GelX®: Prevention and Treatment of oral · PDF file• GRADE 1: Soreness in mouth, no ulcer; patient can eat a normal diet • GRADE 2: sore mouth with ulcers, patient is still able

GelX®: Prevention and Treatment of oral mucositis

Oral rinse that forms a protective barrier which adheres to the oral mucosa protecting it against further external damages and promoting healing

EU : Medical Device (Class II)US: RX 510k

15ml per application, 2 or 3 times per day

Zinc Gluconate and Taurine: when combined together they form a bioactive complex under physiological conditions, that provides excellent bacteriostatic qualities without the cytotoxicity seen in other preservative systems. Furthermore, Zinc-Taurine complex are effective in addressing mineral deficiency and inflammatory processes associated with oral discomfort and pain

300ml or 450ml trade pack, 100ml sample pack

Regulatory status

Dosage

Principle ingredients

Indication

Contents

PRODUCT PROFILE

Description

Symptomatic treatment of pain of oral cavity lesions such as mucositis, stomatitis due to radiotherapy, chemotherapy, pharmacological therapy, and labial mucosa lesions.

Oral Spray that forms a protective barrier over the labial mucosa, promoting healing

EU : Medical Device (Class II)US: RX 510k under approval

Spray 2 or 3 times at least twice a per day

Description

Regulatory status

Dosage

Principle ingredients

Indication

Contents

Symptomatic treatment of signs and symptoms associated with oral cavity lesions such as mucositis, stomatitis due to radiotherapy, chemotherapy, pharmacological therapy, and labial mucosa lesions.

100ml

Zinc Gluconate and Taurine: when combined together they form a bioactive complex under physiological conditions, that provides excellent bacteriostatic qualities without the cytotoxicity seen in other preservative systems. Furthermore, Zinc-Taurine complex are effective in addressing mineral deficiency and inflammatory processes associated with oral discomfort and pain

PRODUCT PROFILE

DISEASE OVERVIEW

When oral mucositis occurs, the mucous membranes of the mouth can become injured through simple actions such as talking, eating or swallowing causing painful and sometimes sores, bleeding and inflammation. Oral mucositis is a common side effect of chemotherapy or radiation treatment for cancer.Oral mucositis first appears following the first week of cancer treatment: the early sings include redness, minor swelling in tongue and gums, minor discomfort when eating or swallowing.As mucositis get worse, the pain can become more severe and inflammation can increase; the symptoms of oral mucositis include pain, burning and discomfort.The degrees of grades of oral mucositis are classified by the WHO (World Healt Organization):

• GRADE 0: No symptoms of oral mucositis

• GRADE 1: Soreness in mouth, no ulcer; patient can eat a normal diet

• GRADE 2: sore mouth with ulcers, patient is still able to eat a normal diet

• GRADE 3 : extreme sensitivity when swallowing solid food, patient needs to be on a liquid diet

• GRADE 4: patient is not able to eat, drink or swallow, a parenteral nutrition or tube feeding is necessary

MARKET COMPARISON

GelX Gelclair Caphosol Kepivance Mugard Episil

Key Ingredients

Zinc Gluconate

Taurine

PVP

Glicerretinic Acid

Hyaluronic Acid

PVP

Calcium Phosphate Palifermin Glycerin, Benzyl

alcohol

Soy Phosphatidylcholine

(lecithin) , Glycerol dio-

leate

It contains ethanol

Regulatory Status

Class II Medical Device

in EU

RX Medical Device in the

US

Medical Device RX Medical Device Drug RX Medical Device RX Medical Device

Therapy

Rinse (330ml & 450ml ):

prevention and treatment

Spray ( 100ml ) :

prevention and treatment

1 month

treatment

1 week 1 week 6 doses , 3 before

therapy+ 3 after the-

rapy to be administe-

red by intravenous

bolus injection

Prior and during

the cancer therapy

( 250ml bottle)

Oral liquid (10ml) :

65 applications

Method of Use

Rinse : 2 / 3 times

a day before and during

therapy

Spray : 3 times a day

for 1 month

box with 21 single-

use packet of 15ml:

one 15ml 3 times a day

4 to 10 times a day 6 doses , 3 before

therapy+ 3 after the-

rapy ( not in the 24

hours before or

immediately after

it

5 or 10ml of product

4-6 times a day

spray 1-3 times to the

oral cavity, 2/3 times a day or

as needed

Claims

Pain relief from o-

ral mucositis and

stomatitis

Management & relief

of pain caused by

mouth sores

Symptom relief of

Mucositis &

Xerostomia

Decrease incidence

and duration of seve-

re oral mucoisitis

Management of o-

ral wounds, mucosi-

tis, stomatitis

Relief of pain

from oral

mucositis

Notes

Delays the onset of mu-

cositis by inhibiting the

inflammatory cyle, re-

duces the severity of the

ulceration and pain,

extends the period of

patient comfort

Forms a barrier that

protects the nerve

endings that cause

pain

Moistens, lubricates

and clean the oral

cavity.

Patients restricted to

a low sodium diet

cannot use it

It is a human kera-

tinocyte growth fac-

tor

Forms a protective &

soothing layer

Ethanol can cause a

burning

sensation, soy and /or

peppermint oil can cause

allergic reactions.

Patented combination of

ingredients

Price EU

€ 52,70 450ml

€ 38,50 300ml

€ 25,00 -€29,00100ml

spray

€ 82,79 for 21 sachets

of 15ml

reimbursed in the UK

£ 54,62 1 week

treatment , £ 96,98

2 weeks treatment

€56,70 1 week

treatment, € 225,00

monthly treatment

To be used only in the

hospital, reimbursed

€ 36,00

£ 20,00

£ 50,00 approximately

Price USA

$ 175, 00 450ml

$ 52,00 100ml spray

$ 75,00 for 21 sachets

of 15ml, $ 135,00 for

42 sachets, $ 250,00

for 84 sachets of 15ml

Special offer $128,00

1 month treatment

Reimbursed $ 150,00 1 week

treatment( $ 1000,00

for a 6 weeks

treatment )

NOT AVAILABLE

CLINICAL TRIALS 1

THE EFFECT OF

PROTECTIVE

GELS ON

MUCOSITIS:

A PILOT STUDY,

UNIVERSITY of

CATANIA, ITALY

60 patientsTwo groups, one treated with GelX rinse, one with no treatment (control group)2/3 applications per day evaluation of :• Complete healing• Lesion present, but asymptomatic• Halving of the symptoms• Persistence if signs and symptoms• Side effects

Complete healing : % on the nr of patients treated

CLINICAL TRIALS RESULTS

Persistence of signs & symptoms at the end of the treatment

CLINICAL TRIALS RESULTS

Animal species: white mice Age : 8 weeksNr : 12 Different groups of mice randomly formed • HCL solution• HCL solution +GelX placebo• HCL solution +GelX Oral Gel• HCL solution + Clobesol

IN VIVO EXPERIMENTAL TRIAL

EFFECTS OF GELX IN

HYDROCHLORIDRIC

ACID –INDUCED

DAMAGE ON MICE

SKIN - DMU,

UNIVERSITY of MILAN,

ITALY

RESULTS : GelX placebo & GelX act as mechanical

intermediary in protection againast HCL-ulcers formation

in mice skin; both demonstrated a film-forming activity

that protects the skin from HCL- damage

CLINICAL TRIALS 2 - RESULTS

HCL solution GelX placebo GelX Clobesol

GROUP 1

GROUP 2

GROUP 3

GROUP 4

X

X

X

X

X

X

X

Study A - MULTICENTER

- Reduction and delay the onset of oral mucositis, reduce the pain and severity of oral mucositis and decrease the time to resolution of oral mucositis.(DELAY, REDUCE, EXTEND)

- 30 + 30 patients

- GelX Oral Gel 300ml rinse, 2 times per day (10 days each) and GelX Oral Sray, 100ml spray, 3 times per day 3 spray each time (30 days each)

- Two assessment:- Physician assessment (RTOG mucous membrane assessment scale)- Patient assessment (Pain & Saliva assessments scale)

Study B - PAKISTAN- Reduction and delay the onset of oral mucositis, reduce the pain and severity of oral mucositis

and decrease the time to resolution of oral mucositis.(DELAY, REDUCE, EXTEND)- 60 patients open trial 2 centers- GelX Oral Gel PREVENTION, 300ml rinse, 2 times per day (10 days each)- GelX Oral Spray TREATMENT, 100ml spray, 3 times per day 3 spray each time (30 days each)- Two assessment:

- Physician assessment (RTOG mucous membrane assessment scale)- Patient assessment (Pain & Saliva assessments scale)

CLINICAL STUDIES ON GOING

Prevention and Treatment of oral mucositis