Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Pharmacyclics (PCYC) -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (470)	7/23/1999 10:42:00 AM
From: Biomaven	Read Replies (1) \| Respond to of 717

squetch, MZ: Here are some relevant quotes: "We are very excited about our phase Ib/II results," stated Richard A. Miller, M.D., president and CEO of Pharmacyclics. "A reduction in neurologic progression has been observed and recent discussions with the FDA indicate that either time to neurologic progression or survival would be an acceptable end point for approval in our phase III trial." Here's an extract from the Phase II results that describes how they determine neurological progression: An intent-to-treat efficacy analysis was performed on all 61 patients entered into the phase Ib/II trial. Although this was not a randomized trial, efficacy results were compared to historical controls using a 528 patient data base containing information on prognostic features and outcomes in patients with brain metastases receiving treatment with identical doses of radiation alone. A case matching method was used to insure that patients in the Gd-Tex treated and the historical control groups were similar with respect to known prognostic features. After 6 months and 12 months, 41% and 25% of Gd-Tex treated patients were alive compared to 30% and 14% of the controls respectively. Gd-Tex treatment was a statistically significant independent prognostic factor in determining survival (p=0.034). The effect of Gd-Tex treatment on neurologic progression was determined by comparing the causes of death in the treated patients to those of the control patients. Death due to tumor progression in the brain was seen in 15% of Gd-Tex treated patients compared to more than 35% in the control group. Also reported at ASTRO, were the results of an independent analysis comparing the survival of the Gd-Tex treated patients to patients treated with radiation therapy for brain metastases by the Radiation Therapy Oncology Group (RTOG), a large cooperative clinical research group in the U.S. In a case-matched control analysis performed by RTOG, it was possible to identify case-matched controls for 37 Gd-Tex treated patients. Gd-Tex treated matched patients had significantly increased survival compared to controls (p=0.05). At 6 months and 12 months, 54% and 30% of Gd-Tex treated matched patients were alive compared to 32% and 11% in the case-matched controls respectively. In RTOG studies, 49% of patients died due to tumor progression in the brain, compared to 15% of Gd-Tex treated patients as noted above. Finally, here is the Phase III protocol: PROTOCOL OUTLINE: This is a randomized, two stage, multicenter study. Patients are stratified according to RTOG recursive partitioning analysis class (RPA class 1 vs class 2) and tumor type (breast vs lung vs other). Stage 1 (lead-in): All patients receive gadolinium texaphyrin IV over 5-10 minutes on the 10 days that they receive radiotherapy. Approximately 2-5 hours later, patients undergo whole brain radiotherapy. Stage 2 (randomization): Patients are randomized to one of two treatment arms. Patients in arm I undergo whole brain radiotherapy for 10 days. Patients in arm II receive gadolinium texaphyrin and radiotherapy as in stage 1. Quality of life is assessed on days 10 and 28, then monthly for 5 months, and then every 3 months thereafter. Patients are followed at day 28, then monthly for 5 months, and then every 3 months until death. Incidentally, the PCYC web site now shows 26 sites open for enrollment in the Phase III, which started in September last year and will enroll 400 patients (200 per arm) in the randomized portion of the trial. Peter