¿ Access Pharmaceuticals Inc., of Dallas, said a Phase I study of its AP5280 polymer platinate program is progressing in Europe. Dosing will continue to be escalated until limiting toxicities are observed. At the current dose of 1,440 mg Pt/m2, about 22 percent more platinum is administered to patients than the standard clinical dose of cisplatin.
¿ Alza Corp., of Mountain View, Calif., and Johnson & Johnson, of New Brunswick, N.J., said the waiting period under the Hart-Scott-Rodino Antitrust Improvement Act concerning the acquisition of Alza by J&J has been terminated early.
¿ Avant Immunotherapeutics Inc., of Needham, Mass., said it began treating patients in the second of its placebo-controlled Phase IIb trials of the complement inhibitor TP10. The study in infants undergoing cardiac surgery utilizing cardiopulmonary bypass aims to assess the effect of TP10, prior to initiation of a pivotal trial.
¿ AVI BioPharma Inc., of Portland, Ore., said its therapeutic cancer vaccine, Avicine, will be the subject of Phase II data presented at the American Society of Clinical Oncology meeting next week in San Francisco. The data provided support for previous observations that Avicine is an effective anticancer agent.
¿ BioMarin Pharmaceutical Inc., of Novato, Calif.; Glyco Biomedical Ltd., also of Novato; and Genzyme General, of Cambridge, Mass., said patients receiving Aldurazyme for treatment of mucopolysaccharidosis-I for two years sustained, and, in some cases, improved on the positive results reported after one year of therapy. Follow-up data from the patients will be presented at the 10th International Congress of Human Genetics next week in Vienna, Austria. Data indicated significantly decreased liver and spleen size in all patients of 24 percent and 22 percent average reductions, respectively; reduced levels of urinary carbohydrates of 72 percent at 104 weeks; and improvements in range of motion and physical function.
¿ Boston Life Sciences Inc., of Boston, said its experimental drug candidate O-1369 improved specific motor function in a primate model of Parkinson¿s disease without side effects characteristic of existing treatments. O-1369 is designed to block dopamine transporters and thus dopamine reuptake, allowing localized levels of dopamine high enough to offset the overall deficiency of dopamine production caused by Parkinson¿s. The company said significant improvement was seen in posture, rigidity, tremors, bradykinesia and body freeze, and that the effects were dose related.
¿ BresaGen Ltd., of Thebarton, South Australia, cloned Australia¿s first pig. The pig is five weeks old, has been weaned and is healthy. The project was done in coordination with the Immunology Research Center at St. Vincent¿s Hospital, Melbourne.
¿ Cephalon Inc., of West Chester, Pa., said data from two pilot studies indicated that Provigil (modafinil) tablets reduce fatigue and sleepiness in clinically depressed patients who are partial responders to antidepressant therapy. One six-week, double-blind, randomized study of 136 patients indicated that patients receiving Provigil and antidepressant therapy achieved statistically significant reductions in fatigue as measured by the Fatigue Severity Scale (p<0.05). A second, four-week, prospective, open-label study in 24 adults echoed the results.
¿ Eli Lilly and Co., of Indianapolis, said pivotal Phase III trial data on its bone formation drug, Forteo (teriparatide injection, rDNA origin), will be published in the May 10, 2001, issue of The New England Journal of Medicine. The data indicated, Lilly said, that the compound significantly reduced moderate or severe spinal fracture risk by up to 90 percent and lowered overall nonspinal fracture risk by up to 54 percent compared to placebo in postmenopausal women with osteoporosis-related fractures.
¿ Forest Laboratories Inc., of New York, said two studies demonstrated the neuroprotective effects of memantine in Alzheimer¿s disease patients. The N-methyl-D-aspartate receptor antagonist showed benefit by measurement of cognition, day-to-day function and overall performance in a Phase III study. A second, preclinical, study demonstrated memantine¿s neuroprotective qualities in the setting of a transient ischemic episode. Forest is developing memantine in the U.S.
¿ Genome Therapeutics Corp., of Waltham, Mass., presented information on its Exo-Proofreading SNP Assay to the Annual Genome Sequencing and Biology Conference in Cold Spring Harbor, N.Y. The assay is based on the ability of specific DNA polymerases to proofread the sequence as it¿s generated.
¿ Harvard Bioscience Inc., of Holliston, Mass., entered a collaborative research and development agreement with NexGen Sciences Ltd., of Huntingdon, UK, to develop tools to alleviate bottlenecks in the drug discovery process. The collaboration will focus on tools for protein isolation and ADMET screening. Financial details were undisclosed.
¿ Hemispherx Biopharma Inc., of Philadelphia, said it began a Phase IIb protocol designed to accelerate immunologic gains in patients receiving antiviral therapy for HIV. The trial aims to create optimal conditions for antiviral effectiveness, encourage immune reconstruction and minimize HAART (highly active antiretroviral therapy) toxicity.
¿ Inspire Pharmaceuticals Inc., of Durham, N.C., initiated its Phase III program for INS316 Diagnostic, its second product to enter Phase III trials, as an aid in the diagnosis of lung cancer. The program consists of two parallel studies, one of which is a placebo-controlled, double-blind, parallel-group comparison of two concentrations of INS316 Diagnostic inhaled solution designed to evaluate its effectiveness.
¿ Introgen Therapeutics Inc., of Austin, Texas, said its preclinical studies of INGN 241, an adenoviral vector encoding the mda-7 gene, were published in the current issue of Molecular Medicine. Introgen said the studies demonstrate INGN 241¿s potent antitumor effects in three cancers: breast, lung and colorectal.
¿ Microcide Pharmaceuticals Inc., of Mountain View, Calif., entered a research collaboration with Discovery Partners International Inc., of San Diego, to optimize the drug-like qualities of Microcide¿s broad-spectrum antifungal compound series. Microcide used its proprietary microbial genomics VALID system to discover the compounds.
¿ Neurocrine Biosciences Inc., of San Diego, completed enrollment in its Phase II transient and chronic insomnia trials of NBI-34060. The company expects to announce results from the trial in June. The company also reported the initiation of multiple dose-ranging and efficacy-based clinical trials for the drug¿s immediate- and modified-release formulations, and said the results of those studies will be available this year as well.
¿ RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., said a paper published in the May 2001 issue of Experimental Eye Research characterized the wound-healing properties of its product, thymosin beta 4, in animal models. The product is being developed by RegeneRx under a license from the National Institutes of Health, also of Bethesda.
¿ Sangstat Inc., of Fremont, Calif., said new data on its organ rejection therapeutic Thymoglobulin (anti-thymocyte globulin, rabbit), indicates, among other things, that treatment with Thymoglobulin alone produced a lower incidence of diabetes, infection and hepatitis C than treatment with Thymoglobulin in combination with steroids. Data also showed that a steroid-sparing protocol in pancreas/kidney transplant patients was comparable at preventing rejection to a standard steroid-containing immunosuppressive regimen.
¿ Teva Pharmaceutical Industries Ltd., of Jerusalem, said its Promise trial of Copaxone in primary progressive multiple sclerosis enrolled the largest group of patients ever. Teva researchers presented aggregate information about the enrolled patient group at the American Academy of Neurology, questioning the sensitivity of recently proposed diagnostic criteria for primary progressive multiple sclerosis.
¿ ThromboGenics Ltd., of Dublin, Ireland, and East Hill Advisors LLC, of Boston, said they closed a $12.8 million financing round to support privately held ThromboGenics¿ cardiovascular drug development programs. ThromboGenics has two lead programs, PEG-Sak and SY162. PEG-Sak is being developed for the treatment of acute myocardial infarction and ThromboGenics is enrolling patients in a multinational Phase II trial for the product. SY162 is in Phase II trials for the treatment of central venous catheter occlusion and peripheral arterial occlusive disorder.
¿ Titan Pharmaceuticals Inc., of South San Francisco, said preliminary results from its Phase I/II study of Spheramine for treatment of Parkinson¿s disease demonstrated improvement in motor function and quality of life in all patients treated, with no safety concerns or significant adverse events. The study at Emory University in Atlanta assessed six patients at baseline and post-treatment using the Unified Parkinson¿s Disease Rating Scale.
¿ United Biomedical Inc., of Hauppage, N.Y., said its Taiwan-based Asian operation center, UBI-Asia, entered a series of agreements with GlaxoSmithKline plc, of London, to acquire a pharmaceutical manufacturing plant in Hsinchu, Taiwan. The companies also agreed that UBI-Asia will manufacture all of GSK¿s Taiwan requirements for all GSK products.
¿ Vion Pharmaceuticals Inc., of New Haven, Conn., initiated a Phase I combination trial of its anticancer agent, Triapine, an inhibitor of the enzyme ribonucleotide reductase. Inhibiting this enzyme blocks DNA synthesis, slows or stops cancer cell division, and disrupts repair of DNA damage caused by several standard anticancer agents, the company said.
¿ Wake Forest University Baptist Medical Center researchers said a combination drug therapy may benefit those multiple sclerosis patients who don¿t respond to traditional therapies. Results from a pilot study in patients with aggressive relapsing-remitting or secondary progressive multiple sclerosis whose disease wasn¿t controlled by interferon beta-1b showed a reduction in disease progression with the addition of mitoxantrone. Mitoxantrone is marketed as Novantrone by Immunex Corp., of Seattle.