iCo Therapeutics Announces Completion of Phase 1b Oral Amphotericin B Study Dosing and Follow Up
8:02 am ET February 10, 2020 (Newsfile) Print
Vancouver, British Columbia--(Newsfile Corp. - February 10, 2020) - iCo Therapeutics Inc. (TSXV: ICO) (OTCQB: ICOTF) ("iCo" or "the Company") and its subsidiary, iCo Therapeutics Australia Pty Ltd., announced today that all subjects in its Phase 1b study have received doses of Oral Amphotericin B (either 100mg and 400mg/day) over ten days and, subsequent to dosing, have been followed up for an additional ten days. Full results of the Phase 1b study are currently expected before the end of Q1 2020.
Stated Dr. Peter Hnik, Chief Medical Officer of iCo, "Results from the Phase 1b study using multiple ascending doses of oral Amphotericin B will provide additional safety and pharmacokinetic information needed for the upcoming Phase 2 clinical study in patients with vulvovaginal candidiasis ("VVC").
According to Denning et al, "Worldwide, recurrent vulvovaginal candidiasis affects about 138 million women annually (range 103-172 million), with a global annual prevalence of 3871 per 100?000 women; 372 million women are affected by recurrent vulvovaginal candidiasis over their lifetime. The 25-34 year age group has the highest prevalence (9%). By 2030, the population of women with recurrent vulvovaginal candidiasis each year is estimated to increase to almost 158 million, resulting in 20,240,664 extra cases with current trends using base case estimates in parallel with an estimated growth in females from 3·34 billion to 4·181 billion. In high-income countries, the economic burden from lost productivity could be up to US$14·39 billion annually."*
A Phase 2 study comparing oral Amphotericin B to fluconazole in a head-to-head study in vulvovaginal candidiasis is currently expected to commence in Q2 2020.
A number of additional indications, that may also be difficult and impractical to treat using intravenous formulation, are expected to be explored (active treatment and prevention) in the near future.
iCo also announces that the Company has also engaged Proconsul Capital ("Proconsul") for investor relations activities. Proconsul will be paid $8,000 CDN, excluding taxes, on a month-to-month basis.
