27 October 2022

Muvon Therapeutics announces First Patient Enrolled in Phase II Clinical Study



 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:

More information about the trial:





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