A Study of NTX-001 in the Treatment and Prevention of Facial Paralysis Requiring Surgical Repair.

Recruiting at 5 trial locations

Overseen By Vicki J Abbas, BSN RN

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Neuraptive Therapeutics Inc.

Must not be taking: Corticosteroids

Disqualifiers: Neuropathy, Neuromuscular disease, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 1 week

2 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests NTX-001, a new treatment used during surgery to help repair damaged nerves. It targets patients with facial paralysis from various causes who have ongoing issues like difficulty moving their face and speaking. The treatment aims to speed up and improve nerve healing, helping patients regain facial movement sooner.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on chronic corticosteroid therapy within 14 days of the nerve repair.

What data supports the effectiveness of the treatment NTX-001, Polyethylene Glycol (PEG) Mediated Fusion?

Research shows that polyethylene glycol (PEG) is effective in enhancing cell fusion, which is a process that can be useful in various medical applications, such as tumor immunotherapy and gene mapping. Additionally, PEG has been used successfully in several approved drugs to improve their properties, indicating its potential effectiveness in treatments. ^{1 2 3 4 5}

Is PEG-mediated fusion treatment generally safe for humans?

PEG (polyethylene glycol) has been used in various medical treatments and is generally considered safe, with no significant adverse effects linked to PEG itself in humans. Some studies have shown cellular changes in certain cells, but these have not been associated with any changes in organ function. ^{1 6 7 8 9}

What makes the treatment NTX-001 unique compared to other treatments?

NTX-001, which involves polyethylene glycol (PEG) mediated fusion, is unique because it uses PEG to facilitate the fusion of cells, a method commonly used in creating cell hybrids and in gene mapping. This approach is different from standard treatments as it leverages the fusogenic properties of PEG to enhance cell fusion, which can be particularly useful in research and therapeutic applications involving cell hybridization. ^{2 3 5 10 11}

Research Team

Seth Schulman, MD

Principal Investigator

Chief Medical Officer

Eligibility Criteria

Inclusion Criteria

You have facial paralysis that needs treatment or repair due to a condition or procedure that may cause or has caused paralysis.

Exclusion Criteria

You have Bell's palsy, but if you show signs of getting better on your own within a year, you won't be included in the study.

Subjects whose nerve repair will occur greater than 48 hours after nerve transection.

Subjects on chronic corticosteroid therapy within 14 days of repair.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo surgical repair with NTX-001 and standard neurorrhaphy, including intraoperative EMG evaluation

1 week

1 visit (in-person, operating room)

Follow-up

Participants are monitored for safety and efficacy, including assessments of facial movement and nerve function

48 weeks

Visits at weeks 6, 12, 24, 36, and 48 (in-person)

Long-term follow-up

Participants may continue to be monitored for long-term safety and efficacy outcomes

Additional months beyond 48 weeks

Treatment Details

Interventions

• NTX-001

Participant Groups

Group I: NTX-001 Experimental Treatment 1 Intervention

Solution #1, Solution #2 Active, Solution #3

Group II: Standard of Care Active Control 1 Intervention

Standard neurorrhaphy

Who Is Running the Clinical Trial?

Neuraptive Therapeutics Inc.

Lead Sponsor

Trials

5

Recruited

160+

Findings from Research

A study estimated PEG exposure in children receiving PEGylated therapies for hemophilia, revealing significant annual exposure levels without any reported adverse effects, suggesting long-term safety.

For a 50 kg child on the highest prophylactic dose of FVIII, PEG exposure ranged from 40 to 21,840 mg/year, yet no adverse event patterns related to PEG were identified, indicating that PEG is likely safe for pediatric use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyethylene Glycol Exposure with Antihemophilic Factor (Recombinant), PEGylated (rurioctocog alfa pegol) and Other Therapies Indicated for the Pediatric Population: History and Safety. Stidl, R., Denne, M., Goldstine, J., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

PEGylation of Biopharmaceuticals: A Review of Chemistry and Nonclinical Safety Information of Approved Drugs. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Polyethylene glycol-mediated cell fusion. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Surfactant enhancement of polyethyleneglycol-induced cell fusion. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

PEGylated recombinant human tumor necrosis factor alpha: preparation and anti-tumor potency. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Cell fusion in tumor progression: the isolation of cell fusion products by physical methods. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

PEGylated proteins: evaluation of their safety in the absence of definitive metabolism studies. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

PEGylated Biopharmaceuticals: Current Experience and Considerations for Nonclinical Development. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Polyethylene Glycol Exposure with Antihemophilic Factor (Recombinant), PEGylated (rurioctocog alfa pegol) and Other Therapies Indicated for the Pediatric Population: History and Safety. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Toxicity of high-molecular-weight polyethylene glycols in Sprague Dawley rats. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Is purified poly(ethylene glycol) able to induce cell fusion? [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Influence of gp41 fusion peptide on the kinetics of poly(ethylene glycol)-mediated model membrane fusion. [2019]