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Heberprot-P: A product to enhance diabetic ulcers healing and reduce amputation rate |
Therapeutic area |
Diabetes - wound healing |
Goal |
To develop an injectable formulation for local administration by intralesional route to treat and cure diabetic foot ulcers (DFU). |
Description |
The diabetic foot ulcer is one of the most serious complications of diabetes. Chronic foot ulceration is a major source of morbidity and mortality in diabetic patients. Despite traditional comprehensive wound management, including debridement, appropriate antibiotics and vascular reconstruction, a large number of diabetic patients with chronic ulcers bear non-responding wounds, frequently resulting in lower-limb amputation with considerable healthcare costs and significant loss of quality of life. Scientists at the CIGB have developed a product based on rechEGF, which is supported by a PCT patent application of use for a pharmaceutical composition containing epidermal growth factor (EGF) in an injectable formulation, which is administered by means of infiltration for diabetic foot amputation prevention, which is an unmet medical need. Previous preclinical evidences showing efficacy in the neurogenic ischemia and protection of peripheral tissue have been demonstrated. On the rationale that EGF can enhance healing of chronic wounds following repeated local infiltrations, a compassion study in 29 type-II diabetic patients with clinical macro and/or micro-angiophathy, destined to no other choices than amputation including patients with ischemic and neuropathic ulcer was carried out in Cuba. Results showed that 58% of all the patients were completely healed and they preserved their limbs (Int. Wound J. 2006, 3 (3): 232-239.). Also, a randomized doubled-blind phase I-II clinical trial (CT) in 41 patients was conducted in Cuba in 2003-2005, evaluating two levels of dose (25 and 75 g, with more than 80% of efficacy of limb preservation in the treatment stage) (Int. Wound Journal. Dec.4 (4):326-327).
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Patent Status |
Use of a novel formulation and a method to prevent limb amputations due to DFU. Filed in: Argentina, Brazil, Canada, US, EPO, Indonesia, Japan, Malaysia, Mexico, Thailand and Chile. Issued in: Australia, China, Cuba, Hong Kong, India, Russia, Singapore, South Africa, South Korea and Ukraine. |
Project Status |
National extension: Cuban patients treated to date: >500.
- Controlled treatment Nº 1: 12
- Controlled treatment Nº 2: 113
- Clinical trial phase III: 139 + 26 under evaluation: 165
- National extension: 162 new cases since July 2007.
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Type of collaboration requested |
Out-licensing of the product to treat and cure end-stage diabetic patients with advanced foot ulcers, which remains an unmet medical need for particular territories (Japan, Australia, Singapore, the Arabic-Persian Gulf and Chile).
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Competitives advantages Milestones |
• Treatment with this formulation is effective in end-stage diabetic foot ulcers sized from 1-80 cm2, where the amputation is the only available choice.
• The formulation can be used in neuropathic and ischemic foot ulcer.
• This infiltration therapy has prevented ulcer local recurrence for more than 3 years.
• The formulation can enhance healing of chronic wounds following repeated local infiltrations. Wounds healed by re-epithelization over a productive neo-vascularized and contractile granulation tissue.
• Adverse effects or untoward reactions are rare along the formulation treatments.
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Host Insitutions |
Center for Genetic Engineering and Biotechnology (CIGB). Ave 31, e/158 y 190 Cubanacán, Playa. PO Box 6996, La Habana, 10600, Cuba. Tel. (53-7) 2712397; 2716022. Fax. (53-7) 2736008; 2718070. E-mail: ernesto.lopez@cigb.edu.cu
Web site: http://gndp.cigb.edu.cu
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Project code:
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BIO/CIGB/2008-12
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