Direction for Clinical Research

Havana, Cuba

Direction for Clinical Research

Havana, Cuba
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Quian Y.P.,Direction for Clinical Research | Batista J.F.,Direction for Clinical Research | Prats A.,Direction for Clinical Research | Perera A.,Direction for Clinical Research
Clinical Nuclear Medicine | Year: 2016

Detection of bone metastases indicates poor prognosis for patients with prostate cancer. The immunotherapy with monoclonal antibody has been an important advance in the treatment of the cancer in the last years. Nimotuzumab is a humanized IgG1 monoclonal antibody directed against epidermal growth factor receptor that has been evaluated in solid tumors. The authors show images of 2 patients with bone metastases secondary to prostate cancer, "pre-cold therapy" with nimotuzumab. Immunoscintigraphic images were acquired 4 and 24 hours after the intravenous administration of 1110 MBq (30 mCi) of 99mTc-labeled nimotuzumab. Bone metastases expressing the receptor are visualized. © 2015 Wolters Kluwer Health, Inc. All rights reserved.


Sarduy M.R.,The Surgical Center | Garcia I.,Center for Genetic Engineering and Biotechnology | Coca M.A.,Direction for Clinical Research | Perera A.,Direction for Clinical Research | And 19 more authors.
British Journal of Cancer | Year: 2015

Background:We conducted a phase 1 trial in patients with locally advanced cervical cancer by injecting 0.5 ml of the CK2-antagonist CIGB-300 in two different sites on tumours to assess tumour uptake, safety, pharmacodynamic activity and identify the recommended dose.Methods:Fourteen patients were treated with intralesional injections containing 35 or 70 mg of CIGB-300 in three alternate cycles of three consecutive days each before standard chemoradiotherapy. Tumour uptake was determined using 99 Tc-radiolabelled peptide. In situ B23/nucleophosmin was determined by immunohistochemistry.Results:Maximum tumour uptake for CIGB-300 70-mg dose was significantly higher than the one observed for 35 mg: 16.1±8.9 vs 31.3±12.9 mg (P=0.01). Both, AUC 24h and biological half-life were also significantly higher using 70 mg of CIGB-300 (P<0.001). Unincorporated CIGB-300 diffused rapidly to blood and was mainly distributed towards kidneys, and marginally in liver, lungs, heart and spleen. There was no DLT and moderate allergic-like reactions were the most common systemic side effect with strong correlation between unincorporated CIGB-300 and histamine levels in blood. CIGB-300, 70 mg, downregulated B23/nucleophosmin (P=0.03) in tumour specimens.Conclusion:Intralesional injections of 70 mg CIGB-300 in two sites (0.5 ml per injection) and this treatment plan are recommended to be evaluated in phase 2 studies. © 2015 Cancer Research UK. All rights reserved.


PubMed | Center for Genetic Engineering and Biotechnology, ELEA Laboratories, Direction for Clinical Research, Gyneco obstetric Hospital Ramon Gonzalez Coro and 3 more.
Type: Clinical Trial, Phase I | Journal: British journal of cancer | Year: 2015

We conducted a phase 1 trial in patients with locally advanced cervical cancer by injecting 0.5 ml of the CK2-antagonist CIGB-300 in two different sites on tumours to assess tumour uptake, safety, pharmacodynamic activity and identify the recommended dose.Fourteen patients were treated with intralesional injections containing 35 or 70 mg of CIGB-300 in three alternate cycles of three consecutive days each before standard chemoradiotherapy. Tumour uptake was determined using (99)Tc-radiolabelled peptide. In situ B23/nucleophosmin was determined by immunohistochemistry.Maximum tumour uptake for CIGB-300 70-mg dose was significantly higher than the one observed for 35 mg: 16.1 8.9 vs 31.3 12.9 mg (P = 0.01). Both, AUC24h and biological half-life were also significantly higher using 70 mg of CIGB-300 (P < 0.001). Unincorporated CIGB-300 diffused rapidly to blood and was mainly distributed towards kidneys, and marginally in liver, lungs, heart and spleen. There was no DLT and moderate allergic-like reactions were the most common systemic side effect with strong correlation between unincorporated CIGB-300 and histamine levels in blood. CIGB-300, 70 mg, downregulated B23/nucleophosmin (P = 0.03) in tumour specimens.Intralesional injections of 70 mg CIGB-300 in two sites (0.5 ml per injection) and this treatment plan are recommended to be evaluated in phase 2 studies.

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