Listened to Dr. Perlman's UBS presentation. He mostly just adds detail to Nadine Wong's summary, however the initiation of PII for T131 by year end is confirmed. He did expand some on the EPs for each trial, and talked of the MOAs and safety profiles of the drugs versus competing drugs.
With T67, they're looking for a 25% survival benefit versus doxyrubycin in liver cancer (survival rate said to be 50% after six months, presumably for untreated folks). Interim analysis to occur at the 100 patient mark (not sure what he meant by that -- 100 dead ones?). Enrollment update at year end. He noted safety profile versus doxy. Way less myelosuppression (10% versus 75%); leading to infection rates of 19% versus 50% with no life threatening infections from T67. Better in GI, alopecia, mucocitis.
T607 PII plans by end of year.
T131 Once daily dosing. Binds differently to PPAR Gamma receptor than Actos and Avandia, yielding 5 to 10 times the potency. Lower dosage means less cardiac, weight gain, & hematocrit side effects (mentioned Mayo clinic article linking Actos & Avandia to these) seen in PI. Adiponectin levels, the only marker available for this indication in healthy volunteers, rose in dose dependent fashion, a la Avandia & Actos. PII to begin by end of year. Primary endpoint is fasting glucose on day 29 after 28 day dosing. Also looking at insulin, & adiponectin.
T487 Two PIIs planned to start next Q. Endpoints are immune cell migration levels into psoriatic tissue and into joints for psoriasis and RA trials, respectively. Also usual measures of clinical benefit. 40 patients in each; placebo controlled and double blind. Once daily dosing. Preclinical results showed drastic reduction in immune cell migration at 10mg/kg. PI showed good tolerability up to 500mg/kg. I don't think he said what the doses for PII were to be, maybe they haven't finalized that yet.
Amgen. Too new a deal to offer anything new.
Lilly. Thrombotic disease candidate. Factor Xa. Against lmw heparin for acute disease, and ? (I didn't hear what clearly; perhaps anti-coagulation, i.e. warfarin) in chronic setting, the bigger market. PII to commence "in coming months." No mention if that triggers a milestone, but I would think so. Whether that is currently in anyone's model is anyone's guess; I'm clueless on that point.
Impressions: they all sound good, but it's early for T131 and 487. Not what the odds are for a 25% survival benefit for T67 versus doxy, or if that is clinically relevant. I would guess that it is, but that only a couple of months, right? T67 might be cheaper, being a small molecule drug?
Anyhow, weakness below $10 before this news flow kicks in might be a good position trading opportunity.
Cheers, Tuck |
