TiGenix: TiGenix starts Cx601 Marketing Authorisation Application process
(Thomson Reuters ONE) -
PRESS RELEASE
TiGenix starts Cx601 Marketing Authorisation Application process
Letter of intent submitted to the European Medicines Agency
Leuven (BELGIUM) - 11 June, 2015 -TiGenix NV (Euronext Brussels: TIG), an
advanced biopharmaceutical company focused on developing and commercialising
novel therapeutics from its proprietary platform of allogeneic, expanded
adipose-derived stem cells, or eASC's, in inflammatory and autoimmune diseases,
announced today that it has submitted to the European Medicines Agency (EMA) a
letter of intent to file, and a request for the assignment of Rapporteur/Co-
Rapporteur, for the Marketing Authorisation Application (MAA) of Cx601 in the
treatment of complex perianal fistulas in patients with Crohn's disease.
The letter of intent, which must be filed at least seven months prior to the
submission of a MAA, initiates a process to address a number of pre-submission
requirements, including the assignment of a Rapporteur and Co-Rapporteur, who
are members of the Committee for Advanced Therapies (CAT), and two Co-ordinators
from the Committee for Human Medicinal Products (CHMP). For advanced-therapy
medicines, CAT prepares a draft opinion on the product's quality, safety and
efficacy, based on which the CHMP adopts a final opinion.
In parallel, TiGenix has submitted the request in order to be eligible for the
centralised procedure for the approval of medicinal products in the European
Union (EU). Cx601 falls within the mandatory scope of the procedure because it
is an Advanced Therapy Medicinal Product and an Orphan-designated product.
Confirmation of eligibility by the EMA does not necessarily mean that the EMA
will approve the MAA. For eligible drugs, the centralised procedure offers the
benefit of only having to submit a single marketing application to the EMA. If
approved, a drug can then be marketed in all EU member countries, as well as in
Iceland, Liechtenstein and Norway, instead of having to seek approval in each
country, thereby reducing the time to market.
"This is a key step in the potential submission of Cx601 for marketing
authorisation in Europe for the treatment of complex perianal fistulas in
patients with Crohn's disease" said María Pascual, VP Regulatory Affairs and
Corporate Quality at TiGenix. "It represents another important milestone,
achieved according to plan, to bring Cx601 to Crohn's disease patients in
Europe."
Cx601 is currently completing a randomised, double-blind, placebo-controlled
Phase III trial in Europe and Israel designed to comply with the requirements
laid down by the EMA. TiGenix expects to receive the first clinical report
during the third quarter of 2015. With positive results, the Company intends to
submit a request for marketing authorisation with the EMA in early 2016.
For more information:
Richard Simpson
Senior Consultant, Comfi sprl
T: +32 494 578 278
richard(at)comfi.be
About Cx601
Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASCs)
delivered locally through intra-lesional injection. Cx601 is being developed for
the treatment of perianal fistulas in Crohn's disease patients. Crohn's disease
is a chronic inflammatory disease of the intestine and patients can suffer from
complex perianal fistulas for which there is currently no effective treatment.
In 2009, the European Commission granted Cx601 orphan designation for the
treatment of anal fistulas, recognising the debilitating nature of the disease
and the lack of treatment options. In a Phase II clinical trial, Cx601 showed
efficacy at 24 weeks in 56% of treated fistula tracts, which is more than two
times higher than the current standard of care (TNF inhibitors). Efficacy was
measured as the complete closure and re-epithelisation of the fistula being
treated with an absence of drainage. Additionally, 69.2% of patients
demonstrated a reduction in the number of initially draining tracts. The trial
also confirmed the safety of the use of allogeneic stem cells for the treatment
of perianal fistula. Based on these results, TiGenix sought scientific advice
from the European Medicines Agency (EMA) on the future development path of
Cx601. TiGenix then initiated a randomised, double-blind, placebo-controlled
Phase III trial in Europe and Israel designed to comply with the requirements
laid down by the EMA. 'Madrid Network', an organisation within the Autonomous
Region of Madrid which helps companies to grow through high-technology
innovation, issued a soft loan to help finance this Phase III study. The
programme is funded by The Secretary of State for Research, Development and
Innovation (Ministry of Economy and Competitiveness) within the framework of the
INNTEGRA plan. This pivotal study is intended to enable filing for marketing
authorisation in Europe and to serve as a key supportive study in filing for
approval in other territories, including the US. The study's primary endpoint is
closure of all treated external openings draining at baseline despite gentle
finger compression confirmed by MRI (no collections > 2cm). The trial has a
first complete analysis of results at 24 weeks, with a follow-up analysis to be
performed at 52 weeks post-treatment. Recruitment of the whole sample of
patients was completed in the fourth quarter of 2014. The first clinical report
is expected to be available in the third quarter of 2015. With positive results,
TiGenix intends to submit a request for marketing authorisation with the EMA
early in 2016. TiGenix is preparing to develop Cx601 for the US market. The
company has filed for a Special Protocol Assessment (SPA) by the Food and Drug
Administration (FDA) to ensure that the design of a new Phase III study to be
conducted in the US is aligned with the FDA's requirements for the future
approval of Cx601. The company has appointed Lonza as its contract manufacturing
organisation (CMO) for the clinical development of Cx601 in the US.
About TiGenix
TiGenix NV (Euronext Brussels: TIG) is an advanced biopharmaceutical company
focused on developing and commercialising novel therapeutics from its
proprietary platform of allogeneic, or donor-derived, expanded adipose-derived
stem cells, known as eASCs, in inflammatory and autoimmune diseases. Two
products from this technology platform are currently in clinical development.
Cx601 is in Phase III for the treatment of complex perianal fistulas in Crohn's
disease patients. Cx611 is in Phase IIb for early rheumatoid arthritis, and in
Phase Ib for severe sepsis. TiGenix also developed ChondroCelect, an autologous
cell therapy product for cartilage repair of the knee, which was the first
Advanced Therapy Medicinal Product (ATMP) to be approved by the European
Medicines Agency (EMA). From June 2014, the marketing and distribution rights of
ChondroCelect have been exclusively licensed to Sobi for the European Union
(except for Finland, where it is distributed by the Finnish Red Cross Blood
Service), Norway, Russia, Switzerland and Turkey, and the countries of the
Middle East and North Africa. TiGenix is headquartered in Leuven (Belgium) and
has operations in Madrid (Spain). For more information, please
visit www.tigenix.com
Forward-looking information
This document may contain forward-looking statements and estimates with respect
to the anticipated future performance of TiGenix and the market in which it
operates. Certain of these statements, forecasts and estimates can be recognised
by the use of words such as, without limitation, "believes", "anticipates",
"expects", "intends", "plans", "seeks", "estimates", "may", "will" and
"continue" and similar expressions. They include all matters that are not
historical facts. Such statements, forecasts and estimates are based on various
assumptions and assessments of known and unknown risks, uncertainties and other
factors, which were deemed reasonable when made but may or may not prove to be
correct. Actual events are difficult to predict and may depend upon factors that
are beyond the Company's control. Therefore, actual results, the financial
condition, performance or achievements of TiGenix, or industry results, may turn
out to be materially different from any future results, performance or
achievements expressed or implied by such statements, forecasts and estimates.
Given these uncertainties, no representations are made as to the accuracy or
fairness of such forward-looking statements, forecasts and estimates.
Furthermore, forward-looking statements, forecasts and estimates only speak as
of the date of the publication of this document. TiGenix disclaims any
obligation to update any such forward-looking statement, forecast or estimates
to reflect any change in the Company's expectations with regard thereto, or any
change in events, conditions or circumstances on which any such statement,
forecast or estimate is based, except to the extent required by Belgian law.
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: TiGenix via GlobeNewswire
[HUG#1927692]
Unternehmensinformation / Kurzprofil:
Bereitgestellt von Benutzer: hugin
" alt="Aurora Solar Technologies and SEMCO Group announce strategic partnershipDatum: 11.06.2015 - 07:00 Uhr
Sprache: Deutsch
News-ID 399693
Anzahl Zeichen: 10839
contact information:
Town:
Leuven
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 144 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"TiGenix: TiGenix starts Cx601 Marketing Authorisation Application process"
steht unter der journalistisch-redaktionellen Verantwortung von
TiGenix (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
