A First in Human Phase 1 Study of CG0070, a GM-CSF Expressing Oncolytic Adenovirus, for the Treatment of Nonmuscle Invasive Bladder Cancer

Burke, James; Lamm, Donald L.; Meng, Maxwell V.; Nemunaitis, John; Stephenson, Joseph; Arseneau, James C.; Aimi, Junko; Lerner, Seth P.; Yeung, Alex; Kazarian, T. I.; Maslyar, Daniel; McKiernan, James M.

doi:10.1016/j.juro.2012.07.097

Cited by 187 publications

(137 citation statements)

References 23 publications

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“…Similarly, ERCC1, BRCA1, P53 were found to be useful for the prediction of sensitivity to cisplatin; whereas hENT1 and RRM1 are reported as beneficial for GEM. [56,57] Thus, comparable with the other cancers such as breast and lung cancers, the revolutionary "genome medicine" will allow prediction of drug sensitivity and tailor the individualized approaches. Moreover, since BC is one of the easiest cancers in the body to obtain tumor tissue, we might use in vitro assays of BC for predicting drug resistance for effective intravesical chemotherapies to be applied in the future.…”

Section: Future Conceptsmentioning

confidence: 99%

Alternative therapies in patients with non-muscle invasive bladder cancer

Şanlı

Lotan

2017

Turkish Journal of Urology

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Bladder cancer (BC) is one of the leading causes of cancer-related deaths worldwide. Despite, the majority of the cases were diagnosed as non-muscle invasive bladder cancer (NMIBC) with favorable prognosis, it has tendency to recur or progress to a higher grade or stage. The first line treatment of patients with NMIBC is transurethral resection with adjuvant therapies primarily intravesical Bacillus Calmette-Guérin (BCG) immunotherapy. However, in a portion of patients whose BCG treatment failed, alternative treatments may be required. Furthermore, intravesical BCG may be contraindicated in or untolerated by a group of patients. For these patients, some treatment options are readily available and a variety of them are currently under clinical investigation. In this review, these alternative therapies have been summarized.

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Section: Future Conceptsmentioning

confidence: 99%

Alternative therapies in patients with non-muscle invasive bladder cancer

Şanlı

Lotan

2017

Turkish Journal of Urology

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“…CG0070 is an oncolytic adenovirus that has selectivity and cytotoxic properties specific to bladder tumor cells. The complete response rate of this agent has been shown to be as high as 63% [Burke et al 2012]. Checkpoint inhibitors such as PD-1 and PD-L1 inhibitors have shown dramatic effect in the metastatic tumor setting and are currently being studied in the setting of NMIBC [Powles et al 2014].…”

Section: Discussionmentioning

confidence: 99%

The role of mycobacterial cell wall nucleic acid complex in the treatment of bacillus Calmette–Guérin failures for non-muscle-invasive bladder cancer

Packiam

Pearce

Steinberg

2015

Therapeutic Advances in Urology

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Introduction:The treatment of high-risk non-muscle-invasive bladder cancer (NMIBC) utilizes transurethral resection followed by adjuvant intravesical immunotherapy or chemotherapy. Intravesical bacillus Calmette-Guérin (BCG) is the mainstay of adjuvant immunotherapy, but there are limited nonsurgical options for patients that fail this treatment. Mycobacterial cell wall nucleic acid complex (MCNA) is an immunotherapeutic agent utilized primarily after failure of intravesical BCG. The purpose of this paper is to provide a comprehensive review of the published literature regarding MCNA. Methods: A literature review was performed and identified studies indexed in MEDLINE ® related to utilization of MCNA for patients with NMIBC. Results: Two trials assessed the efficacy of MCNA in patients with NMIBC, comprising a total of 184 patients. Most patients had carcinoma in situ (CIS) with (26%) or without (52%) concomitant papillary tumors. A minority of patients had only papillary tumors (22%). Most patients (95%) previously received BCG or other intravesical therapy prior to receiving MCNA. In the largest available trial, 25% and 19% of patients had no evidence of residual cancer in 1 and 2 years following initiation of MCNA. A total of 2.3% of patients had adverse events (AEs) leading to delay or discontinuation of therapy and 66% of patients had mild drug-related AEs. Conclusion: Based on analysis of available published data, MCNA offers a durable response for a small proportion of patients that have failed prior intravesical therapy. There still exists a large unmet need for nonsurgical treatment options for patients with NMIBC who have failed adjuvant intravesical therapies.

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“…Eight of these trials involve Imlygic Ò , three Cavatak TM , three Reolysin Ò , two HF10, two MV-NIS, two CG0070 (a conditionally replicating oncolytic adenovirus genetically modified to express GM-CSF), 121,248 two Toca 511 (an amphotropic replication-competent retrovirus genetically modified to express an enzyme that converts inactive 5-fluorocytosine into active 5-fluorouracil), [249][250][251][252] and the remaining six various oncolytic viruses including G207, JX-594, OBP-301, DNX-2401 (an oncolytic adenovirus engineered to replicate in cells exhibiting defects in cell cycle control, previously known as Delta-24-RGD or Delta-24-RGD-4C), [253][254][255] MG1-MA3 (an attenuated version of the Maraba rhabdovirus, further engineered to express the TAA melanoma antigen family A3, MAGEA3), 85,256,257 and Ad5-yCD/mutTKSR39rep-hIL12 (an oncolytic adenovirus endowed with an increased cytolytic potential and the ability to express human IL-12) 106,258,259 (Table 1).…”

Section: Recently Initiated Clinical Trialsmentioning

confidence: 99%

Trial Watch—Oncolytic viruses and cancer therapy

et al. 2015

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Oncolytic virotherapy relies on the administration of non-pathogenic viral strains that selectively infect and kill malignant cells while favoring the elicitation of a therapeutically relevant tumor-targeting immune response. During the past few years, great efforts have been dedicated to the development of oncolytic viruses with improved specificity and potency. Such an intense wave of investigation has culminated this year in the regulatory approval by the US Food and Drug Administration (FDA) of a genetically engineered oncolytic viral strain for use in melanoma patients. Here, we summarize recent preclinical and clinical advances in oncolytic virotherapy.

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A First in Human Phase 1 Study of CG0070, a GM-CSF Expressing Oncolytic Adenovirus, for the Treatment of Nonmuscle Invasive Bladder Cancer

Abstract: Intravesical CG0070 was associated with a tolerable safety profile and antibladder cancer activity. Granulocyte-monocyte colony-stimulating factor transgene expression and CG0070 replication were also suggested.

Cited by 187 publications

References 23 publications

Alternative therapies in patients with non-muscle invasive bladder cancer

Alternative therapies in patients with non-muscle invasive bladder cancer

The role of mycobacterial cell wall nucleic acid complex in the treatment of bacillus Calmette–Guérin failures for non-muscle-invasive bladder cancer

Trial Watch—Oncolytic viruses and cancer therapy

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