The European Commission grants Orphan Drug Designation for Intravenous CP-4126 for the Treatment of Pancreatic Cancer

03-Nov-2009 - Norway

Clavis Pharma ASA announced that the European Commission has granted Orphan Drug Designation (Orphan Medicinal Product) for Intravenous CP-4126 for the treatment of pancreatic cancer. The designation follows the recommendation given by the European Medicines Agency (EMEA) in September this year.

The Company has applied for Orphan Drug status for Intravenous CP-4126 in the USA as a potential new treatment for pancreatic cancer following the acceptance by the US Food and Drug Administration (FDA) in July of its Investigational New Drug (IND) to include patients in the USA in its phase II clinical programme, and a decision is expected early next year.

Intravenous CP-4126 is based on Clavis Pharma's proprietary Lipid Vector Technology (LVT) and aimed at improving the therapeutic profile of the current standard treatment for advanced pancreatic cancer, gemcitabine (Gemzar®). Currently it is estimated that pancreatic tumours in up to two-thirds of patients have a deficient cellular uptake of gemcitabine due to deficient expression of a necessary transport protein, hENT1 (human equilibrative nucleoside transporter 1) on the tumour cell membrane1. This is known to limit the efficacy of gemcitabine treatment in these patients. In contrast, cellular uptake of Intravenous CP-4126 is independent of hENT1, which offers a potential clinical advantage for the product in the treatment of pancreatic cancer. In the phase II programme, cancer tissue (biopsies) from each patient will be collected and analysed with regard to levels of hENT1. The relation between response to treatment and hENT1 levels will be studied.

https://www.bionity.com/en/news/108826/the-european-commission-grants-orphan-drug-designation-for-intravenous-cp-4126-for-the-treatment-of-pancreatic-cancer.html