>> You might be interested in looking at a Xoma press release of April
29 '98-- sort of an abstract on PI results, which I found quite startling <<
Yeah, open-label trials are often quite exciting for psoriasis and rheumatoid arthritis. Compare these abstracts, where the second study has been verified......
Br J Dermatol 1995 Dec;133(6):905-908
Systemic high-dose ranitidine in the treatment of psoriasis: an open
prospective clinical trial.
Kristensen JK, Petersen LJ, Hansen U, Nielsen H, Skov PS, Nielsen HJ
Department of Dermatology, Hvidovre University Hospital, Denmark.
We report the results of an open, prospective study on the efficacy of systemic ranitidine in the treatment of psoriasis. Twenty
patients suffering from moderate to severe psoriasis were included in the study. The median pretreatment PASI score was 15.7
(range 6.0-24.7). The patients were treated with oral ranitidine 300 mg twice a day for 6 months; no other medication was
allowed during the study period. Eighteen patients completed the study. The median PASI score was reduced from 15.7 to
14.5, 9.1 and 5.7, after 1, 3 and 6 months of treatment, respectively (P < 0.00001). A significant reduction in PASI score was
evident at 3 months of treatment. A mild to moderate deterioration occurred in 15 patients within the first month of treatment,
but this was followed by improvement during prolonged treatment in most patients. No other clinical and/or biochemical
side-effects were observed. Eight patients continued therapy with ranitidine after the study was completed, and none of these
patients relapsed during a follow-up period of 12-18 months. The results of the present study suggest that ranitidine may be a
beneficial and safe treatment for psoriasis. In addition, high-dose, long-term ranitidine treatment appears to be free from severe
adverse effects.
J Am Acad Dermatol 1997 Jun;36(6 Pt 1):932-934
Ranitidine does not affect psoriasis: a multicenter, double-blind,
placebo-controlled study.
Zonneveld IM, Meinardi MM, Karlsmark T, Johansen UB, Kuiters GR, Hamminga L, Staberg B, van't Veen AJ,
Bossuyt PM, van Niel JC, Bos JD
Department of Dermatology, Academic Medical Center, Amsterdam, The Netherlands.
BACKGROUND: Data from open studies suggest that ranitidine has a beneficial effect on psoriasis and is well tolerated.
OBJECTIVE: Our purpose was to determine the effectiveness of ranitidine in a 24-week, multicenter, double-blind,
placebo-controlled, dose-comparing study of 201 patients with psoriasis. METHODS: Patients with moderate to severe
psoriasis who had stopped systemic antipsoriatic therapy, including PUVA and UVB, for at least 10 weeks were included.
After a washout period of 2 weeks, patients were randomly allocated to use either ranitidine, 150 mg twice a day; ranitidine,
300 mg twice a day; or placebo for up to 24 weeks. Assessment with the Psoriasis Area and Severity Index was performed at
weeks 3, 6, 9, 12, 18, and 24 after randomization. Reduction of the Psoriasis Area and Severity Index score by 70% at the
completion of the study was considered a treatment success. RESULTS: The success rates at week 24 in the 300 mg, 600 mg,
and placebo groups were 11%, 5%, and 12%, respectively. No significant differences were observed between the three
treatment groups at any stage of the study. CONCLUSION: This study provides strong evidence that ranitidine does not affect
the skin disease in patients with psoriasis.
Mike.... there was once a story in the L.A. Times. It was back in XOMA's $32/share days. The story (paraphrased) told about a patient that was on his/her death bed, rec'd a shot of E5, and was miraculously saved. The value of XOMA shares soared. Articles and news releases seemed to appear at opportune times.
I'd wait for phase II data before getting too excited. It will be interesting, however, to see Roche (anti-Tac) going against Genentech (ant-CD11a). Anti-Tac, anti-CD11a, anti-CD40L, CTLA4-Ig, anti-CD2.... it's going to be exciting.
Again..... is there any sales-related anti-CD11a revenue flow to XOMA? Sounds like they are doing the project for the up-front purchase of some shares (they needed the bucks to keep bpi21 alive) and convertible loans..... a CRO with responsibility for production.
Rick |
