Feasibility of the LUM Imaging System for Detection of Primary Pancreatic Cancer and Peritoneal Invasion From Primary Pancreatic Cancer During Surgery

This single-site, non-randomized, open-label study to assess the initial safety and efficacy of the LUM Imaging System for detection of primary pancreatic cancer and peritoneal invasion from primary pancreatic cancer during surgery. In this feasibility study, the tumor detection algorithm will be developed for this indication.

Start Date01 Jan 2026

Sponsor / Collaborator

Lumicell, Inc.

NCT04440982 / TerminatedPhase 2

Feasibility Study to Evaluate Performance of the LUM Imaging System for Intraoperative Detection of Residual Tumor in Breast Cancer Patients Receiving and Not Receiving Neoadjuvant Therapy

This is a prospective, multi-center, randomized, clinical trial evaluating patients undergoing breast conserving surgery using the LUM Imaging System.

Start Date01 Sep 2020

Sponsor / Collaborator

Lumicell, Inc.

[+2]

NCT03686215 / CompletedPhase 3

Pivotal Study of the LUM Imaging System for Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patients With Breast Cancer

This is a multi-center, two-arm randomized, blinded pivotal study to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in identifying residual cancer in the lumpectomy bed of female breast cancer patients undergoing breast surgery in order to assist surgeons in reducing the rates of positive margins.
All enrolled subjects will be injected with LUM015 prior to surgery. Surgeons are blinded to whether a participant will be randomized into the device arm until after the standard of care lumpectomy is complete. Participants will then be randomized to receiving the device. Therapeutic (LUM guided) shaves will be removed based on the guidance of the LUM Imaging System. Patients will be followed until their first standard of care post-operative follow-up visit.

Start Date04 Nov 2019

Sponsor / Collaborator

Lumicell, Inc.

[+1]

100 Clinical Results associated with Pegulicianine

100 Translational Medicine associated with Pegulicianine

100 Patents (Medical) associated with Pegulicianine

Literatures (Medical) associated with Pegulicianine

01 Jul 2022·JAMA surgery

Clinical Impact of Intraoperative Margin Assessment in Breast-Conserving Surgery With a Novel Pegulicianine Fluorescence–Guided System

Article

Author: Dekhne, Nayana ; Lesnikoski, Beth-Ann ; Gold, Linsey ; Madden, Sean ; Lee, David ; Harris, Daniel K ; Smith, Kate ; Dodge, Daleela ; Beitsch, Peter ; Ferrer, Jorge ; Hwang, E. Shelley ; Hunt, Kelly ; Karp, Stephen ; Wapnir, Irene ; Grobmyer, Stephen ; Chang, Manna ; Carr, David ; Clark, Lynne ; Schlossberg, Brian ; Dyess, Donna L. ; Blumencranz, Peter ; Chagpar, Anees ; Strasfeld, David ; Smith, Barbara L.

Importance:

Positive margins following breast-conserving surgery (BCS) are often identified on standard pathology evaluation. Intraoperative assessment of the lumpectomy cavity has the potential to reduce residual disease or reexcision rate following standard of care BCS in real time.

Objective:

To collect safety and initial efficacy data on the novel pegulicianine fluorescence-guided system (pFGS) when used to identify residual cancer in the tumor bed of female patients undergoing BCS.

Design, Setting, and Participants:

This prospective single-arm open-label study was conducted as a nonrandomized multicenter controlled trial at 16 academic or community breast centers across the US. Female patients 18 years and older with newly diagnosed primary invasive breast cancer or ductal carcinoma in situ DCIS undergoing BCS were included, excluding those with previous breast cancer surgery and a history of dye allergies. Of 283 consecutive eligible patients recruited, 234 received a pegulicianine injection and were included in the safety analysis; of these, 230 were included in the efficacy analysis. Patients were enrolled between February 6, 2018, and April 10, 2020, and monitored for a 30-day follow-up period. Data were analyzed from April 10, 2020, to August 5, 2021.

Interventions:

Participants received an injection of a novel imaging agent (pegulicianine) a mean (SD) of 3.2 (0.9) hours prior to surgery at a dose of 1 mg/kg. After completing standard of care (SOC) excision, pFGS was used to scan the lumpectomy cavity to guide the removal of additional shave margins.

Main Outcomes and Measures:

Adverse events and sensitivity, specificity, and reexcision rate.

Results:

Of 234 female patients enrolled (median [IQR] age, 62.0 [55.0-69.0] years), 230 completed the trial and 1 patient with a history of allergy to contrast agents had an anaphylactic reaction and recovered without sequelae. Correlation of pFGS with final margin status on a per-margin analysis showed a marked improvement in sensitivity over standard pathology assessment of the main lumpectomy specimen (69.4% vs 38.2%, respectively). On a per-patient level, the false-negative rate of pFGS was 23.7% (9 of 38), and sensitivity was 76.3% (29 of 38). Among 32 patients who underwent excision of pFGS-guided shaves, pFGS averted the need for reexcision in 6 (19%).

Conclusions and Relevance:

In this pilot feasibility study, the safety profile of pegulicianine was consistent with other imaging agents used in BCS, and was associated with a reduced need for second surgery in patients who underwent intraoperative additional excision of pFGS-guided shaves. These findings support further development and clinical performance assessment of pFGS in a prospective randomized trial.

Trial Registration:

ClinicalTrials.gov Identifier: NCT03321929.

01 May 2021·Breast cancer research and treatmentQ2 · MEDICINE

Performance of a novel protease-activated fluorescent imaging system for intraoperative detection of residual breast cancer during breast conserving surgery

Q2 · MEDICINE

Article

Author: Specht, Michelle C ; Tang, Rong ; Smith, Barbara L ; Rai, Upahvan ; Brown, Carson L ; Lanahan, Conor R ; Gadd, Michele A ; Brachtel, Elena F ; Kelly, Bridget N ; Hughes, Kevin S ; Rice-Stitt, Travis

Abstract:

Purpose:

Safe breast cancer lumpectomies require microscopically clear margins. Real-time margin assessment options are limited, and 20–40% of lumpectomies have positive margins requiring re-excision. The LUM Imaging System previously showed excellent sensitivity and specificity for tumor detection during lumpectomy surgery. We explored its impact on surgical workflow and performance across patient and tumor types.

Methods:

We performed IRB-approved, prospective, non-randomized studies in breast cancer lumpectomy procedures. The LUM Imaging System uses LUM015, a protease-activated fluorescent imaging agent that identifies residual tumor in the surgical cavity walls. Fluorescent cavity images were collected in real-time and analyzed using system software.

Results:

Cavity and specimen images were obtained in 55 patients injected with LUM015 at 0.5 or 1.0 mg/kg and in 5 patients who did not receive LUM015. All tumor types were distinguished from normal tissue, with mean tumor:normal (T:N) signal ratios of 3.81–5.69. T:N ratios were 4.45 in non-dense and 4.00 in dense breasts (p = 0.59) and 3.52 in premenopausal and 4.59 in postmenopausal women (p = 0.19). Histopathology and tumor receptor testing were not affected by LUM015. Falsely positive readings were more likely when tumor was present < 2 mm from the adjacent specimen margin. LUM015 signal was stable in vivo at least 6.5 h post injection, and ex vivo at least 4 h post excision.

Conclusions:

Intraoperative use of the LUM Imaging System detected all breast cancer subtypes with robust performance independent of menopausal status and breast density. There was no significant impact on histopathology or receptor evaluation.

01 Jun 2020·Annals of surgical oncologyQ2 · MEDICINE

Feasibility Study of a Novel Protease-Activated Fluorescent Imaging System for Real-Time, Intraoperative Detection of Residual Breast Cancer in Breast Conserving Surgery

Q2 · MEDICINE

Article

Author: Specht, Michelle C ; Ferrer, Jorge M ; Tang, Rong ; Biernacka, Anna ; Brachtel, Elena F ; Rai, Upahvan ; Lanahan, Conor R ; Kelly, Bridget N ; Brown, Carson ; Strasfeld, David B ; Rice-Stitt, Travis ; Gadd, Michele A ; Smith, Barbara L

Abstract:

Background:

Obtaining tumor-free margins is critical to prevent recurrence after lumpectomy for breast cancer. Unfortunately, current approaches leave positive margins that require second surgeries in 20–40% of patients. We assessed the LUM Imaging System for real-time, intraoperative detection of residual tumor.

Methods:

Breast lumpectomy cavity walls and excised specimens were assessed with the LUM Imaging System after 1 mg/kg intravenous LUM015, a protease-activatable fluorescent agent. Fluorescence at potential sites of residual tumor in lumpectomy cavity walls was evaluated intraoperatively with a sterile hand-held probe, with real-time predictive results displayed on a monitor intraoperatively, and later correlated with histopathology.

Results:

In vivo lumpectomy cavities and excised specimens were imaged after LUM015 injection in 45 women undergoing breast cancer surgery. Invasive ductal and lobular cancers and intraductal cancer (DCIS) were included. A total of 570 cavity margin surfaces in 40 patients were used for algorithm development. Image analysis and display took approximately 1 s per 2.6-cm-diameter circular margin surface. All breast cancer subtypes could be distinguished from adjacent normal tissue. For all imaged cavity surfaces, sensitivity for tumor detection was 84%. Among 8 patients with positive margins after standard surgery, sensitivity for residual tumor detection was 100%; 2 of 8 were spared second surgeries because additional tissue was excised at sites of LUM015 signal. Specificity was 73%, with some benign tissues showing elevated fluorescent signal.

Conclusions:

The LUM015 agent and LUM Imaging System allow rapid identification of residual tumor in the lumpectomy cavity of breast cancer patients and may reduce rates of positive margins.

News (Medical) associated with Pegulicianine

19 Apr 2024

·www.fiercebiotech.com

FDA approves Lumicell’s fluorescent system for highlighting residual breast cancer tissue

In a clinical trial, 27 of 357 patients undergoing surgery with LumiSystem had extra tumor tissue removed after a standard lumpectomy. The FDA has granted a groundbreaking approval to a fluorescent light system that illuminates leftover breast cancer tissue in real-time during surgery—to help ensure a thorough removal of the tumor and avoid the need for follow-up procedures. Lumicell’s approach starts with an injectable imaging agent, Lumisight (pegulicianine)—which is inactive at first but begins to glow when it interacts with particular enzymes found around tumor cells. At the same time, the company’s computerized, handheld imaging probe scans the inside of the surgical cavity created during a breast-conserving lumpectomy and logs any signs of residual cancer hidden among the healthy cells. Lumisight was approved via the FDA’s pharmaceutical review pathway—after receiving a positive recommendation from an independent advisory committee in early March—while Lumicell’s Direct Visualization System hardware took a parallel track through the agency’s device center. “We are immensely proud of the dual approval of Lumisight and Lumicell DVS—we believe this is the first drug-device combination product approved in over a decade to have followed both of the FDA’s most stringent NDA and PMA review processes,” Lumicell’s president and chief operating officer Howard Hechler said in a statement. “With the FDA’s approval, LumiSystem is now the first and only imaging combination product capable of detecting cancerous tissue where it matters most, inside the breast cavity.” According to the company, about one-third of women who undergo the removal of a breast tumor have to return to the operating room for another surgery. Meanwhile, about two-thirds of those follow-up procedures end up not finding any residual cancer, leaving clinicians to wonder if previous assessments were wrong or if the cancer was simply missed a second time. Lumicell said its system—which previously received both the FDA’s pharmaceutical fast track and breakthrough device designations—can provide 84% diagnostic accuracy. In a clinical trial of about 400 participants undergoing breast cancer surgery, follow-up procedures were avoided in 9 of 62 patients that had positive tumor margins. At the same time, 27 of 357 patients in the LumiSystem arm had extra tumor tissue removed after a standard lumpectomy, including 22 who were initially ascribed negative margins. Administration of the Lumisight imaging agent was halted due to side effects in six patients; two patients developed serious adverse events related to pegulicianine. The study’s results were published in April 2023 in the journal NEJM Evidence. Lumicell is also studying its combination imaging approach in gastrointestinal tumors, sarcomas and peritoneal metastases—the last of which can be difficult to detect with a CT, PET or MRI scan—as well as in brain and prostate cancers. Last October, Lumicell co-founder Moungi Bawendi shared the 2023 Nobel Prize in chemistry for his research in the discovery and synthesis of quantum dots—nano-sized particles used in optical electronics ranging from solar cells to LED displays to lasers, as well as biomedical imaging. The company’s fluorescent visualization system was developed in Bawendi’s lab at the Massachusetts Institute of Technology, where he serves as the Lester Wolfe Professor of Chemistry. According to Lumicell, Bawendi’s expertise in optics and tissue imaging helped guide the design of the device, while his work on the physio-chemical properties of fluorescent molecules led to the imaging agent. A separate company developing a similar injectable approach for lung and ovarian cancers, On Target Laboratories, raised $30 million in a series C round last November to help commercialize its Cytalux (pafolacianine) fluorescent agent and near-infrared imaging device.

Clinical ResultFast Track

19 Apr 2024

·www.nsmedicaldevices.com

Lumicell gets FDA nod for LumiSystem breast cancer visualisation system

The drug-device breast cancer detection combination system illuminates cancerous tissue and conducts real-time breast cavity scanning post-lumpectomy to detect and remove any residual cancer that may have been overlooked LUMISIGHT and Lumicell DVS are together referred to as LumiSystem. (Credit: Business Wire) Massachusetts-based Lumicell has received US Food and Drug Administration (FDA) approval for its breast cancer visualisation system dubbed LumiSystem. LumiSystem system combines LUMISIGHT (pegulicianine) optical imaging agent and Lumicell direct visualisation system (DVS), which is a fluorescence imaging device. Separately, the FDA approved the company’s new drug application (NDA) for LUMISIGHT. On the other hand, Lumicell DVS secured premarket approval (PMA). The drug-device breast cancer detection combination system is designed to illuminate cancerous tissue. It performs real-time breast cavity scanning following a lumpectomy to identify and remove any residual cancer that might have gone undetected. According to Lumicell, LumiSystem has an 84% diagnostic accuracy rate and potentially saves some patients from needing repeat procedures. The LumiSystem combo is recommended for fluorescence imaging in adults with breast cancer. It is indicated as a supplement during intraoperative detection of malignant tissue after the primary specimen is removed during lumpectomy surgery. Previously, LUMISIGHT and Lumicell DVS secured FDA fast track and breakthrough device designations, respectively. Lumicell president and chief operating officer Howard Hechler said: “We are immensely proud of the dual approval of LUMISIGHT and Lumicell DVS – we believe this is the first drug-device combination product approved in over a decade to have followed both of the FDA’s most stringent NDA and PMA review processes. “With the FDA’s approval, LumiSystem is now the first and only imaging combination product capable of detecting cancerous tissue where it matters most, inside the breast cavity.” LumiSystem’s safety was determined from the results of over 700 breast cancer patients at some of the academic and community cancer centres across the US. LUMISIGHT is also being assessed for further development for a wide variety of solid tumour indications. Lumicell chief scientific officer Jorge Ferrer said: “We want to thank our clinical investigators and the hundreds of women who participated in our breast programme for LUMISIGHT and Lumicell DVS. “Due to your important contributions, LUMISIGHT and Lumicell DVS are now approved and will be available in the US shortly.”

Fast Track

18 Apr 2024

·www.biospace.com

Lumicell’s Cutting-Edge Imaging Platform Receives Historic FDA Approval to Illuminate Residual Breast Cancer

LUMISIGHT™ and Lumicell™ Direct Visualization System (DVS) offer 84% diagnostic accuracy in detecting residual cancer, in real-time, that may have been otherwise missed during lumpectomy surgery, while sparing some from second surgeries LUMISIGHT and Lumicell DVS previously received FDA Fast Track and Breakthrough Device designations, respectively NEWTON, Mass.--(BUSINESS WIRE)-- Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery, today announced the U.S. Food & Drug Administration (FDA) approved the company’s New Drug Application (NDA) for its LUMISIGHT™ (pegulicianine) optical imaging agent and its Premarket Approval (PMA) application for Lumicell™ Direct Visualization System (DVS), together referred to as LumiSystem™. This press release features multimedia. View the full release here: (Graphic: Business Wire) With 84% diagnostic accuracy, LumiSystem enables surgeons to scan the breast cavity post-lumpectomy, in real-time, to detect and resect residual cancer that may have otherwise been missed, potentially sparing some patients from second surgeries.1-2 The LumiSystem combination is indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. “We are immensely proud of the dual approval of LUMISIGHT and Lumicell DVS – we believe this is the first drug-device combination product approved in over a decade to have followed both of the FDA's most stringent NDA and PMA review processes,”3 said Howard Hechler, President and Chief Operating Officer, Lumicell. “With the FDA’s approval, LumiSystem is now the first and only imaging combination product capable of detecting cancerous tissue where it matters most, inside the breast cavity.” “Breast cancer is all too common, and sadly, 1 in 8 women will develop it during their lifetime,”4 said Kelly Hunt, MD, Chair of the Department of Breast Surgical Oncology at MD Anderson Cancer Center and President of the Society of Surgical Oncology. “Our most common surgical procedure to treat these women is lumpectomy. Unfortunately, the intraoperative tools we have are limited and do not identify the extent of tumor accurately enough, making it challenging to achieve a complete tumor resection, leading to as many as 36% of patients needing a second surgery.”5 “Up to 65% of the time, we do not find residual cancer in the second surgery and are left wondering if we performed an unnecessary surgery due to a false positive margin assessment or if the cancer was missed again in the second surgery,”6 said Irene Wapnir, MD, Breast Surgical Oncologist and Professor of Surgery, Stanford University School of Medicine. “During lumpectomy surgery, surgeons still struggle to identify and remove all of the tumor during the first operation,”7 said Barbara Smith, MD, PhD, Director of the Breast Program at Massachusetts General Hospital and Professor of Surgery at Harvard Medical School. “With LumiSystem, we will now have a technology that is clinically proven to achieve a more complete cancer resection during lumpectomy that could help some patients avoid a second surgery.”2 The safety of the system was established using data from more than 700 breast cancer patients across five clinical studies at top academic and regional community cancer centers across the U.S. The most common side effects with LUMISIGHT are hypersensitivity and an abnormal color in urine. LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Results of the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial, used to support the efficacy of the system, were published in NEJM Evidence. “We want to thank our clinical investigators and the hundreds of women who participated in our breast program for LUMISIGHT and Lumicell DVS,” said Jorge Ferrer, Chief Scientific Officer, Lumicell. “Due to your important contributions, LUMISIGHT and Lumicell DVS are now approved and will be available in the United States shortly.” Please visit to learn more about LUMISIGHT and Lumicell DVS. About Lumicell Inc. Lumicell is a privately held company focused on enabling a more complete resection of cancer by advancing the development and commercialization of its innovative fluorescence guided surgery technology. The company’s lead products are LUMISIGHT™ (pegulicianine) and Lumicell™ DVS which are designed for use in combination to illuminate cancerous tissue within the breast cavity during the initial lumpectomy procedure, as an adjunct to the Standard of Care. Lumicell’s proprietary, pan-oncologic optical imaging agent, LUMISIGHT, is also being explored for further development across a wide variety of solid tumor indications. For more information, please visit and follow the company on Facebook, X, and LinkedIn. Indications for Use LUMISIGHT, an optical imaging agent, and Lumicell DVS, a fluorescence imaging device, are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. Important Safety Information What is the most important information I should know about LUMISIGHT? LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. Tell your doctor if you have any history of hypersensitivity reactions to pegulicianine or to contrast media or products containing polyethylene glycol (PEG). Your healthcare provider should have emergency resuscitation drugs, equipment, and trained personnel available during use of LUMISIGHT. Healthcare providers should monitor all patients for hypersensitivity reactions and if one is suspected, immediately discontinue the injection and initiate appropriate therapy. What other safety information should I know about LUMISIGHT? Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue. Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid using dyes before imaging with LUMISIGHT. What are the most common side effects of LUMISIGHT? The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see full Prescribing Information, including Boxed Warning. What is the most important information I should know about Lumicell DVS? Adjunctive use: Lumicell DVS is for use as part of the lumpectomy procedure and is not a replacement for the standard of care procedures and pathology. Your healthcare provider must be trained on proper use of the Lumicell DVS, and breast conserving surgery prior to performing any procedures. Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue. Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid using dyes before imaging with LUMISIGHT. Tissue perforation or damage: During the procedure, your healthcare provider should avoid excessive pressure or torque with the handheld probe while inside the cavity as it can cause tissue perforation or damage. Infection risk: To avoid infection risk, the reusable handheld probe and cables should be properly and completely disinfected and reprocessed after each use. Your healthcare provider should also ensure proper use of the sterile, single-use probe cover. Eye discomfort: Avoid direct eye exposure to handheld light probe as it may cause pain. Please see the LUMISIGHT Prescribing Information, including Boxed Warning, and Lumicell DVS Instructions for Use. For complete product information, visit . Diagnostic accuracy is based on true positive and true negative images detected in the LumiSystem pivotal trial Smith, et al., NEJM Evidence 2023; 2(7) Data on File – Lumicell American Cancer Society. Key Statistics for Breast Cancer. Accessed November 1, 2023 Dupont, et al., Ann Surg 2021; 273(5): 876-881 Bundred, et al., BMJ 2022; 378:e070346 Tang, et.al., Am J Surg 2015

Fast Track

100 Deals associated with Pegulicianine

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Breast Cancer	US	Lumicell, Inc.	17 Apr 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Cancer	Phase 2	US	Lumicell, Inc.	20 Mar 2019
Peritoneal Neoplasms	Phase 2	US	Lumicell, Inc.	18 Mar 2019
Colorectal Cancer	Phase 2	US	Lumicell, Inc.	04 Aug 2016
Esophageal Carcinoma	Phase 2	US	Lumicell, Inc.	04 Aug 2016
Pancreatic Cancer	Phase 2	US	Lumicell, Inc.	04 Aug 2016
Stomach Cancer	Phase 2	US	Lumicell, Inc.	04 Aug 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03686215 (CL0007, FDA_CDER) Manual	Phase 3	Breast Cancer	357	LUMISIGHT	qksjiwbecf(fdjxijkqvd) = stfdgeskhs geofplntlg (jianivtnel, 5.0-10.8) View more	Positive	17 Apr 2024
NCT03686215 (pivotal study \| CL0007, CTgov)	Phase 3	Breast Cancer	406	Study Device Arm (Device Intervention: LUM Imaging System Used During Surgery)	apovabubof(fzkybhkekj) = tspznakcro tkgdmhkzyp (cvhykqowym, ergdrvjzqe - yrsfahivmu) View more	-	24 Aug 2023
				LUM015 (Standard of Care Arm)	tchbltazxy(peqodmuqec) = vifykixjmn aztjvvydkg (kghbccbhpp, zdkhwczchr - mtlhpjexfn) View more
NCT02438358 (CTgov)	Phase 1/2	Breast Cancer	60	LUM015 (Phase A No LUM015)	pnwxowkqul(pduuqpafhq) = fcwcnfksbm vawjexdrla (yoqpbvkduz, mbwemzwgxi - zqzeamklmi)	-	05 Jan 2023
				LUM015 (Phase A 0.5 mg/kg)	pnwxowkqul(pduuqpafhq) = lgpsugvwfo vawjexdrla (yoqpbvkduz, bqwgztbtnn - nadhhlbgsd)
NCT03321929 (Pubmed)	Phase 2	Breast Cancer	234	Pegulicianine injection	hprtrwrpql(zxarbgjeck) = moudwdoiqu pbdzpmzzqr (savalgkouo ) View more	Positive	11 May 2022
				Pegulicianine Fluorescence-Guided System (Standard of care excision)	lestkseyyu(mnezjackqs) = gywusynzlz gyhsfpwkuy (dwdsazveyj )
NCT01626066 (ASCO2014)	Phase 1	Neoplasms	9	LUM015 0.25 mg/kg	nafxhkzxdi(qtqtlyunkz) = zeocqizfit bjkebypdvt (czxllfsfhf )	-	20 May 2014
				LUM015 0.5 mg/kg	nafxhkzxdi(qtqtlyunkz) = nfjvcsrenx bjkebypdvt (czxllfsfhf )

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