Antisense Evidence of Clinical Activity

Randomized Phase II Trial of Custirsen (OGX-011) in Combination with Docetaxel or Mitoxantrone as Second-Line Therapy in Patients with Metastatic Castrate-Resistant Prostate Cancer Progressing After First-Line Docetaxel: CUOG Trial P-06c

Saad F, Hotte S, North S, Eigl B, Chi K, Czaykowski P, Wood L, Pollak M, Berry S, Lattouf JB, Mukherjee SD, Gleave M, Winquist E; Canadian Uro-Oncology Group

Clin Cancer Res. 2011 Sep 1;17(17):5765-73

Phase I Study of LY2181308, an Antisense Oligonucleotide Against Survivin, in Patients With Advanced Solid Tumors

Tanioka M, Nokihara H, Yamamoto N, Yamada Y, Yamada K, Goto Y, Fujimoto T, Sekiguchi R, Uenaka K, Callies S, Tamura T

Cancer Chemother Pharmacol. 2011 Aug;68(2):505-11

Molecular Imaging and Pharmacokinetic Analysis of Carbon-11 Labeled Antisense Oligonucleotide LY2181308 in Cancer Patients

Saleem A, Matthews JC, Ranson M, Callies S, André V, Lahn M, Dickinson C, Prenant C, Brown G, McMahon A, Talbot DC, Jones T, Price PM

Theranostics. 2011;1:290-301

Tumor Survivin is Downregulated by the Antisense Oligonucleotide LY2181308: a Proof-of-Concept, First-in-Human Dose Study

Talbot DC, Ranson M, Davies J, Lahn M, Callies S, André V, Kadam S, Burgess M, Slapak C, Olsen AL, McHugh PJ, de Bono JS, Matthews J, Saleem A, Price P

Clin Cancer Res. 2010 Dec 15;16(24):6150-8

Randomized Phase II Study of Docetaxel and Prednisone With or Without OGX-011 in Patients With Metastatic Castration-Resistant Prostate Cancer

Chi KN, Hotte SJ, Yu EY, Tu D, Eigl BJ, Tannock I, Saad F, North S, Powers J, Gleave ME, Eisenhauer EA

J Clin Oncol. 2010 Sep 20;28(27):4247-54

Efficacy and Safety of Mipomersen, an Antisense Inhibitor of Apolipoprotein B, in Hypercholesterolemic Subjects Receiving Stable Statin Therapy

Akdim F, Stroes ES, Sijbrands EJ, Tribble DL, Trip MD, Jukema JW, Flaim JD, Su J, Yu R, Baker BF, Wedel MK, Kastelein JJ

J Am Coll Cardiol. 2010 Apr 13;55(15):1611-8

Mipomersen, an Apolipoprotein B Synthesis Inhibitor, for Lowering of LDL Cholesterol Concentrations in Patients with Homozygous Familial Hypercholesterolaemia: a Randomised, Double-Blind, Placebo-Controlled Trial

Raal FJ, Santos RD, Blom DJ, Marais AD, Charng MJ, Cromwell WC, Lachmann RH, Gaudet D, Tan JL, Chasan-Taber S, Tribble DL, Flaim JD, Crooke ST

Lancet. 2010 Mar 20;375(9719):998-1006

Phase II Trial of OGX-011 in Combination With Docetaxel in Metastatic Breast Cancer

Chia S, Dent S, Ellard S, Ellis PM, Vandenberg T, Gelmon K, Powers J, Walsh W, Seymour L, Eisenhauer EA

Clin Cancer Res. 2009 Jan 15;15(2):708-13

Potent Reduction of Apolipoprotein B and Low-Density Lipoprotein Cholesterol by Short-Term Administration of an Antisense Inhibitor of Apolipoprotein B

Kastelein JJ, Wedel MK, Baker BF, Su J, Bradley JD, Yu RZ, Chuang E, Graham MJ, Crooke RM

Circulation. 2006 Oct 17;114(16):1729-35

Safety and Efficacy of Two Dose Formulations of Alicaforsen Enema Compared with Mesalazine Enema for Treatment of Mild to Moderate Left-Sided Ulcerative Colitis: a Randomized, Double-Blind, Active-Controlled Trial

Miner PB Jr, Wedel MK, Xia S, Baker BF

Aliment Pharmacol Ther. 2006 May 15;23(10):1403-13.

Bioavailability and therapeutic activity of alicaforsen (ISIS 2302) administered as a rectal retention enema to subjects with active ulcerative colitis.

Miner PB Jr, Geary RS, Matson J, Chuang E, Xia S, Baker BF, Wedel MK.

Aliment Pharmacol Ther. 2006 May 15;23(10):1427-34.

A phase II dose ranging, double-blind, placebo-controlled study of alicaforsen enema in subjects with acute exacerbation of mild to moderate left-sided ulcerative colitis.

van Deventer SJ, Wedel MK, Baker BF, Xia S, Chuang E, Miner PB Jr.

Aliment Pharmacol Ther. 2006 May 15;23(10):1415-25.

Phase I trial of ISIS 104838, a 2'-Methoxyethyl modified antisense oligonucleotide targeting tumor necrosis factor-a

Sewell, K.L., Geary, R.S., Baker, B.F., Glover, J.M., Mant, T.G., Yu, R.Z., Tami, J.A., and Dorr, A.

J Pharmacol Exp Ther. 2002 Dec;303(3):1334-43.

Double blind, placebo controlled trial of the remission inducing and steroid sparing properties of an ICAM-1 antisense oligodeoxynucleotide, Alicaforsen (ISIS 2302), in active steroid dependent Crohn’s disease.

Yacyshyn, B.R., Chey, W.Y., Goff, J., Salzberg, B. Baerg, R., Buchman, A.L., Tami, J., Yu, R., Gibiansky, E., and Shanahan, W.R.

Gut. 51: 30-36, 2002.

A randomized controlled clinical trial of intravitreous fomivirsen for treatment of newly diagnosed peripheral cytomegalovirus retinitis in patients with AIDS.

Vitravene Study Group.

American Journal of Ophthalmology 133(4): 467-474, 2002.

Randomized dose-comparison studies of intravitreous fomivirsen for treatment of cytomegalovirus retinitis that has reactivated or is persistently active despite other therapies in patients with AIDS.

Vitravene Study Group

American Journal of Ophthalmology 133(4): 475-483, 2002.

Safety of intravitreous fomivirsen of treatment of cytomegalovirus retinitis in patients with AIDS.

Vitravene Study Group

American Journal of Ophthalmology 133(4): 484-498, 2002.

A placebo-controlled trial of ICAM-1 antisense oligonucleotide in the treatment of Crohn's disease.

Yacyshyn, B.R., Bowen-Yacyshyn, M.B., Jewell, L., Tami, J.A., Bennett, C.F., Kisner, D.L., and Shanahan, Jr., W.R.

Gastroenterology. 1998 Jun;114(6):1133-42.