AmpliMed compound receives new orphan designation

Amplimexon is also currently in phase I/II clinical trials evaluating safety and efficacy in a number of cancers, including pancreatic, lung, breast, prostate, and multiple myeloma.

The drug was first shown to have activity in limited studies in lung cancer, melanoma and breast cancer that were documented in publications in the 1980s. However, the potential of the drug as a cancer drug was not fully explored until 1994, when AmpliMed initiated a program to decipher Amplimexon’s novel mechanism of action.

This led to the initiation in 2003 of an ongoing phase I clinical study of the drug as a stand-alone therapy in late-stage cancer patients. Further preclinical research revealed that the combined use of Amplimexon and certain other chemotherapeutics resulted in a significant increase in efficacy compared to either drug alone.

These findings are now being translated into a series of phase I/II clinical studies of combination therapy in patients with various types of cancer.

European orphan drug designation allows for EU market exclusivity for up to ten years in the given indication, as well as a reduction in fees associated with various aspects of the regulatory process.

“Amplimexon has now been granted two orphan designations in Europe, for the treatment of ovarian and pancreatic cancer, and four designations in the US, for the treatment of melanoma, multiple myeloma, pancreatic and ovarian cancer,” noted Robert Ashley, CEO of AmpliMed Corporation.