The European Medicines Agency recommends Orphan Drug Designation of Intravenous CP-4126 for the Treatment of Pancreatic Cancer

15-Sep-2009 - Norway

Clavis Pharma announced that the European Medicines Agency (EMEA) has recommended Orphan Drug Designation to Intravenous CP-4126 for the treatment of pancreatic cancer. Clavis Pharma is currently conducting a Phase II study with Intravenous CP-4126 in patients with pancreatic cancer.

"We are pleased that EMEA has recommended our application for orphan drug designation for Intravenous CP-4126, and we are looking forward to receiving the final designation from the European Commission in a few weeks," said Geir-Christian Melen, CEO of Clavis Pharma. "Patients with pancreatic cancer need more effective therapies as current treatment options are unsatisfactory. This designation will allow Clavis Pharma to accelerate the clinical development of Intravenous CP-4126 and is an important milestone in the company's strategy to achieve marketing approval for this exciting drug candidate as rapidly as possible."

The Company plans to apply 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.

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 membrane(1). 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/106271/the-european-medicines-agency-recommends-orphan-drug-designation-of-intravenous-cp-4126-for-the-treatment-of-pancreatic-cancer.html