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Investigation of Gelclair® Bioadherent Oral Gel: Novel Analyses and a Proposed Study on Oral Mucositis Development and Management in Comparison to Magic Mouthwash
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Investigation of Gelclair® Bioadherent Oral Gel: Novel Analyses and a Proposed Study on Oral Mucositis Development and Management in Comparison to Magic Mouthwash/Standard of Care

Mark S Chambers,1 Kate Ciarrocca,2 Mary Kay Delmedico,3 Andrea True Kelly3
1MD Anderson Cancer Center, 2Augusta University, 3Midatech Pharma US Inc.

ABSTRACT:

Significance and Background: Oral Mucositis (OM) is a debilitating side-effect of chemo/radio-therapy occurring in most patients receiving myeloablative (MA) conditioning prior to stem cell transplantation (SCT). Severe OM may result in opiate use, total parenteral nutrition (TPN), secondary infections, decreased QoL and reduction/interruption of therapy, ultimately compromising outcomes and increasing costs. Magic mouthwash (MMW) is frequently utilized for OM despite recommendations against by professional organizations due to limited efficacy and adverse effects including dysgeusia, numbness, burning, or aspiration. Gelclair® (GEL) is a well-tolerated, alcohol-free, bioadherent, oral/topical gel containing polyvinylpyrrolidone, sodium-hyaluronate and glycyrrhetinic acid (from licorice root), broadly indicated for the management of oral lesions, including OM. Promising results on duration and level of pain control and reduced analgesic use, incidence of OM and infection have been reported with GEL use in cancer patients prior to lesion development. Additional trials that minimize bias with a relevant active relevant comparator could be helpful to support these positive findings.

Purpose: To determine the impact of GEL or MMW treatment on OM in SCT recipients receiving MA conditioning, when initiated during conditioning or after OM is noted, in patients following a standardized oral care protocol in a blinded, randomized, controlled trial.

Interventions: Subjects will be randomized (1:1:1) to initiate GEL for 28d on conditioning day 1 or after G1 or 2 OM is diagnosed (WHO scale) within 14d of conditioning vs. MMW.

Evaluation: Daily assessments by a blinded clinician will occur and the incidence, time to onset, duration of any or severe OM (G3 or 4), overall mouth/throat pain, duration of effect, healthcare resources and subject burden associated with OM (e.g., # treatments/day, opiate use, TPN, infection, impact on ADL, etc.) will be determined. New hypothesis-generating analyses of existing datasets will also be presented showing that in patients with chemo/rad-induced OM, by 3 and 5hr post-treatment, only 10% and 35% of GEL patients required a 2nd dose vs. 27% and 58% of MMW patients (p=0.037 or 0.034), respectively, suggesting that GEL may control pain longer than MMW. 

Discussion/Innovation: The randomized/blinded study under development at leading US cancer centers will address the impact of GEL on the incidence and severity of OM and related symptoms, complications and costs in SCT recipients receiving MA conditioning relative to MMW.

BACKGROUND AND RATIONALE:
• SCT patients receiving MA pre-transplant conditioning regimens are at significant risk for developing severe OM.1 Severe OM can be associated with significantly poorer QoL and functional status, as well as with use of heavy opiate analgesics for pain control2
• Mixed medication mouthwashes (eg, MMW) are not recommended for management of OM because of tolerability issues or lack of
consistent efficacy3,4
• Despite this, MMW containing diphenhydramine, viscous lidocaine, and aluminum/magnesium hydroxide is one of the most commonly  prescribed agents for OM

Rationale for proposed comparative GEL study:
• GEL is an alcohol-free, bioadherent, oral/topical gel containing polyvinylpyrrolidone, sodium hyaluronate, and glycyrrhetinic acid
(from licorice root) (see Figure 1 for mechanism of action)

• GEL has been shown to be effective in managing pain and other OM-related symptoms in numerous small studies5-8
• Significantly fewer patients with CT-/RT-induced OM required additional treatments with GEL compared with MMW, based on additional analysis of data from a multicenter, randomized, controlled study9 (see Figure 2)
• GEL treatment initiated at the start of multiday CT/RT in a smaller study:
— Reduced percentage of patients who experienced oral pain and required opiate analgesics10,11 (see Figure 3)
—Led to improved patient compliance, increased QoL, and significantly reduced pain symptoms and rates of infection10

• Given these findings, a randomized, stratified, 3-arm, blinded, well-controlled study is being initiated to investigate:
— The use of GEL for the management of OM compared with MMW/SOC when initiated at time of pre-transplant conditioning
— The efficacy and tolerability of GEL vs MMW in the management of OM after the diagnosis of G1 or G2 OM
Patient population and number of patients planned:
• Up to 60 patients being conditioned with multiday MA CT/RT regimens prior to SCT will be randomized via a stratified allocation scheme in a 1:1:1 ratio to 3 treatment arms (see Figure 4 for study design details)

CONCLUSIONS:
• Based on a new analysis of a multicenter, randomized, controlled study, GEL significantly reduced the percentage of CT/RT patients requiring additional treatments for the management of OM-related symptoms at 3 hours and 5 hours post-treatment compared with MMW

— These data suggest that GEL controls OM-related symptoms longer than MMW does
• Positive data with GEL in smaller studies suggest that initiating treatment at the time of mucosal insult (ie, at initiation of CT/RT) has benefit to patients
• A randomized, blinded, well-controlled study is needed to address:
— The ideal time to initiate GEL treatment in patients receiving multiday MA conditioning prior to SCT
— The efficacy and tolerability of GEL for the management of OM in comparison with MMW when initiated early after OM diagnosis

CONTACT INFORMATION AND CITATIONS:
If you have questions or would like more information, please email MedicalAffairs@MidatechPharmaUS.com.

1. Wardley AM, Jayson GC, Swindell R, et al. Br J Haematol. 2000;110:292-299. 2. Lalla RV, Sonis ST, Peterson DE. Dent Clin
North Am. 2008;52(1):61–77,viii. 3. AAN: American Academy of Nursing. Choosing Wisely: Ten Things Nurses and Patients Should
Question. Released October 16, 2014 (items 1–5), Released April 23, 2015 (items 6–10). 4. ONS: Oncology Nursing Society. Putting
Evidence Into Practice (PEP) guidelines. https://www.ons.org/intervention/magic-mouthwash-mixed-medication-mouthwash. Accessed
February 28, 2017. 5. D’Andrea N, Giorgiutti E, De Corti D, Piga A. Ann Oncol. 2003;14(suppl 4):iv97. 6. Innocenti M, Moscatelli G,
Lopez S. J Pain Symptom Manage. 2002;24(5):456-457. 7. Bonassi L, Cotroneo G, Nastasi G. Treatment with Gelclair in patients
suffering grade III-IV oral mucositis: efficacy and impact on quality of life (QOL). In: Annals of Oncol. 2003;14(suppl 4):iv58. 8. McLean M.
An audit of the efficacy of Gelclair® for mouth pain in patients undergoing radiotherapy or chemotherapy. Poster presented at: British
Association of Head and Neck Oncology Nurses National Study Day on Sharing Good Practice in Head and Neck Cancer Nursing;
June 12, 2009; Leeds, United Kingdom. 9. McKenzie M et al. Support Care in Cancer. 2006;14(6):641. 10. Wildfang I, Tschechne B,
Borghardt J, et al. J Clin Oncol 28, 2010 (suppl; abstr e19613). 11. Pomper L, Ostojic´ A, Ruža J, et al. Poster presented at 27th EBMT
Meeting; April 3-6, 2011; Paris, France.

Disclosure: Kate Ciarrocca is a paid consultant for Midatech Pharma US Inc.

GELCLAIR® is a registered trademark of Helsinn Healthcare SA, Switzerland
Marketed and distributed in the US by: Midatech Pharma US Inc. Raleigh, NC info@midatechpharmaus.com
Distributed under license of Helsinn Healthcare SA, Switzerland

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