Frequently Asked Questions

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¿What is the starting point of Heberprot-P’s action?

The product’s action starts with its direct interaction with a highly specific receptor protein which is present in cell of most epithelial and mesenchymal tissues as demonstrated from the 60s. The expression of the gen coding for this receptor starts from very early stages of embryo development, and its critical importance for morphogenesis and functional maturation of most epithelial organs with laminar or glandular shapes has been demonstrated in Knock out animal models. The receptor is known as c-erb1 or HER-1. The interaction takes place on the extracellular domain such as a ligand simultaneously activates two receptor molecules. The receptor activity depends on the carboxyl-terminal domain with Tyrosine Kinase activity in terms of Early Response Genes (ERG) activation, and critical transduction pathways for cell division and cytoprotection.  This also increases the phosphorylation level of an isoform of the OKC that function as reverse modulator of a negative FEEDBACK.

                                                                                                                                                                                                                                                                                                                                                             

How much time takes the Heberprot-P’s action?

Every action performed by EGF depends on the phosphorylation of the TYROSINE KINASE domain of the receptor stationarily exposed. The reaction time of the Tyrosine phosphorylation process is lower than 1 minute in vitro. In most studied cell lines, the process starts to turn off after 30 minutes. However, while this takes place, there is a wide range of transduction and accessory proteins in the cytoplasm that have just been phosphorylated, and activated, which equally takes place in Transcription Factors. It is not easy to establish a time frame for these actions, because they depend on many biological phenomena. However, investigations using pharmacokinetic and pharmacodynamics modelling in murine models with acute and controlled wounds have shown, since 1985, that fibroblast proliferation demands receptor activation during hours.

What is the difference between the Hebermin and Heberprot-P?

Hebermin is a semisolid composition for topical use containing silver sulfadiazine with antibacterial effect, particularly for the control of Pseudomona sepsis in local burn wound. It is prescribed for partial or total thickness injury of particularly acute course. The EGF in this topical form is exposed to degradation by wound’s proteases and bacteria. In the case of Heberprot-P, its deposit has been conceived in deeper levels of chronic injuries, atonic, and active "Bio-Film" as in wound of diabetic patients for facilitating tissue regeneration and angiogenesis.
 
What is the current status of approval for commercialization of Heberprot-P outside Cuba?

To date it has been approved for commercialization in Algeria, Argentina, Azerbaijan, Brazil, China, Colombia, European Union, Arabian Gulf and Middle East, Indonesia, Mexico, Ecuador, Panama, Russia, South Africa, South Korea, Turkey, Uruguay and Venezuela.

Growth factors and carcinogenesis. Particularity of the EGF present in Heberprot-P with respect to other EGF present in the human body.

The EGF present in Heberprot-P is the same molecule as that present in the human body. There is a report of PDGF growth factor (platelet-derived growth factor), which is a product that was approved by FDA in the late 90s, and now has a warning for being in pharmacovigilance product, increased cancer mortality in any location in the patients treated. It was prescribed for patients with diabetic foot grade 1 and 2, according to Wagner’s clasification, with sized lower than 10 cm2. In the case of EGF, no such relationship has been demonstrated. a strict pharmacosurveillance is being performed in this direction.
 
What organs metabolize Heberprot-P?

The EGF, as active pharmaceutical ingredient of Heberprot-P, is a peptide which is degraded by protease in body fluids. The main route of elimination is the kidney.
 
After studies with rats in 1994 (remyelination), Why was made the decision of treating diabetic foot ulcers, and not nerve degeneration diseases?
The animal model used in 1994 was a model of acute trauma. From the physiological point of view, this is not comparable with neurodegenerative diseases in which usually the cause persists and etiopathogenic degeneration in axons occurs. However, investigations are currently performed at CIGB using animal models of peripheral and central neurodegenerative processes, and combinations of EGF and other peptides.

Toxic dose. How much Heberprot-P can be used in a patient?
 
The product exhibits an acceptable safety profile for use in humans by parenteral route. The highest dose that was used was that of 75 µg and the results so far have been good for the proposed prescription. There is no need for increasing the dose above this level, at which the product is tolerable, and no serious adverse events associated with the active ingredient have been reported.
 
What are the main adverse events found in clinical trials? Are there reports in peer-review publications and presentations?

The most common clinical adverse events reported with the use of Heberprot-P are local infection, burning sensation, pain at the administration site, shivering, chills and fever. The frequency of major adverse events is shown in the following table, which are also referred to in publications and presentations on the product:

Adverse event

Dose75 mg

Dose 25 mg

Total

N

108

173

281

Local infection

16 (14,8%)

16 (9,2%)

32 (11,4%)

Burning sensation

27 (25,0%)

22 (12,7%)

49 (17,4%)

Pain at the administration site

18 (16,7 %)

48 (27,7%)

66 (23,5%)

Shivering

33 (30,6%)

16 (9,2%)

49 (17,4%)

Chills

25 (23,1 %)

13 (7,6%)

38 (13,5%)

Fever

6 (5,6%)

15 (8,7%)

21 (7,4%)

 

What is the action pathway of Heberprot-P?
 
For chronic and complex wounds such as diabetic: (1) Rescue stunned cells, usually fibroblasts, (2) Induction of Fibroblast proliferation, Mio-Fibroblasts, and vascular precursors (NOVO angiogenesis), (3) cell migration, (4) Activation of genes for extracellular matrix synthesis, and (4) acceleration of alpha-SMA synthesis in mio-fibroblasts.
 
What is the Heberprot-P ratio that enters the bloodstream and is not removed?

At present, there is a result which demonstrates the amount of EGF that is absorbed by the body after administration of the product, being in the order of picograms. The half-life is extremely short, and the product is eliminated by the kidney in an hour and a half. The presence of endogenous EGF and its possible increasing, derived from the handling after the cure or injection of the product, was found in values collected during the first application, and in patients who were exposed to a single placebo dose.

What are the routes of Heberprot-P elimination?

The kidney is the primary route of disposal.

When stopping treatment after having good response?
Results of clinical studies have shown that patients with neuropathic or neuro-infectious component exhibit an important relationship between the 100% granulation and lesion healing time. This relationship can be seen much better in patients exposed to the dose of 75 µg, so that its continuity could cause a supergranulation. However, the opposite happens in ischemic patients which results indicate that the treatment should continue until healing because relapses and amputations are frequent even after effective granulation.

How is the treatment of adverse reactions?

Treatment of adverse reactions that until the date when these questions were answered have not been neither so serious nor severe for permanent discontinuation of the treatment, unless a decision has been made by the patient, they can be assumed as preventive and curative. Thus, pain at the site of administration and burning sensation, wound infections, so prevalent and dangerous for these cases, may be considered in this regard.

 

In case of obvious infection, when treatment is not prescribed?

The treatment is not contraindicated in case of obvious infection: it is suspended until the infection problem has been solved, and the treatment is restarted again.

What are the main complementary studies to be performed before the treatment with Heberprot-P?

Due to the large deterioration found in most of these patients with impact in different organs and the need to cover the safety profile of the product, it is recommended:
-Interrogation, insisting on family history of present illness, death or cancer.
-Complete physical exam, but respiratory, breast exam, abdomen and genitourinary pelvic examination in women (Pap smear last date of conduct and outcome of it), and DRE in men are crucially important.
-Complementary: Haemoglobin, erythrocyte sedimentation rate, white blood cell count, transaminase (SGPT), Glucose, etc.

When patients may receive ambulatory treatment with Heberprot-P?

-As long as you meet the conditions both at home or health area, where it is preferred to apply the product.
-They are not complicated with local infections.
-Having a good metabolic control.

Can be associated Heberprot-P with other topical medications?

No, because it would result in the interference of the vehicle of the same topical product or active ingredient that may influence on the effect of EGF. This could secondarily activate response proteins including proteases that could degrade EGF.

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