robert, andrew, you guys are GOOD. Here is what I found most interesting for our purposes>>> [that is, maybe we can extrapolate based on this "model" to what we know about XOMA - when did XOMA's phase III start?]
""The international trial, conducted at 30 centers, was initiated in September of 1996 and was designed with an interim analysis which would permit its early conclusion if a significant number of
patients were receiving clear benefit from Panretin Topical Gel treatment.
The protocol stated:
``If there is a large benefit for the active treatment it will be important to stop the trial early. Therefore one interim analysis will be undertaken. If the results show a clear benefit for the active
treatment they may be submitted to European Regulatory Authorities for early Product Registration.''
The interim analysis compared the response rates of the two treatment groups statistically to determine if the level of significance (``p value'') was 0.005 or less. If that level of significance had
not been reached, the trial would have continued to 270 patients as originally planned. However, the level of significance, ``p value'' of 0.00027 was reached triggering an early stop as permitted by the
protocol.
Results
Of 82 patients with biopsy confirmed KS, 36 received therapy with 0.1% Panretin(TM) Topical Gel and 46 were treated with placebo (vehicle gel with no active drug). Patients were seen for assessment at 2, 4, 8 and 12 weeks after trial entry and responses were defined using ACTG criteria applicable to topical therapy. After 12 weeks, patients could be enrolled in a separate open label protocol and be treated with Panretin Gel for up to nine additional months.
Forty-two percent (42%) of patients treated with Panretin Topical Gel had a complete or partial response as compared with 7% of patients treated with placebo.
Because the required level of significance in response was achieved, ALRT determined that Panretin Gel was active in the trial and new patients should no longer be enrolled. Patients currently enrolled
in the Allergan sponsored trial of Panretin Topical Gel will continue with their assigned treatment and, upon completion of the ``blinded'' phase, be allowed to enroll in the ``open label'' trial which
provides Panretin Topical Gel to all the patients in the trial without comparison to placebo.
In the U.S. Phase III pivotal trial of Panretin Topical Gel in KS sponsored by Ligand, patient accrual is complete and the treatment and follow- up evaluation of 268 patients is ongoing. ALRT does not
expect the positive results in the international trial to significantly interfere with the U.S. trial patient
follow-up now underway. |
