin. The 109 patients, all of whom had advanced-stage cancer and a variety of tumor types, received 408 infusions of Dmxaa over 19 dose levels from 6 to 4900 mg/m2. Doses below the maximum tolerated dose were generally well tolerated, with mild temporary visual disturbance being the most commonly observed side effect.
BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., said results of a preclinical trial demonstrating the effectiveness of its calcium phosphate nanoparticulate vaccine adjuvant and delivery system, Bio-Vant, as a mucosal vaccine adjuvant were presented at the International Congress of Mucosal Immunology in Orlando, Fla. Also, a study reported in May at the Immunopotentiators in Modern Medicine meeting showed a tuberculosis subunit vaccine was combined with Bio-Vant in a formulation developed by BioSante's researchers to determine mucosal antibody responses. The immune responses elicited by Bio-Vant were compared to those seen using cholera toxin, a mucosal adjuvant, not approved for human use. Bio-Vant was shown in the study to be an effective mucosal adjuvant, the company said.
Cell Therapeutics Inc., of Seattle, said data from an ongoing Phase I trial evaluating Xyotax (polyglutamate paclitaxel) in combination with cisplatin were presented at the European Spring Oncology meeting in Marbella, Spain. Disease control was achieved in 10 of 12 patients, with five achieving a major objective response (partial remission) and five achieving stable disease. All five treated for ovarian cancer experienced disease control accompanied by a clinically significant decline in their tumor markers (CA-125). Of the five ovarian cancer patients, three achieved a partial remission and two achieved stable disease.
Centagenetix Inc., of Cambridge, Mass., received from the Technology and Life Sciences Division of Comerica Inc., of Detroit, a $1.8 million credit facility that includes a $750,000 equipment term loan, a $700,000 revolving credit line and a $350,000 standby letter of credit. Centagenetix was founded to decipher the genetic basis of longevity and to develop pharmaceutical products to promote health into old age.
CollaGenex Pharmaceuticals Inc., of Newton, Pa., said it initiated a multicenter, double-blind, placebo-controlled study of Periostat in the treatment of meibomianitis, a disease characterized by chronic inflammation and dysfunction of the meibomian glands. The study will look to enroll 70 patients. Periostat is approved by the FDA to treat periodontal disease.
DNA Sciences Inc., of Fremont, Calif., entered an agreement with GlaxoSmithKline plc, of London, to study how inherited genetic variants may predispose certain individuals to drug-induced cardiovascular adverse events, specifically drug-induced long QT syndrome. The condition results in an abnormality in the electrical system of the heart. Financial terms were not disclosed.
GeneMachines Inc., of San Carlos, Calif., said that as part of a corporate reorganization plan to reduce operating expenses and improve financial performance, it promoted Terry Allread to chief operating officer. Most recently Gene-Machines' vice president of manufacturing, he previously was the vice president of operations at ThermoFinnigan Corp., of San Jose, Calif.
Genentech Inc., of South San Francisco, IDEC Pharmaceuticals Corp., of San Diego, and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, reported at the International Conference on Malignant Lymphoma in Lugano, Switzerland, initial positive results of a randomized multicenter study evaluating extended therapy with single-agent Rituxan (rituximab) in patients with both chemotherapy-naive and relapsed indolent non-Hodgkin's lymphoma. All 188 patients received an induction course of Rituxan (375mg/m2 weekly for four weeks). The overall response rate was 66 percent for chemotherapy-naive patients and 46 percent for those with relapsed disease. Genentech and IDEC co-market the drug in the U.S., while Roche markets Rituxan to the rest of the world, except Japan, where it is co-marketed with Zenyaku Kogyo Co. Ltd., of Tokyo.
Immunomedics Inc., of Morris Plains, N.J., reported at the Society of Nuclear Medicine meeting in Los Angeles on progress in the areas of therapy and imaging of cancer and other diseases. Preclinical studies evaluated bispecific antibodies for imaging and therapy of pancreatic cancer and for the therapy of colon cancer, showing improved, selective uptake of the imaging or therapeutic agent at the tumor site. In a study of its infectious disease-imaging agent LeukoScan, labeled with the isotope technetium-99m, 341 patients underwent LeukoScan imaging for suspicion of bone infection, infected prosthesis, septic arthritis and/or other soft-tissue infections. The overall sensitivity and specificity were 88 percent and 83 percent, respectively.
Phylos Inc., of Lexington, Mass., was awarded by the National Institute of Allergy and Infectious Disease a Phase II Small Business Innovation Research grant, a follow-on to one received three years ago, to provide further funding over the next two years to develop a multiplex cytokine array using its Trinectin-binding proteins as capture and detection agents. The multiplex assay, based on a protein microarray platform, is a high-throughput format to measure cytokine levels using small volumes of biological samples. Combined, the two grants provide $1.4 million for the development of a microarray to detect cytokines in biological samples.
Regma Bio Technologies Ltd., of London, entered a research agreement with the Institut Pasteur in Lille, France, in which Regma will sponsor research at the institute to develop phage therapies in response to antibiotic resistance, particularly against Mycobacterium tuberculosis microorganisms. Both parties said they view the agreement and studies as a first step towards a broader collaboration in the creation of a joint research unit, aimed at collecting and typing TB strains in the development of Regma's phage therapy. Financial terms were not disclosed.
Signase Inc., of Houston, appointed David McWilliams CEO. For the past 10 years, McWilliams served as president and CEO of Texas Biotechnology Corp., also of Houston. Signase focuses on developing small-molecule protein tyrosine kinase inhibitors.
Xencor Inc., of Monrovia, Calif., said it delivered optimized protein candidates six months after entering a research agreement with the Torrey Mesa Research Institute in La Jolla, Calif., a unit of Syngenta AG, of Basel, Switzerland. Xencor said the protein candidates would enable Syngenta to develop consumer products for the food and feed industries. Xencor optimized the protein leads with its protein design automation technology, which combines computational methods, high-performance computing and experimental screening for optimization and sequence design.