Products

Immunservice's most advanced drug candidate is Pulmoleukin, a natural biomimetic interleukin-2 drug. Its inhalational use prevents patients with progressive lung tumors from suffocating. The Committee for Orphan Medicinal Products of EMEA (21. January 2008) describes the stage of development in the public summary of positive opinion for orphan designation for inhalational use in renal cell carcinoma as follows: 1. clinical trials in patients with renal cell carcinoma were completed and 2. effects were evaluated in experimental models. Presently Immunservice's GmbH is preparing for market authorization of Pulmoleukin in Europe. Development of Pulmoleukin is protected by strong international patents exclusively owned by Immunservice GmbH. Immunservice GmbH has receiveds significant grants from the Hamburg Foundation for Innovation (Innovationsstiftung Hamburg) for scientific developments of our lead product.

Lead Product

In 2006 the European Approval Authorities (EMEA) granted an Orphan Drug Designation for Pulmoleukin (inhalation use in renal cell carcinoma) confirming EMEA's opinion of a potential for a significant clinical benefit through Pulmoleukin. Pulmoleukin was developed for inhalation use in patients with pulmonary metastatic renal cell cancer, who are in high unmet medical need.

Clinical Trials

Phase I and II studies using inhaled human interleukin-2 showed excellent safety as well as effective local lung tumor control to prevent suffocation. Insome patients it- even induced complete tumor remissions in the lung, which may result in final cure. Of particular importance is the fact, that patients on therapy can lead a nearly normal life. They are able to perform their job and their role in society, a unique feature of our therapy and most important to patients with a limited prognosis.

Orphan Medicinal Products

Pulmoleukin is an orphan medicinal drug product. Orphan designation medicinal products have significant advantages from fee reductions, and upon market authorization they receive market exclusivity for 10-12 years. Since 2006 European regulations make orphan medicinal products typical candidates for conditional approval, which is granted on the basis of a positive risk benefit ratio even before comprehensive clinical data are available. This reduces the time to market and assures rapid access to therapy for patients in high need.