Regulatory News:
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.
About pancreas cancer:
Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. Every year about 45,000 patients are diagnosed with pancreatic cancer in the US, and about 80,000 in Europe. According to the American Cancer Society, for all stages of pancreatic cancer combined, the one-year relative survival rate is 20%, and the five-year rate is 6% to 10%. Pancreatic cancer is currently the fourth most common cause of cancer death in the EU for men and women. Death rates from the disease are predicted to rise from 7.8 in 2009 to 8.0 in 2013 per 100,000 among men, and from 5.3 to 5.5 per 100,000 among women in same period. In fact, the pancreas is the only major cancer site for which no improvements in mortality rates is predicated1.
About ERYTECH and ERY-ASP/GRASPA®: www.erytech.com
ERYTECH is a French biopharmaceutical company providing new prospects for cancer patients, particularly those with acute leukemia and selected solid tumors. The company is also developing other indications in solid tumors and certain orphan indications outside oncology.
ERYTECH is listed on Euronext regulated market in Paris. (ISIN code: FR0011471135, ticker: ERYP) and is part of the CAC All Shares, CAC Healthcare, CAC Pharma & Bio, CAC Small, CAC Mid&Small, CAC All Tradable and Next Biotech indexes. ERYTECH shares are eligible to PEA-PME (French share savings plan for SMEs).
For more information about the Company, please read About ERYTECH and ERY-ASP/GRASPA
Forward-looking information
This document may contain forward-looking statements, forecasts and estimates (“Statements”) with respect to the financial situation, the results of operations, the strategy, the project and to the anticipated future performance of ERYTECH Pharma. Documents filed by ERYTECH Pharma with the French Autorité des Marchés Financiers (www.amf-france.org), also available on our website (www.erytech.com) describe such risks and uncertainties for which ERYTECH Pharma makes no representations or warranty as to their accuracy or fairness. Furthermore, such Statements only speak as of the date of the publication of this document. ERYTECH disclaims any obligation to update any such Statements except to the extent required by French law.
For more information about Forward-looking information, please read Forward-looking information
1 Malvezzi M et al., Annals of Oncology 2013, 1-9
