Something I hadn’t seen before on the OPEXA website (official-dom in italics, my comments NOT):
November 10, 2008 Reprint from BIOCENTURY
Banking on Safety
—by Erin McCallister Senior Writer
Even though its Tovaxin missed the primary endpoint in a Phase IIb trial to treat relapsing-remitting multiple sclerosis, Opexa Therapeutics Inc. thinks the autologous stem cell vaccine has a chance in RRMS. The company’s confidence is based in part on a post hoc analysis of secondary endpoint data, and in part on a mechanism of action that it says should make it safer than marketed drugs.
And who wrote up the “hairy/scary” preliminary report in such a way that Opexa had to scramble together a ‘post hoc analysis’? Why didn’t someone stress the safety mechanism—a LOT—in order to keep the program on track? In my opinion, it seems that patient feedback went for zilch—what happened to emphasizing our appreciation of a product that didn’t make us have flu-like symptoms and relief not having to combat injection-site reactions? If personal feedback wasn’t going to mean anything, it shouldn’t have been requested.
And if SOMEONE (I have no idea who—but I’m willing to blame a smartass doctor or biologist who barely passed Freshman Comp that first semester/quarter of college; technical writing has its place, to be sure, but if one cannot successfully persuade in the written form, one should seriously consider staying in the lab full-time) had made this safety factor a prominent concern, we Tovaxinites would surely be in a different place today.
… Late last month, the company released additional data from a subgroup of 50 patients with an ARR of >1 at baseline who were matched in terms of baseline lesions prior to analysis. In Tovaxin patients, the post hoc analysis showed levels of brain atrophy and the number of gadolinium lesions that progressed to black holes had a statistically significant reduction of 88% and 20%, respectively. Tovaxin patients achieved an ARR of 0.28, a statistically significant reduction of 55% compared with placebo.
In the subgroup, Tovaxin also significantly improved disability as measured by the Expanded Disability Status Scale (EDSS). Specifically, 28% of Tovaxin patients had improved EDSS vs. 6% of placebo patients (p=0.045).
President and CEO Neil Warma said while Opexa was hoping to meet the primary endpoint in all comers, it had planned from the start to perform a subset analysis of patients with a baseline ARR >1. “We had noticed in Phase I/II trials that patients with a baseline relapse rate greater than 1 performed better,” he told BioCentury.
Warma did note that matching patients based on baseline lesions resulted in a low number of placebo patients in the subset analysis. Warma contends that both the allcomers group and the subgroup in TERMS had ARR comparable to that seen in pivotal trials of Tysabri natalizumab from Biogen Idec Corp. and Elan Corp. plc, which included only patients with an ARR >1.
In the two-year AFFIRM trial of Tysabri monotherapy, ARR was 0.22 for Tysabri vs. 0.67 for placebo. Thus, the relative reduction for treatment vs. placebo was 67% for Tysabri, 55% for the TERMS subgroup and 37% for TERMS all-comers (see “Tovaxin vs. Tysabri”).
Data from OLETERMS, a one-year, open-label extension study enrolling TERMS patients, are expected in mid-2009.
Warma said he expects ARR to hover around 0.2 after the second year of treatment based on data from an extension study that followed Phase I/II trials of Tovaxin. Patients in a one-year, open-label extension trial of Tovaxin who had already received one year of treatment in a Phase I/II dose-escalation study (n=22) had an ARR of 0.21, or an 82% reduction in ARR compared to baseline.
This is nuts. Our study was sidelined because some jackass didn't know how to make a pitch? Especially now that we can see our stuff performed comparatively with Tysabri!?!?!
WE CANNOT STAND BY AND LET THIS SLIP BY US, GUYS!!!!