|Actinium Initiates cGMP Manufacturing of Iomab-B for Phase 3 Clinical Trial; Celator® Announces Publication Phase 2 Data For CPX-351|
|By Josh Gee|
|Monday, 12 January 2015 20:42|
Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM), a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced it has initiated manufacturing of the Phase 3 clinical lot of BC8, a novel murine monoclonal antibody, which is conjugated with iodine-131 radioisotope to form Iomab-B. The cGMP manufacturing process has been successfully completed, including technology transfer, the qualification and validation of methods, and scale-up to commercial scale. Data on the performance of this manufacturing lot will be included in an Investigational New Drug (IND) application for Iomab-B which is anticipated to be filed with the U.S. Food and Drug Administration. Iomab-B, a radiolabeled antibody, is being developed as a part of bone marrow transplant regimen initially in relapsed and refractory acute myeloid leukemia (AML) patients ages 55 and older.
Kaushik J. Dave, Ph.D., President and CEO of Actinium stated, "We are very pleased to have achieved this critical milestone that supports not only the filing of our IND but also the subsequent commencement of our Phase 3 trial, and ultimately the commercialization of the product. Based on the strong Phase 2 data which demonstrated significant survival and safety benefits when compared to conventional therapy, we remain committed to bringing this potentially lifesaving therapy to market, subject to the successful completion of the Phase 3 trial and FDA approval. We believe Iomab-B addresses a significant unmet need for thousands of elderly AML patients who cannot tolerate current myeloablative conditioning regimens and therefore are unable to receive a potentially curative bone marrow transplant, limiting their life expectancy to only a few months."
About AML -- Acute myeloid leukemia (AML) is an aggressive cancer of the blood and bone marrow. It is characterized by an uncontrolled proliferation of immature blast cells in the bone marrow. The American Cancer Society estimates there will be approximately 18,860 new cases of AML and approximately 10,460 deaths from AML in the U.S. in 2014. Patients over age 60 comprise the majority of those diagnosed with AML, with a median age of diagnosis of about 67 years. Treatment approaches in this population are limited because a majority of these individuals are judged too frail and unable to tolerate standard induction chemotherapy or as having disease generally unresponsive to currently available drugs. Elderly, high risk patients ordinarily have a life expectancy of 5 or fewer months if treated with standard chemotherapy, which only about a third of them do because of toxicity. The other two-thirds receive best supportive care, with 2 months survival, according to Oran and Weisdorf (Haematologica 2012; 1916-24).
About Iomab-B -- Iomab-B will be used in preparing patients for hematopoietic stem cell transplantation (HSCT), the fastest growing hospital procedure in the U.S. The Company established an agreement with the FDA that the path to a Biologics License Application (BLA) submission could include a single, pivotal Phase 3 clinical study if it is successful. The trial population in this two arm, randomized, controlled, multicenter trial will be refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55. The trial size was set at 150 patients with 75 patients per arm. The primary endpoint in the pivotal Phase 3 trial is durable complete remission, defined as a complete remission lasting at least 6 months and the secondary endpoint will be overall survival at one year. There are currently no effective treatments approved by the FDA for AML in this patient population and there is no defined standard of care. Iomab-B has completed several physician sponsored clinical trials examining its potential as a conditioning regimen prior to HSCT in various blood cancers including the Phase 1/2 study in relapsed and/or refractory AML patients. The results of these studies in over 300 patients have demonstrated the potential of Iomab-B to create a new treatment paradigm for bone marrow transplants by: expanding the pool to ineligible patients who do not have any viable treatment options currently; enabling a shorter and safer preparatory interval for HSCT; reducing post-transplant complications; and showing a clear survival benefit including curative potential.
Iomab-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. BC8 has been developed by Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues.
Celator Pharmaceuticals, Inc. (NASDAQ: CPXX), a biopharmaceutical company that is transforming the science of combination therapy and developing products to improve patient outcomes in cancer, today announced the publication of Phase 2 data evaluating CPX-351 in adult patients with first-relapse acute myeloid leukemia (AML) in Cancer, a peer-reviewed journal of the American Cancer Society. The study manuscript entitled, "Phase 2, Multicenter, Randomized Trial of CPX-351 (cytarabine:daunorubicin) Liposome Injection Versus Intensive Salvage Therapy in Adults With First Relapse AML," appears in the January 15, 2015 issue.
The published data suggest a clinical benefit from CPX-351 in first relapse AML patients and demonstrate a clear clinical benefit in those with poor-risk disease as defined by the European Prognostic Index (EPI). Along with the previously published results from the Phase 2 study of CPX-351 in newly diagnosed patients with AML, these data support Celator's Phase 3 study of CPX-351 as a first-line therapy in older patients with high-risk (secondary) AML. Our Phase 3 study, which is being conducted in partnership with The Leukemia & Lymphoma Society® recently completed enrollment.
"Patients with first relapse AML have generally a poor prognosis, with a limited likelihood of response following salvage treatment. This is particularly true for patients classified by the EPI as poor-risk upon entering the trial," said Jorge Cortes, M.D., Lead Investigator and Deputy Chair of the Department of Leukemia at The MD Anderson Cancer Center. "We were very pleased to see promising response rates in this difficult-to-treat population, and we eagerly await results from Celator's pivotal Phase 3 study of CPX-351, which could fulfill a considerable unmet need in AML."
The randomized, controlled Phase 2 study enrolled 125 patients, aged 18-65, from 35 centers in the U.S., Canada, and Europe diagnosed with AML in first relapse after an initial complete remission lasting for one month or longer. Patients were randomized 2:1 to receive CPX-351 (100 u/m2; days 1, 3, and 5 by 90-minute infusion) or investigators' choice of first salvage chemotherapy. Control salvage treatment was usually based on cytarabine and an anthracycline, often with one or more additional agents. The primary endpoint for the study was survival at one year post treatment.
Patients were stratified per the EPI into favorable, intermediate, and poor-risk groups based on duration of first complete remission, cytogenetics, age, and transplant history, and were well-balanced between the control and the treatment arms. Results showed improved efficacy following CPX-351 and the protocol-defined EPI-poor-risk subset demonstrated statistically significant improvement in overall survival (HR, 0.55; P=0.02), improvement in event-free survival (HR, 0.63; P=0.08) and higher response rate (39.3% vs 27.6%). Additionally, 60-day mortality was lower in the CPX-351 study arm for poor-risk patients (16.1% vs 24.1%).
Treatment with CPX-351 was associated with well-characterized and manageable adverse events. Compared to the control arm, CPX-351 was associated with more frequent hematologic adverse events.
"The insights from this Phase 2 study were very relevant as we designed our Phase 3 pivotal study in older patients with secondary AML, from which initial results, induction response rate, are expected in the second quarter of 2015," commented Arthur C. Louie, Chief Medical Officer of Celator Pharmaceuticals. "There is a clear need for a therapy with better response rates and lower early mortality than what current first-line and salvage therapies provide, and we hope to be able to offer this with CPX-351."
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