Ziopharm (ZIOP): se vi interessa un titolo per la vostra pensione, leggete qui (parte 3)
La terza parte dell’articolo, quella che state leggendo, non era preventivata. Il motivo per cui ora si trova sui vostri monitore è che settimana scorsa Ziopharm (ZIOP) ha comunicato qualche interessante aggiornamento sulla sperimentazione targata Intrexon. Siamo agli albori del processo di sviluppo per quel che riguarda il farmaco immunoterapico di cui parlo oggi, ma vale la pena fare qualche riflessione al proposito.
Devo fare un riassunto delle puntate precedenti?
Forbes pubblica un articolo online nel quale mette in dubbio la conduzione della fase 2 di palifosfamide, candidato numero uno di Ziopharm (ZIOP) che presto darà gli attesi risultati dello studio registrativo. L’accusa riguarda la mancata comunicazione agli azionisti dei problemi legati alla conduzione della fase 2 ed il fatto che nascolndendo quella notizia abbiano potuto raccogliere fondi e finanziarsi senza problemi. Ziopharm (ZIOP) ha smentito, Forbes ha fatto sparire l’articolo. Caso chiuso? Per ora si, ma se i dati della fase 3 non fossero positivi?
Nei due articoli precedenti ho parlato dell’enorme interesse costituito dall’accordo con Randal J. Kirk ed Intrexon, del prezzo medio delle azioni in carico al miliardario con il fiuto sopraffino per ilbiotech e del disinteresse verso palifosfamide.
Oggi vediamo i primi frutti dell’acciordo Ziopharm/Intrexon.
ZIOPHARM Oncology, Inc. ZIOP -2.15% , a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced that compelling clinical activity was seen in its Phase 1 study of Ad-RTS IL-12, a novel DNA-based therapeutic candidate, in advanced melanoma. Based on early activity, and determination of a biologically effective dose, the Company also announced that the study has advanced to Phase 2 in which the first patient has been dosed.
Initiation of the Phase 2 study follows the successful, dose-escalation Phase 1 study in which clinical activity was observed in 5 of 7 (71%) patients dosed at the two highest dose levels. The data also showed a correlation between T-cell immune responses and clinical outcome, with no dose-limiting toxicities reported. A total of 13 patients were enrolled in the Phase 1 study, and were treated with a range of doses of an orally administered activator ligand. Three serious adverse events (SAE) were reported: two related to therapy (pyrexia and cytopenia), and one unrelated (deep vein thrombosis). Unrelated to the study therapy, one patient death was reported due to bacterial sepsis and progression of disease. The Company expects to submit full results of the study for presentation at a major medical meeting.
The Phase 2 multi-center, single-arm, open-label expansion study will enroll up to 15 patients with unresectable Stage III or IV melanoma and further evaluate the safety and efficacy of intratumoral injections of Ad-RTS IL-12 in combination with an oral activator ligand. Data from this study are expected in the first half of 2013.
“ZIOPHARM, working with our DNA therapy platform, is ushering in a paradigm shift in how we treat cancer, one that transforms our ability to deliver therapy, leading to better, safer treatment and ultimately, to cures,” said Samuel Broder, M.D., Chairman of Intrexon Therapeutic Opportunities Committee and former Director of the NCI (National Cancer Institute). “We look forward to seeing additional data as ZIOPHARM expands the Ad-RTS IL-12 DNA program into multiple indications, including breast cancer, and to the introduction of the next generation of DNA-based therapeutic candidates for oncology.”
“This Phase 1 study demonstrates that IL-12 dosing, delivered and controlled through a pioneering DNA therapeutic strategy, is both tolerable and clinically active,” stated Hagop Youssoufian, M.D., President of Research and Development and Chief Medical Officer of ZIOPHARM. “An important early sign of this effect was manifested in lesions not injected with Ad-RTS IL-12, where clinical response was observed, indicating systemic, anti-cancer immune activity. We also saw activity in patients who had been previously exposed to ipilimumab, as well as other forms of immunotherapy, suggesting that Ad-RTS IL-12 may provide benefit for patients with advanced disease.”
In connection with the achievement of this milestone, ZIOPHARM announced today that it will issue 3,636,926 shares of the Company’s common stock to Intrexon Corporation in accordance with the terms of the Exclusive Channel Partner Agreement (ECP) between the companies entered into in January 2011. All of the shares issued to Intrexon will be unregistered but certain registration rights in accordance with the Registration Rights Agreement entered into by the companies at the time of the ECP.