ERYTECH Pharma (Paris:ERYP) (Euronext Paris: FR0011471135 - ERYP), a French biopharmaceutical company that develops innovative treatments for acute leukemia and other oncology indications with unmet medical needs, announces that the ANSM, French healthcare agency, has granted the authorization to start a Phase II study in second line treatment of patients affected by pancreatic cancer.
As part of its strategy to broaden the scope of it lead product ERY-ASP, ERYTECH has retained pancreatic cancer, a very aggressive form of cancer with few treatment options, as the first indication for the product in solid tumors. In Europe and the USA alone, every year about 125,000 patients are newly diagnosed with pancreatic cancer. With an overall 5 year survival of less than 10%, pancreas cancer is one of the most aggressive forms of cancer.
Having already successfully completed a Phase I study in late stage pancreas cancer, in which the tolerability of ERY-ASP has been confirmed in this very fragile patient population, ERYTECH decided to continue the development in solid tumors by performing a Phase II study in second-line therapy for patients with progressive metastatic pancreas cancer.
Scientific advice had been obtained at then end of last year from the European Medicines Agency (EMA) and a clinical trial application (CTA) was subsequently submitted to the ANSM (Agence Nationale de Sécurité du Médicament, the French healthcare agency), who now gave its green light for the study.
In a study of about 100 patients, ERY-ASP in addition to the best standard of care will be compared to the best standard of care alone in a 2 to 1 randomization. The primary endpoint will be progression free survival (PFS) at 4 months. Patients will be stratified according to the expression of asparaginase synthetase (ASNS) of their primary tumor. Low expression of ASNS is believed to be an indicator of tumor sensitivity to asparaginase. ERYTECH estimates that around 70% of patients are low on ASNS and could be responders to the treatment. Patient enrollment is expected to start in Q2 2014.
Professor Pascal Hammel, gastroenterologist specialized in digestive oncology at Hôpital Beaujon (Clichy-Paris, France), is the principal investigator of the study. He comments: "We observe an increasing number of pancreas cancer patients eligible to a second-line therapy, where we have an important medical need. Tumor starvation is an interesting approach and with the anticipated limited toxicity profile thanks to the encapsulation in red blood cells, we are hopeful ERY-ASP can contribute to enlarge our therapeutic arsenal for these patients."
"The approval of this new study is an important step for ERYTECH, fully along the lines of the strategy outlined in our IPO to broaden the scope of our technology platform to solid tumor indications. With our unique formulation in red blood cells we hope be able to contribute to extending the toolbox in treating patients affected by this terrible disease" adds Gil Beyen, Chairman & CEO of ERYTECH.