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Abstract Background Cervical cancer is now considered the second leading cause of death among women worldwide, and its incidence has reached alarming levels, especially in developing countries. Similarly, high grade squamous intraepithelial lesion (HSIL), the precursor stage for cervical cancer, represents a growing health problem among younger women as the HSIL management regimes that have been developed are not fully effective. From the etiological point of view, the presence of Human Papillomavirus (HPV) has been demonstrated to play a crucial role for developing cervical malignancies, and viral DNA has been detected in 99.7% of cervical tumors at the later stages. CIGB-300 is a novel cyclic synthetic peptide that induces apoptosis in malignant cells and elicits antitumor activity in cancer animal models. CIGB-300 impairs the Casein Kinase (CK2) phosphorylation, by targeting the substrate's phosphoaceptor domain. Based on the perspectives of CIGB-300 to treat cancer, this "first-in-human" study investigated its safety and tolerability in patients with cervical malignancies. Methods Thirty-one women with colposcopically and histologically diagnosed microinvasive or pre-invasive cervical cancer were enrolled in a dose escalating study. CIGB-300 was administered sequentially at 14, 70, 245 and 490 mg by intralesional injections during 5 consecutive days to groups of 7 – 10 patients. Toxicity was monitored daily until fifteen days after the end of treatment, when patients underwent conization. Digital colposcopy, histology, and HPV status were also evaluated. Results No maximum-tolerated dose or dose-limiting toxicity was achieved. The most frequent local events were pain, bleeding, hematoma and erythema at the injection site. The systemic adverse events were rash, facial edema, itching, hot flashes, and localized cramps. 75% of the patients experienced a significant lesion reduction at colposcopy and 19% exhibited full histological regression. HPV DNA was negative in 48% of the previously positive patients. Long term follow-up did not reveal recurrences or adverse events. Conclusion CIGB 300 was safe and well tolerated. This is the first clinical trial where a drug has been used to target the CK2 phosphoaceptor domain providing an early proof-of-principle of a possible clinical benefit.

Novel therapeutic peptides are increasingly making their way into clinical application. The cationic and amphipathic properties of certain peptides allow them to cross biological membranes in a non-disruptive way without apparent toxicity increasing drug bioavailability. By modifying the primary structure of the Limulus-derived LALF32-51 peptide we designed a novel peptide, L-2, with antineoplastic effect and cell-penetrating capacity. Interestingly, L-2 induced cellular cytotoxicity in a variety of tumor cell lines and systemic injection into immunocompetent and nude mice bearing established solid tumor, resulted in substantial regression of the tumor mass and apoptosis. To isolate the gene transcripts specifically regulated by L-2 in tumor cells, we conducted suppressive subtractive hybridization (SSH) analysis and identified a set of genes involved in biological processes relevant to cancer biology. Our findings describe a novel peptide that modifies the gene expression of the tumor cells and exhibits antitumor effect in vivo, indicating that peptide L-2 is a potential candidate for anticancer therapy. Copyright © 2009 European Peptide Society and John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

The article reports the development, validation, and registration of an anti-transglutaminase system called HerberFast Line. The focus of the article is the contribution the system is making to the diagnosis of Celiac disease (CD) in patients in Cuba. Topics include an overview of CD, which is a common enteropathy in human beings resulting from food intolerance, and an example of how the HeberFast Line anti-transglutaminase system functions. The system's clinical sensitivity and specificity in the areas of immunochromatographic assay, ELISA, and indirect immunofluorescence are also discussed. A brief analysis of CD prevalence studies in risk groups such as patients with giardiasis and patients with type 1 diabetes is presented.

El artículo enfoca en el sistema de diagnóstico HeberFast Line antitransglutaminasa para la detección de anticuerpos de clase IgA e IgG relacionados con la enfermedad celíaca (EC). Se describe la sensibilidad y especificidad clínica en ensayos inmunocromatológicos, de ELISA y de inmunofluorescencia indirecta. Se ofrece además un breve análisis de la prevalencia de EC en grupos de riesgo como pacientes con giardiasis y aquellos con Diabetes tipo 1.

The emergence and expansion of biotechnology in Cuba as a new branch of the economy provide a good example of the challenges faced by a high-technology sector which deserves analysis. There are already clearly visible results in this sector such as investment in the research and production infrastructure, a qualified workforce, high-quality research and good product pipelines in the Cuban health system coupled with a growing export capacity, supporting a positive cash flow. These advances have been aided by the integration of research-production organisations, state funding, social ownership, export orientation and the comprehensive integration of the Cuban biotechnology multi-institutional system. In the forthcoming years, the future development of this sector in Cuba should produce a more evident impact on the economy and Cuban society. [ABSTRACT FROM AUTHOR]

CIGB-247 is a novel cancer therapeutic vaccine that uses a mutated form of human vascular endothelial growth factor (VEGF) as antigen in combination with the oil-free adjuvant VSSP (very small sized proteoliposomes of Neisseria meningitidis outer membrane). The vaccine was designed to affect tumor neo-vascularization and tumor cell viability by eliciting antibodies that block the interaction of VEGF and its receptors in activated endothelial cells, as well as specific cytotoxic T cells that can directly destroy tumor and tumor stroma cells producing VEGF. Our previous experimental studies with CIGB-247 in mice, in which VEGF shares an 87% homology to the human molecule, have shown that the vaccine has anti-tumoral and anti-metastatic activity, and produces anti-VEGF antibodies and a specific T cell cytotoxic response against tumor cells. Herein we extend the immunogenicity and safety studies of CIGB-247 in mice, rats, rabbits and non-human primates. All the species develop antigen-specific IgG antibodies able to block the interaction of VEGF and VEGF receptor 2 in an ELISA assay. Purified IgG from CIGB-247 immunized monkey sera effectively impair human microvascular endothelial cells' proliferation and capillary-like structures formation in Matrigel™. In monkeys and mice, DTH and direct cell cytotoxicity experiments suggest that specific T cell responses are elicited after vaccination. Immunization with CIGB-247 does not affect animal behavior, hematology counts, blood biochemistry or histology of critical organs. Skin deep wound healing was not affected in vaccinated rats and monkeys. Altogether, these results support further clinical development of CIGB-247 therapeutic cancer vaccine, and shed light on the potential mechanisms underlying its effects. [ABSTRACT FROM AUTHOR]

The High Tech Enterprises (HTE) are playing an increasingly significant role in the economy, generating a substantial amount of intangible assets which are a significant part of the whole enterprise portfolio. In Cuba, the Biotechnology sector group a number of HTEs with intangible assets of great value in the context of the globalize market. Therefore, it is necessary to draw theoretical and practical frameworks for the negotiation of biotechnological products and their related intangible assets, and, particularly, to develop methodological tools for their adequate negotiation process. For that purpose, a documentary analysis followed by an expert survey was conducted to identify how much attention and the relevance that intangible assets received during the negotiations in HTEs at the BioCubaFarma biopharmaceutical enterprise. There was evident the lack of a standardized evaluation tool and a negotiation methodology for intangible assets. In this work, a new methodology for the valuation and negotiation of the intangible assets is presented. It was prepared by theoretical review of the literature available and designed by including the calculation methods, parameters and indicators required for their negotiation, and their adequate values and ranges both at pre-marketing and marketing commercialization stages. This work granted the Annual Award of the National Academy of Sciences of Cuba for the year 2015. [ABSTRACT FROM AUTHOR]

The article discusses research investigating a mutated variant of human vascular endothelial growth factor as a vaccine candidate for cancer immunotherapy. Topics include anti-angiogenic therapy, which targets pro-angiogenic growth factors produced by tumors and/or their cell surface receptors in endothelial cells using synthetic and natural molecules, and the anti-tumor effect of vascular endothelial growth factor (VEGF).

Novel therapeutic peptides are increasingly making their way into clinical application. The cationic and amphipathic properties of certain peptides allow them to cross biological membranes in a non-disruptive way without apparent toxicity increasing drug bioavailability. By modifying the primary structure of the Limulus-derived LALF(32-51) peptide we designed a novel peptide, L-2, with antineoplastic effect and cell-penetrating capacity. Interestingly, L-2 induced cellular cytotoxicity in a variety of tumor cell lines and systemic injection into immunocompetent and nude mice bearing established solid tumor, resulted in substantial regression of the tumor mass and apoptosis. To isolate the gene transcripts specifically regulated by L-2 in tumor cells, we conducted suppressive subtractive hybridization (SSH) analysis and identified a set of genes involved in biological processes relevant to cancer biology. Our findings describe a novel peptide that modifies the gene expression of the tumor cells and exhibits antitumor effect in vivo, indicating that peptide L-2 is a potential candidate for anticancer therapy.