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DeveloGen Announces Completion of a Phase 1 Clinical Trial of DG3173, a Novel Somatostatin Analogue for the Treatment of Acromegaly

Goettingen, Germany - October 8th, 2008: DeveloGen AG, a privately
held biopharmaceutical company developing novel therapeutics for the
treatment of metabolic and endocrine diseases announced today that it
has completed a Phase 1 trial of DG3173, also known as Somatoprim.
DG3173 is a novel somatostatin analogue for potential treatment of
acromegaly, carcinoid tumours as well as diabetic retinopathy. In
this Phase 1 study DG3173 was generally well tolerated and safe.

DeveloGen investigated the safety, tolerability and pharmacokinetic
profile of DG3173 in a double-blind, randomized, placebo-controlled,
single dose escalation Phase 1 study involving 72 healthy volunteers.
Individuals received up to 2000 µg of DG3173 via single dose
subcutaneous injection. Final results including pharmacokinetic
profiles are expected in November this year.
Dr. Cord Dohrmann, Chief Executive Officer of DeveloGen said: "We are
very pleased that we have been able to complete all planned dose
steps without reaching clinical safety or tolerability limitations.
Awaiting final data analysis, we are optimistic that this Phase 1
study will support preclinical data which indicate that DG3173 has a
significantly improved safety profile over currently marketed
somatostatin analogues." Dr. Dohrmann continued: "It is well
documented that approximately 40 to 50% of acromegalic patients
cannot be adequately controlled with currently available somatostatin
analogues. Preclinical data indicate however that DG3173 has the
potential to significantly increase the number of acromegalic
patients that can be successfully treated with this drug class. Based
on these preclinical and clinical results, we are confident that
DG3173 is well positioned to become the best-in-class somatostatin
analogue."

For further information please contact
DeveloGen AG
Dr. Cord Dohrmann,
Chief Executive Officer
Marie-Curie-Strasse 7
37079 Goettingen, Germany
Phone: +49 551 50558 650
Fax: +49 551 50558 586
email: info@develogen.com

Notes to Editors

About DG3173
DG3173 is a new chemical entity somatostatin analogue (SSA) based on
its novel amino acid composition and its unique backbone cyclization
technology used for stabilization of the peptide. During extensive
preclinical testing, DG3173 has demonstrated a unique receptor
binding and pharmacological profile which is significantly
differentiated from SSAs that are currently marketed or in clinical
development. In particular, DG3173 has demonstrated an improved side
effect profile with minimal adverse effects on the gastrointestinal
tract and metabolic control. Furthermore, assessment of growth
hormone secretion in cultured human somatotroph adenoma tissue
treated with DG3173 suggests that it has the potential to
significantly increase the response rate of acromegalic patients to
SSA therapy. These preclinical and clinical results position DG3173
as best-in-class SSA in a market that currently generates more than
US$ 1 billion in sales annually.

About DeveloGen
DeveloGen AG is a biopharmaceutical company engaged in the discovery
and development of novel therapeutics for the treatment of metabolic
and endocrine diseases. The Company has a highly innovative and deep
preclinical discovery pipeline addressing the key drivers in the
development of diabetes and obesity such as insulin resistance and
loss of insulin-producing beta cells. This pipeline includes two
programs at advanced stages of lead optimization, a small molecule
inhibitor program based on a novel and proprietary target to address
insulin resistance (type 2 diabetes) and a growth factor targeting
beta-cell regeneration (type 1 and type 2 diabetes). In addition, the
Company is developing DG3173 (Somatoprim), a potentially
best-in-class somatostatin analogue for the treatment of acromegaly
and diabetic retinopathy, which is currently in Phase 1 clinical
development. DeveloGen is based in Goettingen, Germany. For more
information on DeveloGen, please visit www.develogen.com.
Copyright © Hugin AS 2008. All rights reserved.



 
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