Serendex Pharmaceuticals A/S (OSE: SENDEX) has received approval from the Japanese authorities (PMDA) to initiate a phase II/III clinical trial of inhaled molgramostim (Molgradex®) for patients with pulmomary alveolar proteinosis (PAP).

The Japanese authorities (PMDA) has approved Serendex's application to start a pivotal phase II/III clinical trial for PAP in Japan. The trial which is named IMPALA will also be carried out in multiple sites in Europe, Israel and Russia. The trial has already been fully approved in Denmark and the Netherlands.

Together with a Japanese clinical research organization (CRO), Serendex is now preparing to submit IMPALA clinical trial applications to four Institutional Review Boards (IRBs) (regional ethics committees) in Japan and expects to be able to initiate investigator sites in May 2016 upon approval from the IRBs.

'We are well prepared to include the first patients in the IMPALA trial in Japan by the end of May 2016 or as soon as we have IRB approval. We hope the trial will demonstrate positive results that will pave the road for a marketing approval of Molgradex® in Japan in 2019', says Kim Arvid Nielsen, Serendex CEO.

The IMPALA trial will recruit at least 10 patients in Japan at specialised pulmonary centers in four different hospitals. All sites are part of the Japanese PAP research network, one of the world's leading groups within the field of PAP basic research and clinical management.

The recruited patients will be dosed with Molgradex®, Serendex's proprietary nebulised formulation of recombinant human GM-CSF and lead candidate drug, or placebo. Primary aim of the IMPALA trial is to confirm the efficacy and safety of Molgradex® in PAP patients.

The IMPALA trial is a randomised, double-blind, placebo-controlled multicentre study lead by Coordinating Principal Investigator Dr. Cliff Morgan from the Royal Brompton Hospital in London, United Kingdom.

Serendex is currently also developing Molgradex® for the treatment of ARDS (acute respiratory distress syndrome) in a phase IIb clinical trial in Germany.

For download 19 February 2016 Serendex pivotal clinical trial for PAP approved in Japan

For further information, please contact:

Nadia Vega Vasiljev
Head of Communication and IR
Mobile +45 2014 9615
E-mail: nvv@serendex.com

Kim Arvid Nielsen
CEO
Mobile +45 2143 1017
E-mail: kan@serendex.com

About Serendex Pharmaceuticals A/S

Serendex Pharmaceuticals develops drugs to treat severe respiratory conditions such as PAP (pulmonary alveolar proteinosis) and ARDS (acute respiratory distress syndrome). These conditions are acute or chronic and have no existing medical treatment. All Serendex drugs are inhaled or induced to the lungs of the patient. This improves the risk/efficacy ratio of the drug and treatment. Serendex has obtained orphan drug designation (ODD) for several indications in both Europe and USA. The company's sole business focus is drug repositioning, i.e. finding new indications and administration routes for existing drugs. Serendex Pharmaceuticals is listed on Oslo Axess. Please visitwww.serendex.com to learn more.

Serendex Pharmaceuticals A/S issued this content on 19 February 2016 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 19 February 2016 08:20:24 UTC

Original Document: http://www.serendex.com/serendex-pivotal-clinical-trial-for-pap-approved-in-japan/