Peter, I'll post some notes on Metaphore this weekend.
I just posted PCYC's 1/5/04 press release announcing publication of their Phase III Xcytrin study in the Journal of Oncology here:
Message 19700204
I am totally new to PCYC, so I appreciate your warning about management's propensity for hiding bad news. The news from the brain metastases trial looks rather convincing to me though. There were 401 patients in the last Phase III trial. The endpoint, neurological progression, was reached at 7.4 mos. for placebo vs. 12 mos. for Xcytrin. That is more than a 4-month difference. Only a 2-month difference will be required for the pivotal trail.
The pivotal trial will have 500 patients, which they say is powered at a p-value of .001 to detect a 2 months' difference in time to neurological progression -- the clinical endpoint approved by the FDA in the Special Protocol Assessment. They claim that the new pivotal trial includes some improvements over the measurements made in the last Phase III trial and that they will be including some sicker patients this time around.
The CEO also promised good news-flow (hopefully a flow of good news too) throughout the coming year. To quote from his letter to stockholders, they "have launched several Phase 1 and 2 clinical trials evaluating Xcytrin either as a single agent or in combination with antibodies, radiation and/or chemotherapy for many cancers including lung, head and neck, prostate, breast, ovarian, primary brain tumors and lymphomas and leukemias." The company expects to present at AACR in April, at ASCO in June, at ASTRO in October, and at ASH in December. They expect to file another IND in oncology sometime this year.
The NCI is paying for a Phase II trial in glioblastoma (always nice to have someone else pay the bills). In the Phase I head and neck cancer study, 8 of 9 patients had a complete response.
I don't know what bad news was being omitted from the presentation, but there was a surfeit of good news.
Marc |
