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Havana, Cuba

CIGB-300 is a synthetic peptide that inhibits the phosphorylation mediated by enzyme casein kinase 2 (CK2) and has a marked antineoplastic effect in different preclinical models. In the clinical setting, it's explored in phase I and II studies using different routes of administration. In particular, the use of the intravenous route requires a reliable analytical method for the detection of CIGB-300 in plasma. A competitive ELISA was developed to detect and quantify the CIGB-300 peptide in human plasma samples. This system showed a detection limit of 0.030 μg/mL and a working range from 10 to 0.039 μg/mL, including concentrations achieved in plasma of patients treated with CIGB-300. In addition, the intra and inter-assay precisions were (coefficient of variation < 5 %) and (CV < 17 %) and the recovered range from 98.9 to 119.8 %. Finally, the impact of three freeze-thaw cycles and the sample storage at - 80 °C on the stability of the analyte was evaluated. We obtained a CV < 20 % for all samples in the stability study. The results support the application of this analytical method as a new tool for the pharmacokinetic studies of the early stages of clinical research with the new anti cancer drug CIGB-300. Source


Mola E.L.,CIGB | Buxado J.A.,CIGB | Herrera L.,CIGB
Journal of Commercial Biotechnology | Year: 2011

This article deals with repurposing of the epidermal growth factor (EGF) to the treatment of diabetic foot ulcers (DFU) grades III and IV, according to the Wagner scale. The design of a repurposing commercial strategy is described in this document as a contribution to a body of knowledge with high uncertainty and lack of methodology for decision-makers. An analysis of the potential market suggested a significant impact of the product Heberprot-P on costs associated to DFU treatment. Unexpected findings, obtained from a study of the competence, are reported here. The feasibility of a repurposing strategy containing short-, medium- and long-term action plans, without mutual interferences, and adopting strategic intent, strategic assessment and strategic choice as fundamental concepts is demonstrated in this work. © 2011 Macmillan Publishers Ltd. Source


Rosales I.,CIGB | Garcia G.,CIGB
Biotecnologia Aplicada | Year: 2014

CIGB-300 is a synthetic peptide that inhibits the phosphorylation mediated by enzyme casein kinase 2 (CK2) and has a marked antineoplastic effect in different preclinical models. In the clinical setting, it's explored in phase I and II studies using different routes of administration. In particular, the use of the intravenous route requires a reliable analytical method for the detection of CIGB-300 in plasma. A competitive ELISA was developed to detect and quantify the CIGB-300 peptide in human plasma samples. This system showed a detection limit of 0.030 μg/mL and a working range from 10 to 0.039 μg/mL, including concentrations achieved in plasma of patients treated with CIGB-300. In addition, the intra and inter-assay precisions were (coefficient of variation < 5 %) and (CV < 17 %) and the recovered range from 98.9 to 119.8 %. Finally, the impact of three freeze-thaw cycles and the sample storage at - 80 °C on the stability of the analyte was evaluated. We obtained a CV < 20 % for all samples in the stability study. The results support the application of this analytical method as a new tool for the pharmacokinetic studies of the early stages of clinical research with the new anti cancer drug CIGB-300. Source


Camacho H.,Biomedical Research Direction | Fernandez M.E.,Biomedical Research Direction | Guillen I.A.,Biomedical Research Direction | Perez L.,CIGB | And 8 more authors.
Minerva Biotecnologica | Year: 2013

Aim. In order to analyze the potential carcinogenic effect of epidermal growth factor (EGF) on cancer cells, we have studied the effect of EGF in vitro experiments to follow the proliferation of tumor cells lines expressing different levels of Epidermal Growth Factor Receptor (EGFR). Additionally, in these cells, the gene expression profile involved in cancer and EGFR signaling pathways were explored. Methods. We studied the effects of nanomolar concentration (2.2, 33 and 165 nM) of recombinant human EGF (rhEGF) or control, in the proliferation of six human cancer cell lines cultured for 72 hours, stained with trypan blue and counted with a hematocytometer. The real-time PCR technique allowed to study the differential gene expression profile of 44 genes selected from the EGF signaling cascade and cancer pathway. Results. The results showed evidence of the possible correspondence between the levels of EGFR on the cells and the inhibition of cell proliferation. Other factors that could be considered are the genetic background and the concentrations of EGF added to the culture. The analysis of gene expression profile after the cell culture treatment, determined groups of genes co-expressed or co-inhibited between cell lines that over-express EGFR. Conclusion. The most downstream genes of the EGF signal cascade such as CDKN1A and caspases, are the most relevant contributors to cell proliferation and the programmed cell death regulation due to the effect of nanomolar concentration of EGF on cancer cells expressing high levels of EGFR. Source


Berlanga J.,Center for Genetic Engineering and Biotechnology | Fernandez J.I.,National Institute for Angiology and Vascular Surgery | Lopez E.,CIGB | Lopez P.A.,CIGB | And 8 more authors.
MEDICC Review | Year: 2013

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. Source

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