Tag: Heberprot-P

South Korea approves Cuban medicine

In a rare breakthrough into a developed market, the South Korean pharmaceutical regulatory agency approved a Cuban medicine, Cuba’s Center for Genetic Engineering and Biotechnology (CIGB) announced in a tweet.

No further context was immediately available.

According to the CIGB tweet, South Korea’s Ministry of Food and Drug Safety approved Heberprot-P, a biotech product that treats diabetic foot ulcers, for use with Korean patients.

Recombinant human epidermal growth factor-based Heberprot, which was first approved in Cuba in 2006, has been registered in Vietnam, Malaysia, Turkey, Argentina, Colombia, Kuwait, Ukraine, and Russia, among others. An agreement with a U.S. company in 2016 to bring Heberprot-P to clinical testing in the United States seems to have faded … read more

Cuba inaugurates a biotechnological industrial complex

Cuba inaugurated this Monday the CIGB-Mariel Biotechnological Industrial Complex, the first high-tech industry located in the Mariel Special Development Zone (ZEDM), the island’s flagship megaproject for commerce and attracting foreign investment …Among the Cuban drugs that he will produce, he cited the anti-covid vaccine Abdala and the Jusvinza drugs -for the treatment of severe and critical patients with covid-19-, Heberprot P -employed to cure diabetic foot ulcers- and Heberferon, applied to patients with skin cancer, dengue and conjunctivitis … read more

Cuba aims to boost exports at China’s import expo (Heberprot-P)

Cuba plans to put on a big show at the upcoming China International Import Expo (CIIE) in a bid to expand its export market, Vice President of Cuba’s Chamber of Commerce Ruben Ramos told Xinhua in a recent interview … While Cuba plans to tout its traditional strengths at the expo, it also intends to introduce its ground-breaking biotechnology products such as CIMAvax-EGF, a therapeutic vaccine against lung cancer and Heberprot-P, a unique treatment for diabetic foot ulcers.

Heberprot-P to Deliver Effective Treatment Against Amino Acid

Metabolism Disorders; Nestle Health Sciences and Codex Collaboration to Enhance CodeEvolver Enzyme Platform

 

Metabolism is essentially a process that the human body uses to gain energy from food intake. In case of a metabolic disorder, improper food digestion takes place. Amino acids are referred to as building blocks. In case of metabolism disorders, breaking of amino acids becomes difficult that can lead to difficulty in getting them in cells. These complications can lead to generation of harmful substances in the body that can ultimately lead to life threatening or serious health problems. Such disorders are typically inherited, which makes their early diagnosis followed by effective treatment imperative. New-born babies are screened for such disorders via blood tests. According to analysis of Future Market Insights, the global market for amino acid metabolism disorders treatment is expected to grow at a high CAGR during the forecast period, 2017-2026 … read more

 

 

Treatment of Diabetic Foot Ulcers

Diabetic wound is the most common cause of non-traumatic
lower extremity amputation, and response to traditional
interventions is poor in many patients. The lifetime risk of
developing an ulcer among diabetics is 25%, and recurrent
wounds are common after healing. Stigmatization, social
isolation, unemployment, and depression are some of the
negative consequence of Diabetic Foot Ulcer (DFU) on the
quality of life of diabetics. DFU adds a substantial economic
burden to afflicted patients and health systems, primarily
attributable to frequent hospitalization, medication, surgical
procedures, amputation, prosthesis, rehabilitation, and loss of
productivity … read more

Heberprot-P: a novel product for treating advanced diabetic foot ulcer

Diabetic foot ulcer is a principal diabetic complication. It has been shown that diabetic patients have decreased growth factor concentrations in their tissues, particularly epidermal growth factor. Growth factor shortage impairs wound healing, which leads to chronic nonhealing wounds and sometimes eventual amputation. Ischemic diabetic foot ulcer is the most difficult to treat and confers the highest amputation risk. Injecting epidermal growth factor deep into the wound bottom and contours encourages a more effective pharmacodynamic response in terms of granulation tissue growth and wound closure. Epidermal growth factor injected into the ulcer matrix may also result in association with extracellular matrix proteins, thus enhancing cell proliferation and migration. Heberprot-P is an innovative Cuban product containing recombinant human epidermal growth factor for peri- and intra-lesional infiltration; evidence reveals it accelerates healing of deep and complex ulcers, both ischemic and neuropathic, and reduces diabetes-related amputations. Clinical trials of Heberprot-P in patients with diabetic foot ulcers have shown that repeated local infiltration of this product can enhance healing of chronic wounds safely and efficaciously. As a result, Heberprot-P was registered in Cuba in 2006, and in 2007 was included in the National Basic Medications List and approved for marketing. It has been registered in 15 other countries, enabling treatment of more than 100,000 patients. Heberprot-P is a unique therapy for the most complicated and recalcitrant chronic wounds usually associated with high amputation risk. Local injection in complex diabetic wounds has demonstrated a favorable risk-benefit ratio by speeding healing, reducing recurrences and attenuating amputation risk. Further testing and deployment worldwide of Heberprot-P would provide an opportunity to assess the product’s potential to address an important unmet medical need.

Article from PubMed

Approval for commercialization of Heberprot-P® in Mexico

Havana, Cuba, May 4, 2018 – Heberprot-P® has been approved for commercialization in México. The Center for Genetic Engineering and Biotechnology (CIGB) is excited to announce regulatory approval of this innovative medicine indicated for advanced diabetic foot ulcer (DFU), which is expected to save thousands of people from lower limb amputation. The official approval date of Heberprot-P® was April 30th, 2018. Heberprot-P® stimulates granulation, accelerates DFU re-epithelization, and reduces healing time, surgical debridement, amputation risk, and recurrences. The intralesional infiltration of Heberprot-P® may be applied in combination with Good Wound Care (GWC), revascularization, and antibiotics. This medicine is an effective solution for an unmet medical need, a first in class product, unique worldwide, for DFU treatment. It is the only therapeutic choice available for advanced and complex DFU, reluctant to healing (grades 3, 4, and 5, according to Wagner’s classification).

 

Clinical experience derived from the intervention with Heberprot-P® in daily medical practice in Cuba was analyzed in 2013 in a study that reviewed the evolution of more than 2 000 patients as well as the pharmacovigilance of 1 788 patients, showing a 75% probability of granulation response, 61% healing rate, 71% amputation risk reduction, Bayes’ favorable factor (5.40), and complete granulation in 76% of ulcers in 5 weeks (Adv. Pharmacoepidem. 2013, 2 (2): 1000128; BMC Pharm. & Toxicol, 2013, 14: 44). The International Working Group of Diabetic Foot (IWGDF) evaluated results of the clinical trial performed with Heberprot-P® in Cuba and reported in 2009 as promising, highlighting the results obtained in only 2 weeks of treatment (Diabetes Metab Res Rev 2012; 28 (Suppl 1): 119-141).

 

In a later systematic review, clinical trials comparing the use of growth factors with GWC (Cochrane Database of Systematic Reviews 2015, Issue 10, Art. No. CD008548), the IWGDF’s evaluation was reported on all major issues and requirements of Heberprot-P® clinical trials in Cuba. Similar criteria were expressed by the IWGDF in the guidelines on DFU healing (IWGDF Guidance, 2015: 10). A fourth study reported similar observations on the intralesional EGF infiltration method: “… a highly significant difference between groups in the prevalence of granulation tissue after just 2 weeks” (Diabetes Metab Res Rev 2016; 32 (Suppl 1): 154- 168).

 

Results of clinical studies performed in Cuba, Russia, Turkey, Vietnam, Argentina, Mexico, and Ukraine were enough to demonstrate safety and efficacy profile of Heberprot-P®. This medicine has been used in more than 290 000 patients with diabetic foot ulcer (DFU) in Russia, Belarus, Georgia, Ukraine, Turkey, Algeria, China, Panama, Argentina, Cuba, Dominican Republic, Venezuela, Ecuador, Libya, Uruguay, Paraguay, Colombia, Guatemala, Philippines, Vietnam, Nicaragua, Saudi Arabia, Indonesia, Seychelles, Saint Lucia, Saint Vicente, Sri Lanka, Jordan, and Kuwait.

 

A national survey of health and nutrition in Mexico reported that prevalence of diabetes is 9.4% of total population, which sums up more than 11 million people, 9.1% of adult diabetic suffers DFU, and amputation is indicated to 5.5% of adult diabetics (National Survey of Health and Nutrition, INEGI 2016). According to recent reports, lower limb amputation is the unique alternative for 45% of diabetics with advanced DFU in Mexico (Diabet. Foot. Ankle. 2017 Sep 6, 8 (1): 1367210). In a previous study, similar results were reported: 42% patients with advanced DFU required major amputation (Wound Repair & Regen. 24 (5): 923-927).
Written by Jose A. Buxado, MSc., Assistant Researcher, CIGB.

 

The Center for Genetic Engineering and Biotechnology of Havana is an institution devoted to research, development, manufacturing, and commercialization of products and technology derived from life science.

 

Alyane Vazquez González, BA., Communication & Media, e-mail: alyane.vazquez@cigb.edu.cu
. Ave 31 e/ 158 y 190, Playa, P.O. Box 6162, Habana 10600, Cuba.

 

This release was published on openPR.