CLINICAL TRIALS PROFILE FOR LYMPHOSEEK KIT

All Clinical Trials for Lymphoseek Kit

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00671918 ↗	Trial of Lymphoseek in Intraoperative Localization of Lymph Nodes in Breast Cancer and Melanoma	Completed	Navidea Biopharmaceuticals	Phase 3	2008-04-01	Data from this pivotal clinical trial will be used to support a marketing application (i.e., NDA) for Navidea's Lymphoseek for use in intraoperative localization of lymph tissue (nodes) in the lymphatic pathway draining the primary site of a tumor.
NCT00911326 ↗	Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma	Terminated	Navidea Biopharmaceuticals	Phase 3	2009-05-01	The purpose of this study is to determine the false negative rate (FNR) associated with Lymphoseek-identified sentinel lymph nodes (SLNs) relative to the pathological status of non-sentinel lymph nodes in elective neck dissection (END) in head & neck squamous cell carcinoma (HNSCC). NEO3-06 (this study) is a Phase 3 clinical trial designed to supplement NEO3-05, a completed Phase 3 clinical trial conducted in patients with breast cancer or melanoma. NEO3-05 was designed to establish Lymphoseek as an effective radio-diagnostic agent to be used in the intraoperative localization of lymph tissue (nodes) in the lymphatic pathway draining the primary site of a tumor.
NCT01106040 ↗	Breast and Melanoma Trial With Lymphoseek to Identify Lymph Nodes	Completed	Navidea Biopharmaceuticals	Phase 3	2010-06-01	Data from this pivotal clinical trial will be used to support a marketing application (i.e., NDA) of Navidea's Lymphoseek for use in anatomical delineation of lymphoid tissue (nodes) in the lymphatic pathway draining the primary site of a tumor. Multicenter, open-label, within-patient comparative study of Lymphoseek and vital blue dye in the detection of excised lymph nodes in patients with known melanoma and breast cancer. All patients will receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and vital blue dye.
NCT01902953 ↗	Lymphoseek® as Lymphoid Tissue Targeting Agents in Colon Cancer(CNC)	Completed	Maimonides Medical Center	Phase 2	2013-03-01	45 patients undergoing a colon (large bowel/intestine)removal operation for the diagnosis of colon cancer will be included in this study. During colon operation the affected portion of the colon is removed. In addition, lymph nodes are included in the specimen and evaluated by a pathologist. Analysis of the lymph nodes in the specimen are important because this is an important aspect of determining the stage of the cancer. Once the standard technique is used for the colon removal operation and the specimen is removed it will be injected with two drugs to help identify the lymph nodes. One is a blue dye and the other a radiotracer. The colon and ALL of the lymph nodes will then be sent for the standard pathologic evaluation. The patient themselves will never be injected with these drugs being used for research. Following the standard lymph node evaluation, an additional pathologist at an outside research facility will further examine the lymph nodes in the specimen using more in depth techniques which are above and beyond the standard of care. The results of all the pathologic tests will be conveyed to the surgeon of record to help in their decision making regarding further treatment. The study hypothesis is that radiotracer will be at least as effective as blue dye in identifying the lymph nodes most likely to harbor cancer cells (sentinel nodes). Once identified, these sentinel nodes can then undergo a more in depth review leading to improved staging of colorectal cancer and more accurate treatment.
NCT02065232 ↗	Sentinel Lymph Node Mapping Post-Injection Site Pain	Completed	Navidea Biopharmaceuticals		2014-03-01	This is a pain survey study that will compare the level of discomfort experienced by breast cancer patients after injection of either technetium-labeled sulfur colloid or technetium-labeled tilmanocept, both FDA-approved agents used for sentinel lymph node biopsy (SLNB). Breast cancer patients who are already scheduled for SLNB as part of their original surgical plan will be asked to participate in this study and be randomized to receive either technetium-labeled sulfur colloid or technetium-labeled tilmanocept. After injection, patients will complete pain questionnaires to measure the amount of discomfort they are feeling during and after they receive the injection. There will be no change to the patient's treatment plan other than the addition of pain questionnaires. The investigators' hypothesis is that patients will feel less discomfort after injection of tilmanocept versus sulfur colloid.

Clinical Trial Conditions for Lymphoseek Kit

Condition Name

Condition Name for Lymphoseek Kit
Intervention	Trials
Rheumatoid Arthritis	5
Breast Cancer	5
Melanoma	5
Endometrial Cancer	2

Condition MeSH

Condition MeSH for Lymphoseek Kit
Intervention	Trials
Arthritis	5
Melanoma	5
Breast Neoplasms	5
Arthritis, Rheumatoid	5

Clinical Trial Locations for Lymphoseek Kit

Trials by Country

Trials by Country for Lymphoseek Kit
Location	Trials
United States	55
Israel	1
Spain	1
United Kingdom	1
Switzerland	1

Trials by US State

Trials by US State for Lymphoseek Kit
Location	Trials
California	13
Ohio	8
Florida	7
Pennsylvania	5
Alabama	4

Clinical Trial Progress for Lymphoseek Kit

Clinical Trial Phase

Clinical Trial Phase for Lymphoseek Kit
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	4
Phase 2	10

Clinical Trial Status

Clinical Trial Status for Lymphoseek Kit
Clinical Trial Phase	Trials
Completed	11
Terminated	4
Recruiting	4

Clinical Trial Sponsors for Lymphoseek Kit

Sponsor Name

Sponsor Name for Lymphoseek Kit
Sponsor	Trials
Navidea Biopharmaceuticals	17
Cardinal Health 414, LLC	4
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for Lymphoseek Kit
Sponsor	Trials
Industry	21
Other	10
NIH	5

LYMPHOSEEK®: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to LYMPHOSEEK®

LYMPHOSEEK® (technetium Tc 99m tilmanocept) is a groundbreaking radioactive diagnostic agent specifically designed for targeted lymphatic mapping and guiding sentinel lymph node biopsies (SLNB). Developed by Navidea Biopharmaceuticals and now part of Cardinal Health’s portfolio, LYMPHOSEEK® has revolutionized the field of oncology by providing accurate and precise lymph node identification in patients with solid tumors.

Clinical Efficacy and Trials

Solid Tumors: Breast Cancer and Melanoma

The clinical efficacy of LYMPHOSEEK® was demonstrated in two pivotal Phase 3 open-label, multicenter, single-arm, within-subject active-comparator trials involving patients with breast cancer or melanoma. These trials compared LYMPHOSEEK® with vital blue dye (VBD), a long-standing agent for lymphatic mapping. The results showed high concordance between LYMPHOSEEK® and VBD, with LYMPHOSEEK® identifying lymph nodes in 94-100% of patients, significantly outperforming VBD in several metrics[1][2][4].

Head and Neck Squamous Cell Carcinoma (SCC)

In a Phase 3 trial focusing on head and neck SCC, LYMPHOSEEK® demonstrated a high sensitivity for detecting cancer in lymph nodes, with a false negative rate of only 2.6%. The study involved 83 patients and showed that LYMPHOSEEK® identified at least one sentinel lymph node in 97.6% of patients, including those with challenging floor of mouth tumors[1].

Pediatric Indication

A recent clinical study has expanded the use of LYMPHOSEEK® to pediatric patients aged one month and older with solid tumors such as melanoma, rhabdomyosarcoma, and non-rhabdomyosarcoma soft tissue sarcoma. The study confirmed the safety and efficacy of LYMPHOSEEK® in this population, with minimal adverse reactions reported[3].

Mechanism of Action

LYMPHOSEEK® works by binding to a specific receptor found on the surface of dendritic cells and macrophages, which are highly concentrated in lymph nodes. This receptor-targeted property allows LYMPHOSEEK® to attach to and remain within lymph nodes, enabling precise identification during surgical procedures[2][4].

Market Analysis

Regulatory Approvals

LYMPHOSEEK® has received significant regulatory approvals. In the United States, it was approved by the FDA for use in intraoperative lymphatic mapping and lymphoscintigraphy in 2013. Additionally, Navidea received positive guidance from the European Medicines Agency (EMA) for a Marketing Authorization Application (MAA) submission, paving the way for its approval in the EU[2].

Market Impact

The approval and adoption of LYMPHOSEEK® have significantly impacted the market for lymphatic mapping agents. It is the first and only receptor-targeted agent specifically designed for this purpose, offering a more accurate and efficient alternative to traditional methods like vital blue dye. This has led to increased interest from potential commercial partners and has stimulated discussions for mutually beneficial arrangements[2].

Economic Benefits

The use of LYMPHOSEEK® has been shown to have economic benefits, particularly in terms of procedure time and hospital resource utilization. A case study at Mercy Medical Center demonstrated that using LYMPHOSEEK® reduced procedure times, allowing for additional surgical cases to be performed each day. This resulted in improved patient satisfaction and operational efficiency[5].

Projections and Future Outlook

Expanding Indications

With its recent approval for pediatric use, LYMPHOSEEK® is expected to expand its market reach. The ability to accurately stage disease in pediatric cancer patients will open new avenues for its application, potentially increasing its market share in the pediatric oncology segment[3].

Global Registration

The positive EMA guidance and ongoing regulatory activities suggest that LYMPHOSEEK® will soon be available in the European market, further expanding its global presence. This global registration process is expected to enhance its market penetration and adoption rates worldwide[2].

Technological Advancements

As medical technology continues to evolve, LYMPHOSEEK® is likely to benefit from advancements in gamma detection devices and surgical techniques. This could lead to even more precise and efficient lymph node identification, further solidifying its position in the market[2].

Key Takeaways

• High Clinical Efficacy: LYMPHOSEEK® has demonstrated superior performance in identifying lymph nodes in patients with solid tumors, including breast cancer, melanoma, and head and neck SCC.
• Regulatory Approvals: Approved by the FDA and with positive EMA guidance, LYMPHOSEEK® is set for global market expansion.
• Pediatric Indication: Recent approval for pediatric use expands its market potential.
• Economic Benefits: Reduces procedure times and enhances operational efficiency, leading to improved patient satisfaction and economic savings.
• Future Outlook: Expected to continue growing with expanding indications and global registrations.

FAQs

Q: What is LYMPHOSEEK® used for?

LYMPHOSEEK® is used for targeted lymphatic mapping and guiding sentinel lymph node biopsies in patients with solid tumors.

Q: How does LYMPHOSEEK® work?

LYMPHOSEEK® works by binding to specific receptors on dendritic cells and macrophages in lymph nodes, allowing for precise identification during surgery.

Q: What are the key clinical trials that demonstrated the efficacy of LYMPHOSEEK®?

The efficacy was demonstrated in Phase 3 trials involving patients with breast cancer, melanoma, and head and neck SCC, as well as a pediatric study.

Q: Is LYMPHOSEEK® approved for pediatric use?

Yes, LYMPHOSEEK® has been approved by the FDA for use in pediatric patients aged one month and older with certain solid tumors.

Q: What are the economic benefits of using LYMPHOSEEK®?

Using LYMPHOSEEK® reduces procedure times, allows for additional surgical cases, and improves patient satisfaction, leading to economic savings and operational efficiency.

References

1. LYMPHOSEEK Clinical Efficacy: Solid Tumors - Lymphoseek.com
2. Navidea Obtains Positive EMA Guidance for Lymphoseek - Navidea.com
3. Cardinal Health Receives FDA Approval for New Lymphoseek Pediatric Indication - PRNewswire.com
4. About LYMPHOSEEK - Lymphoseek.com
5. Lymphoseek Mercy Medical Case Study - Lymphoseek.com