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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