Muvon
Therapeutics AG, an innovative clinical-stage biotechnology company, today
announced that the first patient with Stress Urinary Incontinence has been
enrolled as part of the planned Phase II clinical trial (SUISSE MPC
2-Study) using its novel proprietary cell therapy platform.
This is a randomized blinded
clinical study, evaluating the safety and efficacy of a low and high dose
of autologous skeletal muscle precursor cell injections into the urethral
sphincter muscle of women living with stress urinary incontinence (SUI)
with the goal of restoring strength and function. An earlier Phase I study presented at the International
Continence Society (ICS) Annual Meeting 2022 in Vienna,
Austria, demonstrated the safety, feasibility and potential efficacy. No
serious adverse events or unexpected adverse events were observed.
This Phase II study is funded
through the University of Zurich with further support from the Wyss Zurich translational center.
Deana Mohr, PhD, CEO and
co-founder stated: "The goal of the study is to evaluate the efficacy
of a novel treatment for SUI in women, with a unique mechanism of action,
using their own muscle precursor cells to regenerate the urinary sphincter
muscle. This minimally invasive therapy offers significant differentiation
with ease of administration and patient tolerability relative to the
standard of care including bulking agents, slings and meshes with related
surgical complications."
Jenny Prange, PhD, CSO and
co-founder of Muvon Therapeutics, added: "We have made tremendous
progress with our qualified and validated manufacturing process to
facilitate the production of patient-specific muscle precursor cells to
enable this study."
Dr John Coelho, Medical Affairs
Leader, concluded: "We remain on schedule with our comprehensive
clinical development program milestones to advance this novel therapy which
has drawn considerable interest from the international research, medical
and most importantly, the patient community."
A sufficient number of patients
will be enrolled to complete the study with 70 evaluable patients. Patients
will participate in the study for up to approximately 9 months, and include
a baseline visit for screening, a visit for a muscle biopsy, an injection
of muscle precursor cells, and follow-up visits after 1, 3 and 6-months
post-injection. All patients will be treated with one of the two doses
assigned according to the study's randomization plan. A core study team and
an independent Data Safety Monitoring Board have been established drawn
from leading international centers of excellence to oversee the safety
aspects of this trial.
To provide potential study
participants with the opportunity to learn more about this Phase II
clinical trial, Muvon Therapeutics is collaborating with admedicum, a company
specializing in patient engagement. Together with a qualified patient expert,
admedicum has created a study website where patients can find adequate
information about the study, pre-check their eligibility for study
participation, and personal support via a patient information service: www.muvon-trials.ch
More information about the
trial: https://clinicaltrials.gov/ct2/show/NCT05534269
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