Phase III study: AES-14 in @entity1 at risk for mucositis secondary to XXXX -based chemotherapy.

@entity1 @entity3136 @entity0 @entity5948 @entity9640 @entity7366
UNASSIGNED: 8008 Background: @entity3136 ( @entity3136 ) limits chemotherapy dosing and increases health care costs. AES-14 (Saforis) enhances direct oral mucosal cell uptake of @entity9640 by the Aesgen UpTec system. Prior AES-14 studies in chemotherapy @entity1 suggested safe, effective reduction (20%) of clinically significant @entity3136 . METHODS: A randomized, double-blind, placebo-controlled crossover multicenter trial was conducted in @entity0 @entity1 receiving at least 3 cycles of an @entity5948 regimen (AC, CAF or @entity7366 ). @entity1 developing WHO Grade (Gr) 2-4 @entity3136 during screening cycle were randomized for crossover in 2 subsequent cycles. Study drug began 1st day of chemotherapy and continued 14 days after last chemotherapy dose or 5 days after @entity3136 resolved. Safety was assessed by Adverse Event (AE)/Serious AE evaluations. Primary endpoint analysis compared proportion of @entity1 with >=  Gr 2 @entity3136 while on AES-14 versus placebo. Secondary endpoints included @entity3136 duration and @entity3136 Assessment Scale outcomes. RESULTS: 2,064 female @entity1 were screened for @entity3136 >=  WHO Gr 2. 326 @entity1 (mean age 51 years) were randomized (15.7% @entity3136 rate). Peak @entity3136 was primarily WHO Gr 2. No significant randomization imbalances occurred. Comparison of treatment versus placebo outcomes in crossover design requires that no significant drug treatment carryover effect exists. AES-14 administered during 1st treatment cycle reduced >=  Gr 2 @entity3136 incidence in the placebo 2nd treatment cycle (p=0.0269). This carryover effect invalidated crossover efficacy comparison. Primary endpoint analysis thus compared parallel group treatment during 1st cycle only. Incidence of clinically significant @entity3136 (WHO Gr 2-4) was 22% less with AES-14 versus placebo (p=0.0261). No AES-14-related SAEs and 2 placebo-associated SAEs were reported. CONCLUSIONS: AES-14 reduced incidence of 1st cycle Gr 2-4 @entity3136 by 22% in these chemotherapy @entity1 . The significant AES-14 carryover effect suggests that optimizing mucosal repair during one cycle may protect @entity1 from @entity3136 during subsequent chemotherapy. Supported by Aesgen Inc. [Table: see text].
