The company will present updated, preliminary primary and new secondary endpoint data from the Phase 3 VISTA trial of Vicineum® for patients with high-risk non-muscle invasive bladder cancer who have been previously treated with bacillus Calmette-Guérin on Monday, May 13, 2019.
In January, Sesen Bio announced positive preliminary data from its ongoing Phase 3 VISTA trial, a single-arm, multi-center clinical trial designed to support the approval of Vicineum for the treatment of patients with high-risk, BCG-unresponsive NMIBC. The trial completed enrollment in the second quarter of 2018, with a total of 133 patients across three cohorts based on histology and time to disease recurrence after adequate BCG treatment. Cohort 1 enrolled 86 patients with Carcinoma in situ with or without papillary disease that was determined to be refractory or recurred within six months of their last course of adequate BCG. Cohort 2 enrolled seven patients with Carcinoma in situ with or without papillary disease that was determined to be refractory or recurred after six months, but less than 12 months, after their last course of adequate BCG. Cohort 3 enrolled 40 patients with high-risk papillary disease without Carcinoma in situ that was determined to be refractory or recurred within six months of their last course of adequate BCG.
Company management will host a conference call and webcast on Monday, May 13, 2019 at 8:00 a.m. EDT to review operating results for the first quarter ended March 31, 2019.
Stock influences and risk factors
If they are unable to raise capital when needed, they could be forced to delay, reduce or eliminate product development programs or commercialization efforts.
Limited operating history may make it difficult for stockholders to evaluate the success of the business to date and to assess future viability.
THEY are dependent on their lead product candidate, Vicineum for the treatment of high-risk NMIBC.
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