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The aim of this investigation was to evaluate by first time the pharmacokinetics and pharmacodynamics of this combination in patients with mycosis fungoides.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>An exploratory, prospective, open-label clinical trial was conducted. Twelve patients, both genders, 18 to 75\u00a0years-old, with mycosis fungoides at stages IB to III, were eligible for the study. All of them received intramuscularly a single high dose (23\u2009\u00d7\u200910<jats:sup>6<\/jats:sup>\u00a0IU) of a novel synergistic IFN mixture (HeberPAG\u00ae) for pharmacokinetic and pharmacodynamic studies. Serum IFN alpha-2b and IFN gamma concentrations were measured during 96\u00a0hours by commercial enzyme immunoassays (EIA) specific for each IFN. Other blood IFN-inducible markers and laboratory variables were used as pharmacodynamics and safety criteria.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The pharmacokinetic evaluation by EIA yielded a similar pattern for both IFNs that are also in agreement with the well-known described profiles for these molecules when these are administered separately. The average values for main parameters were: Cmax: 263 and 9.3\u00a0pg\/mL; Tmax: 9.5 and 6.9\u00a0h; AUC: 4483 and 87.5\u00a0pg.h\/mL, half-life (t<jats:sub>1\/2<\/jats:sub>): 4.9 and 13.4\u00a0h; mean residence time (MRT): 13.9 and 13.5\u00a0h, for serum IFN alpha-2b and IFN gamma, respectively. The pharmacodynamic variables were strongly stimulated by simultaneous administration of both IFNs: serum neopterin and beta-2 microglobulin levels (\u03b2<jats:sub>2<\/jats:sub>M), and stimulation of 2\u2019-5\u2019 oligoadenylate synthetase (OAS1) mRNA expression. The most encouraging data was the high increment of serum neopterin, 8.0\u00a0ng\/mL at 48\u00a0h, not been described before for any unmodified or pegylated IFN. Additionally, \u03b2<jats:sub>2<\/jats:sub>M concentration doubled the pre-dose value at 24\u201348\u00a0hours. For both variables the values remained clearly upper baseline levels at 96\u00a0hours.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>HeberPAG\u00aepossesses improved pharmacodynamic properties that may be very useful in the oncologic setting. Efficacy trials can be carried out to confirm these findings.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p>Registro P\u00fablico Cubano de Ensayos Cl\u00ednicos<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/registroclinico.sld.cu\/trials\/RPCEC00000130-En\" ext-link-type=\"uri\">RPCEC00000130<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1186\/2050-6511-13-20","type":"journal-article","created":{"date-parts":[[2012,12,28]],"date-time":"2012-12-28T09:13:49Z","timestamp":1356686029000},"update-policy":"http:\/\/dx.doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Pharmacokinetic and pharmacodynamic characterization of a new formulation containing synergistic proportions of interferons alpha-2b and gamma (HeberPAG\u00ae) in patients with mycosis fungoides: an open-label trial"],"prefix":"10.1186","volume":"13","author":[{"given":"Yanelda","family":"Garc\u00eda-Vega","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Idrian","family":"Garc\u00eda-Garc\u00eda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sonia E","family":"Collazo-Caballero","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Egla E","family":"Santely-Pravia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alieski","family":"Cruz-Ram\u00edrez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"\u00c1ngela D","family":"Tuero-Iglesias","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristian","family":"Alfonso-Alvarado","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mileidys","family":"Cabrera-Placeres","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nailet","family":"Castro-Basart","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yaquel\u00edn","family":"Duncan-Roberts","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tania I","family":"Carballo-Treto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Josanne","family":"Soto-Matos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoandy","family":"Izquierdo-Toledo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dania","family":"V\u00e1zquez-Blomquist","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizeth","family":"Garc\u00eda-Iglesias","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Iraldo","family":"Bello-Rivero","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2012,12,28]]},"reference":[{"key":"130_CR1","doi-asserted-by":"publisher","first-page":"547","DOI":"10.1016\/S0169-409X(02)00027-3","volume":"54","author":"YS Wang","year":"2002","unstructured":"Wang YS, Youngster S, Grace M, Bausch J, Bordensc R, Wyssa DF: Structural and biological characterization of pegylated recombinant interferon alpha-2b and its therapeutic implications. 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