Safety Study of EF-022 in Adults With Recurrent Respiratory Papillomatosis (RRP)

2016-08-04 05:53:22 | BioPortfolio


This study evaluates the safety and tolerability of the investigational drug EF-022 in the treatment of adult patients with Recurrent Respiratory Papillomatosis (RRP). Patients will be administered EF-022, either intramuscular or subcutaneous, for a period of 6 months. Preliminary effect of the drug on the disease will be evaluated by following the number and severity of the lesions in the respiratory tract and the effect on voice changes.


The etiology of RRP is associated with local immune suppression at disease-involved sites.

EF-022, a Vitamin D-Binding protein Macrophage Activating Factor, modulates the innate arm of the immune system to alleviate immune suppression. The investigators hypothesize that EF-022 may modulate the immune response in a manner that might slow down or even prevent disease progression.

Adult subjects will be treated weekly with EF-022 for a period of 6 months by either intramuscular or subcutaneous administration.

The primary objective of the study is to evaluate the safety and tolerability of EF-022 administered to adult subjects with recurrent respiratory papillomatosis either IM or SC.

The main response assessment will be performed over the 6 months period by:

- Evaluating lesion size and/or number of disease-involved sites by Coltera-Derkay score

- Assessment of degree of voice disorder using the VHI-10 score

- Symptomatic assessment of dyspnea/stridor

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Recurrent Respiratory Papillomatosis


EF-022 (Modified Vitamin D Binding Protein Macrophage Activator)


Not yet recruiting


Efranat Ltd.

Results (where available)

View Results


Published on BioPortfolio: 2016-08-04T05:53:22-0400

Clinical Trials [3702 Associated Clinical Trials listed on BioPortfolio]

Study on the Correlation of Free Vitamin d With BMD and Fracture

According to the free hormone hypothesis, the biological activity of a hormone is carried by the portion that is not bound to protein or its carrier in circulation. Based on this, we belie...

Getting Vitamin D Dosing Right

The investigators want to make sure that people get the right dose of Vitamin D treatment. They will therefore investigate how skin colour, body mass index, ethnicity, vitamin D binding pr...

Impact of Vitamin D Supplementation on Recurrent Respiratory Infections in Paediatric Primary Care.

Up to date, some clinical trial have evaluated the efficacy and safety of Vitamin D supplementation in children with RRI, with no conclusive information. Therefore, we designed a prospect...

Using Stable Isotopes to Assess the Effectiveness of Vitamin A Supplementation in Cameroon

This is a study to evaluate the effects of vitamin A supplementation program on the vitamin A status of preschool children. All children aged 3-5 years who do not have severe illness and a...

Study of the Role of Soluble Inhibitor of Interleukin 22, Interleukin 22 Binding Protein (IL-22BP), in Chronic Inflammatory Bowel Disease

IL-22 is an IL-10 family cytokine that plays major actions to increase intestinal epithelial barrier function and regeneration during experimental colitis. IL-22 binding protein is a small...

PubMed Articles [22447 Associated PubMed Articles listed on BioPortfolio]

Alteration of Serum 25(OH) Vitamin D, Vitamin D Binding Protein, and C-reactive Protein Levels in Acute Leukemia Patients.

Acute leukemia is a common hematologic malignancy with poorly differentiated leukocytes. Alteration of circulating vitamin D (VD) and its carrier vitamin D binding protein (VDBP) have been reported in...

Associations of Circulating 25-Hydroxyvitamin D3 Concentrations With Incident, Sporadic Colorectal Adenoma Risk According to Common Vitamin D Binding Protein Isoforms.

25-hydroxyvitamin D3 (25[OH]D3), the main circulating form of vitamin D, is inversely associated with incident, sporadic colorectal adenoma. We investigated whether this association differs by two fun...

Effect of vitamin D supplementation on free and total vitamin D: a comparison of Asians vs Caucasians.

It is well established that UK Asians typically have lower vitamin D levels than Caucasians. It is also known that vitamin D binding protein (DBP) is lower in some races than Caucasians. To investigat...

A High-Protein/Low-Fat Diet May Interact with Vitamin D-Binding Protein Gene Variants to Moderate the Risk of Depression in Apparently Healthy Adults.

Recent studies have shown that depression is inversely correlated with high protein and low fat intake and positively correlated with vitamin D-binding protein (VDBP). Therefore, the aim of this study...

Vitamin D and macrophage polarization in epicardial adipose tissue of atherosclerotic swine.

Vitamin D functions as a potent immunomodulator by interacting with many immune cells however, its role in regulating inflammation in the epicardial adipose tissue (EAT) is unclear. In the EAT of athe...

Medical and Biotech [MESH] Definitions

The vitamin K-dependent cofactor of activated PROTEIN C. Together with protein C, it inhibits the action of factors VIIIa and Va. A deficiency in protein S; (PROTEIN S DEFICIENCY); can lead to recurrent venous and arterial thrombosis.

An autosomal dominant disorder showing decreased levels of plasma protein S antigen or activity, associated with venous thrombosis and pulmonary embolism. PROTEIN S is a vitamin K-dependent plasma protein that inhibits blood clotting by serving as a cofactor for activated PROTEIN C (also a vitamin K-dependent protein), and the clinical manifestations of its deficiency are virtually identical to those of protein C deficiency. Treatment with heparin for acute thrombotic processes is usually followed by maintenance administration of coumarin drugs for the prevention of recurrent thrombosis. (From Harrison's Principles of Internal Medicine, 12th ed, p1511; Wintrobe's Clinical Hematology, 9th ed, p1523)

A protein that plays a fundamental role in the Vitamin D mediated transport of calcium in reptiles, amphibians, birds and mammals. It is found in the intestine, kidneys, egg shell gland, brain, and possibly other organs. Its molecular weight is species dependent.

A 67-kDa sialic acid binding lectin that is specific for MYELOID CELLS and MONOCYTE-MACROPHAGE PRECURSOR CELLS. This protein is the smallest siglec subtype and contains a single immunoglobulin C2-set domain. It may play a role in intracellular signaling via its interaction with SHP-1 PROTEIN-TYROSINE PHOSPHATASE and SHP-2 PROTEIN-TYROSINE PHOSPHATASE.

A heat-stable, low-molecular-weight activator protein found mainly in the brain and heart. The binding of calcium ions to this protein allows this protein to bind to cyclic nucleotide phosphodiesterases and to adenyl cyclase with subsequent activation. Thereby this protein modulates cyclic AMP and cyclic GMP levels.

More From BioPortfolio on "Safety Study of EF-022 in Adults With Recurrent Respiratory Papillomatosis (RRP)"

Quick Search


Relevant Topics

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Asthma COPD Cystic Fibrosis Pneumonia Pulmonary Medicine Respiratory Respiratory tract infections (RTIs) are any infection of the sinuses, throat, airways or lungs.  They're usually caused by viruses, but they can also ...

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Searches Linking to this Trial