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10. Randomized trial of safinamide add‐on to levodopa in Parkinson's disease with motor fluctuations

Author

Borgohain, R, Szasz, J, Stanzione, P, Meshram, C, Bhatt, M, Chirilineau, D, Stocchi, F, Lucini, V, Giuliani, R, Forrest, E, Rice, P, Anand, R, Sahadulla, M, Kardan, U, Keshava, B, Kishore, A, Kothari, S, Krishna Murthy, J, Kumar, S, Pal, P, Mehta, N, Prabhakar, S, Pradhan, S, Roy, A, Sankhla, C, Sethi, P, Shah, A, Shankar, N, Shukla, R, Sowani, A, Srinivasa, R, Varma, M, Vasudevan, D, Sreenivas, P, Velmurugendran, C, Vijayan, K, Bajenaru, O, Bulboaca, A, Campeanu, A, Chirileanu, D, Muresanu, D, Panea, C, Popescu, C, Simu, M, Ticmeanu, M, Avarello, T, Bonuccelli, U, Eleopra, R, Onofrj, M, and Quatrale, R

Subjects
Male, Benzylamines, Levodopa, Parkinson's disease, Motor Activity, Placebo, Severity of Illness Index, law.invention, Dose-Response Relationship, Antiparkinson Agents, chemistry.chemical_compound, Double-Blind Method, Randomized controlled trial, law, Activities of Daily Living, Clinical endpoint, Humans, Medicine, MAO-B inhibitor, Research Articles, Aged, Dyskinesia, Safinamide, Alanine, Dose-Response Relationship, Drug, Female, Follow-Up Studies, Middle Aged, Parkinson Disease, Neurology (clinical), Neurology, safinamide, dyskinesia, business.industry, Parkinsonism, medicine.disease, chemistry, Anesthesia, Settore MED/26 - Neurologia, Drug, medicine.symptom, business, medicine.drug
Abstract

Levodopa is effective for the motor symptoms of Parkinson's disease (PD), but is associated with motor fluctuations and dyskinesia. Many patients require add-on therapy to improve motor fluctuations without exacerbating dyskinesia. The objective of this Phase III, multicenter, double-blind, placebo-controlled, parallel-group study was to evaluate the efficacy and safety of safinamide, an α-aminoamide with dopaminergic and nondopaminergic mechanisms, as add-on to l-dopa in the treatment of patients with PD and motor fluctuations. Patients were randomized to oral safinamide 100 mg/day (n = 224), 50 mg/day (n = 223), or placebo (n = 222) for 24 weeks. The primary endpoint was total on time with no or nontroublesome dyskinesia (assessed using the Hauser patient diaries). Secondary endpoints included off time, Unified Parkinson's Disease Rating Scale (UPDRS) Part III (motor) scores, and Clinical Global Impression-Change (CGI-C). At week 24, mean ± SD increases in total on time with no or nontroublesome dyskinesia were 1.36 ± 2.625 hours for safinamide 100 mg/day, 1.37 ± 2.745 hours for safinamide 50 mg/day, and 0.97 ± 2.375 hours for placebo. Least squares means differences in both safinamide groups were significantly higher versus placebo. Improvements in off time, UPDRS Part III, and CGI-C were significantly greater in both safinamide groups versus placebo. There were no significant between-group differences for incidences of treatment-emergent adverse events (TEAEs) or TEAEs leading to discontinuation. The addition of safinamide 50 mg/day or 100 mg/day to l-dopa in patients with PD and motor fluctuations significantly increased total on time with no or nontroublesome dyskinesia, decreased off time, and improved parkinsonism, indicating that safinamide improves motor symptoms and parkinsonism without worsening dyskinesia.

Published
2013

13. Customizing antiangiogenesis therapy toward vessel normalization results in a long-term glioma growth control

Author

Bello, L, Colleoni, F, Sangiorgi, S, Lucini, V, Pannacci, M, Acerbi, F, Giussani, C, Carrabba, G, Gaini, S, Bikfalvi, A, Bello L., Colleoni F., Sangiorgi S., Lucini V., Pannacci M., Acerbi F., Giussani C., Carrabba G, Gaini S., Bikfalvi A., Bello, L, Colleoni, F, Sangiorgi, S, Lucini, V, Pannacci, M, Acerbi, F, Giussani, C, Carrabba, G, Gaini, S, Bikfalvi, A, Bello L., Colleoni F., Sangiorgi S., Lucini V., Pannacci M., Acerbi F., Giussani C., Carrabba G, Gaini S., and Bikfalvi A.

Published
2006

14. Human skin-derived stem cells inhibit brain tumor growth

Author

Acerbi, F, Giussani, C, Pisati, F, Carrabba, G, Belicchi, M, Lucini, V, Gaini, S, Bikfalvi, A, Torrente, Y, Bello, L, Acerbi F, Giussani C, Pisati F, Carrabba G, Belicchi M, Lucini V, Gaini SM, Bikfalvi A, Torrente Y, Bello L, Acerbi, F, Giussani, C, Pisati, F, Carrabba, G, Belicchi, M, Lucini, V, Gaini, S, Bikfalvi, A, Torrente, Y, Bello, L, Acerbi F, Giussani C, Pisati F, Carrabba G, Belicchi M, Lucini V, Gaini SM, Bikfalvi A, Torrente Y, and Bello L

Published
2005

15. Tailoring of anti angiogenic therapies to tumor stage improves therapeutic efficacy in mouse models of human gliomas

Author

Giussani, C, Acerbi, F, Sangiorgi, S, Colleoni, F, Carrabba, G, Lucini, V, Pannacci, M, Tomei, G, Gaini, S, Bikfalvi, A, Bello, L, Giussani C, Acerbi F, Sangiorgi S, Colleoni F, Carrabba G, Lucini V, Pannacci M, Tomei G, Gaini SM, Bikfalvi A, Bello L, Giussani, C, Acerbi, F, Sangiorgi, S, Colleoni, F, Carrabba, G, Lucini, V, Pannacci, M, Tomei, G, Gaini, S, Bikfalvi, A, Bello, L, Giussani C, Acerbi F, Sangiorgi S, Colleoni F, Carrabba G, Lucini V, Pannacci M, Tomei G, Gaini SM, Bikfalvi A, and Bello L

Published
2005

16. In vivo targeting ability of human glioblastoma by human skin-derived stem cells

Author

Pluderi, M, Costa, F, Giussani, C, Carrabba, G, Lucini, V, Caronzolo, D, Carroll, R, Bikfalvi, A, Torrente, Y, Bello, L, Pluderi M, Costa F, Giussani C, Carrabba G, Lucini V, Caronzolo D, Carroll R, Bikfalvi A, Torrente Y, Bello L, Pluderi, M, Costa, F, Giussani, C, Carrabba, G, Lucini, V, Caronzolo, D, Carroll, R, Bikfalvi, A, Torrente, Y, Bello, L, Pluderi M, Costa F, Giussani C, Carrabba G, Lucini V, Caronzolo D, Carroll R, Bikfalvi A, Torrente Y, and Bello L

Published
2003

17. Local intracerebral delivery of endogenous inhibitors by osmotic minipumps effectively suppresses glioma growth in vivo (vol 63, pg 2499, 2003)

Author

Giussani C, Giussani, C, Carrabba, G, Pluderi, M, Lucini, V, Pannacci, M, Caronzolo, D, Costa, F, Minotti, M, Tomei, G, Villani, R, Carroll, R, Bikfalvi, A, Bello, L, Giussani C, Carrabba G, Pluderi M, Lucini V, Pannacci M, Caronzolo D, Costa F, Minotti M, Tomei G, Villani R, Carroll RS, Bikfalvi A, Bello L, Giussani C, Giussani, C, Carrabba, G, Pluderi, M, Lucini, V, Pannacci, M, Caronzolo, D, Costa, F, Minotti, M, Tomei, G, Villani, R, Carroll, R, Bikfalvi, A, Bello, L, Giussani C, Carrabba G, Pluderi M, Lucini V, Pannacci M, Caronzolo D, Costa F, Minotti M, Tomei G, Villani R, Carroll RS, Bikfalvi A, and Bello L

Published
2003

18. Cierre de comunicación interventricular membranosa en adulto joven usando ADO II. Una mirada crítica desde la óptica del especialista en cardiopatías congénitas

Author

Damsky Barbosa, Jesús M, primary, Alonso, José, additional, Ferrin, L., additional, Peirone, A., additional, Trentacoste, L., additional, Rivarola, M., additional, Lucini, V., additional, Sciegata, A., additional, Pibernus, J., additional, Gómez, J., additional, Gómez, R., additional, Gamboa, R., additional, Molina, A., additional, Vagnola, O., additional, Robredo, A., additional, Henestrosa, G., additional, and Faella, H., additional

Published
2016
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19. Low-dose chemotherapy combined with an antiangiogenic drug reduces human glioma growth in vivo

Author

Bello, L., Carrabba, G., CARLO GIORGIO GIUSSANI, Pluderi, M., Tomei, G., Villani, R., Lucini, V., Cerutti, F., Scaglione, F., Carroll, R. S., Black, P. M. L., Landré, J., Bikfalvi, A., Bello, L, Carrabba, G, Giussani, C, Lucini, V, Cerutti, F, Scaglione, F, Landré, J, Pluderi, M, Tomei, G, Villani, R, Carroll, R, Black, P, and Bikfalvi, A

Subjects
Male, Antineoplastic Combined Chemotherapy Protocol, Dose-Response Relationship, Drug, Neovascularization, Pathologic, Brain Neoplasms, Animal, Mice, Nude, Angiogenesis Inhibitors, Recombinant Protein, Xenograft Model Antitumor Assays, Peptide Fragments, Recombinant Proteins, Carboplatin, Brain Neoplasm, Mice, Peptide Fragment, Antineoplastic Combined Chemotherapy Protocols, Animals, Humans, Matrix Metalloproteinase 2, Glioblastoma, Cell Division, Angiogenesis Inhibitor, Etoposide, Human
Abstract

This study evaluates the efficacy of the combination of an antiangiogenic drug and conventional chemotherapeutics for the treatment of experimental human gliomas. As an antiangiogenic, we used recombinant human PEX, a fragment of matrix metalloproteinase-2 that we have previously shown to have a significant antimitotic, anti-invasive, and antiangiogenic properties against human glioblastoma in vitro and in vivo. We used carboplatin and etoposide as the two chemotherapeutic drugs routinely used in our institution (Ospedale Maggiore de Milano) for the treatment of malignant gliomas. Conventional chemotherapeutic drugs were administered at high dose or at a low and semicontinuous regimen. Combined treatment of high-dose chemotherapy and PEX did not produce an improvement of survival in comparison with chemotherapy alone, but it was associated with a decrease in tumor volume, vascularity, and proliferative index and an increased apoptosis. All of these animals experienced severe side effects. The longest survival was documented in animals submitted to low and semicontinuous chemotherapy and antiangiogenic treatment. This regimen was associated with no side effects, marked decrease in tumor volume, vascularity, and proliferative index, and an increased apoptosis. Our data suggest that low-dose chemotherapy in combination with PEX can be successfully used against human malignant glioma in vivo.

Published
2001

26. Reassessing the melatonin pharmacophore--enantiomeric resolution, pharmacological activity, structure analysis, and molecular modeling of a constrained chiral melatonin analogue

Author

Rivara S., Diamantini G., Di Giacomo B., Lamba D., Gatti G., Lucini V., Pannacci M., Mor M., Spadoni G., and Tarzia G.

Abstract

3-(Acetylaminomethyl)-2-(ethoxycarbonyl)-6-methoxy-1,3,4,5-tetrahydrobenzo[cd]indole (2) is a rigid melatonin analogue that as a racemate displays about the same affinity and intrinsic activity of melatonin (1) in in vitro experiments. We report here the resolution of the racemate by preparative medium pressure liquid chromatography (MPLC) and the X-ray determination of the R absolute configuration of the (-)-enantiomer. The two enantiomers were separately tested as MT1 and MT2 ligands, and the (+)-(S)-2 showed a potency comparable to that of melatonin and about three orders of magnitude greater than that of its enantiomer. The information obtained by crystallographic analysis and NMR studies about the conformational preference for 2 and by the pharmacological characterization of (R)-2 and (S)-2 was employed in a molecular modeling study, aimed at reassessing the melatonin receptor pharmacophore model for agonist compounds. Chiral enantioselective agonists reported in the literature were also included in the study.

Published
2006

30. Distribution and pharmacological characterization of melatonin receptors in the brain of the Japanese quail (Coturnix japonica)

Author

Cozzi, B., Stankov, B., Viglietti Panzica, C., Simona Capsoni, Aste, N., Lucini, V., Fraschini, F., Panzica, Gc, Cozzi, B, Stankov, B, VIGLIETTI PANZICA, C, Capsoni, Simona, Aste, N, Lucini, V, Fraschini, F, and Panzica, Gc

Subjects
Socio-culturale
Abstract

2-[125I]iodomelatonin was used to study the distribution and properties of the melatonin receptor in the Japanese quail brain. High receptor density was detected in the major targets of direct retinal input (optic tectum, nucleus of the optic basal rout, ventrolateral geniculate nucleus), as well as areas representing terminals in the visual pathways (nucleus rotundus, ectostriatum, thalamo-hyperstriatal pathway). Binding was also found in the piriform cortex, the hypophyseal pars tuberalis, the oculomotorius nucleus and the associated Edinger-Westphal nucleus, and in the nuclei of the third, fourth and sixth cranial nerves. A comparison of the receptor pharmacological profile to that of the mammalian brain demonstrated pharmacological identity of the two binding sites. In the saturation experiments, GPT gamma S decreased the binding affinity, numerical Kd values increasing from approximately 35 pM to approximately 150 pM.

Published
1993

37. Effect of human skin-derived stem cells on vessel architecture, tumor growth, and tumor invasion in brain tumor animal models

Author

Pisati, F, Belicchi, M, Acerbi, F, Marchesi, C, Giussani, C, Gavina, M, Javerzat, S, Hagedorn, M, Carrabba, G, Lucini, V, Gaini, S, Bresolin, N, Bello, L, Bikfalvi, A, Torrente, Y, Gaini, SM, Torrente, Y., GIUSSANI, CARLO GIORGIO, Pisati, F, Belicchi, M, Acerbi, F, Marchesi, C, Giussani, C, Gavina, M, Javerzat, S, Hagedorn, M, Carrabba, G, Lucini, V, Gaini, S, Bresolin, N, Bello, L, Bikfalvi, A, Torrente, Y, Gaini, SM, Torrente, Y., and GIUSSANI, CARLO GIORGIO

Abstract

Glioblastomas represent an important cause of cancer-related mortality with poor survival. Despite many advances, the mean survival time has not significantly improved in the last decades. New experimental approaches have shown tumor regression after the grafting of neural stem cells and human mesenchymal stem cells into experimental intracranial gliomas of adult rodents. However, the cell source seems to be an important limitation for autologous transplantation in glioblastoma. In the present study, we evaluated the tumor targeting and antitumor activity of human skin-derived stem cells (hSDSCs) in human brain tumor models. The hSDSCs exhibit tumor targeting characteristics in vivo when injected into the controlateral hemisphere or into the tail vein of mice. When implanted directly into glioblastomas, hSDSCs distributed themselves extensively throughout the tumor mass, reduced tumor vessel density, and decreased angiogenic sprouts. In addition, transplanted hSDSCs differentiate into pericyte cell and release high amounts of human transforming growth factor-beta1 with low expression of vascular endothelial growth factor, which may contribute to the decreased tumor cell invasion and number of tumor vessels. In long-term experiments, the hSDSCs were also able to significantly inhibit tumor growth and to prolong animal survival. Similar behavior was seen when hSDSCs were implanted into two different tumor models, the chicken embryo experimental glioma model and the transgenic Tyrp1-Tag mice. Taken together, these data validate the use of hSDSCs for targeting human brain tumors. They may represent therapeutically effective cells for the treatment of intracranial tumors after autologous transplantation

Published
2007

48. Combinatorial administration of molecules that simultaneously inhibit angiogenesis and invasion leads to increased therapeutic efficacy in mouse models of malignant glioma

Author

Bello, L, Lucini, V, Costa, F, Pluderi, M, Giussani, C, Acerbi, F, Carrabba, G, Pannacci, M, Caronzolo, D, Grosso, S, Shinkaruk, S, Colleoni, F, Canron, X, Tomei, G, Deleris, G, Bikfalvi, A, Bikfalvi, A., GIUSSANI, CARLO GIORGIO, Bello, L, Lucini, V, Costa, F, Pluderi, M, Giussani, C, Acerbi, F, Carrabba, G, Pannacci, M, Caronzolo, D, Grosso, S, Shinkaruk, S, Colleoni, F, Canron, X, Tomei, G, Deleris, G, Bikfalvi, A, Bikfalvi, A., and GIUSSANI, CARLO GIORGIO

Abstract

PURPOSE: We investigated the ability of the combinatorial administration of different inhibitors with activities on glioma angiogenesis, migration, and proliferation to produce a prolonged inhibition of glioma growth. EXPERIMENTAL DESIGN: We combined inhibitors affecting solely tumor angiogenesis (PF-4/CTF, cyclo-VEGI) or inhibitors affecting both angiogenesis and invasion together (PEX, PF-4/DLR). RESULTS: When administered in combination, these drugs produced a prolonged and increased inhibition of glioma growth independently from the type of inhibitor used. The combinatory administration was more effective than the administration of a single inhibitor alone, and a strong therapeutic response was reached with a significantly lower amount of protein. The strongest inhibition was observed when human PEX and PF-4/DLR, which affect both glioma angiogenesis and invasion by separate mechanisms, were combined. CONCLUSIONS: This supports the concept that prolonged glioma growth inhibition can be achieved by simultaneous delivery of molecules that target both tumor and endothelial cells and acting by separate mechanisms.

Published
2004

49. Human skin-derived stem cells inhibit brain tumor growth

Author

Acerbi, F, Giussani, C, Carrabba, G, Costa, F, Pisati, F, Belicchi, M, Lucini, V, Bikfalvi, A, Torrente, Y, Bello, L, Acerbi, F, Giussani, C, Carrabba, G, Costa, F, Pisati, F, Belicchi, M, Lucini, V, Bikfalvi, A, Torrente, Y, and Bello, L

Published
2004

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