Enrollment of patients in a Phase I clinical trial with Graspa? in pancreatic cancer has been completed. This product contains the enzyme L-asparaginase encapsulated in red blood cells. The technology for encapsulating asparaginase was developed by Erytech Pharma.
The first results in this study demonstrated that Graspa was active, with a safety profile that was satisfactory for patients in last-line therapy. On the back of this success, the company expects to forge ahead with the clinical development of Graspa for the treatment of pancreatic cancer in so called responder patients.
Tumor growth factor
Asparagine is a tumor growth factor. Tumor cells are unable to produce their own asparagine and depend of its presence in patient?s serum. The antitumor activity of asparaginase is based on the degradation of circulating asparagine.
Acute Lymphoblastic Leukemia
Asparaginase enzyme has been used as part of an efficient treatment protocols in the treatment of patients with Acute Lymphoblastic Leukemia (ALL) which accounts for 80% of acute childhood leukemias and 20% of adult leukemias.
Toxicity and coagulation disorders
L-asparaginase is associated with high immunogenicity and great side effects such as liver toxicity and coagulation disorders. Graspa is a new enzyme formulation of L-asparaginase, with a safer and broader range of clinical uses than existing forms due to the enzyme?s entrapment and protection inside homologous red blood cells. By encapsulating L-asparaginase in red blood cells, Graspa added value relates to its ability to overcome existing limitations associated with conventional L-asparaginase via longer efficacy, better compliance, reduced doses and a better safety profile.
Particularly fragile patients
Based on the initial pre-clinical trial resilts, Yann Godfrin M.D., Erytech Pharma?s co-founder, Vice President and Chief Scientific Officer, commented ?We are delighted with these results in pancreatic cancer. Graspa showed good safety and tolerability in these particularly fragile patients, whereas other clinical studies have shown significant toxicity with forms of asparaginase. We had obtained the same results in leukemia; it is the first time in a solid tumor?.
Pancreatic cancer remains a significant medical challenge, with over 140,000 new cases reported every year in Europe and the USA. It is the ninth-ranked cause of cancer-related death in Europe.
Sensitive to L-asparaginase
Published academic studies and Erytrch’s own research on mice and on patient samples have shown that a subgroup of tumors is sensitive to the action of L-asparaginase. In order to select responders, the company is working with private-sector and academic partners with a view to fine-tuning a predictive test for the efficacy of encapsulated asparaginase. Of note is a research agreement signed with the MD Anderson Cancer Center in the US, which has identified a biomarker for the prediction of L-asparaginase on solid tumors.
Professor Thierry Andr? from the Hepatogastroenterology Department at Piti?-Salp?tri?re Medical Centre and investigator of the study, emphasized that ?asparagine depletion appears to be an attractive approach to treating this cancer. It would be especially valuable if, in future clinical studies, we could select patients likely to show a treatment response to this depletion?.
Pierre-Olivier Goineau, co-founder and chairman of the company concluded that with ?Graspa?s efficacy and tolerance profile, we are expecting to widen its scope for appropriate use – particularly in solid tumors. The overall potential market could well amount up to several million Euros in the future.?
Graspa has been granted orphan drug designation by the European Medicines Agency for the treatment of pancreatic cancer. It has also received this status in the treatment of acute lymphoblastic leukemia.
Erytech Pharma?s use of encapsulation technology opens up new cancer treatment possibilities, in which enhanced efficacy and reduced toxicity are key elements in an improved prognosis and quality of life for patients.