A mouse-human phase 1 co-clinical trial of a protease-activated fluorescent probe for imaging cancer

Melodi Javid Whitley; Diana M. Cardona; Alexander L. Lazarides; Ivan Spasojevic; Jorge M. Ferrer; Joan Cahill; Chang-Lung Lee; Matija Snuderl; Dan G. Blazer; E. Shelley Hwang; Rachel A. Greenup; Paul J. Mosca; Jeffrey K. Mito; Kyle C. Cuneo; Nicole A. Larrier; Erin K. O’Reilly; Richard F. Riedel; William C. Eward; David B. Strasfeld; Dai Fukumura; Rakesh K. Jain; W. David Lee; Linda G. Griffith; Moungi G. Bawendi; David G. Kirsch; Brian E. Brigman

doi:10.1126/scitranslmed.aad0293

Research ArticleCancer Imaging

A mouse-human phase 1 co-clinical trial of a protease-activated fluorescent probe for imaging cancer

Melodi Javid Whitley¹,²,
Diana M. Cardona³,
Alexander L. Lazarides⁴,
Ivan Spasojevic⁵,⁶,
Jorge M. Ferrer⁷,
Joan Cahill⁸,
Chang-Lung Lee⁸,
Matija Snuderl⁹,*,
Dan G. Blazer III¹⁰,
E. Shelley Hwang¹⁰,
Rachel A. Greenup¹⁰,
Paul J. Mosca¹⁰,
Jeffrey K. Mito¹,²,
Kyle C. Cuneo⁸,
Nicole A. Larrier⁸,
Erin K. O’Reilly¹¹,
Richard F. Riedel⁵,
William C. Eward¹²,
David B. Strasfeld⁷,
Dai Fukumura⁹,
Rakesh K. Jain⁹,
W. David Lee⁷,
Linda G. Griffith¹³,
Moungi G. Bawendi¹⁴,
David G. Kirsch¹,⁸,†,‡ and
Brian E. Brigman¹²,‡

¹Department of Pharmacology and Cancer Biology, Duke University Medical Center, Durham, NC 27710, USA.
²Medical Science Training Program, Duke University Medical Center, Durham, NC 27710, USA.
³Department of Pathology, Duke University Medical Center, Durham, NC 27710, USA.
⁴School of Medicine, Duke University Medical Center, Durham, NC 27710, USA.
⁵Department of Medicine, Duke University Medical Center, Durham, NC 27710, USA.
⁶PK/PD Core Laboratory, Duke Cancer Institute, Duke University Medical Center, Durham, NC 27710, USA.
⁷Lumicell Inc., Wellesley, MA 02481, USA.
⁸Department of Radiation Oncology, Duke University Medical Center, Durham, NC 27710, USA.
⁹Edwin L. Steele Laboratory, Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, USA.
¹⁰Department of Surgery, Duke University Medical Center, Durham, NC 27710, USA.
¹¹Duke Translational Medicine Institute, Regulatory Affairs Group, Duke University Medical Center, NC 27710, USA.
¹²Department of Orthopaedic Surgery, Duke University Medical Center, Durham, NC 27710, USA.
¹³Department of Biological Engineering, Massachusetts Institute of Technology, Cambridge, MA 02142, USA.
¹⁴Department of Chemistry, Massachusetts Institute of Technology, Cambridge, MA 02142, USA.

↵†Corresponding author. E-mail: david.kirsch{at}duke.edu

↵* Present address: Department of Pathology, NYU Langone Medical Center, New York, NY 10016, USA.
↵‡ Co-senior authors.

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Science Translational Medicine 06 Jan 2016:
Vol. 8, Issue 320, pp. 320ra4
DOI: 10.1126/scitranslmed.aad0293

Melodi Javid Whitley

1Department of Pharmacology and Cancer Biology, Duke University Medical Center, Durham, NC 27710, USA.

2Medical Science Training Program, Duke University Medical Center, Durham, NC 27710, USA.

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Diana M. Cardona

3Department of Pathology, Duke University Medical Center, Durham, NC 27710, USA.

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Alexander L. Lazarides

4School of Medicine, Duke University Medical Center, Durham, NC 27710, USA.

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Ivan Spasojevic

5Department of Medicine, Duke University Medical Center, Durham, NC 27710, USA.

6PK/PD Core Laboratory, Duke Cancer Institute, Duke University Medical Center, Durham, NC 27710, USA.

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Jorge M. Ferrer

7Lumicell Inc., Wellesley, MA 02481, USA.

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Joan Cahill

8Department of Radiation Oncology, Duke University Medical Center, Durham, NC 27710, USA.

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Chang-Lung Lee

8Department of Radiation Oncology, Duke University Medical Center, Durham, NC 27710, USA.

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Matija Snuderl

9Edwin L. Steele Laboratory, Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, USA.

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Dan G. Blazer III

10Department of Surgery, Duke University Medical Center, Durham, NC 27710, USA.

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E. Shelley Hwang

10Department of Surgery, Duke University Medical Center, Durham, NC 27710, USA.

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Rachel A. Greenup

10Department of Surgery, Duke University Medical Center, Durham, NC 27710, USA.

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Paul J. Mosca

10Department of Surgery, Duke University Medical Center, Durham, NC 27710, USA.

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Jeffrey K. Mito

1Department of Pharmacology and Cancer Biology, Duke University Medical Center, Durham, NC 27710, USA.

2Medical Science Training Program, Duke University Medical Center, Durham, NC 27710, USA.

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Kyle C. Cuneo

8Department of Radiation Oncology, Duke University Medical Center, Durham, NC 27710, USA.

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Nicole A. Larrier

8Department of Radiation Oncology, Duke University Medical Center, Durham, NC 27710, USA.

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Erin K. O’Reilly

11Duke Translational Medicine Institute, Regulatory Affairs Group, Duke University Medical Center, NC 27710, USA.

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Richard F. Riedel

5Department of Medicine, Duke University Medical Center, Durham, NC 27710, USA.

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William C. Eward

12Department of Orthopaedic Surgery, Duke University Medical Center, Durham, NC 27710, USA.

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David B. Strasfeld

7Lumicell Inc., Wellesley, MA 02481, USA.

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Dai Fukumura

9Edwin L. Steele Laboratory, Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, USA.

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Rakesh K. Jain

9Edwin L. Steele Laboratory, Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, USA.

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W. David Lee

7Lumicell Inc., Wellesley, MA 02481, USA.

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Linda G. Griffith

13Department of Biological Engineering, Massachusetts Institute of Technology, Cambridge, MA 02142, USA.

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Moungi G. Bawendi

14Department of Chemistry, Massachusetts Institute of Technology, Cambridge, MA 02142, USA.

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David G. Kirsch

1Department of Pharmacology and Cancer Biology, Duke University Medical Center, Durham, NC 27710, USA.

8Department of Radiation Oncology, Duke University Medical Center, Durham, NC 27710, USA.

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For correspondence: david.kirsch@duke.edu

Brian E. Brigman

12Department of Orthopaedic Surgery, Duke University Medical Center, Durham, NC 27710, USA.

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A first-in-human phase 1 clinical trial of the PEGylated protease-activated fluorescent probe, LUM015, enables tumor imaging at a safe and tolerable dose in humans.

A mouse-human phase 1 co-clinical trial of a protease-activated fluorescent probe for imaging cancer

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