Intravenous administration of Reolysin®, a live replication competent RNA virus is safe in patients with advanced solid tumors

R. Gollamudi1, Mohammad H. Ghalib2, Kavita Desai2, Imran Chaudhary2, Benny Wong2, Mark H. Einstein3,4, Matthew Coffey5, George M. Gill5, K.L. Mettinger5, John M. Mariadason3,2, Sridhar Mani2,3, Sanjay Goel3,2
1Department of Oncology, Montefiore Medical Center, Bronx, NY, USA
2Department of Oncology, Montefiore Medical Center, Bronx, USA
3Albert Einstein College of Medicine and Cancer Center, Bronx, USA
4Division of Gynecologic Oncology, Department of Obstetrics & Gynecology and Women’s Health, Montefiore Medical Center, Bronx, USA
5Oncolytics Biotech Inc., Calgary, Canada

Tóm tắt

Từ khóa


Tài liệu tham khảo

Sabin AB (1959) Reovirus: a new group of respiratory and enteric viruses formerly classified as ECHO type 10 is described. Science 130:1387–1389

Tyler KL, Fields BN (1990) Reovirus. In: Fields BN, Knipe DM, Chanock RM (eds) Virology. Raven, New York, pp 1307–1328

Rosen L (1960) Serologic grouping of reoviruses by hemagglutination-inhibition. Am J Hyg 71:242–249

Jackson GG, Muldoon RL (1973) Viruses causing common respiratory infection in man. IV. Reoviruses and adenoviruses. J Infect Dis 128:811–866

Selb B, Weber B (1994) A study of human reovirus IgG and IgA antibodies by ELISA and western blot. J Virol Methods 47:15–25

Rosen L, Evans HE, Spickard A (1963) Reovirus infections in human volunteers. Am J Hyg 77:29–37

Jackson GG, Muldoon RL, Cooper GS (1961) Reovirus type 1 as an etiologic agent of the common cold. J Clin Invest 40:1051 meeting abstract

Coffey MC, Strong JC, Forsyth PA, Lee PW (1998) Reovirus therapy of tumors with activated Ras pathway. Science 282:1332–1334

Strong JE, Coffey MC, Tang D, Sabinin P, Lee PW (1998) The molecular basis of viral oncolysis: usurpation of the Ras signaling pathway by reovirus. Embo J 17:3351–3362

Hirasawa K, Nishakawa SG, Normal KL et al (2003) Systemic reovirus therapy of metastatic cancer in immune-competent mice. Cancer Res 63:348–353

Norman KL, Coffey MC, Hirasawa K et al (2002) Reovirus oncolysis of human breast cancer. Human gene therapy 13:641–652

Hirasawa K, Nishikawa SG, Norman KL, Alain T, Kossakowska A, Lee PW (2002) Oncolytic reovirus against ovarian and colon cancer. Cancer Res 62:1696–1701

Alain T, Hirasawa K, Pon KJ et al (2002) Reovirus therapy of lymphoid malignancies. Blood 100:4146–4153

Etoh T, Himeno Y, Matsumoto T et al (2003) Oncolytic viral therapy for human pancreatic cancer cells by reovirus. Clin Cancer Res 9:1218–1223

Yang WQ, Senger DL, Lun XQ et al (2004) Reovirus as an experimental therapeutic for brain and leptomeningeal metastases from breast cancer. Gene therapy 11:1579–1589

Norman KL, Hirasawa K, Yang AD, Shields MA, Lee PW (2004) Reovirus oncolysis: the Ras/RalGEF/p38 pathway dictates host cell permissiveness to reovirus infection. Proc Natl Acad Scie USA 101:11099–11104

Bos JL (1989) Ras oncogenes in human cancer: a review. Cancer Res 49:4682–4689

Bos JL, Fearon ER, Hamilton SR et al (1987) Prevalence of ras gene mutations in human colorectal cancers. Nature 327:293–297

Lemoine NR, Mayall ES, Wyllie FS et al (1988) Activated ras oncogenes in human thyroid cancers. Cancer Res 48:4459–4463

Needelman SW, Kraus MH, Srivastava SK, Levine PH, Aaronson SA (1986) High frequency of N-ras activation in acute myelogenous leukemia. Blood 67:753–757

Rodenhuis S, Slebos RJ, Boot AJ et al (1988) Incidence and possible clinical significance of K-ras oncogene activation in adenocarcinoma of the human lung. Cancer Res 48:5738–5741

Grunewald K, Lyons J, Frohlich A et al (1989) High frequency of Ki-ras codon 1w mutations in pancreatic adenocarcinomas. Int J Cancer 43:1037–1041

Eisenhauer EA, O’Dwyer PJ, Christian M, Humphrey JS (2000) Phase I clinical trial design in cancer drug development. J Clin Oncol 18:684–692

Therasse P, Arbuck SG, Eisenhauer EA et al (2000) New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92:205–216

ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcv20_4-30-992.pdf [accessed Jun 3, 2009]

White CL, Twiggen KR, Vidal L et al (2008) Characterization of the adaptive and innate immune response to intravenous oncolytic reovirus (Dearing type 3) during a phase I clinical trial. Gene Ther 15:911–920

http://www.cirion.com/ [Accessed Jun 3, 2009]

www.pyrosequencing.com [accessed Jun 3, 2009].

Ogino S, Kawasaki T, Brahmandam M et al (2005) Sensitive sequencing method for KRAS mutation detection by pyrosequencing. J Mol Diagn 7:413–421

Vidal L, Pandha HS, Yap TA et al (2008) A phase I study of intravenous oncolytic reovirus type 3 dearing in patients with advanced cancer. Clin Can Res 14:7127–7137

Liu TC, Galanis E, Kirn D (2007) Clinical trial results with oncolytic virotherapy: a century of promise, a decade of progress. Nat Clin Pract Oncol 4:101–117

Csatary LK (1971) Viruses in the treatment of cancer. Lancet 2:825

Bischoff JR, Kirn DH, Williams A et al (1996) An adenovirus mutant that replicates selectively in p53-deficient human tumor cells. Science 274:373–376

Garber K (2006) China approves world's first oncolytic virus therapy for cancer treatment. J Natl Cancer Inst 98:298–300

Alonso MM, Gomez-Manzano C et al (2007) Combination of the oncolytic adenovirus ICOVIR-5 with chemotherapy provides enhanced anti-glioma effect in vivo. Cancer Gene Ther 14:756–761

Pecora AL, Rizvi N, Cohen GI et al (2002) Phase I trial of intravenous administration of PV701, an oncolytic virus, in patients with advanced solid tumors. J Clin Oncol 20:2251–2266

Data on File. Reolysin Investigator Brochure. Oncolytics Biotech Inc. Release Date January 31, 2009

Rochlitz CF, Scott GK, Dodson JM et al (1989) Incidence of activating ras oncogene mutations associated with primary and metastatic human breast cancer. Cancer Res 49:357–360

Lane ME, Fahey JM, Besanceney C, et al. (2007) In vivo synergy between oncolytic reovirus and gemcitabine in ras-mutated human HCT116 xenografts. AACR Meeting Abstracts, Apr 2007; 2007: 4812