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