Glycotope's Fully Human and Glycooptimized Recombinant FSH-GEX(TM) Showed Superior Activity and Excellent Tolerability in a Phase II Clinical Trial for In Vitro Fertilisation
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Glycotope GmbH /
Glycotope's Fully Human and Glycooptimized Recombinant FSH-GEX(TM) Showed
Superior Activity and Excellent Tolerability in a Phase II Clinical Trial for In
Vitro Fertilisation
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Berlin, Germany, November 18th, 2013 - Glycotope GmbH, a global leader in
developing therapeutic antibodies targeting glycosylated epitopes on cancer
cells and optimizing the sugar chains (glycosylation) of biopharmaceuticals,
today announced results from the Phase II clinical trial with FSH-GEX(TM) for
Assisted Reproductive Technologies. Results showed that FSH-GEX(TM) has superior
activity and excellent tolerability when compared to the standard treatment
Gonal-f®. FSH-GEX(TM) is the first fully human glycosylated FSH (follicle-
stimulating hormone), recombinantly expressed in human cells and glycooptimized
to mimic endogenous human FSH.
The Phase II, multicenter, multinational, randomized clinical trial investigated
the efficacy and safety of varying doses and schedules of FSH-GEX(TM) in
comparison with daily 150 IU Gonal-f® in 247 women undergoing artificial
insemination by intracytoplasmic sperm injection (ICSI) treatment in an agonist
protocol. FSH-GEX(TM) was tested in five dose cohorts, 52.5 IU, 75 IU, 112.5 IU
and 150 IU daily doses, and 150 IU given every second day, compared to the
standard daily dose of 150 IU Gonal-f®.
The data show that FSH-GEX(TM), even at half the biologic dose (75 IU FSH-
GEX(TM)), is at least as active as Gonal-f (150 IU) in all FSH mediated
parameters and endpoints. These data confirm the superior preclinical, Phase Ia
and Ib data regarding biological activity and clinical efficacy.
For example, the FSH-GEX(TM) dose of 112.5 IU, showed superiority over all FSH
mediated aspects and endpoints compared to a 33% higher Gonal-f® standard dose
including follicular response, as well as high biochemical (57.5%) and ongoing
(50.0%) pregnancy rates. Particularly important for future clinical use are the
statistically significantly improved numbers of retrieved oocyte complexes
(+29.5%) and high quality metaphase II oocytes (+24.5%), as well as a strong
trend for more pronuclear (PN) 2 oocytes (+21%) which could be observed in this
dose regimen.
Furthermore, the results at a dose regimen with 150 IU FSH-GEX(TM) applied every
second day and 75 IU FSH-GEX(TM) administered on a daily basis were fully
comparable, allowing for a flexible or alternative dosing regimen with the same
product.
The treatment with FSH-GEX(TM) was safe and very well tolerated, while Gonal-f®
showed the highest rate of OHSS (Ovarian hyperstimulation syndrome) during the
trial. No inductions of anti drug antibody (ADA) responses were observed in
FSHGEX(TM) patients.
"FSH-GEX(TM) is the first of our glycooptimized, fully human non-antibody
molecules validating our unique GlycoExpress(TM )platform and proving our
commitment to delivering better, clinically superior therapies combined with
commercially attractive terms," said Dr. Steffen Goletz, CEO, CSO and Founder of
Glycotope. "The superior activity and improved properties of FSH-GEX(TM), which
allows for lower FSH doses and the significantly improved numbers of high
quality mature oocytes that can be achieved for in vitro fertilisation, are seen
as a key driver for best clinical performances. These results strongly indicate
not only a high relevance of FSHGEX(TM) in the tested broad patient cohort but
also yield hope for women whose ovaries are particularly hard to stimulate and
who are experiencing major difficulties in becoming pregnant. We are excited
about these results and anticipate starting Phase III clinical trials in 2014,"
he added.
About FSH and In Vitro Fertilisation
The follicle-stimulating hormone (FSH) is responsible for follicle maturation.
Its main clinical use is administration during the onset of in vitro
fertilization procedures t induce maturation of multiple oocytes for retrieval.
Currently, approved preparations of FSH originate from either human urine or
recombinant sources from non-human cells. While urinary versions of FSH carry a
heterogeneous but human glycosylation, the generally better biological safety of
recombinant products makes them the product of choice for most patients, despite
a non-human glycosylation profile and higher product costs associated with the
treatment.
Glycotope's glycooptimized and fully human version of FSH, FSH-GEX(TM), combines
the advantages of both product types into one single product and adds efficacy
advantages. The aim of the program was to generate a BioSuperior molecule
mimicking the FSH of a healthy woman. Using GlycoExpress(TM), which allows for
fully human glycosylation and optimization of this process, FSH-GEX(TM) showed
an improved activity in human in vitro assays as well as in the first trials and
superior production yields and reproducibility of quality by production in
GlycoExpress(TM). It thereby provides the safety advantages of a recombinant
protein with the advantages of a fully human glycosylation and an optimized
glycosylation.
About Glycotope
Glycotope, founded 2001 in Berlin, focuses on the development of innovative
antibodies for the treatment of various cancer types. These GlycoBodies(TM)
target glycostructures or carbohydrate-peptide mixed epitopes on cell surfaces.
In addition, Glycotope develops so-called BioSuperiors, antibody and non-
antibody recombinant biopharmaceuticals with optimized and fully human sugar
structures for clinical superiority. Key to the glycooptimization technology is
a toolbox of glycoengineered proprietary human cell lines that allow the
glycooptimization of proteins in respect to a whole series of different
determining sugars and is based on fully human glycosylation. GlycoExpress(TM)
allows the selection of the most appropriate and best suitable human glycoform
of a product and a high yield production superior in reproducibility, quality
and yield. Glycooptimization via GlycoExpress(TM) provides improved efficacy,
bioavailability, immunogenicity and broadens the potential patient populations
and indications, as well as providing a much improved cost-effectiveness.
Glycotope has currently four products in clinical development from late stage
Phase I to late stage Phase II. The Company's additional pipeline includes
preclinical non-antibody and antibody biopharmaceuticals for various
indications.
Together with its subsidiary, Glycotope Biotechnology in Heidelberg, Glycotope
has evolved into a leading fully integrated glycobiology company, covering the
entire workflow from discovery, molecule optimization, clone and process
development, preclinical and clinical drug development to GMP production. With
more than 160 employees and a strong, broad IP-platform, Glycotope today is one
of the largest biotechnology companies in Germany.
Contact:
Glycotope GmbH
Dr. Franzpeter Bracht, CFO & CBO
Robert-Roessle-Str. 10, D-13125 Berlin, Germany
Phone: +49-(0)30 94 89-2600
Fax: +49-(0)30 94 89-2609
Email: Franzpeter.Bracht(at)glycotope.com
Website: www.glycotope.com
Press Release PDF:
http://hugin.info/157017/R/1743809/586693.pdf
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Source: Glycotope GmbH via Thomson Reuters ONE
[HUG#1743809]
Unternehmensinformation / Kurzprofil:
Datum: 18.11.2013 - 08:58 Uhr
Sprache: Deutsch
News-ID 317438
Anzahl Zeichen: 8575
contact information:
Town:
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Kategorie:
Business News
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