phase ii clinical trials

Summary

Summary: Studies that are usually controlled to assess the effectiveness and dosage (if appropriate) of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques. These studies are performed on several hundred volunteers, including a limited number of patients with the target disease or disorder, and last about two years. This concept includes phase II studies conducted in both the U.S. and in other countries.

Top Publications

  1. ncbi Phase I studies with bendamustine: an update
    Dirk Schrijvers
    Department of Medical Oncology, University Hospital Antwerp, Edegem, Belgium
    Semin Oncol 29:15-8. 2002
  2. pmc Prognostic significance of a complete pathological response after induction chemotherapy in operable breast cancer
    P Chollet
    Centre Jean Perrin, Bureau de Recherche Clinique, 58 rue Montalembert, B P 392, 63011 Clermont Ferrand Cedex 1, France
    Br J Cancer 86:1041-6. 2002
  3. ncbi Assessing the quality of life of patients in phase I and II anti-cancer drug trials: interviews versus questionnaires
    Karen Cox
    Faculty of Medicine and Health Sciences, University of Nottingham, Medical School Room B50, Nottingham, UK
    Soc Sci Med 56:921-34. 2003
  4. pmc Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy
    Z A Nurgat
    Pharmacy Department, Aberdeen Royal Infirmary, Foresterhill Site, Aberdeen AB25 2ZN, UK
    Br J Cancer 92:1001-5. 2005
  5. ncbi Statistical design in phase II clinical trials and its application in breast cancer
    Francesco Perrone
    Clinical Trials Unit, National Cancer Institute, Naples, Italy
    Lancet Oncol 4:305-11. 2003
  6. ncbi Phase I trial design for solid tumor studies of targeted, non-cytotoxic agents: theory and practice
    Wendy R Parulekar
    National Cancer Institute of Canada Clinical Trials Group, Queen s University, Kingston, Ontario, Canada
    J Natl Cancer Inst 96:990-7. 2004
  7. ncbi Population pharmacokinetic analysis of ten phase II clinical trials of pemetrexed in cancer patients
    Jane E Latz
    Global Pharmacokinetics, Pharmacodynamics, and Trial Simulation, Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA
    Cancer Chemother Pharmacol 57:401-11. 2006
  8. ncbi Challenges to conducting HIV preventative vaccine trials with adolescents
    Cori A McClure
    Vanderbilt University Department of Pediatrics, Nashville, TN, USA
    J Acquir Immune Defic Syndr 36:726-33. 2004
  9. ncbi Adaptive two-stage designs in phase II clinical trials
    Anindita Banerjee
    Department of Statistics, North Carolina State University, Raleigh, NC 27695, USA
    Stat Med 25:3382-95. 2006
  10. ncbi Informed consent and decision-making: patients' experiences of the process of recruitment to phases I and II anti-cancer drug trials
    Karen Cox
    Post Graduate Division, Faculty of Medicine and Health Sciences, School of Nursing, University of Nottingham, Nottingham, UK
    Patient Educ Couns 46:31-8. 2002

Detail Information

Publications240 found, 100 shown here

  1. ncbi Phase I studies with bendamustine: an update
    Dirk Schrijvers
    Department of Medical Oncology, University Hospital Antwerp, Edegem, Belgium
    Semin Oncol 29:15-8. 2002
    ..This article presents an overview of the recent phase I trials and a summary of ongoing clinical trials...
  2. pmc Prognostic significance of a complete pathological response after induction chemotherapy in operable breast cancer
    P Chollet
    Centre Jean Perrin, Bureau de Recherche Clinique, 58 rue Montalembert, B P 392, 63011 Clermont Ferrand Cedex 1, France
    Br J Cancer 86:1041-6. 2002
    ....
  3. ncbi Assessing the quality of life of patients in phase I and II anti-cancer drug trials: interviews versus questionnaires
    Karen Cox
    Faculty of Medicine and Health Sciences, University of Nottingham, Medical School Room B50, Nottingham, UK
    Soc Sci Med 56:921-34. 2003
    ..The paper concludes by reflecting on some of the methodological issues that arise when assessing the quality of life of patients with a life threatening disease in clinical trials...
  4. pmc Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy
    Z A Nurgat
    Pharmacy Department, Aberdeen Royal Infirmary, Foresterhill Site, Aberdeen AB25 2ZN, UK
    Br J Cancer 92:1001-5. 2005
    ..Trialists should be aware, and take account of the expectations that participants place in trial drugs...
  5. ncbi Statistical design in phase II clinical trials and its application in breast cancer
    Francesco Perrone
    Clinical Trials Unit, National Cancer Institute, Naples, Italy
    Lancet Oncol 4:305-11. 2003
    ..15) were independently predictive of the presence of statistical design. Publication in journals with high impact factors and short intervals between the start of the study and publication were also correlated with statistical design...
  6. ncbi Phase I trial design for solid tumor studies of targeted, non-cytotoxic agents: theory and practice
    Wendy R Parulekar
    National Cancer Institute of Canada Clinical Trials Group, Queen s University, Kingston, Ontario, Canada
    J Natl Cancer Inst 96:990-7. 2004
    ..Because little is known about the optimal methods of recommended phase II dose selection of targeted, non-cytotoxic therapies, we reviewed the strategies that were used in completed phase I studies of these drugs...
  7. ncbi Population pharmacokinetic analysis of ten phase II clinical trials of pemetrexed in cancer patients
    Jane E Latz
    Global Pharmacokinetics, Pharmacodynamics, and Trial Simulation, Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA
    Cancer Chemother Pharmacol 57:401-11. 2006
    ....
  8. ncbi Challenges to conducting HIV preventative vaccine trials with adolescents
    Cori A McClure
    Vanderbilt University Department of Pediatrics, Nashville, TN, USA
    J Acquir Immune Defic Syndr 36:726-33. 2004
    ....
  9. ncbi Adaptive two-stage designs in phase II clinical trials
    Anindita Banerjee
    Department of Statistics, North Carolina State University, Raleigh, NC 27695, USA
    Stat Med 25:3382-95. 2006
    Two-stage designs have been widely used in phase II clinical trials. Such designs are desirable because they allow a decision to be made on whether a treatment is effective or not after the accumulation of the data at the end of each ..
  10. ncbi Informed consent and decision-making: patients' experiences of the process of recruitment to phases I and II anti-cancer drug trials
    Karen Cox
    Post Graduate Division, Faculty of Medicine and Health Sciences, School of Nursing, University of Nottingham, Nottingham, UK
    Patient Educ Couns 46:31-8. 2002
    ....
  11. ncbi Phase II clinical trials in oncology: strengths and limitations of two-stage designs
    James J Schlesselman
    Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, Pennsylvania 15213, USA
    Cancer Invest 24:404-12. 2006
    ..These points are discussed in context of the role of Phase II clinical trials in the development of new treatments for cancer.
  12. ncbi Optimal two-stage randomized phase II clinical trials
    Brent R Logan
    Division of Biostatistics, Medical College of Wisconsin, Milwaukee, WI, 53226 0509, USA
    Clin Trials 2:5-12. 2005
    Randomized phase II clinical trials can be an efficient means of evaluating several potential new treatments prior to a comparative phase III clinical trial...
  13. ncbi Is patient travel distance associated with survival on phase II clinical trials in oncology?
    Elizabeth B Lamont
    Department of Medicine and Cancer Research Center, The University of Chicago, Chicago, IL, USA
    J Natl Cancer Inst 95:1370-5. 2003
    ..We hypothesized that this phenomenon, often called "referral bias" or "distance bias," may also be evident in curative-intent cancer trials at specialized cancer centers...
  14. ncbi Monitoring the rates of composite events with censored data in phase II clinical trials
    Ying Kuen Cheung
    Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, New York 10032, USA
    Biometrics 58:89-97. 2002
    In many phase II clinical trials, interim monitoring is based on the probability of a binary event, response, defined in terms of one or more time-to-event variables within a time period of fixed length...
  15. ncbi Innovative strategies in lymphoma therapy
    Ulrich Jager
    Division of Hematology and Hemostaseology, Department of Internal Medicine I, University of Vienna, Vienna, Austria
    Wien Klin Wochenschr 115:462-70. 2003
    ..These exciting new strategies will improve the success rate in aggressive NHLs and may even challenge the paradigm of incurability of indolent lymphomas...
  16. ncbi Lanthanum carbonate (Shire)
    Francesco Locatelli
    A Manzoni Hospital, Department of Nephrology and Dialysis, Via Dell Eremo 9 11, 23900 Lecco LC, Italy
    IDrugs 6:688-95. 2003
    ..It is currently in pre-registration in the US, Canada and Western Europe, and earlier stage clinical trials are ongoing in Japan...
  17. ncbi Technology evaluation: bevacizumab, Genentech/Roche
    Michael L Salgaller
    Toucan Capital Corp, 7600 Wisconsin Ave, 7th Floor, Bethesda, MD 20814, USA
    Curr Opin Mol Ther 5:657-67. 2003
    ..The antibody is currently in phase III trials for non-small-cell lung, colorectal and breast cancers, and in phase II trials for various other solid tumor types...
  18. ncbi [Anti-epidermal growth factor receptor treatment: a new paradigm for conducting therapeutic trials]
    Michel Marty
    Institut Gustave Roussy, 39, rue Camille Desmoulins, 94804 Villejuif
    Bull Cancer 90:S245-50. 2003
    ....
  19. ncbi Epidermal growth factor receptor: a promising target in solid tumours
    Janessa J Laskin
    Division of Medical Oncology, British Columbia Cancer Agency, 600 West 10th Avenue, Vancouver, BC V5Z 4E6, Canada
    Cancer Treat Rev 30:1-17. 2004
    ....
  20. ncbi Ferucarbotran (Resovist): a new clinically approved RES-specific contrast agent for contrast-enhanced MRI of the liver: properties, clinical development, and applications
    Peter Reimer
    Department of Radiology, Stadtisches Klinikum Karlsruhe, Moltkestrasse 90, 76133 Karlsruhe, Germany
    Eur Radiol 13:1266-76. 2003
    ....
  21. ncbi [Combination therapy with S-1 plus docetaxel (DOC) for previously treated patients with non-small cell lung cancer]
    Shinji Atagi
    Dept of Internal Medicine, National Hospital Organization Kinki chuo Chest Medical Center, Osaka, Japan
    Gan To Kagaku Ryoho 33:197-201. 2006
    ..Partial response was achieved in 4 of the 9 patients. This combined chemotherapy consisting of S-1 and DOC may prove effective for treating recurrent cases of NSCLC. A phase II study is ongoing...
  22. ncbi [Lung cancer]
    Akira Ono
    Division of Thoracic Oncology, Shizuoka Cancer Center
    Gan To Kagaku Ryoho 34:367-73. 2007
    ..A phase III study of carboplatin+etoposide versus amrubicin under way. These studies should aim to optimize several agents for elderly patients and prolong survival, palliative care...
  23. ncbi Developmental chemotherapy and management of recurrent ovarian cancer
    Michael A Bookman
    Fox Chase Cancer Center, Philadelphia, PA 19111, USA
    J Clin Oncol 21:149s-167s. 2003
    ....
  24. ncbi Drug evaluation: MGCD-0103, a histone deacetylase inhibitor for the treatment of cancer
    Jonathan Kell
    Address University Hospital of Wales, Heath Park, Cardiff CF14 4XN, UK
    Curr Opin Investig Drugs 8:485-92. 2007
    ..MGCD-0103 is currently undergoing phase II clinical trials in patients with lymphoma, leukemia, myelodysplastic syndromes and solid tumors, including pancreatic ..
  25. ncbi BNP-7787 (BioNumerik/Baxter Oncology/Grelan)
    R Todd Reilly
    The Johns Hopkins School of Medicine, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, 1650 Orleans Street Room 4M08, Baltimore, MD 21231, USA
    IDrugs 7:64-9. 2004
    ....
  26. ncbi [Development of novel molecular targeted drug, "Iressa", for the treatment of malignant diseases--its basic and clinical studies]
    Shigeru Tsukagoshi
    Cancer Institute, Japanese Foundation of Cancer Research
    Gan To Kagaku Ryoho 30:2155-67. 2003
    ..This paper gives an overview covering development history to date, clinical study results, and post-launch safety reports...
  27. ncbi [Therapy of hormone refractory prostate cancer: new standards, new trends]
    C Wulfing
    Klinik und Poliklinik fur Urologie, Universitatsklinikum Munster
    Aktuelle Urol 36:342-8. 2005
    ....
  28. ncbi Clinical experience with the HER1/EGFR tyrosine kinase inhibitor erlotinib
    Alan Sandler
    Division of Hematology Oncology, Vanderbilt University, Medical Center, Nashville, Tennessee, USA
    Oncology (Williston Park) 17:17-22. 2003
    ..The phase III BR.21 trial is assessing erlotinib monotherapy in advanced refractory non-small-cell lung cancer. Results of these phase II trials will soon be available...
  29. ncbi PTK/ZK (Novartis)
    Joachim Drevs
    Institute of Molecular Oncology, Department of Medical Oncology, Tumor Biology Center, Breisacher Strasse 117, 79106 Freiburg, Germany
    IDrugs 6:787-94. 2003
    ..PTK/ZK, a VEGF receptor tyrosine kinase inhibitor, is under development by Novartis AG and Schering AG as an inhibitor of angiogenesis for the potential treatment of various cancers...
  30. ncbi Radiotherapy and oral capecitabine in the preoperative treatment of patients with rectal cancer: rationale, preliminary results and perspectives
    Renzo Corvò
    National Institute for Cancer Research, Genoa, Italy
    Tumori 89:361-7. 2003
    ..It is likely that these new chemoradiation associations might increase rectal cancer clearance, hopefully without increasing toxicity...
  31. ncbi Clinical trials for treatment of primary generalized epilepsies
    Edward Faught
    University of Alabama at Birmingham Epilepsy Center, University of Alabama School of Medicine, Birmingham, Alabama 35294, USA
    Epilepsia 44:44-50. 2003
    ....
  32. ncbi ChimeriVax-JE. Acambis
    Taff Jones
    ID Biomedical Corp, 7150 Frederick Banting, Ville St Laurent, Quebec H4S 2A1, Canada
    Curr Opin Investig Drugs 4:1019-22. 2003
    ..By May 2003, Acambis had initiated a phase II trial in Australia...
  33. ncbi Rapid development of S-1 in the west for therapy of advanced gastric carcinoma
    Jaffer A Ajani
    Department of Gastrointestinal Medical Oncology, The University of Texas M D Anderson Cancer Center, Houston, Texas, USA
    Gan To Kagaku Ryoho 33:117-20. 2006
    ..Phase I/II studies of the combination of S-1 plus cisplatin have been completed and a global phase III study, accruing rapidly, is comparing S-1 plus cisplatin to 5-fluorouracil plus cisplatin (a reference regimen)...
  34. ncbi Edotecarin
    William A Denny
    The University of Auckland, Auckland Cancer Society Research Centre, School of Medical Sciences, Private Bag 92019, Auckland, New Zealand
    IDrugs 7:173-7. 2004
    ..Banyu Pharmaceutical Co Ltd and Pfizer Inc (formerly Pharmacia Corp) are developing edotecarin, an indolocarbazole topoisomerase I inhibitor, for the potential treatment of solid tumors...
  35. ncbi New paradigm in dose-finding trials: patient-specific dosing and beyond phase I
    Andre Rogatko
    Winship Cancer Institute, Atlanta, Georgia 30322, USA
    Clin Cancer Res 11:5342-6. 2005
    ..These examples should be interpreted as an enticement for the development of new methods to implement the proposed new paradigm...
  36. ncbi Potential therapeutic applications of oblimersen in CLL
    Benjamin Koziner
    Instituto Argentino de Diagnostico y Tratamiento, Buenos Aires, Argentina
    Oncology (Williston Park) 18:32-8. 2004
    ..This trial recently completed accrual of 241 patients...
  37. ncbi Partial breast irradiation after breast-conserving surgery
    Georg Sauer
    Department of Gynecology, University of Ulm, Germany
    Strahlenther Onkol 181:1-8. 2005
    ..Since the majority of local recurrences in selected patients occur close to the former tumor bed, the question arises whether a sole tumor bed irradiation might be a therapeutic alternative to total breast irradiation...
  38. ncbi [Cisplatin and derivatives with radiation therapy: for what clinical use?]
    C Durdux
    service d oncologie radiothérapie, Hopital Europeen Georges Pompidou, AP HP, HEGP, 20 rue Leblanc, 75015 Paris, France
    Cancer Radiother 8:S88-94. 2004
    ..The first part of this overview will describe biological mechanisms of interaction between radiation therapy and platinum derivatives. The second part will report the major clinical impact of their association...
  39. ncbi Discovery, Development, and clinical applications of bortezomib
    Laura Jung
    Syntaxx Communications, Inc Atlanta, Georgia 30097 5906, USA
    Oncology (Williston Park) 18:4-13. 2004
    ..Further studies of bortezomib are needed to establish its full spectrum of activity, the ideal regimens for various tumor types, and clinically useful prognostic indicators that predict successful outcomes...
  40. ncbi Pharmacology, pharmacokinetics, and practical applications of bortezomib
    Rowena Schwartz
    University of Pittsburgh, School of Pharmacy, Pennsylvania 15261, USA
    Oncology (Williston Park) 18:14-21. 2004
    ..Based on the results of phase II clinical trials, bortezomib received accelerated US Food and Drug Administration approval on May 13, 2003, for the ..
  41. ncbi Prospective clinical trials of biotherapies in solid tumors: a 5-year survey
    Alessandro Ottaiano
    Department of Medical Oncology, ULSS2, Santa Maria del Prato Hospital, via Bagnols Ceze, Feltre BL, Italy
    Cancer Immunol Immunother 54:44-50. 2005
    ..To review the content and quality of prospective clinical trials of biotherapies in solid tumors...
  42. ncbi [Clinical trials. An overview]
    K Wegscheider
    Universitat, Hamburg
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 48:515-23. 2005
    ..Thus, they allow decisions to be made on solid objective grounds. In this way, clinical trials have contributed substantially to medical progress over the last 50 years and are indispensable for today's medical research...
  43. ncbi Pemetrexed in malignant pleural mesothelioma
    Maitreyee Hazarika
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, USA
    Clin Cancer Res 11:982-92. 2005
    ..Indianapolis, IN) by the U.S. Food and Drug Administration (FDA) of a New Drug Application for the treatment of malignant pleural mesothelioma (MPM)...
  44. ncbi Current concepts and review of efalizumab in the treatment of psoriasis
    Craig L Leonardi
    Department of Dermatology, St Louis University School of Medicine, 1755 S Grand, St Louis, MO 63104, USA
    Dermatol Clin 22:427-35, ix. 2004
    ..Efalizumab represents a new therapeutic option for the long-term management of moderate to severe chronic plaque psoriasis...
  45. ncbi [Proteasome inhibitors]
    J Alexandre
    Service de Medecine Interne, Unité d Oncologie Médicale, Groupe Hospitalier Cochin Saint Vincent De Paul, 27, rue du Faubourg Saint Jacques, 75014 Paris, France
    Rev Med Interne 26:812-5. 2005
    ..Proteasome is involved in cell cycle and apoptosis regulation. Its deregulation could participate to oncogenesis...
  46. ncbi Preclinical pharmacology of the taxanes: implications of the differences
    Joseph Gligorov
    CancerEst, APHP Tenon, Medical Oncology, Paris, France
    Oncologist 9:3-8. 2004
    ..These pharmacological data likely explain the different clinical development strategies for the two molecules as well as the different clinical results from individual trials and direct comparisons...
  47. ncbi [Non-small cell lung cancer (NSCLC): the evolution of neo-adjuvant chemotherapy in the last 15 years]
    Antonio Santo
    Divisione Clinicizzata di Oncologia Medica, Ospedale Civile Maggiore, Verona
    Recenti Prog Med 97:211-8. 2006
    ..The aim of neo-adjuvant chemotherapy is to address early the distant micrometastasis and to allow, through a downstaging, surgical resection of tumor not suitable to surgery or partially respectable at diagnosis...
  48. ncbi Bevacizumab in the treatment of breast cancer: rationale and current data
    Hope S Rugo
    Comprehensive Cancer Center, University of California, San Francisco, 94115, USA
    Oncologist 9:43-9. 2004
    ..As a single agent or added to vinorelbine, bevacizumab has produced encouraging results in phase II clinical trials in patients with refractory metastatic breast cancer...
  49. ncbi Imatinib mesylate (Gleevec/Glivec) a molecular-targeted therapy for chronic myeloid leukaemia and other malignancies
    E Nadal
    Haematology Department, Hammersmith Hospital, Imperial College, London, UK
    Int J Clin Pract 58:511-6. 2004
    ..Imatinib is an example of how a better understanding of the pathogenetic mechanisms of a neoplastic disease can lead to the development of a molecular-targeted therapy...
  50. ncbi [Characteristics of clinical trials in oncology: pharmacist's implication]
    I Madelaine-Chambrin
    Service Pharmacie, Hôpital Saint Louis AP HP, 1 avenue Claude Vellefaux, F75 475 Paris cedex 10
    Ann Pharm Fr 64:36-42. 2006
    ....
  51. pmc Unconventional anticancer agents: a systematic review of clinical trials
    Andrew J Vickers
    Integrative Medicine Service and Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY 10021, USA
    J Clin Oncol 24:136-40. 2006
    ..The objective of this study was to review systematically the methodologies applied in clinical trials of unconventional treatments specifically for cancer...
  52. ncbi Development of the novel biologically targeted anticancer agent gefitinib: determining the optimum dose for clinical efficacy
    Michael Wolf
    Clinical Research, AstraZeneca Pharmaceuticals, Wilmington, Delaware, USA
    Clin Cancer Res 10:4607-13. 2004
    ..Consequently, the recommended dose of gefitinib in NSCLC is 250 mg/day. The early clinical trial development of gefitinib provides a model for the development of novel, noncytotoxic anticancer agents...
  53. ncbi Bevacizumab combined with standard fluoropyrimidine-based chemotherapy regimens to treat colorectal cancer
    Herbert Hurwitz
    Duke University Medical Centre, Durham, N C 27710, USA
    Oncology 69:17-24. 2005
    ..Ongoing trials of bevacizumab in combination with standard first-line chemotherapy regimens will evaluate bevacizumab's potential in a range of cancer types. ...
  54. ncbi GW-1000. GW Pharmaceuticals
    Paul F Smith
    University of Otago, Department of Pharmacology and Toxicology, School of Medical Sciences, Dunedin, New Zealand
    Curr Opin Investig Drugs 5:748-54. 2004
    ..In March 2003, the company filed for approval for the treatment of MS with the UK Medicines Control Agency, and in May 2004, filed for new drug submission with Health Canada...
  55. ncbi Current approaches in ovarian cancer vaccines
    S Reinartz
    Department for Gynecology and Obstetrics, University of Marburg, Marburg, Germany
    Minerva Ginecol 56:515-27. 2004
    ..g. by vaccines targeting a broader range of tumor-derived antigenic structures or activating diverse host immune functions, will be discussed...
  56. ncbi Iseganan (IntraBiotics pharmaceuticals)
    Jeffrey H Toney
    Merck Research Laboratories, Rahway, NJ 07065 0900, USA
    Curr Opin Investig Drugs 3:225-8. 2002
    ..In May 2000, analysts at SG Cowen predicted the drug's potential market at US $100 to US $200 million [376325]...
  57. ncbi Docetaxel in combination with platinums (cisplatin or carboplatin) in advanced and metastatic non-small cell lung cancer
    Chandra P Belani
    Lung and Thoracic Cancer Program, University of Pittsburgh Cancer Institute, PA
    Semin Oncol 29:4-9. 2002
    ....
  58. ncbi Anti-angiogenic strategies and vascular targeting in the treatment of lung cancer
    C S Brock
    Meyerstein Institute of Oncology, Middlesex University College London Hospitals, UK
    Eur Respir J 19:557-70. 2002
    ....
  59. ncbi Pexelizumab Alexion
    Per A Whiss
    Faculty of Health Sciences, Department of Medicine and Care, Linköping Universitet, Sweden
    Curr Opin Investig Drugs 3:870-7. 2002
    ..In the rest of the world, CPB approvals were expected to begin in the second half of 2005. Sales in 2006 were expected to reach US $35 million, rising to US $110 million in 2008 [438051]...
  60. ncbi Safety and tolerability of caspofungin acetate in the treatment of fungal infections
    C A Sable
    Department of Infectious Diseases, Merck Research Laboratories, West Point, Pennsylvania 19486, USA
    Transpl Infect Dis 4:25-30. 2002
    ..Caspofungin may have potentially important drug interactions with cyclosporine and tacrolimus...
  61. ncbi Radioimmunotherapy with yttrium-90 ibritumomab tiuxetan for patients with relapsed CD20+ B-cell non-Hodgkin's lymphoma
    Thierry Alcindor
    Department of Internal Medicine, Division of Hematology, Mayo Clinic and Mayo Foundation, 200 First Street, Rochester, MN 55905, USA
    Curr Treat Options Oncol 3:275-82. 2002
    ..The outcome of these studies will be helpful in deciding how best to integrate this new modality into the treatment paradigm of NHL...
  62. ncbi BMS-275291. Bristol-Myers Squibb
    Vassiliki Poulaki
    Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston 02114, USA
    Curr Opin Investig Drugs 3:500-4. 2002
    ..In January 2002, Morgan Stanley Dean Witter expressed the view that release of positive phase II/III trials data would surprise stock markets...
  63. ncbi Imatinib. Novartis
    Ian R Radford
    Peter MacCallum Cancer Institute, East Melbourne, Victoria, Australia
    Curr Opin Investig Drugs 3:492-9. 2002
    ..In August 2001, Deutsche Bank estimated sales of SFr 233 million in 2001, rising to SFr 850 million in 2005; while Bear Stearns & Co predicted sales of SFr 250 million in 2001, rising to SFr 800 million in 2005...
  64. ncbi Future treatment options with capecitabine in solid tumours
    H Wilke
    Department of Internal Medicine and Oncology Hematology, Kliniken Essen Mitte, Germany
    Eur J Cancer 38:21-5. 2002
    ....
  65. ncbi Fulvestrant (AstraZeneca)
    Stephen R D Johnston
    Department of Medicine, Royal Marsden Hospital and Institute of Cancer Research, London, UK
    Curr Opin Investig Drugs 3:305-12. 2002
    ..Analysts at Lehman Brothers predicted in December 2001, that the product has a 90% chance of making it to market in 2002, with peak sales potential in this year of $800 million [434768]...
  66. ncbi Population pharmacokinetic and adverse event analysis of topotecan in patients with solid tumors
    Diane R Mould
    Projections Research Inc, 535 Springview Lane, Phoenixville, PA 19460, USA
    Clin Pharmacol Ther 71:334-48. 2002
    ..Our objective was to describe the pharmacokinetics and pharmacodynamics of topotecan in patients...
  67. ncbi Tipifarnib (Janssen Pharmaceutica)
    Peter Norman
    Norman Consulting, Burnham, Bucks, UK
    Curr Opin Investig Drugs 3:313-9. 2002
    ..In November 2001, Credit Lyonnais Securities predicted NDAfilings in 2002 and 2003 for pancreatic cancer and other cancers, respectively, and projected US introductions for these indications in 2004 and 2005, respectively [436939]...
  68. ncbi Alimta (pemetrexed disodium): a multitargeted antifolate for the treatment of mesothelioma
    Mark R Green
    Clinical Oncology, Medical University of South Carolina, 96 Jonathan Lucas Street, 903 CSB, Charleston, SC 29425, USA
    Lung Cancer 38:S55-7. 2002
    ..The findings will be presented at the 38th Annual Meeting of the American Society of Clinical Oncology in May 2002...
  69. ncbi Emerging role of topotecan in front-line treatment of carcinoma of the ovary
    Robert L Coleman
    Obstetrics and Gynecology, University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Building J7 124, Dallas, TX 75390 9032, USA
    Oncologist 7:46-55. 2002
    ..This review summarizes the preliminary clinical findings associated with the four strategies and outlines ongoing and future randomized studies of topotecan in front-line ovarian cancer...
  70. ncbi Eptifibatide in percutaneous coronary intervention. A review
    J P Dery
    Duke Clinical Research Institute and Duke University Medical Center, Durham, NC, USA
    Minerva Cardioangiol 50:531-46. 2002
    ..These landmark studies, which are the focus of this review, emphasize the importance of considering the use of GP IIb-IIIa inhibitors in all patients undergoing PCI...
  71. ncbi Axokine (Regeneron)
    Antonio Preti
    Genneruxi Medical Center, via Costantinopoli 42, I 09129 Cagliari, Italy
    IDrugs 6:696-701. 2003
    ..Axokine, a second-generation neurotrophic factor that is related to ciliary neurotrophic factor (CNTF), is under development by Regeneron for the potential treatment of obesity and associated complications such as type 2 diabetes...
  72. ncbi Sequential, alternating, and maintenance/consolidation chemotherapy in advanced non-small cell lung cancer: a review of the literature
    Francesco Grossi
    Medical Oncology A, Disease Management Team Lung Cancer, National Institute for Cancer Research, Genoa, Italy
    Oncologist 12:451-64. 2007
    ..In the meantime, sequential, alternating, and maintenance/consolidation therapy should still be considered investigational...
  73. ncbi Clinical trial designs for targeted agents
    Brigette B Y Ma
    Department of Medical Oncology, Princess Margaret Hospital, University Health Network, 610 University Avenue, Toronto, ON M5G 2M9, Canada
    Hematol Oncol Clin North Am 16:1287-305. 2002
    ....
  74. ncbi Replicating adenoviruses in cancer therapy
    M Dobbelstein
    Institut fur Virologie, Philipps Universitat Marburg, Robert Koch str 17, 35037 Marburg, Germany
    Curr Top Microbiol Immunol 273:291-334. 2004
    ..gene product, termed dl1520 or ONYX015, was injected into squamous cell carcinomas of head and neck in phase II clinical trials, and the results were encouraging when chemotherapy was applied in parallel...
  75. ncbi Cetuximab: an epidermal growth factor receptor chemeric human-murine monoclonal antibody
    Joanne Harding
    Medical Information Department, Prous Science, Barcelona, Spain
    Drugs Today (Barc) 41:107-27. 2005
    ..In fact, analysis of four phase II clinical trials of cetuximab in combination with chemotherapy in patients with colorectal cancer, squamous cell carcinoma ..
  76. ncbi The inefficiency of incisions of ecteinascidin 743-DNA adducts by the UvrABC nuclease and the unique structural feature of the DNA adducts can be used to explain the repair-dependent toxicities of this antitumor agent
    M Zewail-Foote
    Department of Chemistry and Biochemistry, The University of Texas at Autin, 78712, USA
    Chem Biol 8:1033-49. 2001
    ..743 (Et 743), a natural product derived from a marine tunicate, is a potent antitumor agent presently in phase II clinical trials. Et 743 binds in the minor groove of DNA and alkylates N2 of guanine via a unique mechanism involving ..
  77. pmc Intracellular metabolism of the orally active platinum drug JM216: influence of glutathione levels
    F I Raynaud
    Cancer Research Campaign Centre for Cancer Therapeutics, Institute of Cancer Research, Sutton, Surrey, UK
    Br J Cancer 74:380-6. 1996
    JM216 (bis-acetato ammine dichloro cyclohexylamine Pt IV) is an oral platinum complex presently undergoing phase II clinical trials. Previous studies have identified some of its biotransformation products in clinical materials...
  78. ncbi Clinical studies with targeted toxins in malignant glioma
    Nikolai G Rainov
    The University of Liverpool, Dept Neurological Science, The Walton Centre for Neurology and Neurosurgery NHS Trust, Clinical Sciences Centre for Research and Education, Lower Lane, Liverpool L9 7LJ, UK
    Rev Recent Clin Trials 1:119-31. 2006
    ..Four targeted toxins advanced to at least phase II clinical trials and are being used for treatment of adult or pediatric patients with recurrent or progressive malignant ..
  79. ncbi Advantageous toxicity profile of inhaled antisense oligonucleotides following chronic dosing in non-human primates
    Alain Guimond
    Topigen Pharmaceuticals Inc, 2901 East Rachel Street, Suite 13, Montreal, Quebec, Canada H1W 4A4
    Pulm Pharmacol Ther 21:845-54. 2008
    ....
  80. ncbi Intraliposomal chemical activation patterns of liposomal cis-bis-neodecanoato-trans-R,R-1,2-diaminocyclohexane platinum (II) (L-NDDP)-a potential antitumour agent
    D S Maclean
    Department of Thoracic Head and Neck Medical Oncology, MD Anderson Cancer Center, Houston, TX 77030, USA
    J Microencapsul 17:307-22. 2000
    ....
  81. pmc Voreloxin is an anticancer quinolone derivative that intercalates DNA and poisons topoisomerase II
    Rachael E Hawtin
    Sunesis Pharmaceuticals, Inc, South San Francisco, California, United States of America
    PLoS ONE 5:e10186. 2010
    ..This study defined voreloxin's anticancer mechanism of action as a critical component of rational clinical development informed by translational research...
  82. ncbi Current state of vaccine therapies in non-small-cell lung cancer
    Pedro Romero
    Division of Clinical Onco Immunology, Ludwig Institute for Cancer Research, Lausanne Branch, Lausanne, Switzerland
    Clin Lung Cancer 9:S28-36. 2008
    ..A limited number have also been tested in randomized phase II clinical trials. Encouraging trends toward increased survival in the vaccine arms have been recently observed for 2 ..
  83. pmc Natural BH3 mimetic (-)-gossypol chemosensitizes human prostate cancer via Bcl-xL inhibition accompanied by increase of Puma and Noxa
    Yang Meng
    Department of Radiation Oncology, University of Michigan Comprehensive Cancer Center, 4424E Med Sci I SPC5637, 1301 Catherine Street, Ann Arbor, MI 48109 5637, USA
    Mol Cancer Ther 7:2192-202. 2008
    ..Gossypol, a natural BH3 mimetic, is a small-molecule inhibitor of Bcl-2/Bcl-xL/Mcl-1 currently in phase II clinical trials as an adjuvant therapy for human prostate cancer...
  84. ncbi Revealing the multidimensional framework of the Minnesota nicotine withdrawal scale
    Joseph C Cappelleri
    Pfizer Inc, Global Research and Development, Groton, CT 06340, USA
    Curr Med Res Opin 21:749-60. 2005
    ..No psychometric analyses of this version have been published. The objectives of this investigation were to perform a factor analysis and to further assess the psychometric properties of the MNWS...
  85. ncbi Ixabepilone: a novel microtubule-stabilizing agent for the treatment of metastatic breast cancer
    Susan Goodin
    Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey, Piscataway, USA
    Am J Health Syst Pharm 65:2017-26. 2008
    ..The pharmacology, pharmacokinetics, clinical efficacy, safety, dosage, and administration of ixabepilone in patients with metastatic breast cancer are examined...
  86. pmc DEB025 (Alisporivir) inhibits hepatitis C virus replication by preventing a cyclophilin A induced cis-trans isomerisation in domain II of NS5A
    Lotte Coelmont
    Department of Microbiology and Immunology, Rega Institute for Medical Research, University of Leuven, Leuven, Belgium
    PLoS ONE 5:e13687. 2010
    ..It is currently being evaluated in phase II clinical trials. DEB025 binds to CypA, a peptidyl-prolyl cis-trans isomerase which is a crucial cofactor for HCV ..
  87. ncbi Multifaceted approach to determine the antagonist molecular mechanism and interaction of ibodutant ([1-(2-phenyl-1R-[[1-(tetrahydropyran-4-ylmethyl)-piperidin-4-ylmethyl]-carbamoyl]-ethylcarbamoyl)-cyclopentyl]-amide) at the human tachykinin NK2 receptor
    Stefania Meini
    Pharmacology Department, Menarini Ricerche SpA, Florence, Italy
    J Pharmacol Exp Ther 329:486-95. 2009
    ..is a tachykinin NK(2) receptor (NK(2)R) antagonist currently under phase II clinical trials for irritable bowel syndrome...
  88. ncbi Pharmacological management of acromegaly: a current perspective
    Sunil Manjila
    Department of Neurological Surgery, The Neurological Institute, University Hospitals Case Medical Center, Cleveland, Ohio 44106, USA
    Neurosurg Focus 29:E14. 2010
    ..The novel multireceptor somatostatin analog pasireotide, currently in Phase II clinical trials, also shows promise in the treatment of acromegaly...
  89. ncbi Thrombin receptor antagonism -the potential of antiplatelet medication SCH 530348
    Tracy E Macaulay
    University of Kentucky, Gill Heart Institute, Division of Cardiovascular Medicine, 900 South Limestone, 326 Wethington Building, Lexington, KY 40536 0200, USA
    Expert Opin Pharmacother 11:1015-22. 2010
    ..Recently, there has been more interest in inhibition of the proteinase-activated receptor-1 (PAR-1), which blocks thrombin-mediated platelet activation...
  90. ncbi Syntheses and bio-activities of the L-enantiomers of two potent transition state analogue inhibitors of purine nucleoside phosphorylases
    Keith Clinch
    Carbohydrate Chemistry Team, Industrial Research Limited, P O Box 31310, Lower Hutt, New Zealand
    Org Biomol Chem 4:1131-9. 2006
    ..The C-nucleoside hydrochloride D-ImmH [(-)-5) x HCl], now "Fodosine" is in phase II clinical trials as an anti-T-cell leukaemia agent, while D-DADMe-ImmH is a second generation inhibitor with extreme ..
  91. ncbi [Interferon-alpha2b recombinant improved the cognitive dysfunction in patients with relapsing remitting multiple sclerosis]
    J A Cabrera-Gomez
    Grupo Cubano para la Investigación y el Tratamiento de la Esclerosis Múltiple, Cienfuegos, Cuba
    Rev Neurol 37:214-20. 2003
    Some experimental, Phase II clinical trials and the preliminary reports of the Cuban Phase III clinical trial indicate that alpha-IFN (IFN) may be useful in relapsing remitting (RR) multiple sclerosis (MS)...
  92. ncbi LY231514, a pyrrolo[2,3-d]pyrimidine-based antifolate that inhibits multiple folate-requiring enzymes
    C Shih
    Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285, USA
    Cancer Res 57:1116-23. 1997
    ..acid (LY231514) is a novel pyrrolo[2,3-d]pyrimidine-based antifolate currently undergoing extensive Phase II clinical trials. Previous studies have established that LY231514 and its synthetic gamma-polyglutamates (glu3 and glu5) ..
  93. ncbi The histone deacetylase inhibitor PXD101 synergises with 5-fluorouracil to inhibit colon cancer cell growth in vitro and in vivo
    Anthony Tumber
    TopoTarget UK LTD, 87a Milton Park, Abingdon, Oxon, OX14 4RY, UK
    Cancer Chemother Pharmacol 60:275-83. 2007
    ..We have investigated effects of PXD101 (HDACi in phase II clinical trials) in combination with 5-fluorouracil, on tumour cell proliferation and apoptosis both in vitro and in vivo.
  94. ncbi Update on primary central nervous system lymphoma
    Scott R Plotkin
    Department of Neurology, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, USA
    Curr Opin Neurol 18:645-53. 2005
    ..Numerous studies examining this disorder have been published in the past 2 years. This review will discuss recent advances in the understanding of the pathology, radiographic appearance, and treatment of this disorder...
  95. pmc Differential influence of p38 mitogen activated protein kinase (MAPK) inhibition on acute phase protein synthesis in human hepatoma cell lines
    J Westra
    Department of Rheumatology, University Medical Centre Groningen, PO Box 30 001, 9700 RB Groningen, The Netherlands
    Ann Rheum Dis 65:929-35. 2006
    ..p38 MAPK inhibitors, especially, have been developed and are now in phase II clinical trials for rheumatoid arthritis (RA).
  96. ncbi Modulation of 4E-BP1 function as a critical determinant of enzastaurin-induced apoptosis
    Chad A Dumstorf
    Lilly Research Labs, Eli Lilly and Company, Indianapolis, Indiana 46285
    Mol Cancer Ther 9:3158-63. 2010
    ..HCl) is currently in a phase III registration trial for diffuse large B-Cell lymphoma and numerous phase II clinical trials. Enzastaurin suppresses angiogenesis and induces apoptosis in multiple human tumor cell lines by ..
  97. ncbi Ingested type I interferon: state of the art as treatment for autoimmunity
    Staley A Brod
    Multiple Sclerosis Research Group, Department of Neurology, Graduate School of Biomedical Sciences in Immunology, University of Texas Health Science Center at Houston, Houston, Texas 77030, USA
    Exp Biol Med (Maywood) 227:981-8. 2002
    ..potential efficacy in three phase I (type 1 diabetes, rheumatoid arthritis, multiple sclerosis) and one phase II clinical trials in multiple sclerosis...
  98. ncbi Ingested type I interferon: a potential treatment for autoimmunity
    Staley A Brod
    Multiple Sclerosis Research Group, Department of Neurology, Graduate School of Biomedical Sciences in Immunology, University of Texas Health Science Center at Houston, Houston, TX 77030, USA
    J Interferon Cytokine Res 22:1153-66. 2002
    ..potential efficacy in three phase I (type 1 diabetes, rheumatoid arthritis, multiple sclerosis) and one phase II clinical trials in multiple sclerosis (MS)...
  99. ncbi Vinblastine and interferon-gamma combination with and without 13-cis retinoic acid for patients with advanced renal cell carcinoma. Results of two phase II clinical trials
    C Bacoyiannis
    Medical Oncology Department, Hygeia Hospital, Athens, Greece
    Oncology 63:130-8. 2002
    ....
  100. ncbi Proteomic analysis revealed association of aberrant ROS signaling with suberoylanilide hydroxamic acid-induced autophagy in Jurkat T-leukemia cells
    Jingyi Li
    The State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, P R China
    Autophagy 6:711-24. 2010
    ..hydroxamic acid (SAHA) is a newly emerging histone deacetylase inhibitor (HDACi) and has been approved in phase II clinical trials for treating patients with cutaneous T-cell lymphoma...
  101. ncbi Clinical development and perspectives of CIMAvax EGF, Cuban vaccine for non-small-cell lung cancer therapy
    Pedro C Rodriguez
    Molecular Immunology Center, Havana, Cuba
    MEDICC Rev 12:17-23. 2010
    ..The vaccine is based on active immunotherapy by which an individual's immune response is manipulated to release its own effector antibodies (Abs) against the epidermal growth factor (EGF)...

Research Grants70

  1. Phase II Clinical Trial of Lactoferrin in Asthma
    Atul Varadhachary; Fiscal Year: 2005
    ..this research is to determine the efficacy of orally administered recombinant human lactoferrin (rhLF) in Phase II clinical trials in patients with mild to moderate asthma...
  2. Alzheimer's Disease Therapeutic
    Trevor P Castor; Fiscal Year: 2012
    ..Series A raise, Amylon plans to initiate the establishment of a $25 million USD Series B round to conduct Phase II clinical trials in year 3...
  3. Iowa Phase II Clinical Trials of Novel Therapies for Lung Diseases (U01
    Lakshmi Durairaj; Fiscal Year: 2012
    ..Giving xylitol as a nebulizer into the lungs may be a simple and safe way to ward off lung infections. (End of Abstract) ..
  4. Development of a Next Generation Vaccine for Smoking Cessation and Relapse Preven
    Grayson B Lipford; Fiscal Year: 2010
    ..Supportive data from two independent phase II clinical trials indicate a correlation between anti-nicotine antibody titers and smoking cessation...
  5. Fluorescein for Sentinel Lymph Node Detection
    James M McGreevy; Fiscal Year: 2012
    ..4) Conduct two statistically-robust Phase II clinical trials of the fluorescent dye and visualization devices in 80 patients undergoing SLN biopsy for malignant ..
  6. Obesity, Inflammation, and Lung Injury After Lung Transplantation
    David J Lederer; Fiscal Year: 2013
    ..In addition, we propose to identify specific molecules that could be targeted in phase II clinical trials to decrease PGD risk and potentially improve outcomes after lung transplantation.
  7. FOSMIDOMYCIN RESISTANCE IN PLASMODIUM FALCIPARUM
    AUDREY RAGAN ODOM; Fiscal Year: 2013
    ..Fosmidomycin is a validated inhibitor of the MEP pathway and is currently in Phase II clinical trials of combination therapy to treat malaria...
  8. In vivo and in vitro roles played by Hdac3 in genomic stability maintenance
    Srividya Bhaskara; Fiscal Year: 2010
    ..Pharmacological inhibitors of HDACs are in Phase I and Phase II clinical trials for various cancers, yet we still do not have a clear understanding of how broad-spectrum HDAC inhibitors ..
  9. PHASE II TRIAL OF SLEEP APNEA TREATMENT TO REDUCE CARDIOVASCULAR MORBIDITY
    SUSAN S REDLINE; Fiscal Year: 2010
    ..End of Abstract) ..
  10. Mechanism of Slow Onset Enzyme Inhibition and Drug Target Residence Time
    Peter J Tonge; Fiscal Year: 2013
    DESCRIPTION (provided by applicant): Many drug candidates fail due to lack of efficacy in Phase II clinical trials. This failure occurs in all therapeutic areas and primarily stems from poo in vivo efficacy as well as lack of safety (..
  11. Novel Early Intervention to Prevent Post-Traumatic Osteoarthritis
    Dominik R Haudenschild; Fiscal Year: 2013
    ..Specific cdk9 kinase inhibitors are readily available, an are currently in phase II clinical trials as anti-cancer drugs. Preliminary data support our hypothesis...
  12. Mechanisms of radiosensitization by 2-methoxyestradiol in prostate cancer models
    James M Larner; Fiscal Year: 2012
    ..Since 2-ME as a single agent has shown anti-cancer efficacy and was well-tolerated in Phase II clinical trials against prostate cancer, these pre-clinical studies will provide important information regarding the ..
  13. Survival and growth-promotion mechanisms of the GDNF family ligands (GFLs)
    BRIAN ANTHONY PIERCHALA; Fiscal Year: 2012
    ..Neurturin, a member of this family, is currently in phase II clinical trials for Parkinson's disease...
  14. Small Molecule Probes to Investigate Structure and Function of Y Receptors
    C David Weaver; Fiscal Year: 2013
    ..In fact Obinepitide (TM-30338), a variant of PP and PYY, is currently in phase II clinical trials as a treatment for obesity...
  15. p38 MAPK as a female-specific druggable target in CNS autoimmune disease
    Cory Teuscher; Fiscal Year: 2012
    ....
  16. Control of cancer and metastasis by endothelial-derived epoxyeicosatrienoic acids
    Dipak Panigrahy; Fiscal Year: 2013
    ..1) Drugs which increase EETs are cardioprotective and in phase II clinical trials for hypertension;in view of our preliminary results, the potential of cancer risk must be carefully ..
  17. Genetic Analysis of Airflow Obstruction After Stem Cell Transplantation
    Joan G Clark; Fiscal Year: 2013
    ..These studies will result in genetic biomarkers useful for identifying populations for future phase II clinical trials, provide new insights into the disease pathobiology, and serve as novel therapeutic targets...
  18. POTENTIATED STATE OF THE HSP70 HEAT SHOCK GENE
    DAVID SCOTT GILMOUR; Fiscal Year: 2013
    ..DSIF and P-TEFb both contribute to transcription of the HIV provirus, and an inhibitor of P-TEFb is in phase 2 clinical trials for cancer therapy. ..
  19. VASCULAR ANTI-INFLAMMATORY ACTIONS OF HSP90 INHIBITORS
    John D Catravas; Fiscal Year: 2013
    ..Because these drugs have finished Phase II clinical trials and exhibit low side effects translation of these findings from these studies in cardiovascular disease ..
  20. Scripps Florida Product Development Partnership for smoking cessation therapeutic
    Paul J Kenny; Fiscal Year: 2011
    ..pipeline based on findings during the UH2 phase;2) By year 3 of the UH3, we will have 1 compound entering Phase II clinical trials;and 3) By year 5 of the UH3, we will have 1 compound entering Phase III clinical trials, and another 1-2 ..
  21. Validation of Src kinases as Anti-Dengue Viral Targets
    PRISCILLA LI NING YANG; Fiscal Year: 2012
    ..of imatinib-resistant Chronic Myelogenous Leukemia, and AZD0530, a dual Src-Abl inhibitor that is in phase II clinical trials for the treatment of solid tumors, cause a greater than 100-fold reduction in viral titers at single-..
  22. Transdermal Cannabidiol Prodrug Delivery
    Audra L Stinchcomb; Fiscal Year: 2011
    ..The future CBD transdermal system could also be tested in Phase II clinical trials for opiate addiction, analgesic effect, inflammation relief (arthritis), and nausea and vomiting ..
  23. A Small Animal Model for Viscerotropic Disease to Improve Yellow Fever Vaccine
    KATHERINE D RYMAN; Fiscal Year: 2013
    ..g. Japanese encephalitis) in a 17D vaccine virus backbone. Such chimeric vaccines are in phase II clinical trials. Surprisingly, little is known about the molecular mechanisms that govern the virulence of wild-type YFV ..
  24. Clavulanic acid: a potential abuse-deterrent and CNS-active therapeutic
    Scott M Rawls; Fiscal Year: 2012
    ..often approved by regulatory agencies for human use, any newly identified use can be rapidly evaluated in phase II clinical trials, which typically last two years and cost $17 million...
  25. Development of a Live Combinational Microbicide for Women
    Qiang Xu; Fiscal Year: 2010
    ..LACTIN-V, is a naturally occurring human vaginal isolate of Lactobacillus crispatus presently undergoing phase II clinical trials to examine its safety and efficacy in preventing recurrent urinary tract infections (UTIs) and bacterial ..
  26. Glucose Modifications of Proteins in Diabetic Nephropathy
    BILLY GERALD HUDSON; Fiscal Year: 2013
    ....
  27. Preclinical Development of a Tularemia Vaccine
    Jason F Huntley; Fiscal Year: 2013
    ..The projects outlined in this proposal seek to advance a lead tularemia vaccine candidate and test new vaccine formulations for efficacy and safety. ..
  28. NF-KB and mTOR regulation in Waldenstrom Macroglobulinemia
    Irene M Ghobrial; Fiscal Year: 2013
    ....
  29. Enhanced Propagation of Adult Human Renal Epithelial Cells
    Angela Westover; Fiscal Year: 2009
    ..based renal assist device (RAD) containing human cells has been evaluated in FDA-approved Phase I/II and Phase II clinical trials. Currently, biotherapeutic renal devices are in development to ameliorate the effects of ARF, acute ..
  30. Phase II study: Mobilization of progenitor cells in peripheral arterial disease
    Arshed A Quyyumi; Fiscal Year: 2010
    ..of Fundamental Research Findings into Clinical Treatments for Heart, Lung, and Blood Diseases, 2) Phase II Clinical Trials Program of Novel Therapies for Heart, Lung, and Blood Diseases. SPECIFIC AIM...
  31. Mechanisms of colon cancer chemoprevention by ursodeoxycholic acid
    Jesse D Martinez; Fiscal Year: 2013
    ..on elucidating the mechanism of ursodeoxycholic acid a chemopreventive agent that has proven effective in phase II clinical trials. Our objective is to develop sufficient understanding of how this agent acts so as to develop more ..
  32. Predicting pancreatic cancer responses for a Parp inhibitor-based clinical trial
    Michael G Goggins; Fiscal Year: 2010
    ....
  33. A Controlled Trial of CBT for Multiple Sclerosis Inflammation
    David I Daikh; Fiscal Year: 2010
    ..Consistent with Phase II clinical trials in MS, the primary outcome will be Gd+ MRI brain lesions acquired at screening, and months 3, 6, 12, 18, ..
  34. SYNTHESIS AND BIOTRANSFORMATION OF ANTI-HIV PRODRUGS
    Chung K Chu; Fiscal Year: 2010
    ..developed a promising prodrug, (-)- b-D-2,6-diaminopurine dioxolane (DAPD), which is currently undergoing Phase II clinical trials by Triangle Pharmaceuticals...
  35. Clinical Development of SQ109 for H. pylori Infection
    LISA BETH FERSTENBERG; Fiscal Year: 2013
    ..pylori gastrointestinal infection. The criteria for moving this drug into formal clinical development for treatment of duodenal ulcers will be its ability to eliminate H. pylori (a negative UBT at 21 or 42 days). ..
  36. Immunomodulation of Relapsing Remitting Multiple Sclerosis by Gut Parasites
    Zsuzsanna Fabry; Fiscal Year: 2010
    ..Helminth-therapy, using T. suis ova (TSO), has been successfully applied in phase II clinical trials for Crohn's disease and autoimmune colitis...
  37. Molecular Targeting of Diffuse Large B-cell Lymphoma
    Ari M Melnick; Fiscal Year: 2013
    ..By the end of the funding period, we expect to be moving peptidomimetic BCL6 inhibitor drugs into phase II clinical trials. PUBLIC HEALTH RELEVANCE: B-cell lymphomas are the fourth most common form of cancer in the United States ..
  38. ANTIBODY V GENE EXPRESSION B CELL LYMPHOCYTIC LEUKEMIA
    Thomas J Kipps; Fiscal Year: 2013
    ..Phase I and early phase II clinical trials using recombinant adenovirus vectors encoding a recombinant CD40-ligand (Ad- CD154) are direct ..
  39. Development of sEphB4-HSA as Novel Therapeutic in Cancer
    VALERY G KRASNOPEROV; Fiscal Year: 2013
    ..Therefore, we will manufacture large quantity (1.7 kg) of sEphB4-HSA for the coming human Phase II clinical trials in Kras mutant lung and pancreatic cancers...
  40. The Jefferson Regional Clinical Center for Heart Failure Network
    David J Whellan; Fiscal Year: 2013
    ....
  41. Necrotizing Enterocolitis: Prevention and Prediction
    MARK ALAN UNDERWOOD; Fiscal Year: 2012
    ..The genes of premature infants who get intestinal infections may be slightly different from those who don't;we will test one group of particularly promising genes to see if that is true. ..
  42. Correction of defective deltaF508-CFTR processing in cystic fibrosis
    Gergely L Lukacs; Fiscal Year: 2013
    ..In accord, initial data of phase II clinical trials indicate marginal clinical efficiency of VX-809...
  43. Chemokines in pathogenesis of Experimental Arthritis
    SEEMA SINGH AHUJA; Fiscal Year: 2010
    ..Rheumatoid Arthritis affects 1% of US population, and therapies designed to block CCR2 are in phase II clinical trials. Thus information obtained from proposed studies which explore how CCR2 modulates arthritis will have ..
  44. Commercial development of Src kinase inhibitors for oncology
    ALLEN BARNETT; Fiscal Year: 2010
    ..Tissue samples from patients in the Phase 1 trial are being procured for the development of biomarker tests to measure drug efficacy and to identify potential patient populations who are sensitive to this drug. ..
  45. Enabling high dose regional chemotherapy while minimizing systemic toxicity
    Shaker A Mousa; Fiscal Year: 2010
    ..PHPTM is currently under testing in Phase II clinical trials for a variety of cancers of the liver...
  46. Development of Novel Therapeutic Strategies in Human Leukemias
    JAMES DOUGLAS GRIFFIN; Fiscal Year: 2012
    ..inhibitors as therapeutic agents, and bringing these small molecule inhibitors forward into Phase I and Phase II clinical trials. During the next proposed 5-year study period we will build on these successes, and expand our efforts ..
  47. ChNKG2D-Targeted Cellular Cancer Therapy: Phase I Clinical Trial
    Michael W Fanger; Fiscal Year: 2013
    ..This grant will take chNKG2D T cells into the clinic, and if successful will yield a therapy ready for Phase II clinical trials. Herein we propose to complete the remaining preclinical development and conduct a Phase I clinical trial...
  48. Regulation of Notch Signaling by ErbB-2: Novel Therapeutic Strategy
    Clodia Osipo; Fiscal Year: 2013
    ....
  49. OTHER FUNCTIONS - R&D BIOMEDICAL (BASIC RESEARCH)
    DR DAVID HOUT; Fiscal Year: 2012
    ..TKI treatments have also been used against non-NSCLC RET and DEPDC1 driven cancers in ongoing Phase I and Phase II clinical trials with good efficacy...
  50. OTHER FUNCTIONS - R&D BIOMEDICAL (BASIC RESEARCH)
    DR DAVID HOUT; Fiscal Year: 2013
    ..TKI treatments have also been used against non-NSCLC RET and DEPDC1 driven cancers in ongoing Phase I and Phase II clinical trials with good efficacy...
  51. Studies in Translational Regenerative Medicine
    GEORGE JOSEPH CHRIST; Fiscal Year: 2013
    ..As such, this proposal is timely, thoughtfully planned, and specifically designed to meet the burgeoning need for well-trained investigators in the many facets of regenerative medicine. ..
  52. YK-4-279 specifically targets ETS family fusion-protein cancers in clinical trial
    Jeffrey A Toretsky; Fiscal Year: 2010
    ..Future growth will also arise from the targeting of additional cancers and other diseases that rely on aberrant transcription to improve human health. ..
  53. TRIP: Targeted Gene Therapy for the Treatment of Heart Failure
    Roger J Hajjar; Fiscal Year: 2013
    ..In this grant, we build on our pre-clinical work in stage 1 of CTRIP to propose Phase 1 and Phase 2 clinical trials in gene therapy using novel vectors and a novel gene target for the treatment of heart failure. ..
  54. Early Clinical Trials of New Anti-Cancer Agents with Phase I Emphasis
    Donald W Kufe; Fiscal Year: 2013
    ..to perform Phase I single agent clinical trials* Phase I agent combination clinical trials, limited Phase II clinical trials, and pilot clinical trials of novel anti- cancer agents...
  55. Biomarker discovery and validation in a Duchenne dystrophy natural history study
    Craig M McDonald; Fiscal Year: 2013
    ..The identification of robust biomarkers will have a substantial impact on Phase II clinical trials using biomarkers as endpoints, and will likely to have significant knowledge transfer to other ..
  56. Immunomodulatory Device for Treatment of Pediatric Acute Renal Failure Patients
    Deborah A Buffington; Fiscal Year: 2013
    ..110-85, and the Institutes of Medicine, which has recommended pediatric studies to begin at the end of Phase II clinical trials involving adults...
  57. Rapidly boosting innate immunity in the lungs to protect against pneumonia
    Brenton Scott; Fiscal Year: 2013
    ..this technology further towards commercialization and bridge to funding already secured for Phase I and Phase II clinical trials. The project is organized into four Specific Aims that address the needed data, drug manufacturing, and ..
  58. MECHANISMS OF COMPLEMENT INDUCED MYOCARDIAL ISCHEMIA
    GREGORY STAHL; Fiscal Year: 2007
    ..These preclinical findings have led to two 1000 patient Phase II clinical trials in acute myocardial infarction...
  59. Biomarkers for early intervention in Parkinson disease
    Clemens R Scherzer; Fiscal Year: 2013
    ..Moreover, in phase II clinical trials, testing safety and tolerability of a compound is straightforward, but drug effects on the underlying ..
  60. Electrical impedance myography and quantitative ultrasound in Duchenne muscular d
    Seward B Rutkove; Fiscal Year: 2013
    ..With the successful completion of this work, we will have set the stage for the use of one or both of these techniques as the preferred biomarkers in Phase II clinical trials in DMD.
  61. New York Stroke Trials Network of Columbia and Cornell (NYCCSTN)
    Randolph S Marshall; Fiscal Year: 2013
    ..We propose to continue the highly successful monthly Webinar series that Dr. Marshall initiated through our SPOTRIAS grant, which we hope to implement at the national level. ..
  62. Discovery and Investigation of Novel Angiogenesis Inhibitors Among Existing Drugs
    Jun O Liu; Fiscal Year: 2012
    ..expand the clinical drug library to include more FDA-approved drugs as well as those that have reached phase II clinical trials to identify additional inhibitors of angiogenesis and make the library available to the wider scientific ..
  63. A Novel Method of Nanoparticle Delivery to Brain by Targeting Ec-gp96
    Mark E Davis; Fiscal Year: 2012
    ..deliver drugs or other payloads to treat cancers and some of the methods are being tested in Phase I and Phase II clinical trials. These exciting experimental results set the stage for this proposal which will design Ec-gp96 targeting ..
  64. DETECTION & REVERSAL OF OVARIAN CANCER DRUG RESISTANCE
    Robert Ozols; Fiscal Year: 1992
    ..We also propose to perform Phase I and Phase II clinical trials of biochemical modulators of drug resistance...
  65. DEVELOPMENT OF CLINICAL MARKER FOR PERILYMPH FISTULA
    Steven Telian; Fiscal Year: 1993
    ..b>Phase II clinical trials are also proposed: 1) assuming that a sensitive marker for PLF is developed, a multi- institutional ..
  66. CHELATION THERAPY OF IRON OVERLOAD WITH PIH
    Gary Brittenham; Fiscal Year: 1993
    The proposed Phase II clinical trials are designed to demonstrate the safety and effectiveness of orally administered pyridoxal isonicotinoyl hydrazone (PIH) for the chronic treatment of iron overload...
  67. Low Cost Conductimetric Biosensor for Bacterial Meningitis in Cerebrospinal Fluid
    FINNY MATHEW; Fiscal Year: 2007
    ..Commercialization of the conductimetric sensor technology will enable improvement in the overall quality of human life, not only in the US but around the world. [unreadable] [unreadable] [unreadable]..
  68. PHARMACODYNAMIC PHASE II BREAST, LUNG AND OVARY TRIALS
    James Doroshow; Fiscal Year: 2001
    ..USC), and the University of California, Davis Cancer Center (UCD) to perform pharmacologically-guided Phase II clinical trials that focus on: a) novel high-dose chemotherapies with peripheral blood progenitor cell reinfusion, the ..
  69. STRUCTURES OF ANTIBIOTICS AND RELATED COMPOUNDS
    Robert Coates; Fiscal Year: 2003
    ..ET 743, from the tunicate (sea squirt) Ecteinascidia turbinata, currently in Phase II clinical trials, is present in only 1 g/ton of the tunicate and efforts will be made to increase the quantity available ..
  70. Proteome of Glomerular Cells in Diabetic Nephropathy
    Paul Voziyan; Fiscal Year: 2007
    ..In vivo, PM prevented development of early renal disease in animal models of diabetes and is currently in Phase II clinical trials for treatment of diabetic nephropathy...