ERYTECH Announces Publication of Positive Results from Eryaspase Phase 2 Trial in Hypersensitive ALL
in the
- The study confirms the potential of eryaspase (GRASPA®) as an attractive treatment option for acute lymphoblastic leukemia (ALL) patients with hypersensitivity to PEG-asparaginase
The Phase 2 NOR-GRASPALL-2016 trial evaluated the safety and pharmacological profile of eryaspase in ALL patients who had previously experienced hypersensitivity reactions to pegylated asparaginase therapy. The trial was conducted by the
Eryaspase demonstrated sustained asparaginase enzyme activity above the threshold of >100 U/L at trough levels 14 days after first infusion in 92.5% of patients. Eryaspase was generally well tolerated when added to chemotherapy and almost all patients were able to receive the intended courses of asparaginase (median of 5 doses per patient). Of the 55 patients, only 2 patients had severe allergic reaction and withdrew eryaspase treatment.
The Principal Investigator, Dr. Birgitte Klug Albertsen, Associate Professor at
“We are proud to be working with the NOPHO group in conducting this study in ALL, and hopeful that study results provide the possibility of an alternative treatment for ALL patients with hypersensitivity to PEG-asparaginase.” said Dr.
The paper: “Asparaginase Encapsulated in Erythrocytes as Second-line Treatment in Hypersensitive Patients with Acute Lymphoblastic Leukaemia” by
For additional information and copies of the paper, please contact Wiley at https://wolsupport.wiley.com/s/
About Acute Lymphoblastic Leukemia
Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that is the most common type of cancer in children in the US and
before age 20. Asparaginase has been an integral component of ALL treatment for several years but is associated with treatment- limiting hypersensitivity in up to 30% of patients. Discontinuation of asparaginase therapy in ALL patients has been associated with
inferior event free survival highlighting the need for additional asparaginase based treatment options.
About ERYTECH and eryaspase (GRASPA®)
ERYTECH is a clinical-stage biopharmaceutical company developing innovative red blood cell-based therapeutics for severe forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS® platform, which uses a novel technology to encapsulate drug substances inside red blood cells, ERYTECH is developing a pipeline of product candidates for patients with high unmet medical needs. ERYTECH’s primary focus is on the development of product candidates that target the altered metabolism of cancer cells by depriving them of amino acids necessary for their growth and survival.
The Company’s lead product candidate, eryaspase, which consists of L-asparaginase encapsulated inside donor-derived red blood cells, targets the cancer cells’ altered asparagine and glutamine metabolism. The proof of concept of eryaspase as a cancer metabolism agent was established in different trials in acute lymphoblastic leukemia (ALL) and pancreatic cancer. An investigator sponsored Phase 2 trial (IST) evaluating the use of eryaspase in ALL patients who developed hypersensitivity reactions to pegylated asparaginase recently reported positive results, based on which the Company intends to request approval in
Eryaspase received Fast Track designation from the
ERYTECH produces its product candidates for treatment of patients in
ERYTECH is listed on the Nasdaq Global Select Market in
For more information, please visit www.erytech.com
CONTACTS
ERYTECH CFO & COO | NewCap Investor relations Nicolas Merigeau Media relations |
+33 4 78 74 44 38 investors@erytech.com | +33 1 44 71 94 94 erytech@newcap.eu |
Forward-looking Information
This press release contains forward-looking statements including, but not limited to, statements with respect to the clinical development and regulatory plans of eryaspase including the timing of a potential BLA submission to the FDA for the treatment of acute lymphoblastic leukemia, the Company’s ability to obtain regulatory approval for the treatment of patients with acute lymphoblastic leukemia who developed hypersensitivity reactions to PEG-asparaginase, the Company’s ability to extend the indication scope of eryaspase, the Company’s ability for additional funding under the OCABSA financing agreement or other financing attempts, and the Company’s anticipated cash runway. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond ERYTECH's control. There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results and timeline may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Further description of these risks, uncertainties and other risks can be found in the Company’s regulatory filings with the French Autorité des Marchés Financiers (AMF), the Company’s
Attachment
- 220406 ERYTECH_PR_NOPHO
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