2021 In Review: Clinical Accomplishments

Despite the continuing challenges related to the pandemic, 2021 was a year filled with exciting progress for Cook MyoSite's clinical technologies.

AMDC Gets Its Generic Name

Cook MyoSite’s lead investigational product, heretofore referred to as Autologous Muscle Derived Cells (AMDC), received the generic name iltamiocel. Generic names are the official, trademarked names of drugs, devices, and other products that you might see on an ingredients list – for example, ibuprofen is the generic name for the product marketed under the brand names Advil and Motrin. Keep an eye out for the new name in 2022!

Clinical Trials

2021 was an exciting year for iltamiocel with promising results in trials for a number of different muscle-related disorders.

Cook MyoSite completed the first clinical study investigating iltamiocel for the potential treatment of fecal incontinence in 53 participants
Results from a study investigating iltamiocel for the potential treatment of Male Stress Urinary Incontinence were posted on clinicaltrials.gov
A manuscript was published from an interim analysis of an ongoing study investigating iltamiocel for the potential treatment of Tongue Dysphagia study
Our Expanded Access Program, which provides physicians with the opportunity to use iltamiocel outside of a clinical trial in patients with serious or life threatening conditions, was posted on Clinicaltrials.gov
Recruitment continued for the female stress urinary incontinence CELLEBRATE study, the largest clinical trial investigating iltamiocel to date. Enrollment information can be found at https://www.suiclinicalstudy.com/

Conferences

2021 was another shaky year for conferences due to pandemic-related cancellations and the challenges of virtual events, but Cook MyoSite was still able to attend a number of meetings to advocate for the next generation of muscle cell therapies. October, however, was a busy month with Cook MyoSite exhibiting at several conferences: Managing Vice President Ryan Pruchnic spoke at Meeting on the Mesa, the largest gathering of regenerative medicine industry leaders, sharing Cook MyoSite’s novel insights regarding muscle cell therapies. The following week, Cook MyoSite presented data from a study on the economic burden of failed SUI surgeries at AMCP Nexus 2021, an annual gathering of managed care decision-makers.

At the International Continence Society’s 2021 Annual Meeting, also in October, data from an interim analysis of a clinical trial investigating Cook MyoSite's iltamiocel for the potential treatment of fecal incontinence was presented. The abstract won Best in Category for Anorectal/Bowel Dysfunction.

Product Manager Michael Griffin at Cook MyoSite’s booth for the American Urogynecologic Society’s Pelvic Floor Disorders Week.

Just a month earlier, Cook MyoSite attended the American Urological Association’s 2021 Annual Meeting, where Dr. Melissa Kaufman (Vanderbilt University) and Dr. Michael Chancellor (William Beaumont Hospital) each presented data from Cook MyoSite’s largest clinical study to date, a Phase III trial investigating iltamiocel for the potential treatment of Female Stress Urinary Incontinence (SUI).

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