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2015-04-08

TiGenix: USPTO issues key US patent to TiGenix for the use of adipose-derived stromal cells in the treatment of fistulas

PRESS RELEASE

USPTO issues key US patent to TiGenix for the use of adipose-derived stromal
cells in the treatment of fistulas

Leuven (BELGIUM) - 8 April, 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 in inflammatory and autoimmune diseases, announced
today that the United States Patent and Trademark Office (USPTO) has issued
US Patent
8,999,709
relating to the use of an adipose-derived stromal cell population in the
treatment of fistula. The patent, entitled "Use of adipose tissue-derived
stromal stem cells in treating fistula", expires in 2030 and provides
coverage for the company's lead development product, Cx601, in the key US
market.

"The issuance by the USPTO of this patent is a key achievement in our strategy
for the development and commercialisation of Cx601 in the American market",
said Wilfried Dalemans, Chief Technical Officer of TiGenix. "It further
builds our intellectual property position in the use of eASCs in the
indication we are pursuing. As such, it is an essential component of the
business case for making the product available to patients in the US."

The issuance of this patent further strengthens TiGenix's intellectual
property portfolio of 24 patent families which now includes 15 granted
patents related specifically to its eASC platform. The pending and granted
patents in TiGenix's intellectual property portfolio include patent families
that are directed to its eASC platform; more specifically, to eASC
compositions and therapeutic applications as well as to cell therapy delivery
mechanisms and other eASC technology improvements.

Cx601 is a solution of expanded adipose-derived stem cells (eASCs) for local
injection currently in Phase III of clinical development for the treatment of
complex perianal fistulas in patients with Crohn's disease. Clinical results
from the on-going European Phase III trial are expected in the third quarter
of 2015. Following the positive feedback received at a meeting with the
Center for Biologics Evaluation and Research within the Food and Drug
Administration (FDA), TiGenix is moving ahead with the development of Cx601
for the United States market. The Company has submitted to the FDA the
required documentation for a Special Protocol Assessment (SPA) of its pivotal
Phase III trial design for Cx601 in the treatment of complex perianal
fistulas in patients with Crohn's disease in the United States. Agreement
with the FDA on the SPA will ensure that the trial design is aligned with the
FDA's requirements for the future approval of Cx601. The Phase III trial in
the US, if successful, together with positive data from the European Phase
III trial, would enable the Company to file a biologics license application
(BLA) with the FDA. The Company expects to complete the process of
manufacturing technology transfer to its US-based contract manufacturing
organisation (CMO), Lonza, in the first half of 2016, after which the Phase
III trial of Cx601 in the US can begin.

For more information:

Richard Simpson
Senior Consultant, Comfi sprl
T: +32 494 578 278
richard@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.

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: TiGenix via Globenewswire

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