Advancell Demonstrates Efficacy of its Leukemia Drug Acadra in Patients
In a Phase I/II clinical trial conducted in European hospitals, the drug reduced tumors by up to 75% in patients with chronic lymphocytic leukemia that are resistant to current treatments.
BY BIOCAT
The biopharmaceutical company Advancell, headquartered at the Barcelona Science Park (PCB), has announced positive results for a Phase I/II clinical trial of their drug Acadra (Acadesine) in several patients with chronic lymphocytic leukemia that are resistant to current treatments.
In the trial, held at several Belgian, French and Spanish hospitals, including the Institut Català d'Oncologia (ICO), the Hospital Clínico Universitario de Valencia (HCUV) and the Hospital Universitario Madrid Sanchinarro, patients treated with Acadra exhibited decreases of up to 50% in their number of leukemic cells. Patients that were suffering from compromised lymph nodes at the onset of the study showed reductions of up to 75% after five doses.
An independent panel of experts has affirmed that the study sufficiently demonstrates the efficacy of Acadra to justify continuing its development and that, given the observed safety profile, the new drug shows major potential for treating leukemia in combination with existing treatments.
Chronic lymphocytic leukemia (CLL) is a blood cancer caused by an excess of B cells (a type of white blood cell). It is the most common chronic leukemia in Western developed countries, affecting over 15,000 people in Spain (1,800 new cases are diagnosed annually).
According to sources at Advancell, Acadra® differs from existing drugs because it can remove B cells without destroying T cells. According to Dr. Clara Campàs, Advancell’s vice president in charge of clinical programs, "This drug employs a new mechanism of action offering three major advantages over existing treatments: efficacy in patients resistant to other drugs, selectivity for leukemic cells, and a safety profile that should guarantee quality of life for patients receiving chemotherapy.”
In addition to its clinical efficacy for this indication, Acadra has also proven effective in animal models of multiple myeloma (a type of bone marrow cancer) and of mantle cell lymphoma (MCL; cancer of the lymphatic system).
"With this project, Advancell reaffirms its business model of developing new drugs up to clinical proof of concept (Phase II). We are now in the process of licensing Acadra® out to a pharmaceutical partner that can finish its development and launch it to market," said Advancell CEO Kenneth Weissmahr.
Potential sales of the new drug have been estimated at €500 million annually.
A case of successful knowledge transfer
Acadra is the first drug originating from a Spanish public university to reach clinical trials. It was developed during the doctoral thesis work of Dr. Clara Campàs, at the Faculty of Pharmacy of the University of Barcelona (UB). Campàs discovered the molecule Acadesine for the treatment of leukemia and lymphoma. In 2003 UB patented the drug through its Patent Center. Dr. Campàs, in addition to having performed the research, was also co-author of the patent.
In 2004, the Bosch i Gimpera Foundation (FBG) negotiated transfer of the rights to development and exploitation of Advancell, receiving financial support from the Ministry of Science and Innovation, through its program CDTI, and from the Catalan Government. In 2005 the European Union granted Acadra Orphan Drug Status, a designation given to drugs intended to prevent, diagnose or treat rare diseases.