of their Third Quarter Results conference call.
My summary, so take it for what it's worth.
Highlights from their further analysis of Phase IIb Data
• Number of enhancing lesions in Tovaxin arm was more than twice that of the placebo group at study initiation.
• Made it difficult to achieve statistical significance on primary and secondary endpoints
• Annualized Relapse Rate (ARR) shown is 0.21, which is on the lowest end of all available drugs which range from 0.2 to 0.9, and consistent with prior Tovaxin results.
• Designed study to include many patients with >1 ARR to match earlier Tovaxin studies, where they appeared to have a better response to treatment. Wanted to be able to compare data.
• Focus on sub-group of 50 patients who have an ARR greater than 1.0. Cannot show statistical significance with this group but there are encouraging, non-random results.
◦ Topline data from IIb showed this group to have the largest reduction in relapse rate at .55 reduction in relapses per year across the whole study.
◦ Analyzed clinical, MRI and immunology data to see if there is correlation in this data.
▪ Most significant new data-Patients demonstrated a statistically significant improvement in disability on EDSS scores. P-value of 0.045. 28.1% of patients on Tovaxin showed improvement in EDSS vs. 5.6% in placebo group.
▪ Combined with an ARR of 0.28 in this patient population shows a strong clinical benefit.
▪ On timed 25' walk quality of life measurement, Tovaxin showed 0.14 vs. -0.02 for placebo. Reflective of fatigue benefitting Tovaxin.
▪ Because it is a small sub-group, they do not believe they will be able to show statistical significance with this sub-group, but because all measurements appear to favor Tovaxin, it suggests the results are not random and favor a strong and positive trend.
▪ Analysis showed that patients on Tovaxin showed improvement on all primary, secondary, and tertiary endpoints.
▪ Primary endpoint of cumulative number of enhancing lesions-24% improvement over placebo
▪ Secondary endpoint of cumulative number of new enhancing lesions-22% improvement.
▪ Tertiary endpoint of brain reduction. Tovaxin showed 88% reduction (improvement) in brain atrophy vs. placebo (-0.04 Tovaxin vs. -0.32 placebo), which could indicate a further neuro-protective effect of Tovaxin. Being investigated and will work with Myelin Research Foundation to assess.
▪ Looked at number of Gad enhancing lesions that progressed to black holes. >20% reduction in number that progressed.
▪ 60% greater improvement in absolute change in T2 lesions volume.
◦ Superb safety profile. No serious adverse events associated with Tovaxin treatment, which includes all 150 patients in IIb. Patient compliance will be better addressed with Tovaxin than any currently available therapy.
▪ Currently monitoring reactivity of 109 peptides across 3 proteins. All three proteins are broadly present in MS patients.
▪ They have been able to map Myelin t-cell reactivity over time vs. these peptides over 150 patients to map and are starting to compare these changes with their clinical and radiological data for correlation. First time that any study has been able to accomplish this.
▪ Initial analysis shows that patients on Tovaxin appear to have less myelin peptide reactivity vs placebo.
▪ Following the full course of treatment in "efficacy period of weeks 28-52", ARR dropped to 0.065 Tovaxin vs. 0.749 placebo.
▪ Pattern suggests that patients with higher t-cell reactivity showed worsening of MRI and clinical outcomes. With higher peptide reactivity there seems to be an increase across at least one MRI endpoint and clinical endpoint and converse appears to be true as well.
◦ Much information to be analyzed.
• Looking for potential partner and are keen to acquire an experienced partner to assist in design and execution of Phase III clinical trial.
• Cash position takes them into early 2009.
• Looking at strategic partnership, possible financing, or possible merger and acquisition activity to go forward.