I've followed the issue pretty closely. Dr. Allison at Berkeley is an acquaintance (I hope that he'd say "friend", once he saw and recognized me, but I'd best say acquaintance), and I have followed his work. He's expressed optimism re. MEDX, in one brief discussion a couple of years ago.
I've also been in-house -- on a couple of occasions -- at RGEN and talked to them about the conflict with BMY, going back about three years.
And, given this effort....... I don't have a clue re. who owns what or which approach may be better.
:-)
The last RGEN press release on the subject......
1. it's going to court trial, and
2. it was interesting that RGEN was not successful in throwing out the deposition of an inventor (given that I read and remember the statement correctly).
I own a few RGEN shares (not a large position), waiting on the BMY verdict.
I don't get it...... why would 2 mg/kg be the only dose tested in TNF receptor-treated patients, while both 2 and 10 mg/kg were tested in MTX-treated patients? Anybody know the frequency at which that 10 mg/kg slug was given in the year long study?
Arthritis Rheum 2002 Oct;46(10):2565-70
Life-threatening histoplasmosis complicating immunotherapy with tumor necrosis factor alpha antagonists infliximab and etanercept.
Lee JH, Slifman NR, Gershon SK, Edwards ET, Schwieterman WD, Siegel JN, Wise RP, Brown SL, Udall JN Jr, Braun MM.
Center for Biologics Evaluation and Research, FDA, Rockville, Maryland.
OBJECTIVE: Two tumor necrosis factor alpha (TNFalpha) antagonists were recently licensed in the US. Infliximab was licensed in 1998 for the treatment of Crohn's disease (CD), and since 1999, it has been licensed in combination with methotrexate for treatment of rheumatoid arthritis (RA). Etanercept was licensed in 1998 for treatment of RA and, more recently, for juvenile RA and psoriatic arthritis. Because of potential immunosuppression related to use of anti-TNFalpha agents, we sought to identify postlicensure cases of opportunistic infection, including histoplasmosis, in patients treated with these products. METHODS: The US Food and Drug Administration's (FDA) passive surveillance database for monitoring postlicensure adverse events was reviewed to identify all reports received through July 2001 of histoplasmosis in patients treated with either infliximab or etanercept. RESULTS: Ten cases of Histoplasma capsulatum (HC) infection were reported: 9 associated with infliximab and 1 associated with etanercept. In patients treated with infliximab, manifestations of histoplasmosis occurred within 1 week to 6 months after the first dose and typically included fever, malaise, cough, dyspnea, and interstitial pneumonitis. Of the 10 patients with histoplasmosis, 9 required treatment in an intensive care unit, and 1 died. All patients had received concomitant immunosuppressive medications in addition to infliximab or etanercept, and all resided in HC-endemic regions. CONCLUSION: Postlicensure surveillance suggests that acute life-threatening histoplasmosis may complicate immunotherapy with TNFalpha antagonists, particularly infliximab. Histoplasmosis should be considered early in the evaluation of patients who reside in HC-endemic areas in whom infectious complications develop during treatment with infliximab or etanercept. |
