dm+d

Unassigned

New Medicines

Mild-to-moderate stress incontinence in women - second-line

Information

New molecular entity
Innovacell Biotechnologie
Not Known

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Dec 20According to the Innovacell website, since 2019, the company has been supported by Japanese investors in order to advance clinical development for the Asian region, especially Japan. Development appears to be continuing in the EU, US and Japan (pre-clinical testing in US and Japan) [9].
Apr 20No information is available on the Innovacell website on development of ICES13. Since no update has been made to the EU trials register, it is unclear whether development is continuing [8].
Mar 15PIII trial ongoing [3]; results expected end 2015 [4]
Jun 13EU filing will be via the centralised procedure [2].
May 12PIII trial commences in the EU [2].

Category

An autologous myoblast cell-based therapy which is thought to result in functional improvement of the female urethral closure mechanism
UK prevalence rates of urinary incontinence are between 5-69% in women [1].
Mild-to-moderate stress incontinence in women - second-line
Implantation

Trial or other data

Apr 20A second PIII trial has also been conducted. This was initiated in Apr 2010, to compare the efficacy and safety of the cell therapy and placebo in patients with SUI (IC-01-01-05-005; EudraCT2009-016597-32). In March 2012, the study was completed in Germany and Czech Republic and enrolled 550 patients whereas it is ongoing in Poland and Bulgaria. The trials entry has not been updated to state whether the trial is complete in Poland and Bulgaria [6,7].
Apr 20PIII INNOVATION trial (EudraCT2010-021871-10)) appears to have completed, but no information is accessible on when this occurred. There are also no results posted [5].
May 12PIII INNOVATION (EudraCT2010-021871-10) trial begins enrolling 372 women aged ≥ 18 years with grade 2 or 3 stress incontience. patients will be randomised to a single injection of ICES 13 or placebo, both via intramuscular (IM) injection. Follow-up will be after two years. The primary outcome is responder rate defined as reduction in incontinence episode frequency (IEF), SUI complaints measured by I-QoL score. Secondary outcomes include I-QoL score, IEF score, short pad test resultsc, visual analogue scale (VAS) score, clinical global impression score (CGI) and safety. Results are expected Q2 2014 [1].
May 12The procedure involves taking activated autologous myoblast cells from a muscle biopsy sample and implanting them in two rows in a circumferential manner over the entire volume of the external sphincter of the urethra. The implantation of these cells is to add to the skeletal muscle bulk directly and also to encourage the regeneration of sphincter muscle cells [1].

Evidence based evaluations