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SELECTED PAPERS AND PRESENTATIONS

PRECLINICAL

P1. Hlavka JJ, Abajian HB, Noble JF. Chemistry and pharmacology of novel antidepressant peptides. Pharm Res. 1996; 13:143.

P2. Nicolau G, Baker S, Velagapudi R, Pilon D, Noble J. Pharmacokinetics, mass balance and tissue distribution of a novel antidepressant, INN 00835, following intravenous and subcutaneous administration to rats. Presented at the Seventh North American ISSX Meeting; October 20 – 24, 1996; San Diego, CA.

P3. Hlavka JJ, Nicolau G, Noble JF, Abajian H. INN 00835 Antidepressant, 4-fluoro-L-phenylalanyl-trans-4-hydroxy-L-prolyl-L-arginyl-glycyl-L-tryptophanamide ditrifluoroacetate. Drugs Fut. 1997; 22(12):1314-1318.

P4. Plante G, Beaudry F, Guilbaud R, Molinar R, Nicolau G, Brown, N. Automated on-line SPE/HPLC/MS method for the quantification of INN 00835 (a synthetic pentapeptide) in human plasma. Presented at the Forty-sixth American Society of Mass Spectrometry Conference; June 1998; Orlando Florida.

P5. Li AP, Nicolau G, Abajian H, Feighner JP. An evaluation of the induction potential of INN 00835 for cytochrome P450 isoforms 1A, 2C, 2D, 2E and 3A in rat and human hepatocytes. Presented at the 2001 AAPS Annual Meeting and Exposition; October 21 – 25, 2001; Denver, CO.

P6. Nicolau G, Brown N, Reimer M, et al. Metabolism of an antidepressant pentapeptide: INN 00835 in liver, intestinal and brain preparations. Presented at the Sixth International ISSX Meeting; October 7-11, 2001; Munich, Germany.

P7. Feighner JP, Hu Z, Silber PM, Li AP, Abajian H, Nicolau G. The effects of P450 inhibitors on the metabolism of INN 00835, a pentapeptide antidepressant, in human hepatocytes. Presented at the Sixth International ISSX Meeting; October 7-11, 2001; Munich, Germany.

P8. Hlavka JJ. Computational chemistry studies on a new class of peptide antidepressants. J Appl Res. 2002; 2(1):58-62.

P9. Feighner JP, Nicolau G, Reimer M, et al. Metabolism of the antidepressant nemifitide and is potential for drug interactions. Presented at the XXIII CINP Congress; June 23-27, 2002; Montreal, Canada.

P10. Hlavka JJ, Feighner JP, Abajian H, Nicolau G, Morrison J, Sverdlov L. Chemistry, pharmacology and clinical studies of nemifitide, a novel antidepressant peptide. Drugs Fut. 2002; 27(suppl A):273.

P11. Feighner JP, Abajian H, Nicolau G, Reimer M, Pilon D. Nemifitide, a pentapeptide antidepressant: receptor binding and localization in rat brain. 7th ECNP Regional Meeting, Bucharest, 2002.

P12. Kelly J, Harkin A, Nicolau G, Feighner JP, Leonard BE. A preclinical investigation of the mechanism of action of nemifitide. Inter J of Neuropsychopharm, 5(1):S97, 2002.

P13. Overstreet DH, Hlavka J, Feighner JP, Nicolau G, Freed JS. Antidepressant-like effects of a novel pentapeptide, nemifitide, in an animal model of depression. Psychopharmacology, Springer-Verlag, 10.1007/s00213-004-1815-9, 2004. CLINICAL

C1. Kelly JP, Nicolau G, Redmond A, et al. The effect of treatment with a new antidepressant, INN 00835, on platelet serotonin uptake in depressed patients. J Affec Dis. 1999:231-235.

C2. Feighner JP, Ehrensing RH, Kastin AJ, et al. A double-blind, placebo-controlled, efficacy, safety, and pharmacokinetic study of INN 00835, a novel antidepressant peptide, in the treatment of major depression. J Affec Dis. 2000:119-126.

C3. Feighner JP, Sverdlov L, Nicolau G, Noble JF. Cluster analysis of clinical data to identify subtypes within a study population following treatment with a new pentapeptide antidepressant. Inter J Neuropsychopharm. 2000; 3:237-242.

C4. Feighner JP, Sverdlov L, Nicolau G, Noble JF, Abajian H. Four Different approaches to separate drug-treated populations from placebo after treatment with a new pentapeptide antidepressant. Presented at the Twenty-second Collegium Internationale Neuropsychopharmacologicum (C.I.N.P.) Congress; July 9-13, 2000; Brussels, Belgium.

C5. Feighner, JP, Ehrensing RH, Kastin AJ, et al. Double-blind, placebo-controlled study of INN 00835 (netamiftide) in the treatment of outpatients with major depression. Int Clin Psychopharmacol. 2001; 16:1-8.

C6. Feighner JP, Abajian H, Hlavka J, Nicolau G, Sverdlov L. Clinical effect of INN 00835 vs placebo in depressed outpatients. Presented at the World Psychiatric Association International Congress; September 30 - October 4, 2001; Madrid, Spain.

C7. Feighner JP, Nicolau G, Abajian H, et al. Clinical pharmacokinetic studies with INN 00835 (nemifitide), a novel pentapeptide antidepressant. Biopharm Drug Dispos. 2002; 23:33-39.

C8. Feighner JP, Sverdlov L, Abajian H, et al. Pilot study with nemifitide in patients with severe treatment-resistant depression. Presented at the XXIII CINP Congress; June 23-27, 2002; Montreal, Canada.

C9. Feighner JP, Sverdlov L, Abajian H, et al. Discriminant analysis to separate a study population by the treatment subgroups in a pilot clinical trial with a new antidepressant (nemifitide). Presented at the XXIII CINP Congress; June 23-27, 2002; Montreal, Canada.

C10. Feighner JP. Nemifitide: Clinical overview for treatment of depression. Presented at the XIIth World Congress of Psychiatry; August 24-29, 2002; Yokohama, Japan.

C11. Sverdlov L, Feighner JP. Multivariate statistical analyses in pharmacopsychiatry. Presented at the XIIth World Congress of Psychiatry; August 24-29, 2002; Yokohama, Japan.

C12. Nicolau G, Feighner JP, Stout R, et al. Comparison of systemic exposure to nemifitide following two methods of subcutaneous administration to healthy volunteers. Biopharm Drug Dispos. 2005; 26:379-385.

C13. Montgomery SA, Feighner JP, Sverdlov L, Shrivastava RK, Cunningham LA, Kiev A, Hlavka J and Tonelli G Jr.Efficacy and Safety of 30 mg/d and 45 mg/d Nemifitide Compared to Placebo in Major Depressive Disorder. Inter J of Neuropsychopharm, 2006, 9:5, 517-528.