Actelion Ltd., of Allschwill, Switzerland, reported positive preliminary results from the clinical trial Breathe-2, evaluating Tracleer (bosentan) in adult patients with pulmonary arterial hypertension in combination with the initiation of intravenous epoprostenol. The primary endpoint was the change from baseline in total pulmonary vascular resistance (TPR). Both groups showed improvement in TPR, although the improvement was greater in patients receiving Tracleer in addition to epoprostenol, although not statistically significant, compared to those receiving epoprostenol alone.
Altea Development Corp., of Atlanta, received from the National Institute of General Medical Sciences, a division of the National Institutes of Health in Bethesda, Md., a $105,650, Phase I Small Business Innovative Research grant to develop its patch for delivery of opioid pain medications. Altea said it is developing the micropore opioid patch to initially provide continuous delivery through the day and subsequently for patient-controlled delivery to treat breakthrough pain.
Antex Biologics Inc., of Gaithersburg, Md., reported the initial results of the U.S. Army's tests on AP 158 and several other compounds as potential drugs to treat anthrax. The tests showed the compounds to be active against Bacillus anthracis and provide the basis for further study. AP 158's initial commercial application as a topically applied antibiotic is targeted for skin and soft tissue infections to treat infections caused by methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci and the newly identified vancomycin-resistant S. aureus. Antex also plans to develop the drug in other formulations for use in ophthalmic, oral and systemic applications.
BioMedicines Inc., of Emeryville, Calif., completed enrollment in a Phase Ib trial of its drug, Biomed 101, in patients also receiving therapy with interleukin-2 for treatment of metastatic renal cell cancer. BioMedicines is developing Biomed 101 to mitigate the dose-limiting toxicity associated with interleukin-2 therapy. Biomed 101 is designed to bind to the leukotriene B4 receptor. BioMedicines has exclusive worldwide commercial rights to the drug.
Crucell NV, of Leiden, the Netherlands, expanded the research plan of its cooperative research and development agreement with the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases in Bethesda, Md. The expanded agreement now includes the development of vaccines for Marburg and Lassa infections. In May 2002, Crucell entered an agreement with NIAID to develop an Ebola vaccine.
DOV Pharmaceutical Inc., of Hackensack, N.J., reported Phase II results of its non-narcotic analgesic, bicifadine, in moderate to severe post-surgical dental pain, showing the agent was effective compared to placebo and at least equivalent to codeine, over which it has the advantage of being long acting and not a narcotic or addictive, the company said. The double-blind, placebo-controlled study involved 750 patients who were given one of three doses of bicifadine, one dose of codeine or placebo. The primary endpoint was a pain relief score that reflected total analgesia produced over the six-hour test period. Bicifadine, in a dose-dependent manner, produced a statistically significant (p<0.002) increase in pain relief scores as compared to placebo, while codeine did not, due to its shorter duration of action. DOV said it intends to move into Phase III trials after meeting with the FDA. DOV's stock (NASDAQ:DOVP) gained 72 cents Wednesday, or 21.6 percent, to close at $4.05.
Gambro AB, of Stockholm, Sweden, said its wholly owned subsidiary, Gambro BCT Inc., achieved a milestone in its collaboration with Sangart Inc., of San Diego. Gambro's technology reduced pathogens in the preparation of Sangart's oxygen transport agent, Hemospan. In treated blood and the Hemospan product, Gambro's technology inactivated a representative set of viruses impacting the blood supply, and the process does not confer cytoxic or mutagenic effects, the company said.
Genmab A/S, of Copenhagen, Denmark, said Aug. 16 would be the last day its shares trade on the Neuer Markt. Beginning Aug. 19, the shares will trade on the Regulated Market on the Frankfurt Stock Exchange until completion of the delisting process.
GenVec Inc., of Gaithersburg, Md., reported publication in the Aug. 1, 2002, issue of the Journal of Clinical Investigation an article indicating that its TNFerade gene therapy might be useful in enhancing the effectiveness of chemotherapy for patients with cancer. Findings showed that combined treatment of TNFerade and cisplatin increased TNF-alpha concentrations in tumor tissue by approximately a factor of four, compared to animals treated with TNFerade only. Also, it is likely that similar chemotherapy agents would activate the TNF gene, resulting in the increased production of TNF-alpha within the tumor tissue, the article said.
InSite Vision Inc., of Alameda, Calif., signed a license agreement with Bausch & Lomb, of Rochester, N.Y., to develop InSite's ISV-403 for bacterial ocular infections. The product combines a fourth-generation fluoroquinolone with InSite's DuraSite delivery system. DuraSite consists of a cross-linked, carboxyl-containing polymer that incorporates a drug for delivery to the eye. InSite is responsible for development. Bausch & Lomb, which gains exclusive rights to most of the world besides Japan, has manufacturing and marketing responsibility. It will make a preferred equity investment in InSite and make additional equity investments as milestones are achieved. Specific financial details were not disclosed.
Nanogen Inc., of San Diego, reported a favorable ruling in its litigation with CombiMatrix Corp., of Snoqualmie, Wash., and Donald Montgomery, a former employee of Nanogen now affiliated with CombiMatrix. On July 30, a court denied a partial summary judgment motion by CombiMatrix and Montgomery related to Nanogen claims. Nanogen's complaint alleges that Montgomery misappropriated Nanogen technology after he left the company by disclosing trade secrets to CombiMatrix and by filing patent applications on those trade secrets in his name. Nanogen's complaint seeks a correction of inventorship on U.S. Patent No. 6,093,302; 6,280,595 and related patents or applications, among other things.
OraPharma Inc., of Warminster, Pa., completed a Phase I trial of OC-1012, evaluating it in mucositis in bone marrow transplant patients undergoing chemotherapy at the Fred Hutchinson Cancer Research Center in Seattle. The company said it uncovered no safety issues with the compound. The company said it plans to initiate a Phase I study focusing on patients undergoing head and neck radiation therapy while it optimizes the product's formulation and concludes dose-ranging studies.
Orchid BioSciences Inc., of Princeton, N.J., settled its patent litigation with St. Louis University by acquiring U.S. Patent No. 5,846,710, titled "Method for the Detection of Genetic Diseases and Gene Sequence Variations by Single Nucleotide Primer Extension." Financial details were not disclosed. Separately, Orchid said it placed five SNPstream UHT genotyping systems during the product's initial launch.
The Hereditary Disease Array Group reported publication in the online version of the Aug. 15, 2002, issue of Human Molecular Genetics findings on Huntington's disease. The group, comprised of scientists from universities and companies such as Affymetrix Inc., of Santa Clara, Calif., and 3rd Millennium Inc., of Cambridge, Mass., reported discoveries including the identification of mutant genes, genetic changes in muscle tissue mirroring those in brain tissue, the suggestion of common pathways with other brain disorders and protein breakdown findings.
V.I. Technologies Inc., of Watertown, Mass., and Pall Corp., of East Hills, N.Y., modified their worldwide collaboration for the Inactine red blood cell pathogen inactivation system. Pall will relinquish its exclusive distribution rights in return for a cap on its financial commitments to the program and royalties upon commercialization. During the next 12 months, Vitex will assume sole responsibility for establishing additional partnerships designed to broaden geographic distribution for the Inactine system. Then Pall will have the option of reverting to its exclusive marketing rights in any territories not covered by new partnerships in return for foregoing its potential royalty and committing to a future stream of research and development payments.