Periodic Reporting for period 1 - Murnia (Prevention of Radiotherapy and Chemotherapy Induced Oromucosal Wounds Using an Oral Application Gel: Murnia® Mouth Gel)
Période du rapport: 2023-07-01 au 2024-06-30
Cancer treatment, particularly through chemotherapy and radiotherapy, often results in a painful and debilitating side effect known as oral mucositis (OM). This condition is characterized by severe ulcerations and inflammation in the oral cavity, significantly impacting the quality of life of patients. OM not only causes intense pain but also hinders essential daily functions such as eating and speaking, leading to nutritional deficiencies and potentially necessitating interruptions in cancer therapy. These interruptions can reduce the effectiveness of cancer treatment and prolong recovery times.
Current treatments for OM are limited and primarily focus on managing symptoms rather than preventing the condition or addressing its underlying causes. This leaves a critical unmet need for more effective and preventive solutions.
Umayana has developed a proprietary preventative and curative formulation to combat OM in cancer patients. The patented compositions are enriched in terpenes comprising furanoeudesma, lindestrene and curzerene, and polysaccharides comprise ribofuranose, arabinopyranose, ribopyranose, uronic acid, mannopyranose, allofuronase, galacturonic acid, galactopyranose and allopyranose have increased mucoadhesiveness properties and may be formulated as solutions, drinks, food products, gels, creams, ointments, or toothpaste, for the treatment and prevention of oral mucositis, mucosal inflammations of the gastrointestinal tract, canker sores, dental mouth lining ulcers, Behcet disease, topical inflammations, and for acute or chronic wound healing. Global Patent: WO2020072987 USA Patent: 11331360 (B2). Murnia Mouth Gel includes a proprietary molecular compound.
Within Umayana Women TechEU project we aimed:
• To test and setup Murnia Pilot: To undertake in-house testing and large-scale demonstrations under real operating conditions and identify the technical maturation activities to be implemented in the next phase of the project.
• To Implement the right tools and developing the most appropriate strategy for Murnia gel scale-up. As a result, a staged development process to manage risk, schedule, and cost by providing straightforward, manageable tasks and outputs.
• To manufacture the gel in more significant amounts to build reliable, efficient, and quality production capacity. Addressing the challenges for production scale-up concerning product concept, process flow analysis, capacity study, mapping capacity to flow, defining equipment, adjusting product costs, and detailing investment vs return.
• Perform a market analysis to identify the EU countries that will mainly be the early adopters of Murnia.
• To map the supply and distribution chain, identifying and choosing upstream suppliers.
• To carry out a full market research study of the market, to assess user needs, demand and market size to ensure a swift market uptake.
• To formulate an exploitation and dissemination plan and to establish an optimal go-to market strategy.
• To carry out a full cost/benefit analysis, considering quality, standards and regulatory issues.
• To evaluate the total investment requirements to bring the product to the market.
Current treatments for OM are limited and primarily focus on managing symptoms rather than preventing the condition or addressing its underlying causes. This leaves a critical unmet need for more effective and preventive solutions.
Umayana has developed a proprietary preventative and curative formulation to combat OM in cancer patients. The patented compositions are enriched in terpenes comprising furanoeudesma, lindestrene and curzerene, and polysaccharides comprise ribofuranose, arabinopyranose, ribopyranose, uronic acid, mannopyranose, allofuronase, galacturonic acid, galactopyranose and allopyranose have increased mucoadhesiveness properties and may be formulated as solutions, drinks, food products, gels, creams, ointments, or toothpaste, for the treatment and prevention of oral mucositis, mucosal inflammations of the gastrointestinal tract, canker sores, dental mouth lining ulcers, Behcet disease, topical inflammations, and for acute or chronic wound healing. Global Patent: WO2020072987 USA Patent: 11331360 (B2). Murnia Mouth Gel includes a proprietary molecular compound.
Within Umayana Women TechEU project we aimed:
• To test and setup Murnia Pilot: To undertake in-house testing and large-scale demonstrations under real operating conditions and identify the technical maturation activities to be implemented in the next phase of the project.
• To Implement the right tools and developing the most appropriate strategy for Murnia gel scale-up. As a result, a staged development process to manage risk, schedule, and cost by providing straightforward, manageable tasks and outputs.
• To manufacture the gel in more significant amounts to build reliable, efficient, and quality production capacity. Addressing the challenges for production scale-up concerning product concept, process flow analysis, capacity study, mapping capacity to flow, defining equipment, adjusting product costs, and detailing investment vs return.
• Perform a market analysis to identify the EU countries that will mainly be the early adopters of Murnia.
• To map the supply and distribution chain, identifying and choosing upstream suppliers.
• To carry out a full market research study of the market, to assess user needs, demand and market size to ensure a swift market uptake.
• To formulate an exploitation and dissemination plan and to establish an optimal go-to market strategy.
• To carry out a full cost/benefit analysis, considering quality, standards and regulatory issues.
• To evaluate the total investment requirements to bring the product to the market.
We have performed the following:
- Formulation of Murnia® Mouth Gel: Developed a proprietary gel formulation designed to prevent and treat oral mucositis (OM) in cancer patients. The formulation includes a unique blend of terpenes and polysaccharides with mucoadhesive properties, enhancing its ability to adhere to the oral mucosa and protect against damage caused by reactive oxygen species (ROS).
- Conducted comprehensive biocompatibility testing to ensure the gel's safety for use in mucosal and skin applications. This testing confirmed that Murnia® Mouth Gel is non-cytotoxic, non-irritating, and safe for patients.
- Undertook a thorough regulatory analysis and obtained necessary approvals for Murnia® Mouth Gel, including registration for distribution in pharmacies across Türkiye. This step was crucial in ensuring the product's compliance with medical device regulations and standards.
- Established agreements with Capa Medikal, a major pharmaceutical distributor in Türkiye, and Honnes, a contract manufacturing partner. These partnerships ensured the efficient production and distribution of Murnia® Mouth Gel.
- Formulation of Murnia® Mouth Gel: Developed a proprietary gel formulation designed to prevent and treat oral mucositis (OM) in cancer patients. The formulation includes a unique blend of terpenes and polysaccharides with mucoadhesive properties, enhancing its ability to adhere to the oral mucosa and protect against damage caused by reactive oxygen species (ROS).
- Conducted comprehensive biocompatibility testing to ensure the gel's safety for use in mucosal and skin applications. This testing confirmed that Murnia® Mouth Gel is non-cytotoxic, non-irritating, and safe for patients.
- Undertook a thorough regulatory analysis and obtained necessary approvals for Murnia® Mouth Gel, including registration for distribution in pharmacies across Türkiye. This step was crucial in ensuring the product's compliance with medical device regulations and standards.
- Established agreements with Capa Medikal, a major pharmaceutical distributor in Türkiye, and Honnes, a contract manufacturing partner. These partnerships ensured the efficient production and distribution of Murnia® Mouth Gel.
We have successfully advanced the TRL of Murnia® Mouth Gel from 5-6 to 8-9, indicating the product's readiness for commercialization and market entry following successful development and validation. We have launched Murnia® Mouth Gel and two additional products, Murnia Recovery Gel-A, and Murnia Barrier Cream, expanding the product line and enhancing market presence.