tom,
non-maxamine stub
Not a very good sense. They have something like $8 in cash per share, plus the Cytovia stuff. There's also Maxamine in Hep C, which seemed promising.
Interestingly, their multivariate statistical analysis of the liver met subgroup came up with very different results than the FDA's statistician. Here's an extract from an earlier release:
Included in the data presented at the conference were results of multivariate analyses using the Cox Proportional Hazard Models to assess the influence of various demographic and other prognostic characteristics on the survival benefit observed for advanced melanoma patients treated with Maxamine. The results of these analyses further confirm the significance of the survival benefit provided by Maxamine to patients with liver metastases (p=0.0017), and strengthened the trend toward improved survival in all melanoma patients treated (p=0.0612).
Under the approved protocol and statistical analysis plan for the Phase III study, the Cox Proportional Hazard test was used to evaluate demographic characteristics and other known prognostic factors for advanced melanoma patients enrolled in the trial to determine if any such factors impacted the survival benefit observed with Maxamine. As would be expected for advanced metastatic melanoma patients, these analyses demonstrated that significant predictors of survival in the study were elevated lactate dehydrogenase (LDH) levels, baseline performance status, and metastatic sites in the bone, lung, liver or central nervous system. The overall results were then tested against these and other factors in a multivariate analysis to determine if the survival benefits attributable to Maxamine were in any way influenced by differences in the baseline characteristics or prognostic factors within the two randomized arms of the study. These analyses demonstrated that there were no factors that significantly influenced one treatment group over the other, and that the two groups were well balanced with regards to risk factors.
In the primary population within the Phase III study consisting of all patients randomized into the trial with metastasis of the melanoma to their liver, multivariate analysis using the Cox's Proportionate Hazard Model adjusted for all significant prognostic variables or baseline characteristics demonstrated that treatment with the Maxamine combination significantly improved survival over the control arm (p=0.0017). The highly significant results of the multivariate analyses demonstrate that the significant improvement in survival reported for the Phase III trial did not result from differences in demographic or prognostic characteristics between the Maxamine and control arms of the study. In the primary population consisting of all patients randomized into the trial, the multivariate analysis again demonstrated that the Maxamine survival benefit was attributable to the treatment effect of the drug, and resulted in improved survival over the control arm with a strong trend toward significance (p=0.0612). The results of the multivariate analyses demonstrate that adjusting the survival data from the trial for the prognostic or demographic factors within the patient populations provides further confirmation that the Maxamine survival benefit observed in the study did not result from any differences in such factors. Moreover, these same tests were used to determine if any one particular center or region had an influence on these results. These analyses demonstrated that no single center or geographic region had any significant influence on the trial results.
"The multivariate analyses were part of our approved statistical plan, and these results are included in the recently filed New Drug Application," said Kurt R. Gehlsen, Maxim's Senior Vice President, Development and Chief Technical Officer. "These analyses are important as they help us ensure that the strong results from our Phase III trial are related to the effect of Maxamine as an adjuvant, as opposed to resulting from any differences in geographic region, demographics or known prognostic factors within the treatment arms. These multivariate analyses further strengthen our assessment of the Phase III study results and the benefits of Maxamine demonstrated in the study. It is notable that this Phase III study is the only large, randomized, multi-center, well-controlled trial ever conducted to demonstrate a significant survival benefit in advanced metastatic melanoma."
I don't know enough statistics to reconcile the difference. I sometimes think statistics is harder to understand properly than immunology. <g>
Peter |
