ERYTECH proposes to broaden lead product in solid tumors, begins Phase II study in pancreatic cancer

Jan 7 2014

ERYTECH Pharma (Euronext Paris: FR0011471135 - ERYP), a French biopharmaceutical company that develops innovative treatments for acute leukemia and other oncology indications with unmet medical needs, provides an update on its development plans to broaden the scope of its lead product ERYASP into the large field of solid tumors and announces the launch of a Phase II study in pancreatic cancer.

After having performed multiple clinical studies with promising results in acute leukemia, the research and development teams of ERYTECH have, in collaboration with researchers at the world renowned MD Anderson Cancer Center in Houston, worked intensively at confirming the mode of action and the potential of ERYASP in other cancer indications. In extensive testing on a large number of tumor samples, it was found and published in a high ranking peer reviewed journal that 50% to 90% of known solid tumors are eligible for treatment through the concept of tumor starvation by administration of asparaginase. ERYTECH has demonstrated that solid tumors such as pancreatic, liver, bladder and ovarian cancer are potentially sensitive to an asparaginase-based treatment, which represents a multi-billion market opportunity³ for the product, potentially an order of magnitude much larger than the already sizeable opportunity in acute leukemia.

The company has retained pancreatic cancer, a very aggressive form of cancer with few treatment options, as the lead indication for ERYASP in solid tumors. In Europe and the USA alone, every year about 140,000 patients are newly diagnosed with pancreas cancer. With an overall 5 year survival of 6 to 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 ERYASP has been confirmed in this very fragile patient population, ERYTECH has decided to continue the development in solid tumors by performing a Phase II study in second line pancreas cancer. In a study of about 100 patients, ERYASP in addition to the best standard of care will be compared to the best standard of care alone in a 2-to 1 randomization.

Thanks to an exclusive license from the National Institutes of Health (NIH) in the USA, ERYTECH has a proprietary companion test allowing to identify the potential responders to treatment with asparaginase, in view of offering personalized treatment.

Scientific advice has been obtained from the European Medicines Agency (EMA) and a clinical trial application (CTA) has subsequently been submitted to the ANSM, the French authority for drug safety. Professor Pascal Hammel, gastro-enterologist and oncologist at Hôpital Beaujon (Clichy-Paris, France), will be the principal investigator of the study. Patient enrollment is expected to start in Q2 2014. ERYASP already holds orphan drug designation for the treatment of pancreas cancer in Europe and the USA.

"The extensive research work performed by our teams in collaboration with leading scientists at the MD Anderson Cancer center confirms the interest of asparaginase based products in the treatment of solid tumors. Our unique formulation in red blood cells opens the perspective to offer a therapeutic alternative to a large number of these cancer patients." said Dr Yann Godfrin, CSO at ERYTECH.

"We look forward to evaluating the efficacy of the ERYASP product in patients affected by non-resectable pancreas cancer. Asparagine tumor starvation is an interesting approach to treat cancer and can contribute to enlarge our therapeutic arsenal against this terrible disease. In addition the Phase I clinical data showed a good safety profile so far." said Professor Pascal Hammel, gastro-enterologist and oncologist at Hôpital Beaujon.

Source: ERYTECH Pharma