Here is a template for letting investors know what's really happening with their money -- in case Xoma misplaced theirs during the move to Bermuda.
biz.yahoo.com
Excerpt:
"The results show that the immunomodulating agent Maxamine used in combination with a lower dose regimen of interleukin-2 (IL-2), improved survival for stage-IV malignant melanoma patients compared with those treated with the same doses of IL-2 alone.
Treatment with Maxamine and IL-2 improved overall survival, increased survival rates at 12, 18 and 24 months, and improved time-to-disease-progression over treatment with IL-2 alone. As previously reported, improvement in survival was statistically significant in patients having metastases of their melanoma to the liver, a patient population that historically has had a very poor prognosis, and in all subgroups analyzed under the approved statistical plan. The results from the 305-patient study will be presented today by Sanjiv S. Agarwala, M.D., lead-enrolling investigator for the study and associate medical director of the Melanoma Center at the University of Pittsburgh Cancer Institute.
Included in the new data to be presented at the conference is the fact that 24-month survival occurred in a total of 25% of patients treated with Maxamine and lower-dose IL-2, compared with 17% in those treated with lower-dose IL-2 alone. Published reports indicate that the 24-month survival for patients treated with the approved, high-dose, regimen of IL-2 is 12%.
In addition, overall response was achieved in 38% of the patients treated with Maxamine and lower-dose IL-2, compared with 28% in those treated with the same dose of IL-2 alone.
``The patients in this study represented a group with factors that are indicative of a poor prognosis for survival, including a large percentage of patients with liver metastases,'' explained Dr. Agarwala. ``This is the first well-controlled, multi-center Phase III trial to show a significant increase in survival among patients with advanced metastatic melanoma.''
Achievement of Primary Endpoint
The company also reported that the study had achieved a primary endpoint required to support global applications for registration. The primary endpoint of the Phase III trial under the prospective statistical plan was survival duration evaluated by comparing Kaplan-Meier survival curves using the Log-Rank statistical method. With the achievement of statistically significant survival improvement in the liver metastases population, and the attainment of survival improvement tending toward significance in the overall population, the study results meet the requirements established in advance for regulatory submissions seeking
marketing approval in the United States, Europe and other key markets." |
