Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Celator Pharmaceuticals announced that CPX-351 (also known as VYXEOS) has been selected for participation in a Cardiff University-sponsored clinical trial in adult patients with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).
Subscribe to our email newsletter
"This study is designed to use a risk-based approach to treat younger patients with AML," said Professor Nigel Russell, Centre for Clinical Haematology, Nottingham University Hospital, the trial’s chief investigator.
"CPX-351 has demonstrated encouraging activity in high-risk patients. We are excited to study the product in those patients with the highest risk disease."
Some of the anticipated findings from the trial related to CPX-351:
Evaluating CPX-351 in younger patients ( < 60 years of age) in a front line setting
For poor risk patients, to compare CPX-351 versus FLAG-Ida
In patients who fail following FLAG-Ida (two courses) to evaluate a combination of CPX-351 and fludarabine
Evaluating the clinical activity of CPX-351 in patients following treatment with an immunoconjugate
Evaluating the relevance of detecting minimal residual disease using one of two methods (molecular and immunophenotypic)
Health resource utilization
Clinical trials with CPX-351 have shown improved efficacy and reduced early mortality in the majority of patients studied directly supporting evaluating CPX-351 in these patient populations.
Celator Pharmaceuticals chief medical officer Arthur Louie said: "We are pleased that Professor Russell and the trial sponsors chose to study CPX-351 in these patient populations.
"As we await overall survival data from our CPX-351 Phase 3 trial in patients with high-risk AML, we believe there is significant potential for CPX-351 in other AML populations as well as other blood cancers such as high-risk MDS, and we believe it important to continue to evaluate these opportunities."
About the AML 19 clinical trial
The trial is open to all patients aged 18 to 60 years, and also to patients aged 60 years or over for whom intensive therapy is considered appropriate. In total, across all arms of the study, approximately 3,000 patients are expected to be recruited. The clinical trial has started enrolling patients.
Patients with known adverse cytogenetics will be randomized to receive either FLAG-Ida (fludarabine/cytarabine/G-CSF and idarubicin) or CPX-351 (cytarabine:daunorubicin) liposome injection as induction.
Non-adverse cytogenetic patients will be randomized to compare two courses of FLAG-Ida with DA (daunorubicin/cytarabine) chemotherapy each in combination with one of two doses of the immunoconjugate Mylotarg® (gemtuzumab ozogamicin).
After one course of treatment, patients who are at high risk of relapse based on the AML Risk Score, or who are deemed refractory ( < 50% reduction in blast percentage, and resistant disease) will be eligible to enter a randomized study of FLAG-Ida compared to CPX-351, with the aim of allowing patients to proceed to allogeneic transplant.
Patients who are not in remission after two courses of FLAG-Ida or in relapse within 6 months after FLAG-Ida, are eligible to receive CPX-351 in combination with fludarabine, for induction and consolidation.