Sobre la presentación en la RBC Capital Markets Global Healthcare Virtual Conference del martes
KPTI seemed very confident into upcoming ph.III Xpovio BOSTON data at ASCO, citing solid OS trends despite crossover, once-weekly Velcade backbone, and meaningful improvements in ORR, response depth, PFS,&time to next treatment as likely to resonate most with physicians;
in particular they noted consistency of effects including in high-risk patients and tolerability in more debilitated patients as likely to bolster physician impressions of the agent; we continue to see $600M+ overall MM opportunity.
Bueno estaba claro que lo intentarían, q la FDA q tardo 10años kn amrn haya tardado 2meses no tanto. No se quieren esta claro. De todos modos habrá que ver si es una manera de presionar, recursos, en que condiciones podrían producir..
Resultados primarios COVID en 14 días; secundarios, en 28.
KPTI COVID-19 study of low-dose Xpovio is proceeding toward several planned interim analyses where an improvement of 2 points on ordinal scale primary endpoint appears to be bar that would trigger study stoppage&potential regulatory submission for COVID-19 indication
Karyopharm Announces Dosing of First Patient in Randomized Study Evaluating Low Dose Selinexor in Patients with Severe COVID-1
This important milestone marks the first study of an XPO1 inhibitor in patients with severe viral infections. We remain highly encouraged by the potential anti-viral and anti-inflammatory activity of XPO1 inhibition with selinexor and look forward to working with the medical community of regulators, treating physicians and patients on advancing this important study as quickly as possible.”
SINE compounds have been identified as having the potential to interfere with key host protein interactions with influenza, RSV and other viruses including SARS-CoV-2.1 Furthermore, XPO1 (also called CRM1) was identified as one of the host proteins with the highest number of functional connections with SARS-CoV proteins.2 Finally, SINE compounds, including selinexor, have demonstrated potent anti-inflammatory activity through the inhibition of Nuclear Factor kB (NF-kB), leading to reductions in cytokines such as IL6, IL1, IFNg and others in a variety of models, which may be particularly beneficial to hospitalized patients with COVID-19 and other severe viral infections.
“In my laboratory, we have now used two different approaches to investigate selinexor’s ability to inhibit the viral propagation of the SARS-CoV-2 virus in Vero cells, which are monkey cells commonly used in modeling human viral infections. In our first experiment, with the assistance of Jackelyn Murray in my lab, we demonstrated that selinexor inhibited the production of new virus by 90% at a low concentration (100 nM) from cells that were already infected with SARS-CoV2. This is very exciting as low oral doses of selinexor are expected to deliver levels over 300 nM. In the second experiment, we showed that even lower levels of selinexor, only 10nM, could reduce the ability of the virus to infect new cells by about 99%. I am highly encouraged by these results and thrilled to see how quickly Karyopharm is able to test these scientific findings in patients so dramatically impacted by the current COVID-19 pandemic,”
