Therapeutics Receives MHRA Authorization to Carry Out Phase I
Clinical Trial in the UK for Topical CT327
on = May 30, 2007, 5:42 am
Release Author = creabilis
Release Summary = Colleretto Giacosa (Torino, Italy) May 30, 2007
– CREABILIS therapeutics SpA announced that
it has received authorization from the British Medicines
and Healthcare products Regulatory Agency (MHRA) to carry
out a Phase I Clinical Trial for CT327 in the UK.
Release Body = CT327 is a new chemical entity obtained
throughout the application of the CREABILIS proprietary
technology called “MiniPEGylation”,
based on the conjugation of small molecules with very low molecular
a 2 kDa PEG derivative of K252a, has shown very high efficacy in
animal models and an extremely favorable safety profile. It has
displayed strong antiproliferative activity on keratinocytes by
inhibiting the kinase activity of NGF receptor TrkA. The remarkable
kinase selectivity is the basis of the demonstrated negligible toxicity
new drug has also shown very low or minimal systemic absorption
after dermal administration. The target profile of the desirable
topical drug has thus been fully met. CT327 is
intended to be used for the topical treatment of psoriasis, dermatitis,
and other pathologies related to keratinocyte hyperproliferation.
and dermatitis are relevant skin disorders, impacting also patient’s
quality of life. These pathologies have a prevalence of over 3%
of the population with different levels of severity. All the patients,
even those treated with biologics, need topical treatment: practically
95% of patient population use topical drugs.
then represents a very promising drug with a highly competitive
position versus the current treatments.
Fumero, CEO of CREABILIS therapeutics, commented: “The
approval to enter Clinical Trial of CT327 is an
important achievement for CREABILIS. Considering
that we received the precursor molecule (K252a, kindly offered by
Cephalon Inc. under MTA) in November 2005, we have completed the
entire development for approval in 18 months. This demonstrates
the high efficiency and capability of CREABILIS
team to manage and coordinate the drug development process. We expect
to enter Phase I Clinical Trial in the UK very soon”.
Traversa, CSO of CREABILIS therapeutics, said: “This
is the first successful outcome of our MiniPEGylation technology.
We have other miniPEGylated derivatives in our R&D pipeline
and we strongly believe that they will reach similar successful
achievements based on their high kinase selectivity and outstanding
Conicella, General Manager of the Bioindustry Park del Canavese,
said: “I am very proud of this important result, because CT327
is the first candidate drug discovered and developed inside the
Park facilities. The scientific and technical support of the Park
has been certainly instrumental to the speed of development by which
CREABILIS has brought its molecule to clinical
About CREABILIS therapeutics SpA
CREABILIS therapeutics is an Italian biopharmaceutical
company discovering and developing new therapeutic candidates for
skin pathologies and related conditions with significant unmet medical
needs. Founded in 2003, CREABILIS is located in
the Bioindustry Park del Canavese, with a subsidiary laboratory
in Milano (Centro Cardiologico Monzino). CREABILIS therapeutics
is today strongly committed to exploit the potential of its discovery
assets and its know-how in the fields of inflammation, kinase inhibition,
and cytokine-chemokine networking, especially in, but not limited
to, dermal pathologies.
CT327 is the most advanced project entering now
Phase I. The early stage of this project was partially funded by
Regione Piemonte. Business development of CT327
is supported by Bio3 Reasearch, Milano. A second preclinical stage
asset, derived by the application of the MiniPEGylation
technology (CT335), is under development for the treatment
of Behçet's Disease as orphan drug. A third preclinical stage
project, in collaboration with Nautilus Biotech (Paris), is a mutated
HMGB1 Box A for the systemic treatment of infectious skin disorders
and Systemic Lupus Erythematosus. For more information, please visit:
Site = http://www.creabilistherapeutics.com
Details = Creabilis
Via Ribes 5
10010 Colleretto Giacosa (Torino) Italy
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