Jazz Pharmaceuticals Advances Recombinant Crisantaspase Development Program
"Jazz is committed to the ALL patient community, and we are pleased to advance this development program with the goal of bringing a new treatment option to ALL and LBL patients who are hypersensitive to E. coli-derived asparaginase products as soon as possible," said
A recombinant crisantaspase Phase 1 study in healthy volunteers in the U.S. met safety and efficacy objectives with efficacy based on measurement of serum asparaginase activity levels. Results of this Phase 1 study will be submitted for presentation at an upcoming medical meeting.
JZP-458 is a recombinant crisantaspase that uses a novel Pseudomonas fluorescens expression platform. It is being developed for use as a component of a multi-agent chemotherapeutic regimen in the treatment of pediatric and adult patients with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) who are hypersensitive to E. coli-derived asparaginase products. A Phase 1 study of healthy volunteers was recently completed, and a single-arm, pivotal Phase 2/3 study is planned for initiation later in 2019.
About Acute Lymphoblastic Leukemia (ALL)
Acute Lymphoblastic Leukemia (ALL) is a cancer of the blood and bone marrow that can progress quickly if not treated.1 Leukemia is the most common cancer in children, and about three out of four of these cases are ALL.2 Adults can also develop ALL, and about four of every 10 cases of ALL diagnosed are in adults.3
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to the company's plans regarding its recombinant crisantaspase development program, including plans to initiate a single-arm, pivotal Phase 2/3 study later this year evaluating JZP-458 as a potential treatment option for patients with ALL or LBL who have hypersensitivity to E. coli-derived asparaginase products, the company's goal to bring a new treatment option to such ALL and LBL patients as soon as possible, and other statements that are not historical facts. These forward-looking statements are based on the company's current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: pharmaceutical product development and clinical success thereof, including risks related to failure or delays in completing clinical trials; the regulatory approval process; and other risks and uncertainties affecting the company and its development programs, including those described from time to time under the caption "Risk Factors" and elsewhere in
1 National Cancer Institute. Adult Acute Lymphoblastic Leukemia Treatment (PDQ®)–Patient Version. Available at www.cancer.gov/types/leukemia/patient/adult-all-treatment-pdq. Accessed
2 American Cancer Society. Key Statistics for Childhood Leukemia. Available at www.cancer.org/cancer/leukemia-in-children/about/key-statistics.html. Accessed
3 American Cancer Society. Key Statistics for Acute Lymphocytic Leukemia (ALL). Available at www.cancer.org/cancer/acute-lymphocytic-leukemia/about/key-statistics.html. Accessed August 6, 2019.
4 American Cancer Society. Key Statistics for Acute Lymphocytic Leukemia (ALL). Available at: www.cancer.org/cancer/acute-lymphocytic-leukemia/about/key-statistics.html. Accessed
5 Salzer W, Bostrom B, Messinger Y et al. 2018. Asparaginase activity levels and monitoring in patients with acute lymphoblastic leukemia. Leukemia & Lymphoma. 59:8, 1797-1806, DOI: 10.1080/10428194.2017.1386305.
6 Hijiya N, van der Sluis IM. Asparaginase-associated toxicity in children with acute lymphoblastic leukemia. Leuk Lymphoma. 2016;57(4):748–757. doi:10.3109/10428194.2015.1101098
View original content to download multimedia:http://www.prnewswire.com/news-releases/jazz-pharmaceuticals-advances-recombinant-crisantaspase-development-program-300897313.html
Investors: Kathee Littrell, Vice President, Investor Relations, Jazz Pharmaceuticals plc, Ireland, +353 1 634 7887, U.S., +1 650 496 2717; Media: Jacqueline Kirby, Vice President, Corporate Affairs & Government Relations, Jazz Pharmaceuticals plc, Ireland, +353 1 697 2141, U.S., +1 215 867 4910