Replies to post #160936 on Biotech Values

[iwfal]

XOMA -

The current PoC is targeting the 500,000 patients who have inflammatory EOA as evidenced by elevated C reactive protein (CRP). However, only about a quarter of the patients being screened for the Ph2 trial have elevated CRP levels. Consequently, the company announced a second PoC trial for EOA patients who do not meet the "active inflammatory" CRP threshold. According to the company, "This study will tell us if gevokizumab works in the broader EOA population as estimated to be 1.8 to 2.2 than people in the U.S. or they may tell us gevokizumab only works in the patients who are in inflammatory stage of the disease which might approximate about 500,000 patients." The second EOA trial in low CRP patients should provide better insight into the validity/necessity of the CRP biomarker.

It is up on CT now. In a quick glance it looks very similar to the first trial (no reference to CRP in either writeup). The only difference to be found is that the first trial was described as being for "active inflammatory OA" and for the second the adjective "active" was removed.

http://www.clinicaltrials.gov/ct2/show/NCT01882491?term=osteoarthritis&recr=Open&phase=1&rank=12&submit_fld_opt=

Note that interestingly at the bottom of the Inclusion/Exclusion criteria for both they note that Other protocol-defined inclusion/exclusion criteria may apply. Clearly CRP is one of those - but it wouldn't surprise me if there were other criteria that defined 'active' - e.g. palpable effusions is the most obvious one and there are hints it is more tractable wrt treatment.

[iwfal]

XOMA -

EYEGUARD-A in patients with active disease is expected to read-out by year end; data from EYEGUARD-C, which is studying the effects of gevokizumab in a maintenance setting, is expected in 1Q14; and, EYEGUARD-B which is enrolling patients with Behçet's is expected to read-out last, in 2Q14. Per discussions with the FDA, the company will likely need to meet the primary endpoint in two of the three trials. The risk is that even though all three trials are in NIU, Eyeguard A and C have a different intent-to-treat population than that actually studied in the Ph2 trial. Of course, the trial for which we have the most data, Eyeguard-B, actually reads out last. However, even though the company is running three separate Ph3 trials, the trials are all in non-infectuous inveitis of which Behçet's uveitis is one of the most severe forms. As an investment, it seems logical that if Gevokizumab works in the most severe form of NIU (Eyeguard B) then it should work in the less severe forms (Eyeguard A,C) of the disease as well.

FWIW I wouldn't rate the chances of success in the same order you do - EYEGUARD B being most likely to succeed because it is Beycets, EYEGUARD A and C being less likely because they are all forms of uveitis.

My reasoning - there is a lot of data to indicate that all the different forms of non-infectious uveitis respond the same to the same treatments. Most particularly this appears to be true with anti-TNF agents for which there is boatload of data (almost all pretty mediocre - but in aggregate moderately compelling). And anti-TNFs are next door neighbors to anti-IL-1s.

As for my ranking - I think that the acute disease trial (A) has the best chance of success because the protocol is easy and well-proven in the ph i's. But the chronic treatments have potential protocol problems with confounding - e.g. doc's tapering systemic steroids to offset the benefit coming from Gev - and the fact that it may just be harder to see benefit is a less acute patient population.

BTW - on the topic of tnf agents and IL-1 agents being 'next door neighbors' it is pretty much universally true that if a tnf agent works then the IL-1 agents will probably show some benefit. Sometimes the same, sometimes less (e.g. RA). But if I had to guess I'd guess that uveitis is a disease where the IL-1's show better benefit than the TNFs. For instance, see the Humira ph i results as posted on clinical trials - a much less stringent definition of response and yet they only got a 2/3 response. And the other clinical data in the TNFs all says about the same - about 50% or a little more. That said, there is still a lot of uncertainty on that kind of comparison across trials. (Another interesting case is the case report of scleritis in RA patients - the TNF agents did not solve it, but anakinra did in a repeatable way)

[DewDiligence]

XOMA reports 2Q13 results; no change in cash-usage guidance

http://finance.yahoo.com/news/xoma-highlights-recent-achievements-reports-200100500.html

On June 30, 2013, XOMA had cash and cash equivalents of $57.9 million… The Company reconfirmed its anticipated cash used in ongoing operating activities during 2013 will be approximately $50 million, primarily reflecting the costs associated with conducting clinical and preclinical activities. This guidance initially was provided on March 12, 2013.

CC at 4:30pm ET.