DOLTHERA broadens US patent protection for its lead candidate AVT-01 decoy ODN (PDF)

Martinsried/Munich (Germany), July 07th, 2009.

DOLTHERA GmbH, a privately held biopharmaceutical company dedicated to the development of novel therapies for chronic inflammatory diseases, today announced that the US Patent and Trademark office has granted a further patent on the company’s lead development candidate AVT-01 decoy ODN. Patent no. US 7 485 628 relates in general to oligonucleotide based inhibitors of the transcription factor STAT-1 and their medical use. This new patent broadens the protection for the company’s lead development candidate AVT-01 decoy ODN to additional indications not yet covered by the previous patent already granted in the US. DOLTHERA’s patents protecting the compound AVT-01 decoy ODN and its medical use in various indications are now granted in the USA, Europe, Australia, China, and Russia and are pending in PCT member states including Japan, Canada and India. “With the granting of US 7 485 628 our lead compound AVT-01 decoy ODN is now embraced by two independent families of patents in the US providing extended protection. The granting of this patent is an important step in obtaining global patent protection for our most advanced development candidate, and it further strengthens DOLTHERA’s leading position in the development of targeted decoy oligonucleotide based therapies.” commented Dr. Thomas Schulze, CEO of DOLTHERA.

About AVT-01 decoy ODN

AVT-01 decoy ODN is a double-stranded “decoy” oligonucleotide that effectively inhibits STAT transcription factors (including STAT-1) shown to be strongly involved in the regulation of chronic inflammation. AVT-01 decoy ODN reduced inflammation in numerous pharmacological animal models. In pilot clinical studies this drug candidate showed an excellent safety profile and had demonstrable effects on relevant endpoints.

About chronic inflammation

Chronic inflammation, which includes diseases such as asthma, psoriasis, arthritis, atherosclerosis among others, affects millions of people worldwide. A vast display of complex biological processes is triggered by multiple antigens in an inflammatory environment. In particular the activation of the patient's natural defense mechanisms presents a common underlying of the observed inflammatory complexity. Novel drugs will have to address these fundamental mechanisms. AVT-01 decoy ODN and related oligonucleotides aim at an efficacious and safer treatment enabling the long-term control of the chronic inflammatory disease condition.

About DOLTHERA

DOLTHERA is a biopharmaceutical company specialized in the development of novel nucleic acid based therapeutic treatments targeting transcription factors. Transcription factors are the master switches of gene regulation, able to turn genes on and off with exquisite sensitivity. The molecules developed at DOLTHERA are designed to specifically attenuate abnormal transcription factor signaling, thereby normalizing the underlying cause of the disease. DOLTHERA develops these decoy ODNs as therapeutic agents to treat chronic inflammation. DOLTHERA’s lead programs, AVT-01 in asthma and AVT-02 UE in inflammatory skin diseases, have been successfully advanced into Phase IIa clinical trials. In addition, there are several candidates in the pipeline based on DOLTHERA’s core decoy technology. DOLTHERA operates a lean business model with a seasoned management team experienced in clinical development.

Contact

DOLTHERA GmbH
Fraunhoferstraße 15
D-82152 Martinsried Germany

Dr. Thomas Schulze
Phone: +49 (0) 89 8565 - 1600
Fax: +49 (0) 89 8565 - 1620
E-Mail: t.schulze@DOLTHERA.de

October 10th, 2008
DOLTHERA announces the results of a successful proof of concept within a phase 2a study with its drug candidate AVT-02 UE ointment after topical treatment in patients with mild-to-moderate psoriasis (PDF)

September 25th, 2008
DOLTHERA Receives Research Grant from the Federal Ministry of Education and Research (BMBF) (PDF)

June 18th, 2008
DOLTHERA announces results of a multiple dose clinical phase I study with its drug candidate AVT-02 UE ointment after topical treatment in male healthy volunteers (PDF)

February 28th, 2008
DOLTHERA announce results of a multiple dose clinical proof of concept study with its drug candidate AVT-01 decoy ODN in asthmatic patients (PDF)

January 31th, 2008
DOLTHERA obtains US patent on its drug candidate AVT-01 decoy ODN (PDF)

October 5th, 2007
DOLTHERA’s drug candidate AVT-02 UE for the treatment of inflammatory skin diseases has entered a multiple dosing Phase I study (PDF)

October 1st, 2007
Changes in the Supervisory Board of DOLTHERA GmbH:
Former President and CEO of the GSF and also former Chairman
and CEO of the Pharmaceuticals Division of the Hoechst AG group
elected Chairman of DOLTHERA’s Supervisory Board (PDF)

September 2007
Dr. Helga Grupe appointed Chief Business Officer and Managing Director of DOLTHERA GmbH
(PDF)

January 2007
DOLTHERA and Activaero announce Collaboration Agreement on inhaled Treatment of Severe Asthma
- Gemünden and Martinsried, Germany (January 24, 2007) –
(PDF)