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