GelX®: Prevention and Treatment of oral mucositis
PRODUCT PROFILE
Description
Regulatory status
Dosage
Principle ingredients
Indication
Contents
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
Symptomatic treatment of pain of oral cavity lesions
such as mucositis, stomatitis due to radiotherapy,
chemotherapy, pharmacological therapy, and labial
mucosa lesions.
300ml or 450ml trade pack, 100ml sample pack
PRODUCT PROFILE
Description
Oral Spray that forms a protective barrier over the
labial mucosa, promoting healing
Regulatory status EU : Medical Device (Class II)
US: RX 510k under approval
Dosage Spray 2 or 3 times at least twice a per day
Principle ingredients 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
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
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
Gelclair
Glicerretinic Acid
Hyaluronic Acid
PVP
Caphosol
Calcium Phosphate
Palifermin
Mugard
Glycerin, Benzyl
alcohol
Medical Device
RX Medical Device
Drug
RX Medical Device
1 week
1 week
6 doses , 3 before
therapy+ 3 after therapy to be administered by intravenous
bolus injection
Prior and during
the cancer therapy
( 250ml bottle)
Oral liquid (10ml) :
65 applications
Therapy
Rinse (330ml & 450ml ):
prevention and treatment
Spray ( 100ml ) :
prevention and treatment
1 month
treatment
box with 21 single4 to 10 times a day
use packet of 15ml:
one 15ml 3 times a day
spray 1-3 times to the
oral cavity, 2/3 times a day or
as needed
Pain relief from oral mucositis and
stomatitis
Management & relief
of pain caused by
mouth sores
Symptom relief of
Mucositis &
Xerostomia
6 doses , 3 before
therapy+ 3 after therapy ( not in the 24
hours before or
immediately after
it
Decrease incidence
and duration of severe oral mucoisitis
5 or 10ml of product
4-6 times a day
Method of Use
Rinse : 2 / 3 times
a day before and during
therapy
Spray : 3 times a day
for 1 month
Management of oral wounds, mucositis, stomatitis
Relief of pain
from oral
mucositis
Delays the onset of mucositis by inhibiting the
inflammatory cyle, reduces the severity of the
ulceration and pain,
extends the period of
patient comfort
€ 52,70 450ml
€ 38,50 300ml
€ 25,00 -€29,00100ml
spray
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 keratinocyte growth factor
Forms a protective &
soothing layer
Ethanol can cause a
burning
sensation, soy and /or
peppermint oil can cause
allergic reactions.
Patented combination of
ingredients
£ 50,00 approximately
Key Ingredients
GelX
Zinc Gluconate
T aurine
PVP
Class II Medical Device
in EU
Regulatory Status
RX Medical Device in the
US
Claims
Notes
Price EU
Price USA
$ 175, 00 450ml
$ 52,00 100ml spray
€ 82,79 for 21 sachets
of 15ml
reimbursed in the UK
$ 75,00 for 21 sachets
of 15ml, $ 135,00 for
42 sachets, $ 250,00
for 84 sachets of 15ml
£ 54,62 1 week
treatment , £ 96,98
2 weeks treatment
€56,70 1 week
treatment, € 225,00
monthly treatment
Special offer $128,00
1 month treatment
Kepivance
T o be used only in the
hospital, reimbursed
€ 36,00
£ 20,00
Reimbursed
$ 150,00 1 week
treatment( $ 1000,00
for a 6 weeks
treatment )
Episil
Soy Phosphatidylcholine
(lecithin) , Glycerol dioleate
It contains ethanol
RX Medical Device
NOT AVAILABLE
CLINICAL TRIALS 1
THE EFFECT OF
PROTECTIVE
GELS ON
MUCOSITIS:
A PILOT STUDY,
UNIVERSITY of
CATANIA, ITALY
60 patients
Two 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
CLINICAL TRIALS RESULTS
Complete healing : % on the nr of patients treated
CLINICAL TRIALS RESULTS
Persistence of signs & symptoms at the end of the treatment
IN VIVO EXPERIMENTAL TRIAL
EFFECTS OF GELX IN
HYDROCHLORIDRIC
ACID –INDUCED
DAMAGE ON MICE
SKIN - DMU,
UNIVERSITY of MILAN,
ITALY
Animal species: white mice
Age : 8 weeks
Nr : 12
Different groups of mice randomly formed
• HCL solution
• HCL solution +GelX placebo
• HCL solution +GelX Oral Gel
• HCL solution + Clobesol
CLINICAL TRIALS 2 - RESULTS
HCL solution
GROUP 1
X
GROUP 2
X
GROUP 3
X
GROUP 4
X
GelX placebo
GelX
Clobesol
X
X
X
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 STUDIES ON GOING
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)
Prevention and Treatment of oral mucositis