CLINICAL TRIALS PROFILE FOR XENON XE-129 HYPERPOLARIZED

All Clinical Trials for Xenon Xe-129 Hyperpolarized

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00566410 ↗	A Phase I, Open-Labeled, Single-Arm, Dose Escalation, Clinical and Pharmacology Study of Dichloroacetate (DCA) in Patients With Recurrent and/or Metastatic Solid Tumours	Completed	Cross Cancer Institute	Phase 1	2007-12-01	Dichloroacetate (DCA) is a small molecule that has been used for years to treat lactic acidosis and rare metabolic disorders in humans. Further testing now shows that it may suppress the growth of human cancer cells. Tests of DCA on human cells cultured outside of the body found that it killed lung, breast, and brain cancer cells, without affecting human normal cells. Tumors in rats that were infected with human tumors also shrank considerably. Most cancers are characterized by a resistance to apoptosis (cell death that removes abnormal cells) that makes them more likely to grow as well as be resistant to most cancer treatments. Plus, many current cancer treatments kill both cancerous and healthy cells and are highly toxic. DCA works by reversing the damage to the mitochondria that is present in cancer cells, thus reactivating the apoptosis (cell death) mechanism in them. The result is the death of the cancer cells. This mitochondrial reactivation presents an entirely new approach to treating cancer. DCA is known to be relatively well tolerated with few significant side effects and its selectivity, effectiveness and ease of delivery (oral) make it an attractive opportunity. It is hoped that one day this treatment may become a safe and effective treatment, either along or in conjunction with other treatments, for many forms of cancer.
NCT00566410 ↗	A Phase I, Open-Labeled, Single-Arm, Dose Escalation, Clinical and Pharmacology Study of Dichloroacetate (DCA) in Patients With Recurrent and/or Metastatic Solid Tumours	Completed	AHS Cancer Control Alberta	Phase 1	2007-12-01	Dichloroacetate (DCA) is a small molecule that has been used for years to treat lactic acidosis and rare metabolic disorders in humans. Further testing now shows that it may suppress the growth of human cancer cells. Tests of DCA on human cells cultured outside of the body found that it killed lung, breast, and brain cancer cells, without affecting human normal cells. Tumors in rats that were infected with human tumors also shrank considerably. Most cancers are characterized by a resistance to apoptosis (cell death that removes abnormal cells) that makes them more likely to grow as well as be resistant to most cancer treatments. Plus, many current cancer treatments kill both cancerous and healthy cells and are highly toxic. DCA works by reversing the damage to the mitochondria that is present in cancer cells, thus reactivating the apoptosis (cell death) mechanism in them. The result is the death of the cancer cells. This mitochondrial reactivation presents an entirely new approach to treating cancer. DCA is known to be relatively well tolerated with few significant side effects and its selectivity, effectiveness and ease of delivery (oral) make it an attractive opportunity. It is hoped that one day this treatment may become a safe and effective treatment, either along or in conjunction with other treatments, for many forms of cancer.
NCT00664937 ↗	Exercise Induced Bronchoconstriction (0476-359)	Completed	Merck Sharp & Dohme Corp.	Phase 1	2007-05-01	Exercise-induced bronchoconstriction (EIB) is a condition where airways tighten when you exercise and may cause coughing, wheezing, or shortness of breath. In many patients, this condition can cause lung function to drop making it harder to breath. An instrument called a spirometer is commonly used to measure lung function. This traditional means of assessing lung function in asthma is limited in its ability to provide information as to where in the lung the tightness is. Hyperpolarized helium magnetic resonance imaging (3He MRI) is a novel way to see the where air is going in the lungs using an MRI and special gas. The ability to see where the air can and cannot reach in the lungs may help show more accurately if a medication is working to make the asthma better. The purpose of this study is to examine patients with EIB in order to see if 3He MRI provides a better way to measure lung function. Patients will be given either montelukast sodium, a drug to improve the ability to breath with EIB, or placebo and then put on a treadmill to induce an occurrence of airway constriction. The patient's lung function will be measured more than once using both the spirometer and the 3He MRI.
NCT00846287 ↗	Assessment of Arformoterol for Chronic Obstructive Pulmonary Disease (COPD) Using Hyperpolarized 3He MRI	Completed	University of Massachusetts, Worcester	N/A	2008-11-01	The purpose of this study is to determine efficacy of MR imaging with hyperpolarized helium-3 gas in COPD patients both before and after treatment.

Clinical Trial Conditions for Xenon Xe-129 Hyperpolarized

Condition Name

Condition Name for Xenon Xe-129 Hyperpolarized
Intervention	Trials
Asthma	11
Prostate Cancer	10
Cystic Fibrosis	10
COPD	7

Condition MeSH

Condition MeSH for Xenon Xe-129 Hyperpolarized
Intervention	Trials
Lung Diseases	16
Prostatic Neoplasms	12
Cystic Fibrosis	11
Pulmonary Disease, Chronic Obstructive	10

Clinical Trial Locations for Xenon Xe-129 Hyperpolarized

Trials by Country

Trials by Country for Xenon Xe-129 Hyperpolarized
Location	Trials
United States	82
Canada	14
United Kingdom	2
Taiwan	2
Denmark	1

Trials by US State

Trials by US State for Xenon Xe-129 Hyperpolarized
Location	Trials
California	21
Virginia	13
Texas	11
North Carolina	11
Ohio	10

Clinical Trial Progress for Xenon Xe-129 Hyperpolarized

Clinical Trial Phase

Clinical Trial Phase for Xenon Xe-129 Hyperpolarized
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	4
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Xenon Xe-129 Hyperpolarized
Clinical Trial Phase	Trials
Recruiting	45
Completed	20
Not yet recruiting	18

Clinical Trial Sponsors for Xenon Xe-129 Hyperpolarized

Sponsor Name

Sponsor Name for Xenon Xe-129 Hyperpolarized
Sponsor	Trials
National Cancer Institute (NCI)	13
University of Virginia	11
Children's Hospital Medical Center, Cincinnati	10

Sponsor Type

Sponsor Type for Xenon Xe-129 Hyperpolarized
Sponsor	Trials
Other	132
NIH	30
Industry	23

Xenon Xe-129 Hyperpolarized: A Breakthrough in Lung Ventilation Imaging

Introduction

In December 2022, the U.S. Food and Drug Administration (FDA) approved Polarean Imaging plc's XENOVIEW™, a hyperpolarized contrast agent prepared from the Xenon Xe 129 Gas Blend. This approval marks a significant milestone in the field of pulmonary medicine, offering a novel, non-invasive method for evaluating lung ventilation using magnetic resonance imaging (MRI).

Clinical Trials and Approval

The FDA approval of XENOVIEW was based on the results of two prospective, multi-center, randomized, open-label, cross-over clinical trials. These trials compared XENOVIEW MRI with xenon Xe 133 scintigraphy in adult patients with pulmonary disorders. The trials met their primary endpoints, demonstrating the efficacy and safety of XENOVIEW for evaluating lung ventilation in adults and pediatric patients aged 12 years and older[5].

Key Findings

• The mean XENOVIEW dose used in these trials was 99 mL Dose Equivalent (DE) of hyperpolarized xenon Xe 129 at the time of measurement within 5 minutes of administration.
• The trials showed that XENOVIEW can effectively visualize and evaluate lung ventilation without exposing patients to ionizing radiation.
• The safety profile of XENOVIEW was favorable, with transient effects such as oxygen desaturation and heart rate elevation resolving quickly without intervention[4].

Mechanism of Action and Administration

Hyperpolarization Process

Hyperpolarized Xenon-129 (Xe-129) undergoes a process that increases its nuclear polarization up to five orders of magnitude, significantly enhancing the MRI signal. This process compensates for the low density of gas compared to solid tissue, making lung MRI feasible[2].

Administration

XENOVIEW is prepared on-site using the HPX Hyperpolarization System from the isotopically enriched Xenon Xe 129 Gas Blend. The dose is administered in a single 10-15 second breath hold during an MRI procedure. The HPX Polarization Measurement Station ensures that the dose equivalent (DE) meets the acceptable range before administration[4].

Market Analysis and Projection

Market Opportunity

The approval of XENOVIEW opens up a significant market opportunity, particularly in the diagnosis and management of pulmonary disorders. Given its unique ability to visualize lung ventilation without ionizing radiation, XENOVIEW is poised to become a valuable tool in clinical settings.

Competitive Landscape

While Helium-3 (He-3) is another hyperpolarized noble gas used in lung MRI, its availability has been affected by its use in other applications. Xenon Xe-129, with its lower cost and favorable safety profile, is likely to gain traction in the market[2].

Target Population

XENOVIEW is indicated for use in adults and pediatric patients aged 12 years and older. This broad age range, combined with its non-invasive nature, makes it an attractive option for diagnosing and monitoring various lung conditions, including asthma and chronic obstructive pulmonary disease (COPD)[1][5].

Technological and Clinical Support

XENOVIEW VDP Image Processing Software

Polarean's XENOVIEW VDP is an image processing software that analyzes pulmonary hyperpolarized 129-Xe MR images and proton chest MR images. This software provides visualization and evaluation of lung ventilation, assisting clinicians in the interpretation and numerical classification of hyperpolarized 129-Xe ventilation MR images[1][5].

Polarean XENOVIEW 3.0T Chest Coil

The Polarean XENOVIEW 3.0T Chest Coil is a flexible, single-channel, transmit-receive (T/R) RF coil tuned to the 129Xe frequency on a 3.0T MRI magnetic field. This coil is designed to be used in conjunction with compatible 3.0T MRI scanners and approved xenon Xe 129 hyperpolarized gas for the evaluation of lung ventilation[1][5].

Future Clinical Indications

Ongoing Research

XENOVIEW is currently being studied for its potential in visualizing and quantifying gas exchange regionally in the smallest airways of the lungs, across the alveolar tissue membrane, and into the pulmonary bloodstream. These studies could lead to future clinical indications beyond lung ventilation imaging[5].

Potential in Uncontrolled Asthma and Mucus Plugging

Studies have shown that 129Xe ventilation significantly improved in participants with uncontrolled asthma and those with significant mucus plugging after a single dose of XENOVIEW. This suggests a promising role for XENOVIEW in managing these conditions[3].

Safety and Efficacy

Safety Profile

XENOVIEW has a favorable safety profile, with adverse effects typically resolving shortly after administration. The drug is minimally absorbed systemically following inhalation, and maternal use is not expected to result in fetal exposure[4].

Efficacy in Clinical Trials

The clinical trials demonstrated that XENOVIEW effectively visualizes and evaluates lung ventilation. The mean difference in oxygen saturation and heart rate changes following administration were transient and resolved quickly without intervention[4].

Key Takeaways

• FDA Approval: XENOVIEW was approved by the FDA in December 2022 for evaluating lung ventilation in adults and pediatric patients aged 12 years and older.
• Hyperpolarization: The process increases the nuclear polarization of Xenon-129, enhancing the MRI signal.
• Market Opportunity: XENOVIEW offers a significant market opportunity due to its unique non-invasive imaging capabilities.
• Technological Support: XENOVIEW VDP software and the Polarean XENOVIEW 3.0T Chest Coil support its clinical use.
• Future Indications: Ongoing research may expand its use beyond lung ventilation imaging.

FAQs

What is XENOVIEW used for?

XENOVIEW is used as a hyperpolarized contrast agent for evaluating lung ventilation in adults and pediatric patients aged 12 years and older using MRI.

How is XENOVIEW administered?

XENOVIEW is administered in a single 10-15 second breath hold during an MRI procedure after being prepared using the HPX Hyperpolarization System.

What are the key components of the XENOVIEW system?

The system includes the HPX Hyperpolarization System, XENOVIEW VDP image processing software, and the Polarean XENOVIEW 3.0T Chest Coil.

Is XENOVIEW safe for use in pediatric patients?

Yes, XENOVIEW is approved for use in pediatric patients aged 12 years and older. It has not been evaluated for use in pediatric patients less than 12 years of age.

What are the potential future clinical indications for XENOVIEW?

XENOVIEW is being studied for its potential in visualizing and quantifying gas exchange in the lungs, which could lead to future clinical indications beyond lung ventilation imaging.

Sources

1. Polarean Imaging plc, "FDA Approval - December 28th 2022," 129Xe MRI Clinical Trials Consortium, December 28, 2022.
2. DrugBank, "Xenon Xe-129: Uses, Interactions, Mechanism of Action," DrugBank.
3. Patsnap, "XENON XE 129 hyperpolarized - Drug Targets, Indications, Patents," Synapse.
4. FDA, "XENOVIEW (xenon Xe 129 hyperpolarized), for oral inhalation," FDA Label.
5. BioSpace, "FDA Approves Polarean's XENOVIEW™ (xenon Xe 129 hyperpolarized) for use with MRI for the evaluation of lung ventilation," BioSpace, December 28, 2022.